Compounds > dabigatran
Page last updated: 2024-11-08

dabigatran

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Description

Dabigatran: A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

dabigatran : An aromatic amide obtained by formal condensation of the carboxy group of 2-{[(4-carbamimidoylphenyl)amino]methyl}-1-methyl-1H-benzimidazole-5-carboxylic acid with the secondary amoino group of N-pyridin-2-yl-beta-alanine. The active metabolite of the prodrug dabigatran etexilate, it acts as an anticoagulant which is used for the prevention of stroke and systemic embolism. [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 CID216210
CHEMBL ID48361
CHEBI ID70752
SCHEMBL ID3573
MeSH IDM0553211

Synonyms (90)

Synonym
n-[(2-{[(4-carbamimidoylphenyl)amino]methyl}-1-methyl-1h-benzimidazol-5-yl)carbonyl]-n-pyridin-2-yl-beta-alanine
AB01274802-01
dabigatran
bibr-953
bibr-953zw
bibr 953 zw
chebi:70752 ,
bibr-953-zw
pradaxa (dabigatran)
CHEMBL48361 ,
3-({2-[(4-carbamimidoyl-phenylamino)-methyl]-1-methyl-1h-benzoimidazole-5-carbonyl}-pyridin-2-yl-amino)-propionic acid
bdbm50112086
AKOS005266720
3-[[2-[(4-carbamimidoylanilino)methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoic acid
n-((2-(((4-(aminoiminomethyl)phenyl)amino)methyl)-1-methyl-1h-benzimidazol-5-yl)carbonyl)-n-2-pyridinyl-beta-alanine
D09707
dabigatran (usan/inn)
3-[[2-[[(4-carbamimidoylphenyl)amino]methyl]-1-methyl-benzimidazol-5-yl]carbonyl-pyridin-2-yl-amino]propanoic acid
A815190
3-[[[2-[(4-carbamimidoylanilino)methyl]-1-methyl-5-benzimidazolyl]-oxomethyl]-(2-pyridinyl)amino]propanoic acid
bibr 953 (dabigatran, pradaxa)
211914-51-1
BIBR 953 - DABIGATRAN - PRADAXA
bibr953
i0vm4m70gc ,
n-((2-((p-amidinoanilino)methyl)-1-methyl-5-benzimidazolyl)carbonyl)-n-2-pyridyl-beta-alanine
hsdb 8062
dabigatran [usan:inn:ban]
unii-i0vm4m70gc
beta-alanine, n-((2-(((4-(aminoiminomethyl)phenyl)amino)methyl)-1-methyl-1h-benzimidazol-5-yl)carbonyl)-n-2-pyridinyl-
bibr 953
3-(((2-(((4-carbamimidoylphenyl)amino)methyl)-1-methyl-1h-benzimidazol-5-yl)carbonyl)(pyridin-2-yl)amino)propanoic acid
CS-1399
bibr 953,dabigatran, pradaxa
FT-0648482
NCGC00346575-01
PB38204
3-[[2-[[(4-carbamimidoylphenyl)amino]methyl]-1-methyl-benzoimidazole-5-carbonyl]-pyridin-2-yl-amino]propanoic acid
dabigatran [inn]
3-{[(2-{[(4-carbamimidoylphenyl)amino]methyl}-1-methyl-1h-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propanoic acid
dabigatran [usan]
dabigatran [mi]
dabigatran [who-dd]
dabigatran [mart.]
dabigatran [vandf]
n-((2-((p-amidinoanilino)methyl)-1-methyl-5-benzimidazolyl)carbonyl)-n-2-pyridyl-.beta.-alanine
.beta.-alanine, n-((2-(((4-(aminoiminomethyl)phenyl)amino)methyl)-1-methyl-1h-benzimidazol-5-yl)carbonyl)-n-2-pyridinyl-
EPITOPE ID:186729
S2196
gtpl6380
3-[[2-[[(4-carbamimidoylphenyl)amino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoic acid
HY-10163
1-methyl-2-[(4-amidinophenyl)aminomethyl]benzimidazol-5-yl-carboxylic acid-n-(2-pyridyl)-n-(2-hydroxycarbonylethyl)amide
1-methyl-2-[n-(4-amidinophenyl)aminomethyl]benzimidazol-5-yl-carboxylic acid-n-(2-pyridyl)-n-(2-hydroxycarbonylethyl)amide
1-methyl-2-[n-(4-amidinophenyl)-aminomethyl]-benzimidazol-5-yl-carboxylic acid-n-(2-pyridyl)-n-(2-hydroxycarbonylethyl)-amide
YBSJFWOBGCMAKL-UHFFFAOYSA-N
beta-alanine, n-[[2-[[[4-(aminoiminomethyl)phenyl]amino]methyl]-1-methyl-1h-benzimidazol-5-yl]carbonyl]-n-2-pyridinyl-
AM81238
SCHEMBL3573
Q-102529
AC-25299
AB01274802_02
DTXSID50175419 ,
STL450902
C21556
3-(2-(((4-carbamimidoylphenyl)amino)methyl)-1-methyl-n-(pyridin-2-yl)-1h-benzo[d]imidazole-5-carboxamido)propanoic acid
bibr 953zw
mfcd09837830
NCGC00346575-06
3-[1-(2-{[(4-carbamimidoylphenyl)amino]methyl}-1-methyl-1h-1,3-benzodiazol-5-yl)-n-(pyridin-2-yl)formamido]propanoic acid
bibr 953(dabigatran)
FT-0665441
BCP06664
Q419345
bibr 953 (dabigatran etexilate, pradaxa)
DB14726
AS-11488
b-alanine,n-[[2-[[[4-(aminoiminomethyl)phenyl]amino]methyl]-1-methyl-1h-benzimidazol-5-yl]carbonyl]-n-2-pyridinyl-
SB20292
2,6-bis[(r)-4-phenyloxazolin-2-yl]pyridine
3-(2-(((4-carbamimidoylphenyl)amino)methyl)-1-methyl-n-(pyridin-2-yl)-1h-benzo[d]imidazole-5-carboxamido)propanoicacid
bibr 953; bibr 953zw; dabigatran; n-[[2-[[[4-(aminoiminomethyl)phenyl]amino]methyl]-1-methyl-1h-benzimidazol-5-yl]carbonyl]-n-2-pyridinyl-beta-alanine; n-[[2-[[[4-(aminoiminomethyl)phenyl]amino]methyl]-1-methyl-1h-benzimidazol-5-yl]carbonyl]-n-2-pyridinyl
EN300-7418742
D5902
dabigatran (mart.)
beta-alanine, n-((2-(((4-(aminoiminomethyl)phenyl)amino)methyl)-1- methyl-1h-benzimidazol-5-yl)carbonyl)-n-2-pyridinyl-
dtxcid4097910
3-[2-[[(4-carbamimidoylphenyl)amino]methyl]-1-methyl-n-(2-pyridyl)benzimidazole-5-carboxamido]propanoic acid
SY030371
Z2681891234

Research Excerpts

Overview

Dabigatran is a direct thrombin inhibitor approved for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF) It is an anticoagulant with potential use during cardiopulmonary bypass in children and adults.

ExcerptReferenceRelevance
"Dabigatran is a novel oral anticoagulant that directly inhibits free and fibrin-bound thrombins and exerts rapid and predictable anticoagulant effects. "( Dabigatran Etexilate Induces Cytotoxicity in Rat Gastric Epithelial Cell Line via Mitochondrial Reactive Oxygen Species Production.
Kurokawa, H; Matsui, H; Shigekawa, H; Taninaka, A, 2021)		3.51
"Dabigatran is a direct thrombin inhibitor approved for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). "( Patient perception and treatment convenience of dabigatran versus vitamin K antagonist when used for stroke prophylaxis in atrial fibrillation: Real-world Evaluation of Long-term Anticoagulant Treatment Experience (RE-LATE) study.
Chern, AKC; Choi, EK; Chutinet, A; Hanafy, DA; Jiampo, P; Lee, YS; Oh, YS; Trivedi, P; Zhai, D, 2021)		2.32
"Dabigatran is an anticoagulant with potential use during cardiopulmonary bypass in children and adults. "( Delayed concentration effect models for dabigatran anticoagulation.
Anderson, BJ; Eaton, MP; LeMoine, D; Nadtochiy, SM; Stefanos, T, 2022)		2.43
"Dabigatran is a direct thrombin inhibitor used to treat cardiac arrhythmias, and rates of non-adherence to dabigatran in Polish populations are high. "( Evaluation of a pharmacist-led intervention to improve medication adherence in patients initiating dabigatran treatment: a comparison with standard pharmacy practice in Poland.
Balcerzak, M; Cameron, JD; Hering, D; Jaguszewski, M; Konstanty, M; Merks, P; Religioni, U; Świeczkowski, D; Szymański, FM; Vaillancourt, R, 2022)		2.38
"Dabigatran is a direct oral anticoagulant used to prevent stroke and systemic embolism in patients with atrial fibrillation. "( [Dabigatran Reversal: A Practical Approach].
Ricca Gonçalves, L; Robalo Nunes, A, 2022)		3.07
"Dabigatran etexilate is a suitable choice preoperatively to modify coagulation function and pain in patients with VMs."( Dabigatran etexilate is efficacious in consumptive coagulopathy and pain associated with venous malformations.
Chen, H; Gu, H; Hu, L; Lin, X; Liu, H; Xu, Z; Yang, X, 2023)		3.07
"Dabigatran etexilate is a direct oral anticoagulant (thrombin inhibitor) used for the prevention of stroke and systemic thromboembolic events in patients with permanent atrial fibrillation; prevention of venous thromboembolic events and deep veins thrombosis; treatment and prevention of pulmonary embolism. "( Possible Interaction between Dabigatran and Ranolazine in Patients with Renal Failure.
Damulevičienė, G; Galaunė, V; Gumbrevičius, G; Gumbrevičiūtė, M, 2019)		2.25
"Dabigatran is a novel oral anticoagulant molecule which is a direct thrombin (Factor IIa) inhibitor and is used for prevention of stroke and systemic embolism. "( A Rare Case Report of Dabigatran Induced Oral Ulcers.
Prabha, N; Singh, A; Yadav, H, 2020)		2.32
"Dabigatran is an anticoagulant medication that has been widely used to prevent strokes caused by atrial fibrillation, deep vein thrombosis, and pulmonary embolism. "( Dabigatran-induced esophagitis: A case report.
Dai, Y; Fu, Z; Lu, L; Zhou, Y, 2020)		3.44
"Dabigatran etexilate is a non-vitamin K antagonist oral anticoagulant (NOAC) that is used to prevent stroke and systemic embolism in adults with nonvalvular atrial fibrillation (NVAF) and one or more risk factors. "( Pharmacokinetics and Safety of Dabigatran Etexilate after Single and Multiple Oral Doses in Healthy Chinese Subjects.
Duan, J; Harada, A; Li, H; Yamamura, N; Yang, L, 2020)		2.29
"Dabigatran is a direct oral anticoagulant (DOAC) used for the treatment of several thrombotic conditions. "( Effect of Sex, Use of Pantoprazole and Polymorphisms in SLC22A1, ABCB1, CES1, CYP3A5 and CYP2D6 on the Pharmacokinetics and Safety of Dabigatran.
Abad-Santos, F; Almenara, S; Koller, D; Mejía, G; Navares-Gómez, M; Ochoa, D; Román, M; Saiz-Rodríguez, M; Soria-Chacartegui, P; Zubiaur, P, 2020)		2.2
"Dabigatran is an orally active direct thrombin inhibitor, initially approved by FDA for the prophylaxis of stroke and systemic embolism in the setting of non-valvular atrial fibrillation (NVAF). "( Dabigatran-induced chronic progressive immune hemolytic anemia: A case report.
Gong, JH; Liu, GJ; Sun, ZQ; Zhou, F, 2020)		3.44
"Dabigatran is a direct thrombin inhibitor for which a reversal agent exists."( High-Dose Dabigatran Is an Effective Anticoagulant for Simulated Cardiopulmonary Bypass Using Human Blood.
Angona, RE; Baldzizhar, A; Eaton, MP; Feng, C; Jones-Smith, KL; Nadtochiy, SM; O'Leary, KE; Stefanos, T, 2021)		1.75
"Dabigatran is a direct thrombin inhibitor that is widely used to prevent the formation of thrombus formation. "( Left atrial appendage thrombus formation in a patient with atrial fibrillation on dabigatran therapy associated with CES1 and ABCB1 genetic polymorphisms: A case report.
Chen, W; Fu, J; Wu, T; Xia, X; Zhang, J, 2020)		2.23
"Dabigatran etexilate is a direct oral anticoagulant with potential to overcome the limitations of standard of care in children with venous thromboembolism. "( Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial.
Albisetti, M; Bomgaars, L; Brandão, LR; Brueckmann, M; Chalmers, E; Gorbatikov, K; Gropper, S; Halton, J; Huang, F; Kreuzer, J; Luciani, M; Mitchell, LG; Nurmeev, I; Reilly, P; Sharathkumar, A; Simetzberger, M; Sun, Z; Svirin, P; Tartakovsky, I, 2021)		3.51
"Dabigatran (DAB) is a direct thrombin inhibitor used for preventing blood clots and emboli after orthopedic surgery. "( Introduction of a thrombin sensor based on its interaction with dabigatran as an oral direct thrombin inhibitor.
Ahmadi, E; Gholivand, MB; Paimard, G; Shahlaei, M; Shamsipur, M, 2021)		2.3
"Dabigatran is an orally administrated anticoagulant that directly inhibits thrombin. "( Pitfalls in the assessment of disseminated intravascular coagulation in patients on dabigatran.
Bousounis, A; Ho, WK; Hogan, C; Kanda, GS; Rodrigues, C, 2021)		2.29
"Dabigatran is a direct oral anticoagulant thrombin inhibitor approved for stroke prophylaxis in patients with non-valvular atrial fibrillation and prophylaxis or treatment of venous thromboembolism. "( Idarucizumab (PRAXBIND®) as a sole reversal agent in an unstable hemorrhagic shock patient on an unknown anticoagulant with elevated protime/international normalized ratio (PT/INR).
Kutner, S; Scaturo, N; Williams, B, 2021)		2.06
": Dabigatran is a direct oral anticoagulant drug exhibiting clinical benefits over vitamin K antagonists. "( Rapid and well tolerated action of idarucizumab for antagonizing dabigatran in a patient needing urgent thrombolysis: a case report.
DeGuidi, G; Facchinetti, R; Lippi, G; Pitoni, F; Ricci, G, 2017)		1.41
"Dabigatran is a direct thrombin inhibitor used to reduce the risk of stroke in patients with nonvalvular atrial fibrillation. "( Acute Stroke Despite Dabigatran Anticoagulation Treated with Idarucizumab and Intravenous Tissue Plasminogen Activator.
Bissig, D; Manjunath, R; Ng, KL; Richman, DP; Traylor, BR, 2017)		2.22
"Dabigatran etexilate is an oral thrombin inhibitor that can be reversed by idarucizumab."( Systemic Thrombolysis in Acute Ischemic Stroke after Dabigatran Etexilate Reversal with Idarucizumab-A Case Report.
He, J; Nordling, MM; Tireli, D; Wienecke, T, 2017)		1.43
"Dabigatran is a reversible direct inhibitor of thrombin that has not been studied in neonates using a sophisticated global assay, such as TEG."( In-vitro assessment of the effect of dabigatran on thrombosis of adult and neonatal plasma: comparisons using thromboelastography and microscopic visualization of fibrin clot structure.
Atkinson, HM; Berry, LR; Chan, AKC; Chan, HHW; Gantioqui, J; Nossair, FF, 2017)		1.45
"Dabigatran is an oral anticoagulant and a reversible inhibitor of thrombin. "( Dabigatran reduces thrombin-induced platelet aggregation and activation in a dose-dependent manner.
Brandes, A; Nielsen, C; Nybo, M; Söderström, AC; Vinholt, PJ, 2017)		3.34
"Dabigatran is an oral, reversible and competitive thrombin inhibitor that has shown promising results."( Acute agranulocytosis after oral administration of dabigatran: a rare case report and a short review of literature.
Cosenza, G; Davì, S; Di Franco, F; Fasullo, S; Giubilato, A; La Manna, N; Maringhini, G; Vetrano, G, 2018)		1.45
"Dabigatran is a direct thrombin inhibitor and a non-vitamin-K-antagonizing oral anticoagulant, approved for the prevention of stroke and systemic embolization in atrial fibrillation. "( Reversal of dabigatran using idarucizumab: single center experience in four acute stroke patients.
Brich, J; Geisen, U; Harloff, A; Heck, D; Hieber, M; Hollasch, H; Mächtel, M; Niesen, WD, 2018)		2.3
"Dabigatran etexilate is an oral anticoagulant recognized as noninferior to LMWH."( Incidence of symptomatic venous thromboembolism in 2372 knee and hip replacement patients after discharge: data from a thromboprophylaxis registry in Montreal, Canada.
Banica, A; Benoit, B; Delisle, J; Fernandes, JC; Laflamme, GY; Malo, M; Nguyen, H; Ranger, P; Senay, A; Trottier, M, 2018)		1.2
"Dabigatran is a direct thrombin inhibitor. "( Dabigatran affects thrombin-dependent platelet aggregation after a week-long therapy.
Ivankova, J; Mokan, M; Nehaj, F; Sokol, J; Stasko, J, 2018)		3.37
"Dabigatran is a once daily oral anticoagulant that is FDA approved for venous thromboembolism prophylaxis after orthopedic surgery, uses fixed dosing, and has an antidote."( Dabigatran (Pradaxa) Is Safe for Extended Venous Thromboembolism Prophylaxis After Surgery for Pancreatic Cancer.
Chabot, JA; Dwyer, FA; Jackson, TL; Kluger, MD; Morgan, JA; Rashid, MF; Schrope, BA, 2019)		2.68
"Dabigatran is an oral anticoagulant prescribed as an alternative to warfarin which has been associated with exfoliative esophagitis and esophageal ulcer. "( Symptomatic exfoliative esophagitis induced by dabigatran.
Cuadros Martínez, M; Froilán Torres, C; Gonzalo Bada, N, 2018)		2.18
"Dabigatran is a direct thrombin inhibitor that might be useful in the management of HIT."( Dabigatran as a Treatment Option for Heparin-Induced Thrombocytopenia.
Amouzegar, A; Basi, A; Emami, S; Farasatinasab, M; Mokhtari, M; Nasiripour, S; Saif, M, 2019)		2.68
"Dabigatran etexilate is a selective, specific, reversible direct thrombin inhibitor that has been approved in United States, European countries and in India for SPAF and primary venous thromboembolism prevention and treatment."( Dabigatran - the First Approved DTI for SPAF.
Hiremath, JS; Trailokya, A, 2018)		2.64
": Dabigatran is a direct thrombin inhibitor that was approved as an alternative to warfarin because it offers the benefit of predictable pharmacokinetic properties, favorable safety profile and ease of administration. "( Probable drug-drug interaction between dabigatran and quinidine resulting in thrombin time rebound despite multiple idarucizumab doses.
George, S; Lewis, V; Taburyanskaya, M, 2019)		1.5
"Dabigatran is a kind of oral anticoagulant and there was little review only about dabigatran and warfarin used in patients with atrial fibrillation. "( Comparison of dabigatran and warfarin used in patients with non-valvular atrial fibrillation: Meta-analysis of random control trial.
Chu, HM; Fang, RY; Fu, GH; Gao, F; Liu, J; Yu, YB, 2018)		2.28
"Dabigatran etexilate is a direct thrombin inhibitor that clinicians increasingly prescribe to prevent stroke in patients with non-valvular atrial fibrillation (NVAF). "( Statins and the risk of bleeding in patients taking dabigatran.
Chao, AC; Chen, CF; Chou, PS; Ho, BL; Hu, HH; Lin, RT; Lin, SF; Lin, YJ, 2019)		2.21
"Dabigatran is an oral anticoagulant used for atrial fibrillation and venous thromboembolism. "( The effect of routine preoperative interruption of dabigatran therapy on coagulation parameters and dabigatran plasma levels in a mixed surgical population.
Brett, CN; Brett, OF; Chin, PK, 2019)		2.21
"Dabigatran is a direct oral anticoagulant which is used as an alternative to the traditional vitamin K antagonists. "( [Dabigatran-induced oesophagitis].
Bhalla, A; van der Voorn, MMPJA; Ykema, BLM, 2019)		2.87
"Dabigatran etexilate is a newly approved agent for prophylaxis of stroke in atrial fibrillation. "( Stop the clots, but at what cost? Pharmacoeconomics of dabigatran etexilate for the prevention of stroke in subjects with atrial fibrillation: a systematic literature review.
Dawson, J; Fearon, P; Marshall, S; Quinn, TJ, 2013)		2.08
"Dabigatran is an oral direct thrombin inhibitor (DTI) licensed for stroke prevention in atrial fibrillation and likely to be soon approved in Europe for treatment of venous thrombosis. "( The acute management of haemorrhage, surgery and overdose in patients receiving dabigatran.
Alikhan, R; Baglin, T; Benson, G; Green, L; Keeling, D; Marshall, S; Patel, R; Pavord, S; Rayment, R; Rose, P; Tait, C, 2014)		2.07
"Dabigatran is an oral anticoagulant that inhibits thrombin but not vitamin K. "( Dabigatran: life-threatening bleeding.
, 2013)		3.28
"Dabigatran etexilate is a direct thrombin inhibitor and used widely as an anticoagulant for the prevention of stroke in patients with atrial fibrillation. "( A specific antidote for dabigatran: functional and structural characterization.
Canada, K; Litzenburger, T; Nar, H; Newsome, C; Park, J; Schiele, F; Sepulveda, E; van Ryn, J, 2013)		2.14
"Dabigatran etexilate is a pro-drug of the oral reversible direct thrombin inhibitor dabigatran that interacts with the active site in the catalytic domain of the thrombin molecule."( Dabigatran does not prolong the QT interval with supratherapeutic exposure: a thorough QT study in healthy subjects.
Clemens, A; Friedman, J; Rathgen, K; Reilly, P; Ring, A; Stangier, J, 2013)		3.28
"Dabigatran is a reversible direct thrombin inhibitor recently approved for stroke prevention in patients with atrial fibrillation. "( Hemorrhagic complications in emergency department patients who are receiving dabigatran compared with warfarin.
Berger, R; Chase, M; Ganetsky, M; Salhanick, SD, 2013)		2.06
"Dabigatran is an oral anticoagulant direct thrombin inhibitor recently registered in South Africa (SA) to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation (AF). "( Economic appraisal of dabigatran as first-line therapy for stroke prevention in atrial fibrillation.
Bergh, M; Marais, CA; Miller-Jansön, H; Salie, F; Stander, MP, 2013)		2.15
"Dabigatran etexilate is an effective and safe anticoagulation therapy for AF ablation. "( Usefulness of dabigatran etexilate as periprocedural anticoagulation therapy for atrial fibrillation ablation.
Higashiya, S; Hina, K; Hirohata, S; Kamikawa, S; Kawamura, H; Kusachi, S; Murakami, M; Murakami, T; Yamaji, H, 2013)		2.19
"Dabigatran is an oral direct thrombin inhibitor indicated for thromboembolism prophylaxis in patients with nonvalvular atrial fibrillation. "( Hemodialysis for the treatment of pulmonary hemorrhage from dabigatran overdose.
Chen, BC; Dadzie, KA; Hoffman, RS; Nelson, LS; Sheth, NR; Smith, SW; Winchester, JF, 2013)		2.07
"Dabigatran etexilate is a novel oral direct thrombin inhibitor."( Modeling of the impact on health outcomes of the use of dabigatran in patients with atrial fibrillation.
Chevalier, J; de Pouvourville, G; Giroud, M, 2013)		1.36
"Dabigatran is an oral, direct, and competitive inhibitor of thrombin, which is administered to patients with non-valvular atrial fibrillation for prevention of stroke at a dose of 110 mg twice daily or 150 mg twice daily. "( [Direct oral thrombin inhibitor, "dabigatran"].
Yasaka, M, 2013)		2.11
"Dabigatran is a direct thrombin inhibitor gaining popularity as a stroke prevention agent in patients with atrial fibrillation. "( Traumatic intracranial hemorrhage in patients taking dabigatran: report of 3 cases and review of the literature.
Abel, TJ; Greenlee, JD; Grossbach, A; Howard, MA; Jackson, AW; Viljoen, SV; Wassef, SN, 2013)		2.08
"Dabigatran is an oral direct thrombin inhibitor that is Food and Drug Administration-approved for prevention of stroke in patients with atrial fibrillation. "( Extracorporeal therapy for dabigatran removal in the treatment of acute bleeding: a single center experience.
Hallows, KR; Henry, BL; Maw, TT; Nolin, TD; Pastor-Soler, NM; Singh, T; Unruh, ML, 2013)		2.13
"Dabigatran is an oral direct thrombin inhibitor that does not require routine laboratory monitoring. "( The effect of dabigatran on the activated partial thromboplastin time and thrombin time as determined by the Hemoclot thrombin inhibitor assay in patient plasma samples.
Butler, J; Chunilal, S; Hapgood, G; Malan, E; Tran, H, 2013)		2.19
"Dabigatran is an oral direct thrombin inhibitor for which routine laboratory monitoring is currently not recommended. "( Evaluation of coagulation assays versus LC-MS/MS for determinations of dabigatran concentrations in plasma.
Antovic, JP; Beck, O; Boija, EE; Eintrei, J; Hjemdahl, P; Malmström, RE; Norberg, EM; Onelöv, L; Pohanka, A; Rönquist-Nii, Y; Skeppholm, M; Söderblom, L, 2013)		2.07
"Dabigatran is a direct thrombin inhibitor approved to help prevent thrombotic events in patients with atrial fibrillation. "( Dental management considerations for a patient taking dabigatran etexilate: a case report.
Henry, RG; Miller, CS; Romond, KK, 2013)		2.08
"Dabigatran is an oral direct thrombin inhibitor widely used to prevent and treat various thromboembolic complications. "( Dabigatran and kidney disease: a bad combination.
Berns, JS; Chaknos, CM; Knauf, F; Perazella, MA, 2013)		3.28
"Dabigatran is a new anticoagulant in patients with nonvalvular AF."( The incidence of asymptomatic cerebral microthromboembolism after atrial fibrillation ablation: comparison of warfarin and dabigatran.
Hamasaki, S; Ichiki, H; Iriki, Y; Ishida, S; Maenosono, R; Miyata, M; Namino, F; Ninomiya, Y; Oketani, N; Okui, H; Tei, C, 2013)		1.32
"Dabigatran is a direct thrombin inhibitor and its role in patients with acute coronary syndrome is being explored."( Potential role of oral anticoagulants in the treatment of patients with coronary artery disease: focus on dabigatran.
Doraiswamy, VA; Gesheff, MG; Gurbel, PA; Slepian, MJ; Tantry, US, 2013)		1.32
"Dabigatran is an oral direct thrombin inhibitor that has been shown to be an effective alternative to warfarin in patients with atrial fibrillation. "( Dabigatran versus warfarin in patients with mechanical heart valves.
Blatchford, J; Brueckmann, M; Connolly, SJ; Devenny, K; Eikelboom, JW; Friedman, J; Granger, CB; Guiver, K; Harper, R; Kappetein, AP; Khder, Y; Lobmeyer, MT; Maas, H; Mack, MJ; Simoons, ML; Van de Werf, F; Voigt, JU, 2013)		3.28
"Dabigatran is a relatively novel therapeutic option for patients with AF."( Floating thrombus in the left upper pulmonary vein dissolved by dabigatran.
Takeuchi, H, 2013)		1.35
"Dabigatran is a newer oral anticoagulant, indicated for chronic atrial fibrillation anticoagulation. "( Emergency abdominal surgery in a patient anticoagulated with dabigatran.
DeMuro, JP, 2013)		2.07
"Dabigatran is an oral thrombin inhibitor which has been approved for prevention of stroke or embolism in atrial fibrillation patients as an alternative to vitamin K antagonists. "( Life-threatening epistaxis and red blood cell polyagglutination under dabigatran.
Finsterer, J; Krutisch, G; Stöllberger, C, 2014)		2.08
"Dabigatran is a novel oral anticoagulant approved for thromboprophylaxis in atrial fibrillation. "( Early adoption of dabigatran and its dosing in US patients with atrial fibrillation: results from the outcomes registry for better informed treatment of atrial fibrillation.
Ansell, J; Chang, P; Ezekowitz, MD; Fonarow, GC; Gersh, B; Holmes, DN; Hylek, EM; Kowey, PR; Mahaffey, KW; Peterson, ED; Piccini, JP; Singer, DE; Steinberg, BA; Thomas, L, 2013)		2.17
"Dabigatran is a novel oral anticoagulant for which a well-defined range of toxicity and proven antidote has not been established."( Evaluation of dabigatran exposures reported to poison control centers.
Conway, SE; Harrison, DL; Schaeffer, SE, 2014)		2.21
"Dabigatran is a direct thrombin inhibitor indicated for stroke and systemic embolism prevention in patients with non-valvular atrial fibrillation. "( [Patient with acute renal injury presenting dabigatran overdose: Hemodialysis for surgery].
Bachellerie, B; Conil, JM; Crognier, L; Fourcade, O; Georges, B; Ruiz, S; Seguin, T, 2014)		2.11
"Dabigatran is an oral direct thrombin inhibitor; rivaroxaban and apixaban are oral direct Factor Xa inhibitors. "( Non-vitamin K antagonist oral anticoagulants in cardiovascular disease management: evidence and unanswered questions.
Barillari, G; Cheng, JW, 2014)		1.85
"Dabigatran is a univalent low-molecular-weight direct thrombin inhibitor that has been developed as an alternative to vitamin K antagonists (VKAs). "( Meta-analysis of randomized controlled trials on the risk of bleeding with dabigatran.
Atallah, R; Bloom, BJ; Eisenberg, MJ; Filion, KB, 2014)		2.08
"dabigatran (Pradaxa®) is a direct and specific thrombin inhibitor."( [General characteristics of the new oral anticoagulants].
Berrut, G; Chevalet, P; De Decker, L; Gegu, M; Piloquet, FX, 2013)		1.11
"Dabigatran is a direct, competitive inhibitor of thrombin recently approved for the prophylaxis of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. "( Increased risk of myocardial infarction with dabigatran: fact or fiction?
Basile, E; Di Biase, L; Giglio, AF; Natale, A; Santangeli, P; Trotta, F, 2014)		2.1
"Dabigatran is an oral, reversibly bound, direct thrombin inhibitor currently approved in the United States for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. "( Management of dabigatran-associated intracerebral and intraventricular hemorrhage: a case report.
Faust, AC; Peterson, EJ, 2014)		2.21
"Dabigatran is a novel oral anticoagulant and may be useful during atrial fibrillation (AF) ablation for prevention of thromboembolic events. "( Meta-analysis of risk of stroke or transient ischemic attack with dabigatran for atrial fibrillation ablation.
Aronow, WS; Chatterjee, S; Ghosh, J; Nairooz, R; Sardar, P; Wetterslev, J, 2014)		2.08
"Dabigatran is an oral anticoagulant that is increasingly used for atrial fibrillation (AF). "( A proposal for dose-adjustment of dabigatran etexilate in atrial fibrillation guided by thrombin time.
Begg, EJ; Chin, PK; Doogue, MP; Patterson, DM; Wright, DF, 2014)		2.12
"Dabigatran is an oral direct thrombin inhibitor that is approved for the prevention of stroke and systemic embolism in nonvalvular atrial fibrillation. "( A Review of and Recommendations for the Management of Patients With Life-Threatening Dabigatran-Associated Hemorrhage: A Single-Center University Hospital Experience.
Henry, BL; Kumar, R; Smith, RE, 2015)		2.08
"Dabigatran is a potent oral anticoagulant. "( Reversal of dabigatran-induced bleeding by coagulation factor concentrates in a rat-tail bleeding model and lack of effect on assays of coagulation.
Clemens, A; Kink-Eiband, M; Schurer, J; van Ryn, J, 2014)		2.22
"Dabigatran is a direct thrombin inhibitor that reduces the risk of systemic embolism in patients with nonvalvular atrial fibrillation. "( A case of dabigatran-associated acute renal failure.
Julius, CJ; Negrete, H; Roy, P; Sarac, E; Shafi, ST, 2013)		2.23
"Dabigatran is an oral anticoagulant from the class of the direct thrombin inhibitors, indicated for prevention of thromboembolic events in patients with non valvular atrial fibrillation. "( [Hemodialysis to remove anticoagulant dabigatran during emergencies].
Campbell, S; Carrizo, A, 2014)		2.12
"Dabigatran is a novel oral anti-coagulant (NOAC) that reduces risk of stroke in patients with non-valvular atrial fibrillation (NVAF). "( Adherence to dabigatran therapy and longitudinal patient outcomes: insights from the veterans health administration.
Barón, AE; Bradley, SM; Carey, EP; Cunningham, F; Grunwald, GK; Ho, PM; Jackevicius, CA; Maddox, TM; Marzec, LN; Pilote, L; Rumsfeld, JS; Schneider, PM; Shore, S; Turakhia, MP; Varosy, PD, 2014)		2.21
"Dabigatran is a new oral direct thrombin inhibitor. "( Dabigatran and its reversal with recombinant factor VIIa and prothrombin complex concentrate: a Sonoclot in vitro study.
Engström, M; Johansson, PI; Nilsson, CU; Ostrowski, SR; Sølbeck, S, 2014)		3.29
"Dabigatran is a direct thrombin (factor IIa) inhibitor; rivaroxaban and apixaban are direct factor Xa inhibitors."( Newer clinically available antithrombotics and their antidotes.
Lévy, S, 2014)		1.12
"Dabigatran is a new non-vitamin K antagonist (VKA) anticoagulant with anti-thrombin action, with supposedly fewer haemorrhagic complications. "( Epistaxis and dabigatran, a new non-vitamin K antagonist oral anticoagulant.
Bécares Martínez, C; Calvo González, J; García Callejo, FJ; Marco Algarra, J; Marco Sanz, M; Martínez Beneyto, P, )		1.93
"Dabigatran is an oral intake thrombin inhibitor for preventive administration against stroke accompanied by atrial fibrillation. "( Analysis of the influence of dabigatran on coagulation factors and inhibitors.
Ito, S; Ohhigashi, H; Shimono, J; Shiratori, S; Teshima, T; Tsutsumi, Y, 2015)		2.15
"Dabigatran is a novel direct thrombin inhibitor that has proven effective in the prevention of vascular events in patients with nonvalvular atrial fibrillation. "( Use of Extracorporeal Techniques in the Removal of Dabigatran.
Muddana, N; Nashar, K; Nayer, A; Ortega, LM; Thuyanh, C, )		1.83
"Dabigatran etexilate is an oral prodrug of dabigatran, a selective, reversible, competitive, direct thrombin inhibitor."( Dabigatran etexilate: a review of its use in the treatment of acute venous thromboembolism and prevention of venous thromboembolism recurrence.
Greig, SL; McKeage, K, 2014)		2.57
"Dabigatran is a popular new alternative to warfarin that has no blood monitoring or reversal agent. "( Spontaneous choroidal hemorrhage in a patient on dabigatran etexilate (Pradaxa).
Kang, TS; Kunjukunju, N; Lord, K, 2014)		2.1
"Dabigatran is an anti-aggregation agent used for the treatment of atrial fibrillation."( Depressive symptoms associated with dabigatran: a case report.
Enez Darcin, A; Eryilmaz, G; Gogcegoz Gul, I; Saglam, E, 2015)		1.41
"Dabigatran (DT) is a direct thrombin inhibitor used to prevent venous and arterial thromboembolism due to atrial fibrillation. "( Generation of an anti-Dabigatran Monoclonal Antibody and Its Use in a Highly Sensitive and Specific Enzyme-Linked Immunosorbent Assay for Serum Dabigatran.
Goroku, T; Kariyazono, H; Morinaga, O; Oiso, S; Shoyama, Y; Uto, T, 2015)		2.17
"Dabigatran etexilate is an oral direct thrombin inhibitor. "( Measurement of dabigatran plasma concentrations by calibrated thrombin clotting time in comparison to LC-MS/MS in human volunteers on dialysis.
Gansser, D; Moschetti, V; Schmohl, M; Stangier, J, 2015)		2.21
"Dabigatran is an oral direct inhibitor indicated for stroke prevention in patients with atrial fibrillation. "( Dabigatran overdose: case report of laboratory coagulation parameters and hemodialysis of an 85-year-old man.
Berutti, S; Coglitore, R; Cosseddu, D; Erroi, L; Marangella, M; Migliardi, M; Montaruli, B; Sivera, P; Vitale, C, 2015)		3.3
"Dabigatran is a direct thrombin inhibitor that has been approved for preventing stroke in patients with atrial fibrillation. "( Relation between dabigatran concentration, as assessed using the direct thrombin inhibitor assay, and activated clotting time/activated partial thromboplastin time in patients with atrial fibrillation.
Fujino, T; Kuwahara, T; Nakajima, J; Nakashima, E; Okubo, K; Takagi, K; Takahashi, A; Takigawa, M; Tsutsui, H; Watari, Y; Yamao, K, 2015)		2.2
"Dabigatran is a direct thrombin inhibitor that effectively blocks thrombin's catalytic activity but does not preclude thrombin's exosites and binding to fibrinogen."( Characterization of thrombin-bound dabigatran effects on protease-activated receptor-1 expression and signaling in vitro.
Chen, B; Coronel, LJ; Goss, A; Soto, AG; Trejo, J; van Ryn, J, 2015)		1.42
"Dabigatran etexilate is a fixed-dose oral direct thrombin inhibitor available for use in acute and extended treatment of VTE, as well as prophylaxis in high-risk orthopedic surgical patients."( Current and emerging strategies in the management of venous thromboembolism: benefit-risk assessment of dabigatran.
Fanola, CL, 2015)		1.35
"Dabigatran is a prodrug that undergoes primarily renal elimination and does not affect cytochrome P450 enzymes."( Differential benefit risk assessment of DOACs in the treatment of venous thromboembolism: focus on dabigatran.
Law, EH; Leung, TS, 2015)		1.36
"Dabigatran etexilate is a novel oral anticoagulant indicated for anticoagulation in the management of atrial fibrillation and venous thromboembolism. "( Successful hemostasis and reversal of highly elevated PT/INR after dabigatran etexilate use in a patient with acute kidney injury.
Jones, JM; Leedahl, DD; Ryan, HM; Tieszen, M, 2016)		2.11
"Dabigatran is a reversible direct thrombin inhibitor and currently approved for the prevention of thromboembolic episodes in non-valvar atrial fibrillation."( Dabigatran for left ventricular thrombus.
Kolekar, S; Munjewar, C; Sharma, S, )		2.3
"Dabigatran etexilate is a direct thrombin inhibitor approved for use in patients with non-valvular atrial fibrillation. "( The effect of ultrafiltration with cardiopulmonary bypass on the removal of dabigatran from the circulation of adult pigs.
Carter, CB; DeNino, WF; Goss, A; Mukherjee, R; Sievert, A; Toole, JM; Uber, WE, 2016)		2.11
"Dabigatran is a novel target specific oral anticoagulant for stroke prevention in non valvular atrial fibrillation. "( Efficacy and safety of dabigatran in a "real-life" population at high thromboembolic and hemorrhagic risk: data from MonaldiCare registry.
Bianchi, V; Calabrò, P; Cavallaro, C; D'Onofrio, A; De Vivo, S; Nigro, G; Russo, V; Santangelo, L; Sarubbi, B; Vecchione, F, 2015)		2.17
"Dabigatran is a suitable alternative to warfarin obviating the need for repetitive international normalized ratio monitoring, however, it may need plasma drug monitoring."( Clinical utility of dabigatran in United Arab Emirates. A pharmacovigilance study.
Abu Mandil, M; Al Nuaimi, SK; Al Suwaidi, A; AlShamsi, A; Bhagavathula, A; Elnour, AA; Erkekoglu, P; Hamad, F; Sadik, A; Shehab, A, 2015)		2.18
"Dabigatran is a direct acting (anti-II) oral anticoagulant which does not interfere with CYP and has favourable safety and efficacy profiles compared with VKAs."( Effects of dabigatran on the cellular and protein phase of coagulation in patients with coronary artery disease on dual antiplatelet therapy with aspirin and clopidogrel. Results from a prospective, randomised, double-blind, placebo-controlled study.
Ajjan, RA; Angiolillo, DJ; Bass, TA; Bhatti, M; Cho, JR; DeGroat, C; Franchi, F; Guzman, LA; King, R; Phoenix, F; Rollini, F; Tello-Montoliu, A; Zenni, MM, 2016)		1.55
"Dabigatran is an oral anticoagulant approved for treatment of non-valvular atrial fibrillation, deep venous thrombosis (DVT), pulmonary embolism and prevention of DVT following orthopedic surgery. "( Thrombelastography detects dabigatran at therapeutic concentrations in vitro to the same extent as gold-standard tests.
Johansson, PI; Ostrowski, SR; Solbeck, S; Stensballe, J, 2016)		2.17
"Dabigatran is a direct thrombin inhibitor shown to be an effective alternative to warfarin in patients with non-valvular atrial fibrillation (AF). "( Dabigatran Versus Warfarin After Bioprosthesis Valve Replacement for the Management of Atrial Fibrillation Postoperatively: DAWA Pilot Study.
Albuquerque, FP; Aras, R; de Almeida Nunes, B; de Bulhões, FV; de Souza Fernandes, AM; de Souza Roriz, P; Durães, AR, 2016)		3.32
"Dabigatran is a direct thrombin (factor II) inhibitor while rivaroxaban, apixaban and edoxaban are direct inhibitors of factor Xa."( Bleeding management in patients with new oral anticoagulants.
Marra, A; Perrone, A; Servillo, G; Vargas, M, 2016)		1.16
"Dabigatran is an effective oral alternative to enoxaparin for thromboprophylaxis as demonstrated by the RE-NOVATE II study global results. "( Thromboprophylaxis with dabigatran after total hip arthroplasty in Indian patients: A subanalysis of a double-blind, double-dummy, randomized RE-NOVATE II study.
Babhulkar, S; Clemens, A; Dadi, A; Iyer, R; Kamath, S; Malhotra, R; Mody, B; Mutha, S; Reddy, G; Sanjib, KB; Shah, V; Shetty, N; Tapasvi, S; Wadhwa, M, 2017)		2.2
"Dabigatran is an oral direct thrombin inhibitor that can be used with fixed doses, without the need for routine anticoagulation laboratory monitoring and the advantage of few drug or diet interactions."( Dabigatran in clinical practice: Contemporary overview of the evidence.
Ageno, W; Eikelboom, J; Lip, GY, 2016)		2.6
"Dabigatran is a new direct competitive inhibitor of thrombin and is equally effective and safe as warfarin in the prevention of thromboembolism in patients with nonvalvular atrial fibrillation. "( Left atrial thrombus under dabigatran in a patient with nonvalvular atrial fibrillation.
Durian, MF; Janssen, AM; Szabó, B; van de Kerkhof, D; van der Voort, PH, 2016)		2.17
"Dabigatran is a selective direct thrombin inhibitor that reversibly binds to thrombin."( Dabigatran antagonizes growth, cell-cycle progression, migration, and endothelial tube formation induced by thrombin in breast and glioblastoma cell lines.
Fabris, F; Goss, A; Prandoni, P; Sambado, L; Vianello, F, 2016)		2.6
"Dabigatran etexilate is a direct oral anticoagulant used for the prevention of stroke in atrial fibrillation. "( Reversal of Anticoagulation With Dabigatran in an 82-Year-Old Patient With Traumatic Retroperitoneal Arterial Bleeding Using the New Antidote Idarucizumab: A Case Report.
Brenner, T; Hofer, S; Philipsenburg, C; Weigand, MA, 2016)		2.16
"Dabigatran is a newly commercialized drug that is replacing other anticoagulants in the prevention of venous thromboembolism, stroke and systemic arterial valve embolism. "( Dabigatran: A new oral anticoagulant. Guidelines to follow in oral surgery procedures. A systematic review of the literature.
Casañas-Gil, E; Hernández-Vallejo, G; López-Pintor, RM; Muñoz-Corcuera, M; Ramírez-Martínez-Acitores, L, 2016)		3.32
"Dabigatran is a direct thrombin inhibitor, which is increasingly likely to be encountered in patients presenting for surgery. "( The effect of dabigatran on the kaolin-activated whole blood thromboelastogram.
'Aho, A; Byrne, K, 2016)		2.24
"Dabigatran is an oral, direct thrombin inhibitor approved by international regulatory agencies for stroke prevention in patients with paroxysmal or persistent non-rheumatic atrial fibrillation (AF). "( Dabigatran overdose: a case report of acute hepatitis. Extracorporeal treatment.
Barcellona, D; Cianchetti, ME; Mameli, A; Marongiu, F; Musu, M; Porru, M; Ruberto, MF; Schirru, P, 2017)		3.34
"Dabigatran is a non-vitamin K antagonist oral anticoagulant that has been approved for atrial fibrillation and prevention of venous thromboembolism. "( Dabigatran-related leukocytoclastic vasculitis.
An, J; Garje, R; Leone, JP; Wanat, KA, 2017)		3.34
"Dabigatran etexilate is a substrate of the P-glycoprotein (adenosine triphosphate-binding cassette subfamily B member 1) transport system and is subject to interactions with medications that induce or inhibit this system. "( Development of Left Atrial Thrombus After Coadministration of Dabigatran Etexilate and Phenytoin.
Albers, L; Bolt, J; Duffy, P; Hager, N; Semchuk, W; Wojcik, W, 2017)		2.14
"Dabigatran etexilate is a prodrug whose absorption is opposed by intestinal P-glycoprotein and which is converted by carboxylesterase to its active form, dabigatran. "( Association between statin use and ischemic stroke or major hemorrhage in patients taking dabigatran for atrial fibrillation.
Antoniou, T; Gomes, T; Hollands, S; Juurlink, DN; Macdonald, EM; Mamdani, MM; Tadrous, M; Yao, Z, 2017)		2.12
"Dabigatran is a feasible alternative to warfarin for shortening the hospitalization period and decreasing delayed bleeding rate, although rivaroxaban has a significantly higher delayed bleeding risk."( Effect of direct oral anticoagulants on the risk of delayed bleeding after gastric endoscopic submucosal dissection.
Fujisaki, J; Hirasawa, T; Horiuchi, Y; Igarashi, M; Ishiyama, A; Iwasaki, R; Michitaka, K; Mita, E; Ninomiya, T; Omae, M; Tomida, H; Tsuchida, T; Yamada, T; Yamamoto, Y; Yoshio, T, 2017)		1.18
"Dabigatran etexilate is an orally administered prodrug of dabigatran, which is a potent, concentration-dependent inhibitor of thrombus formation and thrombin-induced platelet aggregation. "( Dabigatran etexilate.
Plosker, GL; Sanford, M, 2008)		3.23
"Dabigatran etexilate is a promising new oral anticoagulant that offers greatly expanded therapeutic options for both patients and physicians."( New therapeutic option for thromboembolism--dabigatran etexilate.
Ieko, M; Nakabayashi, T; Nishio, H, 2008)		2.05
"Dabigatran is an oral direct thrombin inhibitor that has been compared with enoxaparin for prevention of VTE following hip or knee replacement."( New issues in oral anticoagulants.
Francis, CW, 2008)		1.07
"Dabigatran etexilate is a prodrug that is rapidly converted to the active direct thrombin inhibitor dabigatran."( Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran.
Connolly, S; Ezekowitz, MD; Oldgren, J; Parekh, A; Reilly, PA; Themeles, E; Varrone, J; Wallentin, L; Wang, S; Yusuf, S, 2009)		1.29
"Dabigatran etexilate is a novel, oral reversible direct thrombin inhibitor in the clinical development for the treatment and prevention of thromboembolic diseases. "( Dabigatran etexilate: future directions in anticoagulant treatment.
Reilly, PA; Schulman, S, )		3.02
"Dabigatran etexilate is an oral reversible direct thrombin inhibitor that offers potential practical advantages over existing anticoagulants for the prevention of venous thromboembolism after major joint replacement surgery. "( Dabigatran etexilate for the prophylaxis of venous thromboembolism after hip or knee replacement rationale for dose regimen.
Dahl, OE, )		3.02
"Dabigatran etexilate is a novel, oral reversible direct thrombin inhibitor that is rapidly absorbed and converted to its active form, dabigatran. "( Pharmacology, pharmacokinetics, and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor.
Clemens, A; Stangier, J, )		1.82
"Dabigatran is a new oral direct thrombin inhibitor."( Dabigatran versus warfarin in patients with atrial fibrillation.
Alings, M; Connolly, SJ; Darius, H; Diaz, R; Diener, HC; Eikelboom, J; Ezekowitz, MD; Joyner, CD; Lewis, BS; Oldgren, J; Parekh, A; Pogue, J; Reilly, PA; Themeles, E; Varrone, J; Wallentin, L; Wang, S; Xavier, D; Yusuf, S; Zhu, J, 2009)		2.52
"Dabigatran etexilate is a potent, non-peptidic small molecule that specifically and reversibly inhibits both free and clot-bound thrombin by binding to the active site of thrombin molecule."( New direct thrombin inhibitors.
Ageno, W; Dentali, F; Squizzato, A; Steidl, L, 2009)		1.07
"Dabigatran is a direct inhibitor of thrombin and rivaroxaban of factor Xa."( [New oral anticoagulants. Consequences for perioperative coagulation diagnostics and therapy].
Heindl, B; Spannagl, M, 2009)		1.07
"Dabigatran (Pradaxa) is a new oral, direct, selective and reversible inhibitor of the factor IIa of the coagulation cascade. "( [Dabigatran: clinical pharmacology].
Laporte, S; Mismetti, P, 2009)		2.71
"Dabigatran is an oral thrombin inhibitor."( [Oral prevention of thromboembolism with rivaroxaban and dabigatran: are the newly approved drugs innovations in orthopaedic and trauma surgery? ].
Gogarten, W; Pauschert, R; Quante, M, 2010)		1.33
"Dabigatran etexilate is an oral direct thrombin inhibitor in clinical development for the prevention and treatment of thromboembolic disorders. "( Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate: an open-label, parallel-group, single-centre study.
Mazur, D; Rathgen, K; Stähle, H; Stangier, J, 2010)		2.03
"Dabigatran etexilate is an oral, reversible direct thrombin inhibitor that is approved in the EU and several other countries for the prevention of venous thromboembolism after elective hip and knee replacement, and is in advanced clinical development for other thromboembolic disorders. "( Dabigatran etexilate--a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity.
Clemens, A; Feuring, M; Haertter, S; Liesenfeld, KH; Stangier, J; van Ryn, J; Wienen, W, 2010)		3.25
"Dabigatran is a direct thrombin inhibitor; it has stable, predictable pharmacokinetics and does not require routine monitoring."( Dabigatran etexilate: a new thrombin inhibitor.
Verma, AK, 2010)		2.52
"Dabigatran etexilate is a new, effective, reversible, rapid-acting, oral direct inhibitor of thrombin. "( Dabigatran etexilate, a new oral direct thrombin inhibitor, for stroke prevention in patients with atrial fibrillation.
Qureshi, AI; Siddiqui, FM, 2010)		3.25
"Dabigatran is a highly selective, reversible, and potent thrombin inhibitor and is orally available as the prodrug, dabigatran etexilate. "( Dabigatran: an oral novel potent reversible nonpeptide inhibitor of thrombin.
Clemens, A; Eisert, WG; Hauel, N; Stangier, J; van Ryn, J; Wienen, W, 2010)		3.25
"Dabigatran is a fixed-dose, oral direct thrombin inhibitor with similar or reduced rates of ischemic stroke and intracranial hemorrhage in patients with AF compared with those of warfarin."( Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation.
Freeman, JV; Garber, AM; Go, AS; Hutton, DW; Owens, DK; Turakhia, MP; Wang, PJ; Zhu, RP, 2011)		1.41
"Dabigatran is a direct thrombin inhibitor that has undergone clinical trials for VTE prophylaxis and treatment."( New synthetic antithrombotic agents for venous thromboembolism: pentasaccharides, direct thrombin inhibitors, direct Xa inhibitors.
Morris, TA, 2010)		1.08
"Dabigatran is an oral, reversible thrombin inhibitor that has shown promising results in large clinical trials. "( Effects of the oral, direct thrombin inhibitor dabigatran on five common coagulation assays.
Baghaei, F; Blixter, IF; Gustafsson, KM; Hillarp, A; Lindahl, TL; Sten-Linder, M; Stigendal, L; Strandberg, K, 2011)		2.07
"Dabigatran (Pradaxa) is a new oral, direct, selective and reversible thrombin inhibitor (factor IIa) acting as anticoagulant. "( [Medication of the month. Dabigatran etixilate (Pradaxa): an oral anticoagulant acting as a direct selective inhibitor of thrombin].
Lancellotti, P; Scheen, AJ, 2010)		2.1
"Dabigatran is a reasonable alternative to warfarin in patients requiring cardioversion."( Dabigatran versus warfarin in patients with atrial fibrillation: an analysis of patients undergoing cardioversion.
Aikens, TH; Brugada, J; Chernick, M; Connolly, SJ; Ezekowitz, MD; Flaker, G; Kamensky, G; Nagarakanti, R; Oldgren, J; Parekh, A; Reilly, PA; Yang, S; Yusuf, S, 2011)		2.53
"Dabigatran is a reversible inhibitor of free thrombin and clot-bound thrombin."( [Direct inhibitors of thrombin, hirudin, bivalirudin, and dabigatran etexilate].
Meddahi, S; Samama, MM, 2011)		1.33
"Dabigatran etexilate is a promising new option for the prevention of stroke and systemic embolism in patients with atrial fibrillation."( Dabigatran etexilate: a review of its use in the prevention of stroke and systemic embolism in patients with atrial fibrillation.
Garnock-Jones, KP, 2011)		2.53
"Dabigatran etexilate is an oral direct thrombin inhibitor that could be administered in fixed doses and does not require laboratory monitoring. "( A new anticoagulant for a new era: review of recent data on dabigatran etexilate.
Faltas, B, 2010)		2.05
"Dabigatran is a direct thrombin inhibitor, which is not metabolized by cytochrome P450, and thus does not require blood coagulation monitoring or vitamin K intake limitation, or produce drug interaction."( [Dabigatran, a new oral anticoagulant].
Uchiyama, S, 2011)		2
"Dabigatran is an effective and safe alternative to oral vitamin K antagonists for stroke prevention in patients with nonvalvular atrial fibrillation, with fewer drug interactions and monitoring requirements. "( Dabigatran etexilate: a novel oral thrombin inhibitor for thromboembolic disease.
Bovio, JA; Gums, JG; Smith, SM, 2011)		3.25
"Dabigatran etexilate is a novel orally administered anticoagulant that exerts its action through reversible direct thrombin inhibition. "( A benefit-risk assessment of dabigatran in the prevention of venous thromboembolism in orthopaedic surgery.
Majeed, A; Schulman, S, 2011)		2.1
"Dabigatran is an oral, reversible direct thrombin inhibitor approved in Europe and in several other countries for the prevention of venous thromboembolism after elective knee and hip replacement surgery."( Antithrombotic therapy in atrial fibrillation: evaluation and positioning of new oral anticoagulant agents.
Aizawa, Y; Atarashi, H; Inoue, H; Kamakura, S; Koretsune, Y; Kumagai, K; Mitamura, H; Ogawa, S; Okumura, K; Sugi, K; Yamashita, T; Yasaka, M, 2011)		1.09
"Dabigatran etexilate is an oral direct thrombin inhibitor that is approved for use in thromboprophylaxis of atrial fibrillation and deep vein thrombosis. "( Potential inaccuracy of point-of-care INR in dabigatran-treated patients.
Baruch, L; Sherman, O, 2011)		2.07
"Dabigatran is an oral anticoagulant that belongs to the class of direct thrombin inhibitors."( Dabigatran in atrial fibrillation: pharmacology and clinical trials.
Ezekowitz, MD; Nagarakanti, R, 2011)		2.53
"Dabigatran etexilate is an oral, reversible direct thrombin inhibitor and has been recently approved for the prevention of stroke in patients with non-valvular atrial fibrillation. "( Incidence and management of ischemic stroke and intracerebral hemorrhage in patients on dabigatran etexilate treatment.
Qureshi, AI; Siddiqui, FM; Watanabe, M, 2012)		2.04
"Dabigatran is a reversible direct thrombin inhibitor (DTI) that has rapid and predictable anticoagulant effects and does not require the anticoagulation monitoring seen with oral vitamin K antagonists. "( Dabigatran etexilate: A novel oral direct thrombin inhibitor.
Blommel, AL; Blommel, ML, 2011)		3.25
"Dabigatran is a direct thrombin (FIIa) inhibitor, whereas Rivaroxaban and Apixaban are direct factor Xa (FXa) inhibitors."( [The new Anticoagulants - Relevant Facts for the GP].
Asmis, LM, 2011)		1.09
"Dabigatran etexilate is an oral direct thrombin inhibitor that has been approved by the US Food and Drug Administration for the prevention of stroke and systemic embolization in patients with nonvalvular atrial fibrillation. "( Hospital-based clinical implications of the novel oral anticoagulant, dabigatran etexilate, in daily practice.
Pendleton, RC; Rodgers, GM; Smock, KJ; Wilcox, R, 2011)		2.05
"Dabigatran (Pradaxa) is a competitive direct thrombin inhibitor approved by the US FDA for prevention of embolic stroke in patients with nonvalvular atrial fibrillation. "( Dabigatran: review of pharmacology and management of bleeding complications of this novel oral anticoagulant.
Babu, KM; Boyer, EW; Brown, RS; Ganetsky, M; Salhanick, SD, 2011)		3.25
"Dabigatran is a new anticoagulant and may be useful after AF ablation to prevent thromboembolic events."( The use of dabigatran immediately after atrial fibrillation ablation.
Engel, G; Kong, MH; Mead, RH; Patrawala, RA; Winkle, RA, 2012)		1.49
"Dabigatran appears to be an alternative to warfarin after AF ablation."( The use of dabigatran immediately after atrial fibrillation ablation.
Engel, G; Kong, MH; Mead, RH; Patrawala, RA; Winkle, RA, 2012)		1.49
"Dabigatran is a direct inhibitor of thrombin that has recently been approved for primary and secondary stroke prevention and prevention of systemic embolism in patients with atrial fibrillation. "( Preventing cardioembolic stroke in atrial fibrillation with dabigatran.
Diener, HC; Eikelboom, JW; Hohnloser, SH; Weimar, C, 2012)		2.06
"Dabigatran (Pradaxa) is a new oral anticoagulant approved in the United States for the primary prevention of stroke and systemic embolization in patients with nonvalvular atrial fibrillation. "( Dabigatran: will it change clinical practice?
Bartholomew, JR; Wartak, SA, 2011)		3.25
"Dabigatran is an oral direct thrombin inhibitor with a rapid onset. "( Advances in anticoagulation: focus on dabigatran, an oral direct thrombin inhibitor.
Augoustides, JG, 2011)		2.08
"Dabigatran etexilate is a specific oral thrombin inhibitor and rivaroxaban and apixaban are oral inhibitors of factor Xa."( [New anticoagulants. Characteristics, monitoring and management of bleeding].
Heidinger, K; Kemkes-Matthes, B, 2011)		1.09
"Dabigatran is an emerging oral anticoagulant which is a direct inhibitor of thrombin activity. "( Pharmacological basis and clinical evidence of dabigatran therapy.
Barez, A; Martínez, MP; Navarro-Dorado, J; Ramajo, M; Redondo, S; Tejerina, T, 2011)		2.07
"Dabigatran is a direct thrombin inhibitor, acting like other members in its class (bivalirudin, argatroban) to impede the clotting process through selective and reversible binding with both free and clot-bound thrombin."( Spontaneous splenic hemorrhage after initiation of dabigatran (Pradaxa) for atrial fibrillation.
Boniface, K; Moore, CH; Scott, J; Snashall, J, 2012)		1.35
"Dabigatran is a direct thrombin inhibitor approved for nonvalvular atrial fibrillation. "( Dabigatran use in a postoperative coronary artery bypass surgery patient with nonvalvular atrial fibrillation and heparin-PF4 antibodies.
Fieland, D; Taylor, M, 2012)		3.26
"Dabigatran is a new oral anticoagulant recently approved for the prevention of stroke or systemic embolism in patients with atrial fibrillation (AF). "( Twice daily dosing of dabigatran for stroke prevention in atrial fibrillation: a pharmacokinetic justification.
Brueckmann, M; Clemens, A; Friedman, J; Haertter, S; Lehr, T; Stangier, J; van Ryn, J, 2012)		2.14
"Dabigatran etexilate is an oral, reversible, direct thrombin inhibitor licensed for the prevention of venous thromboembolism and stroke prevention in patients with atrial fibrillation. "( Switching from enoxaparin to dabigatran etexilate: pharmacokinetics, pharmacodynamics, and safety profile.
Clemens, A; Feuring, M; Härtter, S; Sennewald, R; Stangier, J; van Ryn, J; Yamamura, N, 2012)		2.11
"Dabigatran is a direct thrombin inhibitor, does not require blood coagulation monitoring and limitation of vitamin K intake as well as very few drug interactions, and thus expected to be an oral anticoagulant alternative to warfarin. "( [Expectation to and problems of thrombin inhibitor].
Uchiyama, S, 2011)		1.81
"Dabigatran etexilate is a new oral anticoagulant recently approved in Europe for the prevention of stroke or systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and at least one risk factor for stroke. "( Dabigatran etexilate for stroke prevention in patients with atrial fibrillation: resolving uncertainties in routine practice.
Brueckmann, M; Clemens, A; Diener, HC; Huisman, MV; Lip, GY; van Ryn, J, 2012)		3.26
"Dabigatran is a reversible, direct thrombin inhibitor, which is administered as dabigatran etexilate, the oral prodrug."( New oral antithrombotics: focus on dabigatran, an oral, reversible direct thrombin inhibitor for the prevention and treatment of venous and arterial thromboembolic disorders.
Dahl, OE, 2012)		1.38
"Dabigatran is an oral direct thrombin-inhibitor recently approved for stroke prevention in atrial fibrillation."( Warfarin versus dabigatran: comparing the old with the new.
Abraham, ME; Marcy, TR, 2012)		1.45
"Dabigatran (Pradaxa) is a member of the relatively new class of antithrombotic drugs known as direct thrombin inhibitors (DTIs). "( Dabigatran (Pradaxa).
Comin, J; Kallmes, DF, 2012)		3.26
"Dabigatran etexilate is an oral anticoagulant that acts as a direct, competitive thrombin inhibitor. "( Neurosurgical complications of direct thrombin inhibitors--catastrophic hemorrhage after mild traumatic brain injury in a patient receiving dabigatran.
Garber, ST; Schmidt, RH; Sivakumar, W, 2012)		2.02
"Dabigatran is a direct thrombin (factor IIa) inhibitor that overcomes many of the limitations associated with warfarin."( Dabigatran and factor Xa inhibitors for stroke prevention in patients with nonvalvular atrial fibrillation.
Ibayashi, S; Matsumoto, M; Nagao, T; Nagata, K; Nakagawara, J; Tanahashi, N; Tanaka, K; Toyoda, K; Uchiyama, S; Yasaka, M, 2012)		2.54
"Dabigatran etexilate is a direct thrombin inhibitor that has been in clinical use for the prevention and treatment of venous and arterial thrombosis. "( Thromboembolic prophylaxis in orthopedic surgery using dabigatran: an oral direct thrombin inhibitor.
Garza, R; Huo, MH, 2012)		2.07
"Dabigatran is a potent reversible, competitive direct thrombin inhibitor which is available as the prodrug, Dabigatran etexilate."( Dabigatran: a new chapter in anticoagulation.
Ahmed, S; Levin, V; Malacoff, R; Martinez, MW, 2012)		2.54
"Dabigatran etexilate is a new oral anticoagulant used for the prevention of systemic thromboembolism in patients with atrial fibrillation. "( Hemopericardium in a patient treated with dabigatran etexilate.
Barton, CA; Keller, RE; McMillian, WD; Raza, SS, 2012)		2.09
"Dabigatran is an oral direct thrombin inhibitor."( [Clinical studies, the interests and limits of using dabigatran in atrial fibrillation].
Chatelain, B; Chatelain, C; Dogné, JM; Douxfils, J; Mullier, F; Spinewine, A; Sternotte, A, 2012)		1.35
"Dabigatran etexilate is a new oral direct thrombin inhibitor for prophylaxis of venous thromboembolism (VTE) in patients who have elective surgery for total hip replacement (THR) or total knee replacement (TKR). "( Economic evaluation of dabigatran etexilate for the primary prevention of venous tromboembolic events following major orthopedic surgery in the Netherlands.
Brouwers, JR; Kappelhoff, BS; Postma, MJ; van Hulst, M, 2012)		2.13
"Dabigatran etexilate is an oral prodrug of the potent, rapidly acting, reversible, competitive inhibitor of thrombin, dabigatran."( Dabigatran etexilate: a review of its use for the prevention of venous thromboembolism after total hip or knee replacement surgery.
Burness, CB; McKeage, K, 2012)		2.54
"Dabigatran is a viable alternative to VKA that provides many advantages over these drugs and is certainly preferred by most patients due to the problems of VKA follow-up."( [Dabigatran: a new therapeutic alternative in the prevention of stroke].
Gállego, J; Gil Alzueta, MC, 2012)		2.01
"Dabigatran etexelate is a new oral direct thrombin inhibitor that has been approved by the US Food and Drug Administration to prevent stroke in patients with nonvalvular atrial fibrillation. "( Acute ischemic stroke treated with intravenous tissue plasminogen activator in a patient taking dabigatran with radiographic evidence of recanalization.
El Khoury, R; Lopez, G; Misra, V; Sangha, N, 2012)		2.04
"Dabigatran is a cost-effective treatment in Sweden, as its incremental cost-effectiveness ratio is below the normally accepted willingness to pay limit."( Cost-effectiveness of dabigatran compared with warfarin for patients with atrial fibrillation in Sweden.
Davidson, T; Husberg, M; Janzon, M; Levin, LÅ; Oldgren, J, 2013)		2.15
"Dabigatran is a novel direct thrombin inhibitor that has recently been approved for primary and secondary stroke prevention and prevention of systemic embolism in patients with atrial fibrillation. "( Dabigatran for stroke prevention in atrial fibrillation.
Diener, HC; Hohnloser, SH, 2012)		3.26
"Dabigatran is an oral direct thrombin inhibitor indicated for the prevention of stroke and systemic thromboembolism in patients with nonvalvular AF, at a dose of 150 mg twice daily. "( Pharmacokinetic and clinical implications of dabigatran use in severe renal impairment for stroke prevention in nonvalvular atrial fibrillation.
Kim, JJ; Mack, DR, )		1.83
"Dabigatran is an oral direct thrombin inhibitor approved for the reduction of stroke and systemic embolism risk in patients with nonvalvular atrial fibrillation. "( Hemopericardium and cardiac tamponade associated with dabigatran use.
Dy, EA; Shiltz, DL, )		1.82
"Dabigatran (Pradaxa) is a new oral anticoagulant approved by the Food and Drug Administration (FDA), available internationally and indicated as an alternative to warfarin for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. "( Fatal gastrointestinal hemorrhage after a single dose of dabigatran.
Boesen, K; Ito, S; Kernan, L; Shirazi, F, 2012)		2.07
"Dabigatran is an effective thromboprophylactic therapy for normal, pre-obese and obese patients, and outcomes in patients with a BMI >25 kg/m(2) do not differ from the overall population."( Dabigatran is effective with a favourable safety profile in normal and overweight patients undergoing major orthopaedic surgery: a pooled analysis.
Clemens, A; Dahl, OE; Eriksson, BI; Feuring, M; Friedman, RJ; Hantel, S; Huo, M; Noack, H, 2012)		3.26
"Dabigatran is a novel oral direct thrombin inhibitor that has been shown to have beneficial outcomes in the prevention of thromboembolic stroke in patients with atrial fibrillation. "( Evaluating and assessing dabigatran drug interactions.
Nguyen, T; Wong, E, 2012)		2.13
"Dabigatran is a direct thrombin inhibitor approved for anticoagulation in non-valvular atrial fibrillation and, in some countries, for thromboembolism prophylaxis following select orthopedic surgeries. "( Hemorrhagic complications associated with dabigatran use.
Basciano, P; Chen, BC; Garlich, FM; Hoffman, RS; Howland, MA; Nelson, LS; Smith, SW; Viny, AD, 2012)		2.09
"Dabigatran etexilate is a novel oral direct thrombin inhibitor, which provides stroke risk reduction for patients with nonvalvular atrial fibrillation."( Dabigatran in clinical practice.
Ellis, CR; Nagarakanti, R, 2012)		2.54
"Dabigatran is a recently introduced direct thrombin inhibitor licensed for use as an oral anticoagulant for stroke prevention in non-valvular atrial fibrillation. "( Dabigatran for anticoagulation in atrial fibrillation - early clinical experience in a hospital population and comparison to trial data.
Boga, T; Michel, J; Mundell, D; Sasse, A, 2013)		3.28
"Dabigatran etexilate is a new oral anticoagulant for the therapy and prophylaxis of venous thromboembolism and stroke prevention in patients with atrial fibrillation. "( Interference of the new oral anticoagulant dabigatran with frequently used coagulation tests.
Aspoeck, G; Goebel, G; Griesmacher, A; Halbmayer, WM; Haushofer, AC; Loacker, L; Quehenberger, P; Schnapka-Koepf, M; Tomasits, J; Weigel, G, 2012)		2.08
"Dabigatran is an oral and direct inhibitor of thrombin. "( Analysis of upper gastrointestinal adverse events among patients given dabigatran in the RE-LY trial.
Aisenberg, J; Bytzer, P; Connolly, SJ; Ezekowitz, M; Formella, S; Reilly, PA; Yang, S, 2013)		2.07
"Dabigatran is an oral direct thrombin inhibitor recently approved for stroke prevention in atrial fibrillation (AF) as an alternative to warfarin. "( Dabigatran compared with warfarin for stroke prevention with atrial fibrillation: experience in Hong Kong.
Chang, AM; Ho, JC; Lam, YY; Lee, VW; Yan, BP; Yu, CM, 2012)		3.26
"Dabigatran etexilate is a competitive, direct thrombin inhibitor that works in the coagulation cascade to ultimately prevent thrombus formation. "( Treatment of dabigatran-associated bleeding: case report and review of the literature.
Harinstein, LM; Morgan, JW; Russo, N, 2013)		2.2
"Dabigatran is a newly available oral direct thrombin inhibitor approved for anticoagulation therapy to prevent strokes in patients with nonvalvular atrial fibrillation. "( Removal of dabigatran by hemodialysis.
Chang, DN; Chin, AI; Dager, WE, 2013)		2.22
"Dabigatran etexilate is a new oral anticoagulant that functions as a direct thrombin inhibitor. "( The effect of dabigatran on select specialty coagulation assays.
Adcock, DM; Dwyre, DM; Gosselin, R; Kitchen, S, 2013)		2.19
"Dabigatran is a new oral anticoagulant that does not require INR monitoring."( Cost-effectiveness of dabigatran for stroke prevention in atrial fibrillation in Switzerland.
Eichler, K; Plessow, R; Pletscher, M; Wieser, S, 2013)		1.43
"Dabigatran etexilate is an oral, reversible direct thrombin inhibitor, with predictable and reproducible pharmacodynamic effects and pharmacokinetic characteristics that permit once-daily dosing."( Dabigatran vs. low molecular weight heparin in preventing venous thromboembolism after elective hip and knee arthroplasty: evaluation of selected clinical parameters.
Jackiewicz, A; Krzemiński, M; Mrozik, D, 2012)		2.54
"Dabigatran etexilate is an oral prodrug of dabigatran, a direct thrombin inhibitor, that provides the first available oral anticoagulant alternative to warfarin for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). "( The pharmacology and therapeutic use of dabigatran etexilate.
Sarah, S, 2013)		2.1
"Dabigatran etexilate is an oral direct thrombin inhibitor undergoing evaluation for the prevention of venous thromboembolism (VTE) following orthopedic surgery."( A new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial.
Ahnfelt, L; Bravo, ML; Büller, HR; Dahl, OE; Eriksson, BI; Hettiarachchi, R; Kälebo, P; Piovella, F; Reilly, P; Rosencher, N; Stangier, J, 2005)		2.04
"Dabigatran etexilate is an oral low-molecular-weight direct thrombin inhibitor. "( Pharmacokinetic profile of the oral direct thrombin inhibitor dabigatran etexilate in healthy volunteers and patients undergoing total hip replacement.
Ahnfelt, L; Dahl, OE; Eriksson, BI; Nehmiz, G; Rathgen, K; Stähle, H; Stangier, J; Svärd, R, 2005)		2.01
"Dabigatran is a reversible and selective, direct thrombin inhibitor (DTI) undergoing advanced clinical development as its orally active prodrug, dabigatran etexilate. "( In-vitro profile and ex-vivo anticoagulant activity of the direct thrombin inhibitor dabigatran and its orally active prodrug, dabigatran etexilate.
Hauel, N; Priepke, H; Ries, UJ; Stassen, JM; Wienen, W, 2007)		2.01
"Dabigatran is a reversible direct, selective thrombin inhibitor, undergoing clinical development as its orally active prodrug, dabigatran etexilate. "( Effects of the direct thrombin inhibitor dabigatran and its orally active prodrug, dabigatran etexilate, on thrombus formation and bleeding time in rats.
Hauel, N; Priepke, H; Ries, UJ; Stassen, JM; Wienen, W, 2007)		2.05
"Dabigatran etexilate is an orally administered prodrug, which is rapidly absorbed and converted to the active form, dabigatran."( Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate.
Stangier, J, 2008)		1.29

Effects

Dabigatran has a favorable impact on effectiveness and safety outcomes compared with vitamin K antagonists in real-world populations. It has a wide therapeutic range that allows for fixed-dose administration without the need for routine monitoring, a requirement of standard vitamin K antagonist (VKA) therapy.

Dabigatran has emerged as a promising alternative to vitamin K antagonists (VKAs) in non-valvular atrial fibrillation (NVAF) It has been shown, relative to warfarin, to reduce thromboembolic events without increasing bleeding.

ExcerptReferenceRelevance
"Dabigatran has a favorable impact on effectiveness and safety outcomes compared with vitamin K antagonists in real-world populations."( Effectiveness and Safety of Dabigatran Compared to Vitamin K Antagonists in Non-Asian Patients with Atrial Fibrillation: A Systematic Review and Meta-Analysis.
Amin, AN; Auladell-Rispau, A; Barrios, V; Escobar, C; Lip, GYH; Requeijo, C; Salazar, J; Santero, M, 2021)		2.36
"Dabigatran has a better safety profile and requires less monitoring, but is costlier than warfarin. "( Cost-Utility Analysis of Dabigatran and Warfarin for Stroke Prevention Among Patients With Nonvalvular Atrial Fibrillation in India.
Aggarwal, R; Aghoram, R; Kar, SS; Kumar, SM; Rajasulochana, SR, 2022)		2.47
"Dabigatran also has a favorable safety profile for prevention of VTE, and rivaroxaban has a favorable safety profile for VTE prevention in children with congenital heart disease."( Just DOAC: Use of direct-acting oral anticoagulants in pediatrics.
Cober, MP; Fenn, NE; Hill, C; King, M; Mills, K; Omecene, NE; Pauley, JL; Sierra, CM; Smith, T, 2023)		1.63
"As dabigatran has a favourable benefit-risk profile, it is being increasingly used."( Dabigatran: patient management in specific clinical settings.
Binder, K; Domanovits, H; Eichinger, S; Függer, R; Gollackner, B; Hiesmayr, JM; Huber, K; Kyrle, PA; Lang, W; Perger, P; Quehenberger, P; Roithinger, FX; Schmaldienst, S; Weltermann, A, 2014)		2.36
"Dabigatran etexilate has a wide therapeutic range that allows for fixed-dose administration without the need for routine monitoring, a requirement of standard vitamin K antagonist (VKA) therapy."( Dabigatran etexilate: a review of its use in the treatment of acute venous thromboembolism and prevention of venous thromboembolism recurrence.
Greig, SL; McKeage, K, 2014)		2.57
"Dabigatran has a stable pharmacokinetic profile with minimum drug interactions, and requires no routine laboratory evaluation to measure level of anticoagulation."( Management of dabigatran-induced bleeding with continuous venovenous hemodialysis.
Ali, A; Assaly, R; Hamouda, D; Khan, A; Mbaso, C; Paul, S; Prashar, R; Shah, S, 2015)		1.5
"Dabigatran has an impact on a large panel of used coagulation tests."( Thrombin time and anti-IIa dabigatran's activity: hypothesis of thrombin time's predictive value.
Kaabar, M; Le Guyader, M; Lemaire, P; Pineau Vincent, F, )		1.15
"Dabigatran has a low level of plasma protein binding and has been considered dialyzable."( The effect of ultrafiltration with cardiopulmonary bypass on the removal of dabigatran from the circulation of adult pigs.
Carter, CB; DeNino, WF; Goss, A; Mukherjee, R; Sievert, A; Toole, JM; Uber, WE, 2016)		1.39
"Dabigatran has a predictable pharmacokinetic profile, allowing for a fixed-dose regimen without the need for routine coagulation monitoring."( Dabigatran etexilate--a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity.
Clemens, A; Feuring, M; Haertter, S; Liesenfeld, KH; Stangier, J; van Ryn, J; Wienen, W, 2010)		2.52
"Dabigatran has a low potential for drug-drug interactions and is predominantly renally excreted."( Dabigatran: an oral novel potent reversible nonpeptide inhibitor of thrombin.
Clemens, A; Eisert, WG; Hauel, N; Stangier, J; van Ryn, J; Wienen, W, 2010)		2.52
"Dabigatran has a pharmacokinetic profile that produces predictable anticoagulation responses, does not undergo CYP 450 metabolism, has few drug-drug and drug-food interactions, and does not require frequent laboratory monitoring of clotting parameters."( Dabigatran: review of pharmacology and management of bleeding complications of this novel oral anticoagulant.
Babu, KM; Boyer, EW; Brown, RS; Ganetsky, M; Salhanick, SD, 2011)		2.53
"Dabigatran has a favorable impact on effectiveness and safety outcomes compared with vitamin K antagonists in real-world populations."( Effectiveness and Safety of Dabigatran Compared to Vitamin K Antagonists in Non-Asian Patients with Atrial Fibrillation: A Systematic Review and Meta-Analysis.
Amin, AN; Auladell-Rispau, A; Barrios, V; Escobar, C; Lip, GYH; Requeijo, C; Salazar, J; Santero, M, 2021)		2.36
"Dabigatran has a better safety profile and requires less monitoring, but is costlier than warfarin. "( Cost-Utility Analysis of Dabigatran and Warfarin for Stroke Prevention Among Patients With Nonvalvular Atrial Fibrillation in India.
Aggarwal, R; Aghoram, R; Kar, SS; Kumar, SM; Rajasulochana, SR, 2022)		2.47
"Dabigatran has been shown to be noninferior to standard of care (SOC) in terms of efficacy, with similar bleeding rates."( Just DOAC: Use of direct-acting oral anticoagulants in pediatrics.
Cober, MP; Fenn, NE; Hill, C; King, M; Mills, K; Omecene, NE; Pauley, JL; Sierra, CM; Smith, T, 2023)		1.63
"Dabigatran has the potential to preserve perfusion and oxygen delivery to the brain, and to prevent parenchymal Aβ-, thrombin- and fibrin-triggered inflammatory and neurodegenerative processes, leading to synapse and neuron death, and cognitive decline."( Alzheimer's Disease-Rationales for Potential Treatment with the Thrombin Inhibitor Dabigatran.
Grossmann, K, 2021)		1.57
"Dabigatran has edge over VKAs like warfarin and acenocoumarol including predictable pharmacokinetic and pharmacodynamic profile, minimal drug-drug and no drug-food interactions while no monitoring is needed."( Dabigatran - the First Approved DTI for SPAF.
Hiremath, JS; Trailokya, A, 2018)		2.64
"Dabigatran use has been linked to gastrointestinal complaints, but it is unknown if this leads to more use of proton pump inhibitors (PPI). "( Direct oral anticoagulant use and subsequent start of proton pump inhibitors as proxy for gastric complaints.
Cannegieter, SC; Huisman, MV; Klok, FA; Lijfering, WM; Rosendaal, FR; Teichert, M; Zielinski, GD, 2018)		1.92
"Dabigatran has stricter prescribing advice than rivaroxaban or apixaban for patients with moderate-to-severe renal impairment."( Novel oral anticoagulants: clinical pharmacology, indications and practical considerations.
Graff, J; Harder, S, 2013)		1.11
"Dabigatran has demonstrated promising results for the prevention of strokes in patients with non-valvular atrial fibrillation (NVAF). "( Bleeding events and activated partial thromboplastin time with dabigatran in clinical practice.
Hachiya, H; Hirao, K; Isobe, M; Kawabata, M; Nakamura, T; Sasano, T; Sugiyama, K; Suzuki, M; Tanaka, Y; Yagishita, A; Yokoyama, Y, 2013)		2.07
"Dabigatran has been approved by the FDA for stroke and systemic embolism prevention in non-valvular atrial fibrillation as an alternative to warfarin."( Patients satisfaction with warfarin and willingness to switch to dabigatran: a patient survey.
DeRemer, CE; Elewa, HF; Gujral, J; Joshua, TV; Keller, K, 2014)		1.36
"Dabigatran has similar efficacy and safety compared with warfarin when used for periprocedural anticoagulation during AF ablation."( Safety and efficacy of dabigatran etexilate during catheter ablation of atrial fibrillation: a meta-analysis of the literature.
Camm, AJ; Hohnloser, SH, 2013)		2.14
"Dabigatran has been associated with greater risk of myocardial infarction (MI) than warfarin. "( Meta-analysis of randomized controlled trials on risk of myocardial infarction from the use of oral direct thrombin inhibitors.
Artang, R; Nielsen, JD; Rome, E; Vidaillet, HJ, 2013)		1.83
"Dabigatran has been introduced into clinical practice, although issues like laboratory monitoring, its use in elderly patients, drug and food interactions, and an antidote have not been completely clarified."( Life-threatening epistaxis and red blood cell polyagglutination under dabigatran.
Finsterer, J; Krutisch, G; Stöllberger, C, 2014)		1.36
"Dabigatran and warfarin have been compared for the treatment of acute venous thromboembolism (VTE) in a previous trial. "( Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.
Christiansen, AV; Eriksson, H; Friedman, J; Goldhaber, SZ; Kakkar, AK; Kearon, C; Le Maulf, F; Mismetti, P; Peter, N; Schellong, S; Schulman, S, 2014)		2.1
"Dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE."( Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.
Christiansen, AV; Eriksson, H; Friedman, J; Goldhaber, SZ; Kakkar, AK; Kearon, C; Le Maulf, F; Mismetti, P; Peter, N; Schellong, S; Schulman, S, 2014)		2.1
"Dabigatran has several advantages over warfarin including predictable pharmacokinetics and pharmacodynamics which eliminates the need for routine laboratory monitoring, superiority over warfarin in preventing stroke, or systemic embolism without having an increased risk of bleeding."( A Review of and Recommendations for the Management of Patients With Life-Threatening Dabigatran-Associated Hemorrhage: A Single-Center University Hospital Experience.
Henry, BL; Kumar, R; Smith, RE, 2015)		1.36
"Dabigatran has advantages over warfarin including predictable pharmacokinetic/pharmacodynamic profile, minimal drug-drug and no drug-food interactions while no monitoring is needed.The 150 mg dose of dabigatran should be considered in younger patients with a low risk of bleeding and good renal function to achieve a superior ischemic stroke reduction, whereas, the 110 mg dose should be considered in elderly patients, those with mild to moderate renal function or those with high risk of bleeding."( Dabigatran etexilate in atrial fibrillation.
Vora, A, 2013)		2.55
"Dabigatran has also been approved for this indication recently."( The potential of target-specific oral anticoagulants for the acute and long-term treatment of venous thromboembolism.
Akwaa, F; Spyropoulos, AC, 2014)		1.12
"As dabigatran has a favourable benefit-risk profile, it is being increasingly used."( Dabigatran: patient management in specific clinical settings.
Binder, K; Domanovits, H; Eichinger, S; Függer, R; Gollackner, B; Hiesmayr, JM; Huber, K; Kyrle, PA; Lang, W; Perger, P; Quehenberger, P; Roithinger, FX; Schmaldienst, S; Weltermann, A, 2014)		2.36
"Dabigatran has emerged as a promising alternative to vitamin K antagonists (VKAs) in non-valvular atrial fibrillation (NVAF)."( [Eligibility for dabigatran therapy: the real-life experience of a Tuscany general hospital].
Banfi, R; Fallani, F; Palazzi, N; Pugi, A, 2014)		1.46
"Dabigatran etexilate has a wide therapeutic range that allows for fixed-dose administration without the need for routine monitoring, a requirement of standard vitamin K antagonist (VKA) therapy."( Dabigatran etexilate: a review of its use in the treatment of acute venous thromboembolism and prevention of venous thromboembolism recurrence.
Greig, SL; McKeage, K, 2014)		2.57
"Dabigatran etexilate has been tested thoroughly in terms of efficacy and safety in clinical trials and studies, involving 'real-world' cohorts."( Warfarin versus dabigatran etexilate: an assessment of efficacy and safety in patients with atrial fibrillation.
Dzeshka, MS; Lip, GY, 2015)		1.48
"Dabigatran has been approved for prevention of thromboembolic complications in nonvalvular atrial fibrillation. "( [Thrombosis of a mechanical prosthetic mitral valve during dabigatran treatment].
Hassager, C; Kjaergaard, J; Saust, LT; Thomsen, JH; Wachtell, K, 2014)		2.09
"Dabigatran has a stable pharmacokinetic profile with minimum drug interactions, and requires no routine laboratory evaluation to measure level of anticoagulation."( Management of dabigatran-induced bleeding with continuous venovenous hemodialysis.
Ali, A; Assaly, R; Hamouda, D; Khan, A; Mbaso, C; Paul, S; Prashar, R; Shah, S, 2015)		1.5
"Dabigatran has been shown, relative to warfarin, to reduce thromboembolic events without increasing bleeding."( Cost-effectiveness analysis of dabigatran and anticoagulation monitoring strategies of vitamin K antagonist.
Alonso-Coello, P; Brosa, M; Carles, M; Garcia-Alamino, JM; Guyatt, G; Souto, JC, 2015)		1.42
"Dabigatran has demonstrated similar efficacy and safety to enoxaparin for VTE prevention in patients undergoing hip and knee arthroplasty, and to warfarin for the treatment of VTE. "( The evolving role of dabigatran etexilate in clinical practice.
Drambarean, B; Hellenbart, E; Lee, J; Nutescu, EA, 2015)		2.18
"Dabigatran has significantly less major or clinically relevant bleeds (MCRBE) compared to rivaroxaban in treatment after index DVT and treatment after DVT or PE combined, but was not significantly different from rivaroxaban after index PE or in extended anticoagulation."( Indirect comparison and cost-utility of dabigatran etexilate and rivaroxaban in the treatment and extended anticoagulation of venous thromboembolism in a UK setting.
De Francesco, M; Hösel, V; Jugrin, AV; Lamotte, M; Sunderland, T; Ustyugova, A, 2016)		1.42
"Dabigatran has an impact on a large panel of used coagulation tests."( Thrombin time and anti-IIa dabigatran's activity: hypothesis of thrombin time's predictive value.
Kaabar, M; Le Guyader, M; Lemaire, P; Pineau Vincent, F, )		1.15
"Dabigatran has a low level of plasma protein binding and has been considered dialyzable."( The effect of ultrafiltration with cardiopulmonary bypass on the removal of dabigatran from the circulation of adult pigs.
Carter, CB; DeNino, WF; Goss, A; Mukherjee, R; Sievert, A; Toole, JM; Uber, WE, 2016)		1.39
"Dabigatran has been shown to be superior to warfarin for stroke prevention in nonvalvular atrial fibrillation (NVAF) but with higher out-of-pocket costs for patients. "( Cost-Effectiveness of Dabigatran (150 mg Twice Daily) and Warfarin in Patients ≥ 65 Years With Nonvalvular Atrial Fibrillation.
Barnes, GD; Froehlich, JB; Hutton, DW; Levine, DA; Salata, BM, 2016)		2.19
"Dabigatran has activity in antagonizing all these effects, thereby impairing tumor growth and progression."( Dabigatran antagonizes growth, cell-cycle progression, migration, and endothelial tube formation induced by thrombin in breast and glioblastoma cell lines.
Fabris, F; Goss, A; Prandoni, P; Sambado, L; Vianello, F, 2016)		2.6
"Dabigatran etexilate has been studied in clinical trials as prophylaxis for venous thromboembolism in patients undergoing total knee replacement or total hip replacement surgeries, as well as for stroke prevention in patients with atrial fibrillation."( Dabigatran etexilate: an oral direct thrombin inhibitor for prophylaxis and treatment of thromboembolic diseases.
Baetz, BE; Spinler, SA, 2008)		2.51
"Dabigatran etexilate has been investigated in three phase III trials for the prevention of venous thromboembolism (VTE). "( Efficacy and safety of dabigatran etexilate for the prevention of venous thromboembolism following total hip or knee arthroplasty. A meta-analysis.
Caprini, JA; Eriksson, BI; Plumb, JM; Roskell, NS; Wolowacz, SE, 2009)		2.11
"Dabigatran has been shown to be a potent, competitive, and reversible inhibitor of thrombin, inhibiting both thrombin activity and generation."( Pharmacology, pharmacokinetics, and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor.
Clemens, A; Stangier, J, )		1.1
"Dabigatran has a predictable pharmacokinetic profile, allowing for a fixed-dose regimen without the need for routine coagulation monitoring."( Dabigatran etexilate--a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity.
Clemens, A; Feuring, M; Haertter, S; Liesenfeld, KH; Stangier, J; van Ryn, J; Wienen, W, 2010)		2.52
"Dabigatran has a low potential for drug-drug interactions and is predominantly renally excreted."( Dabigatran: an oral novel potent reversible nonpeptide inhibitor of thrombin.
Clemens, A; Eisert, WG; Hauel, N; Stangier, J; van Ryn, J; Wienen, W, 2010)		2.52
"Dabigatran has also demonstrated efficacy in the prevention of venous thromboembolism in patients undergoing total hip or knee replacement surgery as well as the prevention of recurrent venous thromboembolism, although these are not current Food and Drug Administration-approved indications."( Dabigatran etexilate: the first oral anticoagulant available in the United States since warfarin.
Cheng-Lai, A; Tran, A, )		2.3
"Dabigatran has predictable pharmacokinetics, without significant drug and food interactions, rapid onset, and requires twice-daily administration without the need for monitoring."( Dabigatran in atrial fibrillation: pharmacology and clinical trials.
Ezekowitz, MD; Nagarakanti, R, 2011)		2.53
"Dabigatran etexilate has demonstrated efficacy in several clinical studies in preventing venous thromboembolism (VTE) for patients undergoing total hip or knee replacement, in preventing strokes in patients with nonvalvular atrial fibrillation, and in treating acute VTE."( Dabigatran etexilate: A novel oral direct thrombin inhibitor.
Blommel, AL; Blommel, ML, 2011)		2.53
"Dabigatran has a pharmacokinetic profile that produces predictable anticoagulation responses, does not undergo CYP 450 metabolism, has few drug-drug and drug-food interactions, and does not require frequent laboratory monitoring of clotting parameters."( Dabigatran: review of pharmacology and management of bleeding complications of this novel oral anticoagulant.
Babu, KM; Boyer, EW; Brown, RS; Ganetsky, M; Salhanick, SD, 2011)		2.53
"Dabigatran has been approved in the United States for prevention of stroke in patients with nonvalvular atrial fibrillation and in the European Union and other countries for primary prevention of thromboembolic events after total knee or hip replacement."( Dabigatran etexilate: what do hospitalists need to know?
Faltas, B; Streiff, M; Zeidan, A, 2012)		2.54
"Dabigatran has been granted authorisation by the FDA in non-valvular atrial fibrillation (RE-LY trial) while rivaroxaban is expecting approval in this same indication (ROCKET trial)."( [Pharmacologic heterogeneity of new anticoagulants].
Combe, S; Conard, J; Flaujac, C; Horellou, MH; Samamaa, MM, 2011)		1.09
"Dabigatran has been investigated for the treatment of established venous thromboembolism and prevention of recurrence in patients undergoing hip or knee replacement, as well as for stroke prevention in atrial fibrillation patients with a moderate and high risk of stroke."( New oral antithrombotics: focus on dabigatran, an oral, reversible direct thrombin inhibitor for the prevention and treatment of venous and arterial thromboembolic disorders.
Dahl, OE, 2012)		1.38
"As dabigatran (Pradaxa) has recently been approved by the Food and Drug Administration, many spine specialists are not familiar with this agent. "( Epidural hematoma and intraoperative hemorrhage in a spine trauma patient on Pradaxa (dabigatran).
Dieterichs, C; Gaudu, T; Geck, M; Stokes, J; Truumees, E, 2012)		1.22
"Dabigatran has predictable and consistent anticoagulant effects and does not require routine coagulation monitoring or dose titration."( Dabigatran etexilate: a review of its use for the prevention of venous thromboembolism after total hip or knee replacement surgery.
Burness, CB; McKeage, K, 2012)		2.54
"Dabigatran has been introduced into the prevention of stroke in patients with atrial fibrillation. "( [Dabigatran and emergency operation on a peritonitis patient].
Ilmakunnas, M; Lassila, R; Louhimo, J, 2012)		2.73
"Dabigatran has the advantage of providing rapid and steady anticoagulation without requiring laboratory monitoring. "( Dabigatran: a primer for neurosurgeons.
Fugate, JE; Lanzino, G; McBane, RD; Rabinstein, AA, 2013)		3.28
"Dabigatran, however, has not been compared to the home-monitoring."( Home-monitoring of oral anticoagulation vs. dabigatran. An indirect comparison.
Alonso-Coello, P; Guyatt, G; Zhou, Q, 2012)		1.36
"Dabigatran has been rapidly adopted into ambulatory practice in the United States, primarily for treatment of atrial fibrillation, but increasingly for off-label indications. "( National trends in oral anticoagulant use in the United States, 2007 to 2011.
Alexander, GC; Kirley, K; Kornfield, R; Qato, DM; Stafford, RS, 2012)		1.82
"Dabigatran has also been approved in several countries for the prevention of venous thrombosis in patients undergoing total knee or hip replacement."( [Waiting for the new oral anticoagulants: questions and answers about dabigatran].
Agnelli, G; Verdecchia, P, 2013)		1.35
"Dabigatran has been shown to specifically and reversibly inhibit thrombin, the key enzyme in the coagulation cascade."( Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate.
Stangier, J, 2008)		1.29

Actions

Dabigatran provides an increase of 0.331 life years and 0.354 quality-adjusted life years for each patient. Dabig atran did not increase the risk of myocardial infarction or major gastrointestinal bleeding in all age groups when compared with warfarin.

ExcerptReferenceRelevance
"Dabigatran-induced increase in the systolic blood pressure was not affected by PAR-1 modulators."( Role of protease-activated receptor-1 (PAR-1) in the glomerular filtration barrier integrity.
Biederman, L; Brodsky, SV; Ivanov, I; Kerlin, BA; Medipally, A; Parikh, S; Rovin, B; Satoskar, AA; Xiao, M, 2022)		1.44
"Dabigatran had a lower risk of stroke/SE and a similar risk of MB when compared with rivaroxaban."( Effectiveness and Safety of Direct Oral Anticoagulants Among Patients with Non-valvular Atrial Fibrillation and Multimorbidity.
Atreja, N; Dhamane, AD; Di Fusco, M; Emir, B; Ferri, M; Gutierrez, C; Keshishian, A; Russ, C; Yuce, H, 2023)		1.63
"Dabigatran showed lower risk of all-cause mortality than warfarin and of intracranial bleeding than rivaroxaban."( Efficacy and Safety of Oral Anticoagulants in Older Adult Patients With Atrial Fibrillation: Pairwise and Network Meta-Analyses.
Chen, K; Chen, X; Chen, Z; Ju, J; Li, Q; Ma, D; Tian, W; Wang, T; Wang, X; Xu, H; Zhang, J, 2023)		1.63
"Dabigatran users had lower incidence rate for stroke (0.65 vs 1.06) and bleed (1.69 vs 2.20), stroke (0.0006 vs 0.0011, p < 0.001) and bleed-specific hospitalizations (0.002 vs 0.003, p = 0.008), and stroke (0.03 vs 0.04, p < 0.001) and bleed-specific outpatient visits (0.07 vs 0.08, p = 0.018), and significantly lower non-persistence (62.1% vs 66.3%, p < 0.001)."( Comparison of all-cause, stroke, and bleed-specific healthcare resource utilization among patients with non-valvular atrial fibrillation (NVAF) and newly treated with dabigatran or warfarin.
Arora, P; Gandhi, P; Gilligan, AM; Henriques, C; Sander, S; Smith, DM; Song, X; Wang, C, 2019)		1.43
"Dabigatran had lower adherence (PDC = 0.76, 0.64, 0.57) compared with rivaroxaban (PDC = 0.83, 0.73, 0.66; P < 0.001) and apixaban (PDC = 0.82, 0.72, 0.66; P < 0.001) at 3, 6, and 9 months of follow-up and twice the number of switches to either other anticoagulants or antiplatelet therapy. "( Adherence to Rivaroxaban, Dabigatran, and Apixaban for Stroke Prevention for Newly Diagnosed and Treatment-Naive Atrial Fibrillation Patients: An Update Using 2013-2014 Data.
Brown, JD; Shewale, AR; Talbert, JC, 2017)		2.2
"Dabigatran users had lower hazard of MH compared with warfarin users among patients with low MCC (hazard ratio [HR], 0.62; 95% CI, 0.47-0.83; P < .001; for MCC defined as low CHA2DS2-VASc score), and similar risk in patients with moderate to high MCC."( Assessment of Outcomes of Treatment With Oral Anticoagulants in Patients With Atrial Fibrillation and Multiple Chronic Conditions: A Comparative Effectiveness Analysis.
Chaudhury, P; Mentias, A; Shantha, G; Vaughan Sarrazin, MS, 2018)		1.2
"The dabigatran group had a lower frequency of minor bleeding and number of medical appointments than the warfarin group, without more embolic events or major bleeding."( Dabigatran and warfarin in nonvalvular atrial fibrillation or atrial flutter in outpatient clinic practice in Brazil.
Jesus, P; Monteiro, JMC; Oliveira Filho, J; San-Martin, DL; Silva, BCG; Souza, IFB, 2019)		2.51
"Dabigatran provides an increase of 0.331 life years and 0.354 quality-adjusted life years for each patient. "( [Economic evaluation of dabigatran for stroke prevention in patients with non-valvular atrial fibrillation].
Ferreira, J; Rocha, E; Silva Miguel, L, )		1.88
"Dabigatran may increase the likelihood of gastrointestinal bleeds."( Bleeding rates in Veterans Affairs patients with atrial fibrillation who switch from warfarin to dabigatran.
Chrischilles, E; Cram, P; Jones, M; Mazur, A; Vaughan Sarrazin, MS, 2014)		2.06
"Dabigatran did not increase the risk of myocardial infarction or major gastrointestinal bleeding in all age groups when compared with warfarin."( Cardiovascular, Bleeding, and Mortality Risks of Dabigatran in Asians With Nonvalvular Atrial Fibrillation.
Chan, YH; Chang, SH; Kuo, CT; Lee, HF; See, LC; Tu, HT; Wu, LS; Yeh, YH; Yen, KC, 2016)		1.41
"Dabigatran did not increase the risk of major gastrointestinal bleeding or myocardial infarction compared with warfarin."( Cardiovascular, Bleeding, and Mortality Risks of Dabigatran in Asians With Nonvalvular Atrial Fibrillation.
Chan, YH; Chang, SH; Kuo, CT; Lee, HF; See, LC; Tu, HT; Wu, LS; Yeh, YH; Yen, KC, 2016)		1.41

Treatment

Dabigatran-treated patients with stroke had significantly lower anti-IIa levels when compared with the trough (40.7 ± 36.9 vs. 40.7) Dabig atran treatment paradoxically increased area under the concentration-time curve and peak values although rivaroxaban decreased peak values (P < 0.01). Dabigsatran treatment had no effect on tyrosine hydroxylase levels.

ExcerptReferenceRelevance
"Dabigatran-treated patients with stroke had significantly lower anti-IIa levels when compared with the trough (40.7 ± 36.9 vs. "( Plasma levels of direct oral anticoagulants in atrial fibrillation patients at the time of embolic stroke: a pilot prospective multicenter study.
Babálová, L; Bolek, T; Dluhá, J; Hajaš, G; Kubisz, P; Kurča, E; Mokáň, M; Nosáľ, V; Petrovičová, A; Samoš, M; Sivák, Š; Škorňová, I; Stančiaková, L; Staško, J, 2022)		2.16
"Dabigatran treatment paradoxically increased area under the concentration-time curve and peak values although rivaroxaban decreased peak values (P < 0.01)."( Effects of rivaroxaban and dabigatran on global hemostasis in patients with atrial fibrillation.
Al-Khalili, F; Ammar, M; Antovic, A; Antovic, JP; Jakovljevic, V; Malmström, RE; Petkovic, A; Pruner, I; Soutari, N; Vranic, A; Zdravkovic, N, 2020)		1.58
"Dabigatran treatment had no effect on tyrosine hydroxylase levels."( Inhibiting thrombin improves motor function and decreases oxidative stress in the LRRK2 transgenic Drosophila melanogaster model of Parkinson's disease.
Grammas, P; Iannucci, J; Johnson, SL; Seeram, NP, 2020)		1.28
"All dabigatran-treated animals had RBC casts in the kidney regardless of the GFR modification."( Role of glomerular filtration rate-modifying drugs in the development of anticoagulant-related nephropathy.
Brodsky, SV; Ivanov, I; Medipally, AK; Qaisar, S; Rovin, BH; Satoskar, AA; Xiao, M, 2021)		1.1
"Dabigatran-treated patients who bled had significantly higher anti-IIa levels when compared with trough (261.4 ± 163.7 vs."( Direct Oral Anticoagulants Plasma Levels in Patients with Atrial Fibrillation at the Time of Bleeding: A Pilot Prospective Study.
Bolek, T; Galajda, P; Kamenišťáková, A; Kubisz, P; Mokáň, M; Samoš, M; Škorňová, I; Stančiaková, L; Staško, J, 2021)		1.34
"In dabigatran-treated patients (216 on 110 mg bid and 194 on 150 mg bid), the duration of dabigatran interruption was a median of 96 (IQR: 61-158) h."( Short-term dabigatran interruption before cardiac rhythm device implantation: multi-centre experience from the RE-LY trial.
Birnie, DH; Connolly, SJ; Coutu, B; Douketis, J; Essebag, V; Ezekowitz, M; Healey, JS; Hohnloser, SH; Lip, GYH; Moriarty, A; Oldgren, J; Parkash, R; Proietti, R; Wang, J, 2017)		1.36
"Dabigatran etexilate treatment led to a significant increase in the duration of wound secretion in both arthroplasty groups when compared to apixaban: wound secretion lasted 1.2 days longer on average in the dabigatran etexilate group than in the apixaban group (4.1 ± 2.1 vs. "( A comparison of apixaban and dabigatran etexilate for thromboprophylaxis following hip and knee replacement surgery.
Fink, B; Mayer, A; Schuster, P, 2017)		2.19
"Dabigatran treatment was as a predictor for lower cardiology costs and lower total hospital care costs in AF patients that initiated oral anticoagulation."( Predictors for total hospital and cardiology cost claims among patients with atrial fibrillation initiating dabigatran or acenocoumarol in The Netherlands.
Cao, Q; Jacobs, MS; Jansman, FGA; Postma, MJ; Tieleman, RG; van Hulst, M; van Leent, MWJ, 2017)		2.11
"The dabigatran treatment discontinued and warfarin was initiated and, in the follow-ups, the thrombus was observed to shrink, and complete resolution was seen 6 weeks after treatment with warfarin."( Newly developed left ventricular apical thrombus under dabigatran treatment.
Adar, A; Cakan, F; Onalan, O, 2018)		1.21
"Dabigatran treatment was initiated after the confirmation of no change in hematoma size and the follow-up CT revealed a reduction in the hematoma."( [A Case of Successful Drug Management with Dabigatran and Idarucizumab to Address Embolic and Hemorrhagic Complications for Asymptomatic and Traumatic Subdural Hematoma with Non-valvular Atrial Fibrillation].
Eto, A; Hiraoka, F; Nii, K; Tsutsumi, M, 2018)		1.46
"Dabigatran-treated patients with acute ischemic stroke who received intravenous recombinant tissue plasminogen activator (rt-PA) after idarucizumab reversal were enrolled in the retrospective nationwide study. "( Intravenous Thrombolysis in Acute Ischemic Stroke After Idarucizumab Reversal of Dabigatran Effect: Analysis of the Cases From Taiwan.
Chen, CL; Chen, HM; Chen, LA; Chen, PL; Chou, PC; Fang, CW; Hsieh, CY; Li, YH; Lu, CM; Shih, YS; Sun, MC; Tsai, YT; Tsao, CR; Yeh, JT, 2019)		2.18
"Dabigatran treatment was discontinued in one patient because of undetectable dabigatran levels despite dose escalation."( Use of dabigatran with antiretrovirals.
Holloway, C; O'Dwyer, E; Perram, J, 2019)		1.69
"Dabigatran-treated animals showed increased adipocyte hypertrophy, but reduced numbers of pro-inflammatory M1-polarized macrophages in the adipose tissue. "( Decreased M1 macrophage polarization in dabigatran-treated Ldlr-deficient mice: Implications for atherosclerosis and adipose tissue inflammation.
Feldmann, K; Fender, AC; Fischer, JW; Gerfer, S; Grandoch, M; Hartwig, S; Kohlmorgen, C; Lehr, S; Nagy, N; Valentin, B, 2019)		2.22
"Dabigatran treatment reduces pro-inflammatory M1 macrophages in atherosclerotic lesions, thereby contributing to plaque stabilizing and atheroprotective effects of the thrombin inhibitor. "( Decreased M1 macrophage polarization in dabigatran-treated Ldlr-deficient mice: Implications for atherosclerosis and adipose tissue inflammation.
Feldmann, K; Fender, AC; Fischer, JW; Gerfer, S; Grandoch, M; Hartwig, S; Kohlmorgen, C; Lehr, S; Nagy, N; Valentin, B, 2019)		2.22
"Dabigatran as first-line treatment compared with warfarin for the use of stroke prevention in patients with AF is deemed cost-effective when used in accordance with its registered indication in the SA private sector."( Economic appraisal of dabigatran as first-line therapy for stroke prevention in atrial fibrillation.
Bergh, M; Marais, CA; Miller-Jansön, H; Salie, F; Stander, MP, 2013)		2.15
"Dabigatran treatment was discontinued, and bronchial artery embolisation (BAE) was performed twice."( Massive haemoptysis following dabigatran administration in a patient with bronchiectasis.
Hayama, M; Inoue, H; Mio, T; Wada, H, 2014)		1.41
"Dabigatran treatment did not prevent or ameliorate the no-reflow phenomenon, suggesting that fibrin does not play a major role in the development of microvascular obstruction."( Dabigatran treatment: effects on infarct size and the no-reflow phenomenon in a model of acute myocardial ischemia/reperfusion.
Hale, SL; Kloner, RA, 2015)		2.58
"Dabigatran treatment discontinuation occurred in a total of 124 patients during follow-up (25.8 per 100 patient-years in Kaplan Meier analysis)."( Effectiveness and safety of dabigatran therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry.
Beyer-Westendorf, J; Daschkow, K; Ebertz, F; Endig, H; Förster, K; Gelbricht, V; Köhler, C; Michalski, F; Pannach, S; Sahin, K; Tittl, L; Weiss, N; Werth, S, 2015)		1.43
"Dabigatran treatment within 24 hours of minor stroke is feasible. "( Dabigatran Therapy in Acute Ischemic Stroke Patients Without Atrial Fibrillation.
Buck, B; Butcher, K; Gioia, L; Jeerakathil, T; Kate, M; Shuaib, A; Sivakumar, L, 2015)		3.3
"Dabigatran treatment caused systemic thrombin inhibitory activity corresponding with dabigatran levels reported in human trials."( Effect of the oral thrombin inhibitor dabigatran on allergic lung inflammation induced by repeated house dust mite administration in mice.
Berkhout, LC; de Boer, JD; de Stoppelaar, SF; Meijers, JC; Ottenhoff, R; Roelofs, JJ; van der Poll, T; van't Veer, C; Yang, J, 2015)		1.41
"For dabigatran-treated patients, idarucizumab recently has been approved for clinical use in cases of life-threatening or uncontrolled bleeding or when patients require emergency surgery or urgent procedures, both associated with a high risk of bleeding."( Idarucizumab and Factor Xa Reversal Agents: Role in Hospital Guidelines and Protocols.
Fanikos, J; Huisman, MV, 2016)		0.92
"For dabigatran-treated patients, idarucizumab recently has been approved for clinical use in cases of life-threatening or uncontrolled bleeding or when patients require emergency surgery or urgent procedures, both associated with a high risk of bleeding."( Idarucizumab and factor Xa reversal agents: role in hospital guidelines and protocols.
Fanikos, J; Huisman, MV, 2016)		0.92
"Dabigatran etexilate treatment exhibited evidence of antitumor activity with a 50% reduction in tumor volume at 4 weeks following orthotopic injection of 4T1 cells in syngeneic Balb/c mice with no weight loss in treated mice."( Use of dabigatran etexilate to reduce breast cancer progression.
Chernick, M; DeFeo, K; Gilmour, SK; Hayes, C; Ryn, JV, 2010)		1.54
"Dabigatran-treated patients had lower acute care and long-term follow-up costs per patient ($52,314 vs."( Dabigatran versus rivaroxaban for the prevention of stroke and systemic embolism in atrial fibrillation in Canada. Comparative efficacy and cost-effectiveness.
Bradley-Kennedy, C; Clemens, A; Kansal, AR; Monz, BU; Peng, S; Roskell, N; Sharma, M; Sorensen, SV, 2012)		2.54
"Dabigatran-treated PVs had slower spontaneous activity (1.1±0.1 Hz; n=10; P=0.0001 versus control)."( Dabigatran and thrombin modulate electrophysiological characteristics of pulmonary vein and left atrium.
Chang, CJ; Chen, SA; Chen, YC; Chen, YJ; Kao, YH; Lin, YK, 2012)		2.54
"Dabigatran treatment (110 mg or 150 mg BID) may not provide sufficient anticoagulation during PCI. "( A randomised study of dabigatran in elective percutaneous coronary intervention in stable coronary artery disease patients.
de Maat, MP; Friedman, J; Jones, RL; Leebeek, FW; Lindeboom, W; Regar, E; Reilly, P; Smits, P; ten Berg, JM; Ulmans, VA; Verheugt, FW; Vranckx, P, 2013)		2.15
"Pre-treatment with dabigatran was performed."( Effects of intermittent hypoxia with thrombin in an in vitro model of human brain endothelial cells and their impact on PAR-1/PAR-3 cleavage.
Perek, N; Puech, C; Roche, F; Zolotoff, C, 2022)		1.04
"Treatment with dabigatran, an oral direct thrombin inhibitor, reduces the virulence of Staphylococcus aureus in in vitro and in vivo models. "( Dabigatran and the Risk of Staphylococcus aureus Bacteremia: A Nationwide Cohort Study.
Andersen, PS; Bruun, NE; Bundgaard, H; Butt, JH; Fosbøl, EL; Gerds, TA; Gislason, GH; Iversen, K; Køber, L; Larsen, AR; Olesen, JB; Petersen, A; Skov, RL; Torp-Pedersen, C; Verhamme, P, 2021)		2.42
"Treatment with dabigatran was associated with a significantly lower incidence rate of SAB compared with treatment with factor Xa-inhibitors."( Dabigatran and the Risk of Staphylococcus aureus Bacteremia: A Nationwide Cohort Study.
Andersen, PS; Bruun, NE; Bundgaard, H; Butt, JH; Fosbøl, EL; Gerds, TA; Gislason, GH; Iversen, K; Køber, L; Larsen, AR; Olesen, JB; Petersen, A; Skov, RL; Torp-Pedersen, C; Verhamme, P, 2021)		2.42
"Treatment with dabigatran 150/110 mg BID or rivaroxaban 15/10 mg QD was associated with a significantly lower risk of major bleeding, but not any bleeding, than warfarin."( Bleeding risk of apixaban, dabigatran, and low-dose rivaroxaban compared with warfarin in Japanese patients with non-valvular atrial fibrillation: a propensity matched analysis of administrative claims data.
Izumi, N; Katada, J; Kohsaka, S; Murata, T; Terayama, Y; Wang, F, 2017)		1.09
"Treatment with dabigatran significantly inhibited the P65 of nuclear factor κB, tumor necrosis factor α, interleukin (IL)‑1β and IL‑6 activities and significantly enhanced the catalase and superoxide dismutase activities in the AMI rabbits."( Effects of dabigatran regulates no‑reflow phenomenon in acute myocardial infarction mice through anti‑inflammatory and anti‑oxidative activities and connective tissue growth factor expression.
Li, H; Ma, C; Sheng, J; Song, K; Wang, Y, 2018)		1.21
"Treatment with dabigatran in patients with PTD having chronic chronometric hypercoagulation and structural hypocoagulation before the administration of the drug is fraught with excessive anticoagulation and a high risk of clinically significant bleeding."( Features of Pharmacodynamics of the Anticoagulant Dabigatran in Secondary Thrombophilia.
Kairov, GT; Kotlovskaya, LY; Solovev, MA; Udut, VV, 2018)		1.07
"Treatment with dabigatran requires less monitoring than warfarin and may therefore enhance the care of this patient group."( Use of dabigatran to prevent stroke in patients with atrial fibrillation.
Mooney, T, )		0.93
"Treatment with dabigatran (220 mg per day) was initiated because of atrial fibrillation."( [Successful thrombolysis without hemorrhage in a patient with cardioembolic stroke under dabigatran treatment-a case report and review of literature].
Inaishi, J; Mano, Y; Nogawa, S; Okada, S; Yoshizaki, T, 2014)		0.96
"Treatment with dabigatran and rivaroxaban does not appear to be associated with changes in markers of platelet reactivity or systemic inflammation."( The effect of dabigatran and rivaroxaban on platelet reactivity and inflammatory markers.
Gutstein, A; Haim, M; Kadmon, E; Kornowski, R; Leshem-Lev, D; Lev, EI; Lev, EL; Mager, A; Orvin, KL; Vaduganathan, M; Zemer-Wassercug, N, 2015)		1.12
"Co-treatment with dabigatran etexilate and low dose CP also significantly decreased the number of arginase(+)Gr-1(+)CD11b(+) myeloid derived suppressor cells as well as levels of TGF-β in spleens from tumor bearing mice."( Thrombin inhibition and cyclophosphamide synergistically block tumor progression and metastasis.
Alexander, ET; Gilmour, SK; Goss, A; Hayes, CS; Minton, AR; Van Ryn, J, 2015)		0.74
"Treatment with dabigatran etexilate resulted in a significant reduction of the mean area of atherosclerotic lesions in the aortic sinus in both the young mice (11,176±1,500 μm(2) (control) versus 3,822±836 μm(2) (dabigatran etexilate), P<0.05) and selectively in the older mice at 28 weeks (234,099±13,500 μm(2) (control) versus 175,226±16,132 μm(2) (dabigatran etexilate), P<0.05). "( Dabigatran etexilate retards the initiation and progression of atherosclerotic lesions and inhibits the expression of oncostatin M in apolipoprotein E-deficient mice.
Bea, F; Cabbage, S; Ieronimakis, N; Preusch, MR; Reyes, M; Ricks, J; Rosenfeld, ME; van Ryn, J; Wijelath, ES, 2015)		2.21
"Co-treatment with dabigatran etexilate and cisplatin significantly decreased the number of Gr1+/CD11b+ myeloid derived suppresser cells and CD11b+/CD11c+ dendritic cells in the ascites of ID8 tumor-bearing mice."( Thrombin inhibition and cisplatin block tumor progression in ovarian cancer by alleviating the immunosuppressive microenvironment.
Alexander, ET; Gilmour, SK; Minton, AR; Peters, MC; van Ryn, J, 2016)		0.76
"Treatment with dabigatran does not require monitoring of haemostasis, whereas vitamin K inhibitors necessitate close INR monitoring."( Dabigatran and atrial fibrillation: the alternative to warfarin for selected patients.
, 2012)		2.16

Toxicity

Dabigatran offers a number of advantages over existing oral and parenteral anticoagulants. Challenges exist for clinicians who must ensure its safe and effective use.

ExcerptReferenceRelevance
"To determine the safe therapeutic range of dabigatran etexilate following total hip replacement."( Dose escalating safety study of a new oral direct thrombin inhibitor, dabigatran etexilate, in patients undergoing total hip replacement: BISTRO I.
Ahnfelt, L; Dahl, OE; Eriksson, BI; Hermansson, K; Kälebo, P; Kohlbrenner, V; Nehmiz, G; Stangier, J, 2004)		0.82
" New oral anticoagulants that require no monitoring and can be administered in a fixed dose without drug-drug and drug-food interactions would clearly offer practical advantages if shown to be safe and effective."( [Dabigatran (Pradaxa): efficacy and safety].
Bellamy, L; Rosencher, N, 2009)		1.26
" Although dabigatran offers a number of advantages over existing oral and parenteral anticoagulants, challenges exist for clinicians who must ensure its safe and effective use."( Dabigatran etexilate in clinical practice: confronting challenges to improve safety and effectiveness.
Dager, WE; Fanikos, J; Gulseth, MP; Nutescu, EA; Spinler, SA; Wittkowsky, AK, 2011)		2.21
" Tolerability was good, with only mild and reversible adverse events during the treatment."( Switching from enoxaparin to dabigatran etexilate: pharmacokinetics, pharmacodynamics, and safety profile.
Clemens, A; Feuring, M; Härtter, S; Sennewald, R; Stangier, J; van Ryn, J; Yamamura, N, 2012)		0.67
" ACS data were tabulated from investigator-reported serious adverse events using ACS-specific Medical Dictionary for Regulatory Authorities (MedDRA) lower-level terms."( Evaluation of the acute coronary syndrome safety profile of dabigatran etexilate in patients undergoing major orthopedic surgery: findings from four Phase 3 trials.
Barsness, GW; Caprini, J; Clemens, A; Eriksson, BI; Feuring, M; Hantel, S; Schnee, J; Smith, JJ, 2012)		0.62
" Dabigatran at a dose of 110mg twice daily was safe for AF ablation in patients with a relatively low risk of thromboemboli, suggesting that it may become an alternative to warfarin in those patients."( Efficacy and safety of periprocedural dabigatran in patients undergoing catheter ablation of atrial fibrillation.
Fuke, E; Hayano, M; Kaseno, K; Kumagai, K; Miki, Y; Naito, S; Nakamura, K; Nishiuchi, S; Oshima, S; Sakamoto, T; Sasaki, T; Tada, H; Tsukada, N; Yamashita, E, 2012)		1.56
"Dabigatran, an oral thrombin inhibitor, and rivaroxaban and apixaban, oral factor Xa inhibitors, have been found to be safe and effective in reducing stroke risk in patients with atrial fibrillation."( Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation.
Avorn, J; Choudhry, NK; Gagne, JJ; Patrick, AR; Schneeweiss, S, 2012)		1.82
" We analyzed data from this trial to quantify upper gastrointestinal nonbleeding adverse events (NB-UGI AEs)."( Analysis of upper gastrointestinal adverse events among patients given dabigatran in the RE-LY trial.
Aisenberg, J; Bytzer, P; Connolly, SJ; Ezekowitz, M; Formella, S; Reilly, PA; Yang, S, 2013)		0.62
"Peri-procedural anticoagulation therapy with dabigatran for RFCA of AF was equally safe and effective compared with warfarin and heparin bridging."( Dabigatran in the peri-procedural period for radiofrequency ablation of atrial fibrillation: efficacy, safety, and impact on duration of hospital stay.
Fujiwara, R; Fukuzawa, K; Hirata, K; Imamura, K; Itoh, M; Kiuchi, K; Matsumoto, A; Nakanishi, T; Suzuki, A; Takami, K; Takami, M; Takei, A; Yamashita, S; Yoshida, A, 2013)		2.09
"We described the changes in the attitudes of attending physicians toward dabigatran prescription after the blue letter in a specialized hospital for cardiovascular care in Japan, which, we believe, involve useful information for safe use of dabigatran in a real-world clinical setting."( "Blue letter effects": Changes in physicians' attitudes toward dabigatran after a safety advisory in a specialized hospital for cardiovascular care in Japan.
Aizawa, T; Kano, H; Kirigaya, H; Koike, A; Matsuno, S; Nagashima, K; Oikawa, Y; Otsuka, T; Sagara, K; Sawada, H; Suzuki, S; Takai, H; Tanabe, H; Uejima, T; Yajima, J; Yamashita, T, 2013)		0.86
" Orally administered dabigatran after discharge from hospital appears safe for venous thromboembolism prophylaxis after RALP."( Dabigatran for thromboprophylaxis after robotic assisted laparoscopic prostatectomy: retrospective analysis of safety profile and effect on blood coagulation.
Joutsi-Korhonen, L; Lassila, R; Pétas, A; Rannikko, AS; Säily, VM; Taari, K, 2014)		2.16
" Dabigatran appears to be safe and effective for peri-procedural anticoagulation in CA of AF."( Safety and efficacy of interrupted dabigatran for peri-procedural anticoagulation in catheter ablation of atrial fibrillation: a systematic review and meta-analysis.
Bahmaid, RA; Bin Abdulhak, AA; Garbati, MA; Khan, AR; Sanders, SU; Spertus, JA; Steigerwalt, KE; Tleyjeh, IM; Wimmer, AP, 2013)		1.58
" The rate of occurrences of adverse effects and bleeding were lower than those seen in the RE-LY trial."( A single centre experience of the efficacy and safety of dabigatran etexilate used for stroke prevention in atrial fibrillation.
Hussin, A; Kaur, S; Muhammad, Z; Omar, R; Rusani, BI; Umadevan, D; Yap, LB, 2014)		0.65
"Evaluate dabigatran adverse event reports with a reported bleeding event and/or reported fatal outcome compared with warfarin."( Evaluation of dabigatran bleeding adverse reaction reports in the FDA adverse event reporting system during the first year of approval.
Bress, A; McConeghy, KW; Nutescu, EA; Qato, DM; Wing, C, 2014)		1.18
"Retrospective analysis of the FDA Adverse Event Reporting System (FAERS) database."( Evaluation of dabigatran bleeding adverse reaction reports in the FDA adverse event reporting system during the first year of approval.
Bress, A; McConeghy, KW; Nutescu, EA; Qato, DM; Wing, C, 2014)		0.76
"Dabigatran was the primary suspected agent in 9029 adverse reports."( Evaluation of dabigatran bleeding adverse reaction reports in the FDA adverse event reporting system during the first year of approval.
Bress, A; McConeghy, KW; Nutescu, EA; Qato, DM; Wing, C, 2014)		2.21
"The objective of this study was to analyse spontaneous adverse event (SAE) reports associated with the oral anticoagulant dabigatran from Australia, Canada and USA and to examine concomitant medicine use."( An international comparison of spontaneous adverse event reports and potentially inappropriate medicine use associated with dabigatran.
Barratt, JD; Caughey, GE; Kalisch Ellett, LM; McDonald, CJ, 2015)		0.83
"Spontaneous adverse event national databases from Australia, Canada and the USA were used to examine all reports of adverse events associated with dabigatran from 1st August 2005 to 31st March 2013."( An international comparison of spontaneous adverse event reports and potentially inappropriate medicine use associated with dabigatran.
Barratt, JD; Caughey, GE; Kalisch Ellett, LM; McDonald, CJ, 2015)		0.82
" Gastrointestinal (GI) disorders were the most commonly reported adverse event, ranging from 27."( An international comparison of spontaneous adverse event reports and potentially inappropriate medicine use associated with dabigatran.
Barratt, JD; Caughey, GE; Kalisch Ellett, LM; McDonald, CJ, 2015)		0.62
"A large proportion of adverse events were associated with concomitant therapies, which may have placed the patient at increased risk of harm."( An international comparison of spontaneous adverse event reports and potentially inappropriate medicine use associated with dabigatran.
Barratt, JD; Caughey, GE; Kalisch Ellett, LM; McDonald, CJ, 2015)		0.62
" Heartburn, the most frequent adverse effect, was reported by 25 patients (22%)."( Safety of dabigatran in an elderly population: single center experience in Italy.
Aita, A; Angeli, F; Bartolini, C; De Filippo, V; di Giacomo, L; Martone, S; Molini, G; Reboldi, G; Valecchi, F; Verdecchia, P, 2015)		0.82
"Compared with warfarin, periprocedural anticoagulation with dabigatran resulted in fewer minor hemorrhages and total adverse events after AF ablation."( Safety of novel oral anticoagulants compared with uninterrupted warfarin for catheter ablation of atrial fibrillation.
Armbruster, HL; Berger, RD; Calkins, H; Habibi, M; Khurram, IM; Lindsley, JP; Marine, JE; Moranville, MP; Spragg, DD, 2015)		0.66
" Rywaroxaban more frequently causes minor bleeding, whereas treatment with dabigatran is associated with more frequent gastrointestinal adverse symptoms."( [Comparison of the safety of rivaroxaban versus dabigatran therapy in patients with persistent atrial fibrillation].
Broncel, M; Ciastkowska, A; Duraj, I; Gorzelak-Pabiś, P; Szlagowska, L, 2014)		0.89
" Overall adverse event (AE) frequency was similar for idarucizumab and placebo, and no relationship with idarucizumab dose was observed."( A randomised study in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of idarucizumab, a specific antidote to dabigatran.
Glund, S; Lang, B; Moschetti, V; Norris, S; Ramael, S; Reilly, P; Schmohl, M; Stangier, J; van Ryn, J, 2015)		0.62
"Dabigatran could be a safe and potentially more effective alternative to warfarin in patients with atrial fibrillation managed in routine practice settings."( Effectiveness and safety of dabigatran and warfarin in real-world US patients with non-valvular atrial fibrillation: a retrospective cohort study.
Brookhart, MA; Fang, G; Farley, JF; Gehi, AK; Lauffenburger, JC; Rhoney, DH, 2015)		2.15
" The objective of this study was to evaluate the interaction between aging and dabigatran- and warfarin-induced gastrointestinal (GI) and nervous system hemorrhage using data available in the FDA Adverse Event Reporting System (FAERS) database."( Evaluation of Dabigatran- and Warfarin-Associated Hemorrhagic Events Using the FDA-Adverse Event Reporting System Database Stratified by Age.
Abe, J; Kato, Y; Kinosada, Y; Nagasawa, H; Nakamura, M; Nakayama, Y; Suzuki, T; Suzuki, Y; Ueda, N; Umetsu, R, 2015)		1.01
"Uninterrupted dabigatran therapy in CA for AF thus may be a safe and effective anticoagulant therapy, and appears to be closely similar to continuous warfarin; however, it is essential to pay close attention to the APTT values when using dabigatran during CA."( Feasibility and safety of uninterrupted dabigatran therapy in patients undergoing ablation for atrial fibrillation.
Fujita, M; Hirai, M; Inden, Y; Ishikawa, S; Kato, H; Miyoshi, A; Murohara, T; Nagao, T; Ohguchi, S; Okumura, S; Shimano, M; Yamamoto, T; Yanagisawa, S; Yoshida, N, 2015)		1.05
"To examine the risk of gastrointestinal adverse effects associated with dabigatran use compared with warfarin among patients with atrial fibrillation (AF)."( Risk of gastrointestinal adverse effects of dabigatran compared with warfarin among patients with atrial fibrillation: a nationwide cohort study.
Bonde, AN; Fosbøl, EL; Gislason, GH; Hansen, ML; Lamberts, M; Lip, GY; Olesen, JB; Staerk, L; Torp-Pedersen, C, 2015)		0.91
" The primary endpoint was incidence of drug-related adverse events, analysed in all randomly assigned participants who received at least one dose of dabigatran etexilate."( Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial.
Gansser, D; Glund, S; Gruenenfelder, F; Kreuzer, J; Lang, B; Moschetti, V; Norris, S; Ramael, S; Reilly, P; Schmohl, M; Stangier, J; van Ryn, J, 2015)		0.83
" Drug-related adverse events were all of mild intensity and reported in seven participants: one in the 1 g idarucizumab group (infusion site erythema and hot flushes), one in the 5 g plus 2·5 g idarucizumab group (epistaxis); one receiving placebo (infusion site haematoma), and four during dabigatran etexilate pretreatment (three haematuria and one epistaxis)."( Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial.
Gansser, D; Glund, S; Gruenenfelder, F; Kreuzer, J; Lang, B; Moschetti, V; Norris, S; Ramael, S; Reilly, P; Schmohl, M; Stangier, J; van Ryn, J, 2015)		0.81
" We studied time to cardioversion, risk of adverse events, and risk of readmission with atrial fibrillation after cardioversion according to anticoagulation therapy."( Cardioversion and Risk of Adverse Events with Dabigatran versus Warfarin-A Nationwide Cohort Study.
Gislason, GH; Hansen, ML; Lindhardt, TB; Olesen, JB; Pallisgaard, JL; Schjerning, AM; Staerk, L; Torp-Pedersen, C, 2015)		0.68
"Anticoagulation treatment with dabigatran allows shorter time to cardioversion for atrial fibrillation than warfarin, and appears to be an effective and safe alternative treatment strategy to warfarin."( Cardioversion and Risk of Adverse Events with Dabigatran versus Warfarin-A Nationwide Cohort Study.
Gislason, GH; Hansen, ML; Lindhardt, TB; Olesen, JB; Pallisgaard, JL; Schjerning, AM; Staerk, L; Torp-Pedersen, C, 2015)		0.96
"9%) of MonaldiCare population reported adverse effects from treatment with dabigatran, of whom 121 patients (5."( Efficacy and safety of dabigatran in a "real-life" population at high thromboembolic and hemorrhagic risk: data from MonaldiCare registry.
Bianchi, V; Calabrò, P; Cavallaro, C; D'Onofrio, A; De Vivo, S; Nigro, G; Russo, V; Santangelo, L; Sarubbi, B; Vecchione, F, 2015)		0.96
"Current methods for prospective drug safety monitoring focus on determining whether and when to generate safety alerts indicating that a new drug may be less safe than a comparator."( Developing alerting thresholds for prospective drug safety monitoring.
Gagne, JJ; Glynn, RJ; Schneeweiss, S; Wangge, G, 2016)		0.43
" Non-vitamin K antagonist oral anticoagulants (NOACs) have emerged as efficacious, safe and convenient stroke prevention agents."( Relative efficacy and safety of non-Vitamin K oral anticoagulants for non-valvular atrial fibrillation: Network meta-analysis comparing apixaban, dabigatran, rivaroxaban and edoxaban in three patient subgroups.
Batson, S; Kachroo, S; Lip, GY; Liu, LZ; Liu, X; Mitchell, SA; Phatak, H, 2016)		0.63
"Anticoagulation with NOAC with a short period of periprocedural interruption without bridging with LMWH seems safe and well-tolerated."( Safety of novel oral anticoagulants in catheter ablation of atrial fibrillation.
Hansen, PS; Sanchez, R; Walfridsson, H, 2016)		0.43
" This study evaluates the total complications and the impact of novel oral anticoagulants (NOACs) compared to phenprocoumon on adverse events in the setting of PVI using CB."( The Total Incidence of Complications and the Impact of an Anticoagulation Regime on Adverse Events After Cryoballoon Ablation of Atrial Fibrillation: A Single-Center Study of 409 Patients.
Dahmen, A; Gorr, E; Hoppe, C; Horlitz, M; Keskin, K; Koektuerk, B; Schoett, M; Turan, CH; Turan, RG; Yang, A; Yorgun, H, 2016)		0.43
"The incidence of adverse events in PVI using the second-generation CB with the periprocedural administration of NAOCs was not significantly different compared to phenprocoumon."( The Total Incidence of Complications and the Impact of an Anticoagulation Regime on Adverse Events After Cryoballoon Ablation of Atrial Fibrillation: A Single-Center Study of 409 Patients.
Dahmen, A; Gorr, E; Hoppe, C; Horlitz, M; Keskin, K; Koektuerk, B; Schoett, M; Turan, CH; Turan, RG; Yang, A; Yorgun, H, 2016)		0.43
" All NOACs seem to be safe and effective alternatives to warfarin in a routine care setting."( Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study.
Kjældgaard, JN; Larsen, TB; Lip, GY; Nielsen, PB; Skjøth, F, 2016)		0.43
" No bleeding events, deaths or drug-related serious adverse events (AEs) were reported; three treatment-emergent AEs, all gastrointestinal-related, occurred in two patients."( Safety, tolerability and clinical pharmacology of dabigatran etexilate in adolescents. An open-label phase IIa study.
Belletrutti, M; Cronin, L; Haertter, S; Halton, JM; Lehr, T; Lobmeyer, MT; Mitchell, LG, 2016)		0.69
"Low-dose DE was safe in AF patients with mildly reduced CCr."( Safety of low-dose dabigatran in patients with atrial fibrillation and mild renal insufficiency.
Ako, J; Fujiishi, T; Fukaya, H; Horiguchi, A; Igarashi, T; Ishizue, N; Kishihara, J; Murakami, M; Nakamura, H; Nishinarita, R; Niwano, S; Oikawa, J; Satoh, A; Yoshizawa, T, 2017)		0.78
" In conclusion, DOACs are effective and safe for the extended treatment of VTE, and may reduce the risk of all-cause mortality."( Safety ad efficacy of direct oral anticoagulants for extended treatment of venous thromboembolism.
Benedetti, R; Fenoglio, L; Imberti, D; Pomero, F, 2016)		0.43
" These findings provide initial evidence that idarucizumab could provide a safe and effective means of reversing anticoagulant activity in patients treated with dabigatran in need of emergency surgery or in emergency bleeding situations."( Idarucizumab, a Specific Reversal Agent for Dabigatran: Mode of Action, Pharmacokinetics and Pharmacodynamics, and Safety and Efficacy in Phase 1 Subjects.
Glund, S; Grottke, O; Reilly, PA; Stangier, J; van Ryn, J, 2016)		0.89
" These findings provide initial evidence that idarucizumab could provide a safe and effective means of reversing anticoagulant activity in patients treated with dabigatran in need of emergency surgery or in emergency bleeding situations."( Idarucizumab, a specific reversal agent for dabigatran: mode of action, pharmacokinetics and pharmacodynamics, and safety and efficacy in phase 1 subjects.
Glund, S; Grottke, O; Reilly, PA; Stangier, J; van Ryn, J, 2016)		0.89
" In order to contribute to the debate on their safety profile, we conducted a comparative analysis of the reports of suspected adverse drug reactions (ADRs) associated with DOACs in VigiBase."( Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions.
Biagi, C; Conti, V; Donati, M; Melis, M; Monaco, L; Motola, D; Vaccheri, A; Venegoni, M, 2017)		0.46
"Cerebrovascular adverse events collected by the Pharmaceutical and Medical Devices Agency (PMDA) during 2014 were analyzed to describe and compare efficacy and safety among patients prescribed DTI and FXa."( Evaluation of the Efficacy and Safety of Direct Oral Anticoagulants in Japanese Patients-Analysis of Pharmaceuticals and Medical Devices Agency Data.
Terayama, Y, 2017)		0.46
" In addition, NOACs have been demonstrated to be safe and associated with a significant reduction in major and intracranial bleeding events."( [New oral anticoagulants in patients with atrial fibrillation: efficacy and safety data from the real world].
Di Pasquale, G; Riva, L, 2017)		0.46
" There were no serious adverse events, bleeding events or recurrent venous thromboembolism."( Phase IIa study of dabigatran etexilate in children with venous thrombosis: pharmacokinetics, safety, and tolerability.
Albisetti, M; Biss, B; Bomgaars, L; Brueckmann, M; Gropper, S; Halton, JML; Harper, R; Huang, F; Luciani, M; Maas, H; Mitchell, LG; Tartakovsky, I, 2017)		0.78
" Safety endpoints included incidence rates of bleeding events and all other adverse events (AEs)."( Phase IIa study of dabigatran etexilate in children with venous thrombosis: pharmacokinetics, safety, and tolerability.
Albisetti, M; Biss, B; Bomgaars, L; Brueckmann, M; Gropper, S; Halton, JML; Harper, R; Huang, F; Luciani, M; Maas, H; Mitchell, LG; Tartakovsky, I, 2017)		0.78
" The secondary efficacy outcome was major adverse cardiovascular events (MACE; composite of myocardial infarction, stroke, and all-cause mortality)."( Meta-Analysis of the Safety and Efficacy of the Oral Anticoagulant Agents (Apixaban, Rivaroxaban, Dabigatran) in Patients With Acute Coronary Syndrome.
Arshad, A; Kaluski, E; Khan, SU; Nasir, F; Riaz, IB; Talluri, S, 2018)		0.7
" Newly initiated anticoagulation with dabigatran in patients with nonvalvular AF scheduled for TEE-guided DCC seems to be as effective and safe as uninterrupted VKA therapy, during long-term follow up."( Efficacy and safety of dabigatran in patients with atrial fibrillation scheduled for transoesophageal echocardiogram-guided direct electrical current cardioversion: a prospective propensity score-matched cohort study.
D'Onofrio, A; Golino, P; Nigro, G; Papa, AA; Rago, A; Russo, V, 2018)		1.06
"In this cohort of Medicare beneficiaries with VHD (excluding patients with prosthetic valves) and new-onset AF between 2011 and 2013, novel oral non-vitamin K anticoagulants were safe and effective options for prevention of systemic thromboembolism."( Safety and Efficacy of Novel Oral Anticoagulants Versus Warfarin in Medicare Beneficiaries With Atrial Fibrillation and Valvular Heart Disease.
Akintoye, E; Alvarez, P; Briasoulis, A; Inampudi, C; Panaich, S; Vaughan-Sarrazin, M, 2018)		0.48
" Patients commenced on NOACs should be assessed and followed up in a multidisciplinary AF clinic to ensure safe and effective prescribing and stroke prevention."( Is the prescription right? A review of non-vitamin K antagonist anticoagulant (NOAC) prescriptions in patients with non-valvular atrial fibrillation. Safe prescribing in atrial fibrillation and evaluation of non-vitamin K oral anticoagulants in stroke pre
Burke, C; Collins, R; Coughlan, T; Egom, EE; McAuliffe, C; McHugh, J; Moore, D; Morrissey, E; O'Brien, J; Pharithi, RB; Ranganathan, D; Ryan, D; Vaughan, M, 2019)		0.51
" These results show dabigatran to be a safe alternative to low-molecular-weight heparin for extended venous thromboembolism prophylaxis with regard to bleeding complications."( Dabigatran (Pradaxa) Is Safe for Extended Venous Thromboembolism Prophylaxis After Surgery for Pancreatic Cancer.
Chabot, JA; Dwyer, FA; Jackson, TL; Kluger, MD; Morgan, JA; Rashid, MF; Schrope, BA, 2019)		2.28
"The safety of the NOACs compared with warfarin was generally favourable across different patient subgroups, including those perceived to be at "high risk" for adverse outcomes."( The safety of NOACs in atrial fibrillation patient subgroups: A narrative review.
Lip, GYH, 2019)		0.51
"Gastrointestinal side effect profiles of these four agents in a real-life setting is consistent with the results obtained from the present study."( A link between cytotoxicity in cell culture and gastrointestinal side effects of oral anticoagulants: bench-to-bedside.
Gurpinar, OA; Karasoy, D; Kubat, E; Onur, MA, )		0.13
"Direct oral anticoagulants (DOACs) are at least as efficacious and safe as warfarin among non-valvular atrial fibrillation (NVAF) patients; limited evidence is available regarding NVAF patients with heart failure (HF)."( Effectiveness and safety of oral anticoagulants in older adults with non-valvular atrial fibrillation and heart failure.
Amin, A; Dhamane, A; Di Fusco, M; Friend, K; Garcia Reeves, AB; Keshishian, A; Li, X; Luo, X; Mardekian, J; Nadkarni, A; Pan, X; Rosenblatt, L; Yuce, H, 2019)		0.51
" Therefore, an effective, safe and convenient new anticoagulant is needed."( Dabigatran must be used carefully: literature review and recommendations for management of adverse events.
Guan, W; Lin, S; Wang, Y; Zhang, L, 2019)		1.96
"This trial found that patients who had CVT anticoagulated with either dabigatran or warfarin had low risk of recurrent VTEs, and the risk of bleeding was similar with both medications, suggesting that both dabigatran and warfarin may be safe and effective for preventing recurrent VTEs in patients with CVT."( Safety and Efficacy of Dabigatran Etexilate vs Dose-Adjusted Warfarin in Patients With Cerebral Venous Thrombosis: A Randomized Clinical Trial.
Alasheev, A; Canhão, P; Caria, J; Coutinho, JM; Dentali, F; Diener, HC; Ferro, JM; Frässdorf, M; Huisman, H; Karpov, D; Kobayashi, A; Nagel, S; Posthuma, L; Reilly, P; Roriz, JM, 2019)		1.06
" The risks of ischemic stroke, intracranial hemorrhage (ICH), major bleeding, mortality, and composite adverse events were compared between NOACs and warfarin in all patients ≥ 65 years of age and, specifically, with different age strata (ie, 65-74, 75-89, ≥ 90 years)."( Comparing the Effectiveness and Safety of Nonvitamin K Antagonist Oral Anticoagulants and Warfarin in Elderly Asian Patients With Atrial Fibrillation: A Nationwide Cohort Study.
Chao, TF; Chen, SA; Chen, TJ; Chiang, CE; Liao, JN; Lip, GYH, 2020)		0.56
"Compared with warfarin, NOACs were associated with a significantly lower risk of adverse events, with heterogeneity in treatment effects among different age strata."( Comparing the Effectiveness and Safety of Nonvitamin K Antagonist Oral Anticoagulants and Warfarin in Elderly Asian Patients With Atrial Fibrillation: A Nationwide Cohort Study.
Chao, TF; Chen, SA; Chen, TJ; Chiang, CE; Liao, JN; Lip, GYH, 2020)		0.56
" All adverse events (AEs) were recorded."( Pharmacokinetics and Safety of Dabigatran Etexilate after Single and Multiple Oral Doses in Healthy Chinese Subjects.
Duan, J; Harada, A; Li, H; Yamamura, N; Yang, L, 2020)		0.84
" None of the subjects experienced a serious adverse event (SAE) or an AE of moderate or severe intensity."( Pharmacokinetics and Safety of Dabigatran Etexilate after Single and Multiple Oral Doses in Healthy Chinese Subjects.
Duan, J; Harada, A; Li, H; Yamamura, N; Yang, L, 2020)		0.84
"Our real-life data study suggests that secondary stroke prevention with DOACs is as effective and safe as primary prevention, both in standard and reduced doses, in a typical group of patients who are older than patients included in RCTs."( Effectiveness and Safety of Direct Oral Anticoagulants in the Secondary Stroke Prevention of Elderly Patients: Ljubljana Registry of Secondary Stroke Prevention.
Frol, S; Hudnik, LK; Oblak, JP; Šabovič, M; Sernec, LP, 2020)		0.56
" Therefore, NOAC is an effective and safe alternative to warfarin in these patients."( Effectiveness and safety of non-vitamin K antagonist oral anticoagulants in Asian patients with atrial fibrillation and valvular heart disease.
Hung, CS; Li, HJ; Lin, FJ; Lin, SY; Wang, CC, 2021)		0.62
"These results suggest that rivaroxaban is an effective and safe treatment option among NVAF patients with obesity in a commercially-insured US population."( Real-world effectiveness and safety of rivaroxaban versus warfarin among non-valvular atrial fibrillation patients with obesity in a US population.
Ashton, V; Berger, JS; Jung, Y; Kharat, A; Laliberté, F; Lefebvre, P; Lejeune, D; Moore, KT, 2021)		0.62
" The NOACs seem to be a safe option also in elderly patients."( Effectiveness and safety of oral anticoagulants in elderly patients with atrial fibrillation.
Ghanima, W; Halvorsen, S; Jonasson, C; Rutherford, OW; Söderdahl, F, 2022)		0.72
"Direct oral anticoagulants (DOACs) have been proven to be effective and safe for prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF)."( Dose specific effectiveness and safety of DOACs in patients with non-valvular atrial fibrillation: A Canadian retrospective cohort study.
Dasgupta, K; Godin, R; Nedjar, H; Rahme, E; Tagalakis, V, 2021)		0.62
" Setting FDA Adverse Event Reporting System (FAERS) database."( Evaluation of rivaroxaban-, apixaban- and dabigatran-associated hemorrhagic events using the FDA-Adverse event reporting system (FAERS) database.
Cui, X; Guo, M; Thai, S; Wang, T; Wei, J; Xu, W; Zhao, Y; Zhou, J, 2021)		0.89
"Oral anticoagulant (OAC)-related adverse events are high post-hospitalization."( Derivation and validation of predictors of oral anticoagulant-related adverse events in seniors transitioning from hospital to home.
Benipal, H; Douketis, J; Foster, G; Holbrook, A; Ma, J; Paterson, JM; Thabane, L, 2021)		0.62
"For a long time, vitamin K antagonists (VKA) were the only oral anticoagulation therapy available to reduce adverse events in atrial fibrillation (AF) patients."( A comparison of front-line oral anticoagulants for the treatment of non-valvular atrial fibrillation: effectiveness and safety of direct oral anticoagulants in the FANTASIIA registry.
Anguita, M; Badimón, L; Bertomeu-Martínez, V; Cequier, Á; Esteve-Pastor, MA; Lip, GYH; López-Gálvez, R; Marín, F; Muñiz, J; Otero, D; Rivera-Caravaca, JM; Roldán-Rabadán, I; Ruiz-Ortiz, M, 2022)		0.72
" Secondary outcomes were major adverse cardiovascular event (MACE), intracranial bleeding, and Major gastrointestinal bleeding."( Efficacy and Safety of the Non-Vitamin K Antagonist Oral Anticoagulant Among Patients With Nonvalvular Atrial Fibrillation and Cancer: A Systematic Review and Network Meta-analysis.
Al Kasasbeh, M; Al-Abdouh, A; Barbarawi, M; Barbarawi, O; Corcoran, J; Mhanna, M; Obeidat, K; Pickett, CC, 2022)		0.72
" It is critical to identify safe and effective anticoagulation therapy for use in this population."( Anticoagulation and BMI: effect of high body weight on the safety and efficacy of direct oral anticoagulants.
Bansal, A; Eisele, CD; Jain, R; Julian, K; Mausteller, KG; Patel, P, 2022)		0.72
" Direct oral anticoagulants are a new, preferred medication option for this, but it is unclear how safe or effective they are in obese people; there is some concern that because of increased body weight, individuals may not get enough medicine to effectively prevent clots from forming, which would ultimately put them at risk for clotting and serious adverse health outcomes such as stroke."( Anticoagulation and BMI: effect of high body weight on the safety and efficacy of direct oral anticoagulants.
Bansal, A; Eisele, CD; Jain, R; Julian, K; Mausteller, KG; Patel, P, 2022)		0.72
" CONCLUSIONS AND RELEVANCE: In our experience, the use of DOAC was safe in selected patients treated with KI, but unclear with bevacizumab."( Safety of direct oral anticoagulants in patients with advanced solid tumors receiving anti-VEGF agents: a retrospective study.
Albiges, L; Baudin, E; Besse, B; Boileve, A; Ducreux, M; Hadoux, J; Leary, A; Malka, D; Maulard, A; Mir, O; Rieutord, A; Scotté, F, 2022)		0.72
"The development of an optimal stroke prevention strategy, including the use of oral anticoagulant (OAC) therapy, is particularly important for patients with atrial fibrillation (AF) who are living with dementia, a condition that increases the risk of adverse outcomes."( Comparative Effectiveness and Safety of Oral Anticoagulants by Dementia Status in Older Patients With Atrial Fibrillation.
Bessette, LG; Bykov, K; Cervone, A; Kim, DH; Lin, KJ; Mastrorilli, JM; Singer, DE, 2023)		0.91

Pharmacokinetics

Dabigatran is dosed twice daily for stroke prevention in nonvalvular atrial fibrillation (AF) The aim of this study was to build a physiologically based pharmacokinetic (PBPK) model.

ExcerptReferenceRelevance
" These pharmacokinetic characteristics confirm the suitability of this oral solid dosage form for use in future clinical trials."( Pharmacokinetic profile of the oral direct thrombin inhibitor dabigatran etexilate in healthy volunteers and patients undergoing total hip replacement.
Ahnfelt, L; Dahl, OE; Eriksson, BI; Nehmiz, G; Rathgen, K; Stähle, H; Stangier, J; Svärd, R, 2005)		0.57
" The objective of the analysis was to develop a population pharmacokinetic model characterizing and quantifying the relationship between covariates and model parameters."( Population pharmacokinetic analysis of the new oral thrombin inhibitor dabigatran etexilate (BIBR 1048) in patients undergoing primary elective total hip replacement surgery.
Liesenfeld, KH; Schäfer, HG; Stangier, J; Tillmann, C; Trocóniz, IF, 2007)		0.57
"To investigate the pharmacokinetic and pharmacodynamic profile of dabigatran in healthy elderly subjects; to assess the intra- and interindividual variability of dabigatran pharmacokinetics in order to assess possible gender differences; and to assess the effect of pantoprazole coadministration on the bioavailability of dabigatran."( Pharmacokinetics and pharmacodynamics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects.
Fuhr, R; Rathgen, K; Stähle, H; Stangier, J, 2008)		0.81
"The primary pharmacokinetic measurements included the area under the plasma concentration-time curve at steady state (AUC(ss)), maximum (C(max,ss)) and minimum (C(min,ss)) plasma concentrations at steady state, terminal half-life (t((1/2))), time to reach C(max,ss) and renal clearance of dabigatran."( Pharmacokinetics and pharmacodynamics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects.
Fuhr, R; Rathgen, K; Stähle, H; Stangier, J, 2008)		0.75
" Intra- and interindividual pharmacokinetic variability in the overall population was low (<30% coefficient of variation), indicating that dabigatran has a predictable pharmacokinetic profile."( Pharmacokinetics and pharmacodynamics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects.
Fuhr, R; Rathgen, K; Stähle, H; Stangier, J, 2008)		0.78
"Dabigatran demonstrated reproducible and predictable pharmacokinetic and pharmacodynamic characteristics, together with a good safety profile, when administered to healthy elderly subjects."( Pharmacokinetics and pharmacodynamics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects.
Fuhr, R; Rathgen, K; Stähle, H; Stangier, J, 2008)		2.02
" The pharmacodynamic profile of dabigatran demonstrates effective anticoagulation combined with a low risk of bleeding."( Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate.
Stangier, J, 2008)		0.85
" While the anticoagulant effect of the new thrombin and FXa inhibitors is similar, differences in the pharmacokinetic and pharmacodynamic parameters may influence their use in clinical practice."( Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor xa inhibitors in development.
Eriksson, BI; Quinlan, DJ; Weitz, JI, 2009)		0.35
" Studies in healthy volunteers and in patients undergoing orthopedic surgery indicate that dabigatran has a predictable pharmacokinetic profile, allowing for a fixed-dose regimen without the need for coagulation monitoring."( Pharmacology, pharmacokinetics, and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor.
Clemens, A; Stangier, J, )		0.6
" Its pharmacokinetic characteristics include rapid absorption, high oral availability, high plasma protein binding and a half-life of aprox."( [Pharmacokinetics and pharmacodynamics of the new oral anticoagulants dabigatran and rivaroxaban].
Climent Grana, E; Jover Botella, A; Ordovás Baines, JP; Valero García, I, )		0.37
" Blood and urine samples were collected up to 96 hours after dosing for determination of dabigatran pharmacokinetic and pharmacodynamic parameters."( Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate: an open-label, parallel-group, single-centre study.
Mazur, D; Rathgen, K; Stähle, H; Stangier, J, 2010)		0.81
" The pharmacokinetic profile of digoxin also remained unchanged in the presence of dabigatran etexilate."( Pharmacokinetics and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor, with coadministration of digoxin.
Körnicke, T; Rathgen, K; Reseski, K; Roth, W; Stähle, H; Stangier, J, 2012)		0.87
" Simulations were based on a population pharmacokinetic model derived from data from 9522 patients from the pivotal phase III study (RE-LY)."( Dabigatran etexilate in atrial fibrillation patients with severe renal impairment: dose identification using pharmacokinetic modeling and simulation.
Clemens, A; Friedman, J; Haertter, S; Lehr, T; Liesenfeld, KH; Reilly, PA; Staab, A, 2012)		1.82
"To characterize the pharmacokinetics of dabigatran in patients with non-valvular atrial fibrillation (AF) from the Randomized Evaluation of Long-term Anticoagulant Therapy (RE-LY) trial and to quantify the effect of selected factors on pharmacokinetic (PK) model parameters."( Population pharmacokinetic analysis of the oral thrombin inhibitor dabigatran etexilate in patients with non-valvular atrial fibrillation from the RE-LY trial.
Connolly, SJ; Dansirikul, C; Ezekowitz, MD; Haertter, S; Lehr, T; Liesenfeld, KH; Reilly, PA; Staab, A; Wallentin, L; Yusuf, S, 2011)		0.87
" Various factors, including body weight and renal clearance, may explain these observed pharmacokinetic differences."( Pharmacokinetics and pharmacodynamics in Japanese and Caucasian subjects after oral administration of dabigatran etexilate.
Clemens, A; Härtter, S; Reilly, PA; Stangier, J; Yamamura, N, 2012)		0.59
" Based on its pharmacokinetic profile, dabigatran is dosed twice daily."( Twice daily dosing of dabigatran for stroke prevention in atrial fibrillation: a pharmacokinetic justification.
Brueckmann, M; Clemens, A; Friedman, J; Haertter, S; Lehr, T; Stangier, J; van Ryn, J, 2012)		0.96
"The pharmacokinetic profile of dabigatran was simulated for AF patients given a total daily dose of 300 mg, either once or twice daily."( Twice daily dosing of dabigatran for stroke prevention in atrial fibrillation: a pharmacokinetic justification.
Brueckmann, M; Clemens, A; Friedman, J; Haertter, S; Lehr, T; Stangier, J; van Ryn, J, 2012)		0.98
" Pharmacokinetic data collected from a phase II study and RE-LY were consistent with the simulation results."( Twice daily dosing of dabigatran for stroke prevention in atrial fibrillation: a pharmacokinetic justification.
Brueckmann, M; Clemens, A; Friedman, J; Haertter, S; Lehr, T; Stangier, J; van Ryn, J, 2012)		0.69
" The aim of this study was to investigate whether, and to what extent, a switch from enoxparin to dabigatran etexilate affects the pharmacokinetic (PK) and pharmacodynamic (PD) parameters and safety profile of dabigatran."( Switching from enoxaparin to dabigatran etexilate: pharmacokinetics, pharmacodynamics, and safety profile.
Clemens, A; Feuring, M; Härtter, S; Sennewald, R; Stangier, J; van Ryn, J; Yamamura, N, 2012)		0.89
"To review the literature regarding the pharmacokinetic (PK) and clinical implications of the use of dabigatran in severe renal impairment for stroke prevention in nonvalvular atrial fibrillation (AF)."( Pharmacokinetic and clinical implications of dabigatran use in severe renal impairment for stroke prevention in nonvalvular atrial fibrillation.
Kim, JJ; Mack, DR, )		0.61
"To evaluate the pharmacokinetic and pharmacodynamic effects of concomitant administration of single loading doses of clopidogrel or multiple doses of clopidogrel with multiple doses of dabigatran etexilate."( Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers.
Baumann, S; Friedman, J; Fritsch, H; Härtter, S; Schepers, C; Sennewald, R, 2013)		0.81
"3-131%), as did its pharmacodynamic effects on the inhibition of platelet aggregation."( Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers.
Baumann, S; Friedman, J; Fritsch, H; Härtter, S; Schepers, C; Sennewald, R, 2013)		0.62
"When given concomitantly, dabigatran etexilate and clopidogrel at clinically relevant doses did not appear to have significant effects on the pharmacokinetic and pharmacodynamic profiles of either agent."( Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers.
Baumann, S; Friedman, J; Fritsch, H; Härtter, S; Schepers, C; Sennewald, R, 2013)		0.92
" Though the anticoagulation efficacy of these NOACs has been characterized, differences in their pharmacokinetic and pharmacodynamic profiles have become a significant consideration in terms of drug selection and dosing."( Importance of pharmacokinetic profile and variability as determinants of dose and response to dabigatran, rivaroxaban, and apixaban.
Gong, IY; Kim, RB, 2013)		0.61
"To review pharmacokinetic and pharmacodynamic drug-drug interactions (DDIs) involving new oral anticoagulants for atrial fibrillation."( Pharmacokinetic and pharmacodynamic drug interactions with new oral anticoagulants: what do they mean for patients with atrial fibrillation?
Gulseth, M; Hellwig, T, 2013)		0.39
"Articles reviewed focused on drugs affecting the permeability glycoprotein (P-gp) efflux transporter protein and/or cytochrome P (CYP) 450 3A4 enzymes, and pharmacodynamic DDIs when drugs are administered concomitantly."( Pharmacokinetic and pharmacodynamic drug interactions with new oral anticoagulants: what do they mean for patients with atrial fibrillation?
Gulseth, M; Hellwig, T, 2013)		0.39
" In this study, in vivo-based [I]/Ki values were used to predict the DDI risks of a P-gp substrate dabigatran etexilate (DABE) using physiologically based pharmacokinetic (PBPK) modelling."( Physiologically based pharmacokinetic modelling and in vivo [I]/K(i) accurately predict P-glycoprotein-mediated drug-drug interactions with dabigatran etexilate.
Hu, ZY; Zhao, Y, 2014)		0.82
"This approach accurately predicted the effects of five P-gp inhibitors on DABE pharmacokinetics (98-133% and 89-104% for the ratios of AUC and Cmax respectively)."( Physiologically based pharmacokinetic modelling and in vivo [I]/K(i) accurately predict P-glycoprotein-mediated drug-drug interactions with dabigatran etexilate.
Hu, ZY; Zhao, Y, 2014)		0.6
" POCT for aPTT is sensitive to increased concentrations of dabigatran, whereas the PT-POCT assessed with test systems such as the GEM PCL Plus may be helpful to measure the pharmacodynamic anticoagulant effects of rivaroxaban in emergency clinical situations."( Point-of-care coagulation testing for assessment of the pharmacodynamic anticoagulant effect of direct oral anticoagulant.
Herrmann, E; Herth, N; Kasper, A; Lindhoff-Last, E; Linnemann, B; Mani, H; Pfeilschifter, W; Schuettfort, G; Weil, Y; Wendt, T, 2014)		0.65
" The mean free dabigatran Cmax was 95."( An evaluation of oral dabigatran etexilate pharmacokinetics and pharmacodynamics in hemodialysis.
Anderson, DR; Goralski, KB; Morrison, M; Mossop, P; Sleno, L; Soroka, SD; Wang, Y; Wilson, JA, 2014)		1.07
" Maximum plasma concentrations were achieved near the end of infusion, followed by a rapid decline, with an initial idarucizumab half-life of ~45 minutes."( A randomised study in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of idarucizumab, a specific antidote to dabigatran.
Glund, S; Lang, B; Moschetti, V; Norris, S; Ramael, S; Reilly, P; Schmohl, M; Stangier, J; van Ryn, J, 2015)		0.62
" To support the possibility that patients may choose to switch treatment from another nonvitamin K antagonist oral anticoagulant to edoxaban, this clinical study was conducted to evaluate the pharmacokinetic and pharmacodynamic effects of edoxaban after switching from rivaroxaban or dabigatran etexilate to edoxaban."( Pharmacokinetics and Pharmacodynamics of the Nonvitamin K Antagonist Oral Anticoagulant Edoxaban When Administered Alone or After Switching from Rivaroxaban or Dabigatran Etexilate in Healthy Subjects.
Brown, KS; Dishy, V; Kochan, J; Maa, JF; Parasrampuria, DA; Shi, M; Weilert, D, 2016)		0.81
"Day 4 edoxaban pharmacokinetic parameters were similar for all treatments."( Pharmacokinetics and Pharmacodynamics of the Nonvitamin K Antagonist Oral Anticoagulant Edoxaban When Administered Alone or After Switching from Rivaroxaban or Dabigatran Etexilate in Healthy Subjects.
Brown, KS; Dishy, V; Kochan, J; Maa, JF; Parasrampuria, DA; Shi, M; Weilert, D, 2016)		0.63
" No impact of age on idarucizumab pharmacokinetics was observed; however, subjects with mild or moderate renal impairment demonstrated increased exposure (up to 84 %), decreased clearance and prolonged (by up to 49 %) initial half-life of idarucizumab compared with healthy middle-aged subjects."( Effect of Age and Renal Function on Idarucizumab Pharmacokinetics and Idarucizumab-Mediated Reversal of Dabigatran Anticoagulant Activity in a Randomized, Double-Blind, Crossover Phase Ib Study.
De Smet, M; Gansser, D; Glund, S; Haazen, W; Kreuzer, J; Lang, B; Moschetti, V; Norris, S; Reilly, P; Schmohl, M; Stangier, J; van Ryn, J, 2017)		0.67
" The antiretroviral pharmacokinetic enhancers, ritonavir and cobicistat, inhibit both these transporters."( Differential Influence of the Antiretroviral Pharmacokinetic Enhancers Ritonavir and Cobicistat on Intestinal P-Glycoprotein Transport and the Pharmacokinetic/Pharmacodynamic Disposition of Dabigatran.
Alfaro, RM; Brooks, KM; George, JM; Gordon, LA; Hadigan, C; Kellogg, A; Kumar, P; Lozier, J; McManus, M; Nghiem, K; Penzak, SR, 2017)		0.65
" The primary endpoints were pharmacokinetics/pharmacodynamics-related: plasma concentrations of DE and its metabolites; activated partial thromboplastin time (APTT), ecarin clotting time (ECT), and dilute thrombin time (dTT); and pharmacokinetic (PK)-pharmacodynamic (PD) correlation."( Phase IIa study of dabigatran etexilate in children with venous thrombosis: pharmacokinetics, safety, and tolerability.
Albisetti, M; Biss, B; Bomgaars, L; Brueckmann, M; Gropper, S; Halton, JML; Harper, R; Huang, F; Luciani, M; Maas, H; Mitchell, LG; Tartakovsky, I, 2017)		0.78
" The pharmacokinetic characteristics of available DOACs (dabigatran, rivaroxaban, apixaban, edoxaban, betrixaban) differ substantially as regards oral bioavailability, plasma protein binding and the relative involvement of renal and non-renal elimination."( Clinical Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants in Patients with Renal Failure.
Padrini, R, 2019)		0.76
" The pharmacokinetics in patients treated with standard and reduced doses of the four anticoagulants using liquid chromatography-tandem mass spectrometry was compared with the concentration ranges estimated using physiologically based pharmacokinetic modeling."( Pharmacokinetics of anticoagulants apixaban, dabigatran, edoxaban and rivaroxaban in elderly Japanese patients with atrial fibrillation treated in one general hospital.
Endo, S; Kishi, H; Kogiku, M; Noda, M; Notsu, Y; Ota, M; Shimizu, M; Takekawa, M; Yamazaki, H; Yamazaki-Nishioka, M, 2019)		0.77
" We conducted virtual drug-drug interactions studies between DABE and the P-glycoprotein inhibitor verapamil in RI populations using physiologically based pharmacokinetic modeling."( Assessing Potential Drug-Drug Interactions Between Dabigatran Etexilate and a P-Glycoprotein Inhibitor in Renal Impairment Populations Using Physiologically Based Pharmacokinetic Modeling.
Doki, K; Homma, M; Neuhoff, S; Rostami-Hodjegan, A, 2019)		0.77
" The objective of this study was to build a physiologically based pharmacokinetic (PBPK) model comprising dabigatran etexilate, dabigatran, and dabigatran 1-O-acylglucuronide to describe the pharmacokinetics in healthy adults and renally impaired patients mechanistically."( A Comprehensive Whole-Body Physiologically Based Pharmacokinetic Model of Dabigatran Etexilate, Dabigatran and Dabigatran Glucuronide in Healthy Adults and Renally Impaired Patients.
Gómez-Mantilla, JD; Hanke, N; Lehr, T; Maas, H; Moj, D; Schaeftlein, A, 2019)		0.96
" The predicted area under the plasma concentration-time curve, trough concentration, and half-life values of the assessed clinical studies satisfied the two-fold acceptance criterion."( A Comprehensive Whole-Body Physiologically Based Pharmacokinetic Model of Dabigatran Etexilate, Dabigatran and Dabigatran Glucuronide in Healthy Adults and Renally Impaired Patients.
Gómez-Mantilla, JD; Hanke, N; Lehr, T; Maas, H; Moj, D; Schaeftlein, A, 2019)		0.74
"Physiologically-based pharmacokinetic (PBPK) modeling is a powerful tool to quantitatively describe drug disposition profiles in vivo, thereby providing an alternative to predict drug-drug interactions (DDIs) that have not been tested clinically."( Physiologically-Based Pharmacokinetic Modeling Approach to Predict Rifampin-Mediated Intestinal P-Glycoprotein Induction.
Costales, C; Eatemadpour, S; Kimoto, E; Lazzaro, S; Varma, MV; Yamazaki, S, 2019)		0.51
"A comprehensive and mechanistic PBPK/PD model to study dabigatran reversal has been established, which includes whole-body PBPK modeling of idarucizumab, the idarucizumab-dabigatran interaction, dabigatran hemodialysis, the pharmacodynamic effect of dabigatran on blood coagulation, and the impact of renal function in these different scenarios."( Effective Removal of Dabigatran by Idarucizumab or Hemodialysis: A Physiologically Based Pharmacokinetic Modeling Analysis.
Fuhr, LM; Hanke, N; Lehr, T; Meibohm, B, 2020)		1.12
" A plasma trough concentration/dose (C/D) ratio was used as a pharmacokinetic index."( Effect of CES1 and ABCB1 genotypes on the pharmacokinetics and clinical outcomes of dabigatran etexilate in patients with atrial fibrillation and chronic kidney disease.
Bochkov, P; Fomin, V; Gurinovich, O; Ivashchenko, D; Kogay, V; Krainyaya, A; Krupenin, P; Listratov, A; Napalkov, D; Ryzhikova, K; Shevchenko, R; Skripka, A; Sokolova, A; Sychev, D, 2020)		0.78
" Pharmacokinetic data on this anticoagulant in Chinese subjects are limited."( Pharmacokinetics and Safety of Dabigatran Etexilate after Single and Multiple Oral Doses in Healthy Chinese Subjects.
Duan, J; Harada, A; Li, H; Yamamura, N; Yang, L, 2020)		0.84
" Blood samples were collected to analyze the pharmacokinetic profile of dabigatran."( Pharmacokinetics and Safety of Dabigatran Etexilate after Single and Multiple Oral Doses in Healthy Chinese Subjects.
Duan, J; Harada, A; Li, H; Yamamura, N; Yang, L, 2020)		1.08
" The plasma concentration of total dabigatran reached its maximum measured concentration at a median time of 3-4 h from the dose of interest (either the initial single dose on day 1 or the final dose on day 10) under fed conditions, and declined with an elimination half-life of 10."( Pharmacokinetics and Safety of Dabigatran Etexilate after Single and Multiple Oral Doses in Healthy Chinese Subjects.
Duan, J; Harada, A; Li, H; Yamamura, N; Yang, L, 2020)		1.12
"This study revealed the pharmacokinetic characteristics and good safety profile of dabigatran in healthy Chinese subjects."( Pharmacokinetics and Safety of Dabigatran Etexilate after Single and Multiple Oral Doses in Healthy Chinese Subjects.
Duan, J; Harada, A; Li, H; Yamamura, N; Yang, L, 2020)		1.07
" There have been limited studies comparing the potential for pharmacokinetic (PK) drug interactions between different anticoagulants."( Comparison of potential pharmacokinetic drug interactions in patients with atrial fibrillation and changing from warfarin to non-vitamin K oral anticoagulant therapy.
Anoopkumar-Dukie, S; Badrick, T; Bernaitis, N, 2021)		0.62
" Pharmacokinetic data were available in 94% (132/140) of patients."( Pharmacokinetics of Direct Oral Anticoagulants in Emergency Situations: Results of the Prospective Observational RADOA-Registry.
Beyer-Westendorf, J; Birschmann, I; Greinacher, A; Grottke, O; Herrmann, E; Konstantinides, S; Kuhn, J; Lindau, S; Lindhoff-Last, E; Lucks, J; Meybohm, P; Nowak-Göttl, U; Schellong, S; Sümnig, A; von Heymann, C; Zydek, B, 2022)		0.72
" The DOACs' peak and trough plasma levels obtained from our study population were compared with those sourced from pharmacokinetic studies among patients without obesity, defined as a normal reference range in the literature."( Pharmacokinetics of Direct Oral Anticoagulants in Patients With Atrial Fibrillation and Extreme Obesity.
Atripaldi, U; Bottino, R; Cattaneo, D; Clementi, E; Giannetti, L; Laezza, N; Russo, V, 2021)		0.62
"As one of the key components in model-informed drug discovery and development, physiologically-based pharmacokinetic (PBPK) modeling linked with in vitro-to-in vivo extrapolation (IVIVE) is widely applied to quantitatively predict drug-drug interactions (DDIs) on drug-metabolizing enzymes and transporters."( Physiologically-based pharmacokinetic modeling to evaluate in vitro-to-in vivo extrapolation for intestinal P-glycoprotein inhibition.
De Zwart, L; Evers, R; Yamazaki, S, 2022)		0.72
"We aimed to report outcome and pharmacokinetic parameters in patients who massively ingested DOACs."( Case series of massive direct oral anticoagulant ingestion-Treatment and pharmacokinetics data.
Camoin-Jau, L; Chevillard, L; Delrue, M; Deye, N; Dragoni, A; Gainnier, M; Malissin, I; Mégarbane, B; Siguret, V; Stépanian, A; Voicu, S, 2022)		0.72
" Further studies using physiologically based pharmacokinetic modelling are required to investigate the drug-drug interactions between these drugs."( Simvastatin, but Not Atorvastatin, Is Associated with Higher Peak Rivaroxaban Serum Levels and Bleeding: an Asian Cohort Study from Singapore.
Chan, ECY; Soh, XQ; Tan, DS, 2023)		0.91
" Population pharmacokinetic (PopPK) analyses can help in identifying such factors while providing predictive models."( Population Pharmacokinetic Models for Direct Oral Anticoagulants: A Systematic Review and Clinical Appraisal Using Exposure Simulation.
Csajka, C; Daali, Y; Fontana, P; Gaspar, F; Guidi, M; Reny, JL; Terrier, J, 2022)		0.72
" Noncompartmental pharmacokinetic parameters and pharmacodynamic variables were evaluated with geometric mean ratios and 90% confidence intervals of Treatment C1/C2 versus A1/A2."( Effect of Daridorexant on the Pharmacokinetics of P-Glycoprotein Substrate Dabigatran Etexilate and Breast Cancer Resistance Protein Substrate Rosuvastatin in Healthy Subjects.
Anliker-Ort, M; Dingemanse, J; Janů, L; Kaufmann, P, 2023)		1.14
"9), respectively, whereas the time to maximum plasma concentration and terminal half-life were comparable between treatments."( Effect of Daridorexant on the Pharmacokinetics of P-Glycoprotein Substrate Dabigatran Etexilate and Breast Cancer Resistance Protein Substrate Rosuvastatin in Healthy Subjects.
Anliker-Ort, M; Dingemanse, J; Janů, L; Kaufmann, P, 2023)		1.14

Compound-Compound Interactions

Dabigatran etexilate can be given with verapamil and clarithromycin. Clinical management of DDIs in Chinese older adults can a priori be similar to the EHRA guideline.

ExcerptReferenceRelevance
"The aim of this study was to develop a PK/PD model to assess drug-drug interactions between dabigatran and P-gp modulators, using the example of clarithromycin, a strong inhibitor of P-gp."( A semi-mechanistic absorption model to evaluate drug-drug interaction with dabigatran: application with clarithromycin.
Accassat, S; Basset, T; Bertoletti, L; Delavenne, X; Garcin, A; Laporte, S; Mismetti, P; Ollier, E; Zufferey, P, 2013)		0.84
"The model proposed effectively describes the complex PK of dabigatran and takes into account drug-drug interactions with P-gp activity modulators, such as clarithromycin."( A semi-mechanistic absorption model to evaluate drug-drug interaction with dabigatran: application with clarithromycin.
Accassat, S; Basset, T; Bertoletti, L; Delavenne, X; Garcin, A; Laporte, S; Mismetti, P; Ollier, E; Zufferey, P, 2013)		0.86
" Co-prescribed drugs that potentially interact with dabigatran etexilate were present in 75% (154/204) of patients and included strong P-gp inhibitors (16%, 32/204), proton-pump inhibitors (46%, 94/204) and anti-platelet drugs (47%, 95/204)."( Dosing of dabigatran etexilate in relation to renal function and drug interactions at a tertiary hospital.
Barclay, ML; Begg, EJ; Chin, PK; Vella-Brincat, JW; Walker, SL, 2013)		1.04
" Most patients were co-prescribed with drugs that potentially interact with dabigatran etexilate."( Dosing of dabigatran etexilate in relation to renal function and drug interactions at a tertiary hospital.
Barclay, ML; Begg, EJ; Chin, PK; Vella-Brincat, JW; Walker, SL, 2013)		1.02
" Dabigatran etexilate was proposed as an in vivo probe substrate for intestinal P-gp inhibition in a recent guidance on drug-drug interactions (DDI) from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA)."( In vitro predictability of drug-drug interaction likelihood of P-glycoprotein-mediated efflux of dabigatran etexilate based on [I]2/IC50 threshold.
Ebner, T; Ishiguro, N; Kishimoto, W; Ludwig-Schwellinger, E; Schaefer, O, 2014)		1.53
"To review pharmacokinetic and pharmacodynamic drug-drug interactions (DDIs) involving new oral anticoagulants for atrial fibrillation."( Pharmacokinetic and pharmacodynamic drug interactions with new oral anticoagulants: what do they mean for patients with atrial fibrillation?
Gulseth, M; Hellwig, T, 2013)		0.39
" Phase I DDI studies have reported pharmacokinetic DDIs mediated by P-gp alone (dabigatran etexilate) or in combination with CYP3A4 enzymes (rivaroxaban and apixaban)."( Pharmacokinetic and pharmacodynamic drug interactions with new oral anticoagulants: what do they mean for patients with atrial fibrillation?
Gulseth, M; Hellwig, T, 2013)		0.62
"In vitro inhibitory potency (Ki )-based predictions of P-glycoprotein (P-gp)-mediated drug-drug interactions (DDIs) are hampered by the substantial variability in inhibitory potency."( Physiologically based pharmacokinetic modelling and in vivo [I]/K(i) accurately predict P-glycoprotein-mediated drug-drug interactions with dabigatran etexilate.
Hu, ZY; Zhao, Y, 2014)		0.6
"To quantify the drug-drug interactions between dabigatran etexilate (DE) and proton pump inhibitors (PPI) and in particular the role of P-gp activity modulation."( In vitro and in vivo evaluation of drug-drug interaction between dabigatran and proton pump inhibitors.
Accassat, S; Basset, T; Bertoletti, L; Delavenne, X; Hodin, S; Mismetti, P; Ollier, E, 2015)		0.91
" The intraday and interday precision and accuracy of the assays were within acceptable ranges, and the assays were successfully applied to support a study where a microdose cocktail was dosed to healthy human subjects for simultaneous assessment of clinical drug-drug interactions mediated by major drug transporters and CYP3A."( Microdosing Cocktail Assay Development for Drug-Drug Interaction Studies.
Bateman, KP; Chavez-Eng, CM; Goykhman, D; Lutz, RW, 2018)		0.48
"The aim of this study is to assess patterns of potential drug-drug interactions (DDIs) with direct oral anticoagulants (DOACs) in an inpatient hospital setting."( Evaluation of Potential Drug-Drug Interactions With Direct Oral Anticoagulants in a Large Urban Hospital.
Karakas-Torgut, A; Mo, Y; Pham, AQ, 2020)		0.56
" The bleeding risk associated with dabigatran is higher in the setting of renal impairment or drug-drug interactions resulting in supratherapeutic serum concentrations."( Probable drug-drug interaction between dabigatran and quinidine resulting in thrombin time rebound despite multiple idarucizumab doses.
George, S; Lewis, V; Taburyanskaya, M, 2019)		1.06
" NOAC have also been studied in combination with platelet antiaggregation in both patients with coronary and peripheral arterial disease, and reduced doses will presumably emerge as routine treatment also in these conditions."( [NOAC in combination with platelet antiaggregation in both patients with coronary and peripheral arterial disease].
Gottsäter, A, 2018)		0.48
" Because the combined effects of drug-drug interactions and RI have not been evaluated by means of clinical studies, the decision of DABE dosing for RI patients receiving P-glycoprotein inhibitors is empirical at its best."( Assessing Potential Drug-Drug Interactions Between Dabigatran Etexilate and a P-Glycoprotein Inhibitor in Renal Impairment Populations Using Physiologically Based Pharmacokinetic Modeling.
Doki, K; Homma, M; Neuhoff, S; Rostami-Hodjegan, A, 2019)		0.77
"We sought to develop a semiautomated screening approach using electronic healthcare data to identify drug-drug interactions (DDIs) that result in clinical outcomes."( A Case-Crossover-Based Screening Approach to Identifying Clinically Relevant Drug-Drug Interactions in Electronic Healthcare Data.
Bykov, K; Gagne, JJ; Glynn, RJ; Mittleman, MA; Schneeweiss, S, 2019)		0.51
" Accordingly, the drug-drug interaction (DDI) potential of darolutamide was investigated in both nonclinical and clinical studies."( Drug-Drug Interaction Potential of Darolutamide: In Vitro and Clinical Studies.
Bairlein, M; Denner, K; Fricke, R; Gieschen, H; Graudenz, K; Korjamo, T; Koskinen, M; Prien, O; von Bühler, CJ; Wilkinson, G; Zurth, C, 2019)		0.51
"Self-controlled designs, specifically the case-crossover (CCO) and the self-controlled case series (SCCS), are increasingly utilized to generate real-world evidence (RWE) on drug-drug interactions (DDIs)."( Drug-Drug Interaction Surveillance Study: Comparing Self-Controlled Designs in Five Empirical Examples in Real-World Data.
Bykov, K; Gagne, JJ; Kim, S; Li, H; Lo Re, V; Vine, SM, 2021)		0.62
" Veverimer is not systemically absorbed, so potential drug-drug interactions (DDIs) are limited to effects on the absorption of other oral drugs through binding to veverimer in the gastrointestinal tract or increases in gastric pH caused by veverimer binding to hydrochloric acid."( Assessment of the Potential for Veverimer Drug-Drug Interactions.
Biyani, K; Guttendorf, R; Klaerner, G; Lee, A; Li, E; Mathur, V; Parsell, D; Shao, J; Stasiv, Y; Tabakman, S; Tsao, L; Wu, YS, 2021)		0.62
"Dexamethasone has the potential to interact with the DOACs via CYP3A4 and/or P-gp induction."( Potential Dexamethasone-Direct Oral Anticoagulant Drug Interaction: Is This a Concern in COVID?
Burns, C; Garwood, CL; Liu, Q; Smythe, MA, 2022)		0.72
" The aim of this study was to assess the potential P-gp-mediated drug-drug interactions between 11 tyrosine kinase inhibitors (TKIs) with apixaban and rivaroxaban."( Tyrosine kinase inhibitors and direct oral anticoagulants: In vitro evaluation of drug-drug interaction mediated by P-glycoprotein.
Bertoletti, L; Bin, V; Delavenne, X; Hodin, S; Lafaie, L; Saïb, S, 2022)		0.72
" Both warfarin and direct oral anticoagulants are susceptible to drug-drug interactions (DDIs)."( Drug Interactions Affecting Oral Anticoagulant Use.
Chung, MK; Dukes, J; Ezekowitz, MD; Gengler, BE; Gopinathannair, R; Lakkireddy, D; Lip, GYH; Mar, PL; Miletello, M; Noseworthy, PA; Olshansky, B; Perez, A; Reiffel, J; Tisdale, JE, 2022)		0.72
"Direct oral anticoagulants (DOACs) can be involved in clinical relevant drug-drug interactions (DDIs) which may compromise safe and effective use."( Drug-drug interactions with direct oral anticoagulants: development of a consensus list for ambulatory care.
Boussery, K; Capiau, A; De Backer, T; De Bolle, L; Mehuys, E; Van Tongelen, I, 2023)		0.91
" Clinical management of DDIs in Chinese older adults in the absence of complex polypharmacy can a priori be similar to the EHRA guideline but routine monitoring of bleeding risk is encouraged when dabigatran etexilate given with verapamil and clarithromycin."( Physiologically-based pharmacokinetic modeling to predict drug-drug interactions of dabigatran etexilate and rivaroxaban in the Chinese older adults.
Cui, C; Lai, X; Li, H; Liu, D; Sia, JEV; Wu, X; Zhang, F, 2023)		1.32
"Whether there are differences in direct oral anticoagulants efficacy and safety in patients with atrial fibrillation (AF) combined with hypertension is unclear."( Efficacy and Safety of Direct Oral Anticoagulants in Patients With Atrial Fibrillation Combined With Hypertension: A Multicenter, Retrospective Cohort Study.
Chen, X; Dai, H; Du, X; Gu, P; Guan, C; Huang, N; Huang, X; Li, R; Lin, X; Liu, X; Liu, Y; Lv, M; Wu, T; Xu, W; Zhang, J; Zhang, M; Zhang, W; Zheng, Q; Zhu, Z, 2023)		0.91

Bioavailability

Dabigatran may be a viable alternative to enoxaparin for thromboprophylaxis in orthopaedic surgery. The main pharmacokinetic characteristics of dabig atran are a bioavailability of approximately 7.5 h.

ExcerptReferenceRelevance
"Dabigatran etexilate (BIBR 1048) is an orally bioavailable double prodrug of the active principle dabigatran (BIBR 953 ZW), which exerts potent anticoagulant and antithrombotic activity."( Population pharmacokinetic analysis of the new oral thrombin inhibitor dabigatran etexilate (BIBR 1048) in patients undergoing primary elective total hip replacement surgery.
Liesenfeld, KH; Schäfer, HG; Stangier, J; Tillmann, C; Trocóniz, IF, 2007)		2.02
"To investigate the pharmacokinetic and pharmacodynamic profile of dabigatran in healthy elderly subjects; to assess the intra- and interindividual variability of dabigatran pharmacokinetics in order to assess possible gender differences; and to assess the effect of pantoprazole coadministration on the bioavailability of dabigatran."( Pharmacokinetics and pharmacodynamics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects.
Fuhr, R; Rathgen, K; Stähle, H; Stangier, J, 2008)		0.81
" The effects of pantoprazole coadministration on the bioavailability of dabigatran were considered acceptable, and dose adjustment is not considered necessary."( Pharmacokinetics and pharmacodynamics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects.
Fuhr, R; Rathgen, K; Stähle, H; Stangier, J, 2008)		0.81
" Its oral bioavailability is low, but shows reduced interindividual variability."( [Pharmacokinetics and pharmacodynamics of the new oral anticoagulants dabigatran and rivaroxaban].
Climent Grana, E; Jover Botella, A; Ordovás Baines, JP; Valero García, I, )		0.37
" Given its safety profile, efficacy, oral bioavailability and stable pharmacokinetic properties, dabigatran may be a viable alternative to enoxaparin for thromboprophylaxis in orthopaedic surgery."( Dabigatran etexilate: a new thrombin inhibitor.
Verma, AK, 2010)		2.02
" Oral bioavailability of dabigatran, together with a rapid onset and offset of action and predictable anticoagulation response, makes this newly available antithrombotic drug an attractive alternative to traditional anticoagulant therapies for numerous thrombosis-related indications."( New options with dabigatran etexilate in anticoagulant therapy.
Azuma, J; Maegdefessel, L; Spin, JM; Tsao, PS, 2010)		1
" In the fasted dog, oral administration of 3 mg kg(-1) S35972 increased TT rapidly and for at least 8 h, and its pharmacologic bioavailability was 75."( S35972, a direct-acting thrombin inhibitor with high oral bioavailability and antithrombotic efficacy.
De Nanteuil, G; Gloanec, P; Marx, I; Mennecier, P; Rupin, A; Vallez, MO; Verbeuren, TJ, 2011)		0.37
"Administration of rifampicin for 7 days resulted in a significant reduction in the bioavailability of dabigatran, which returned almost to baseline after 7 days washout."( Decrease in the oral bioavailability of dabigatran etexilate after co-medication with rifampicin.
Härtter, S; Koenen-Bergmann, M; Lemke, U; Nehmiz, G; Reilly, PA; Sharma, A; Timmer, W, 2012)		0.86
"Dabigatran etexilate is the orally bioavailable pro-drug of dabigatran, a direct thrombin inhibitor."( A combined pharmacometric analysis of dabigatran etexilate in healthy volunteers and patients with atrial fibrillation or undergoing orthopaedic surgery.
Dansirikul, C; Haertter, S; Lehr, T; Liesenfeld, KH; Staab, A, 2012)		2.09
"Due to low bioavailability and high inter-individual variability, monitoring of dabigatran may be required in specific situations to prevent the risk of bleedings or thrombosis."( Impact of dabigatran on a large panel of routine or specific coagulation assays. Laboratory recommendations for monitoring of dabigatran etexilate.
Chatelain, B; Chatelain, C; Dogné, JM; Douxfils, J; Mullier, F; Robert, S, 2012)		1.01
" Similarly, clopidogrel bioavailability remained unchanged by chronic administration of dabigatran etexilate (part 3: ratio test/reference for AUC(0-24) was 103%; 90% CI 80."( Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers.
Baumann, S; Friedman, J; Fritsch, H; Härtter, S; Schepers, C; Sennewald, R, 2013)		0.84
"Concomitant medication with proton pump inhibitors, amiodarone, clarithromycin, and verapamil increased bioavailability whereas rifampicin decreased the bioavailability of dabigatran."( Relevance of P-glycoprotein in stroke prevention with dabigatran, rivaroxaban, and apixaban.
Finsterer, J; Stöllberger, C, 2015)		0.86
"Dronedarone is a strong P-glycoprotein inhibitor with a potential to increase bioavailability of dabigatran."( Concomitant use of dronedarone with dabigatran in patients with atrial fibrillation in clinical practice.
Juhlin, T; Mochalina, N; Platonov, PG; Svensson, PJ; Wieloch, M, 2015)		0.91
"80% relative bioavailability compared with Pradaxa(®) capsules (a commercial DE product)."( A solid self-nanoemulsifying system of the BCS class IIb drug dabigatran etexilate to improve oral bioavailability.
Chai, F; Ding, Y; Liu, X; Sun, L; Webster, TJ; Zhang, Y; Zheng, C, 2016)		0.67
"The developed SNEDDS are promising materials for improving the dissolution and oral bioavailability of BCS class IIb drugs."( A solid self-nanoemulsifying system of the BCS class IIb drug dabigatran etexilate to improve oral bioavailability.
Chai, F; Ding, Y; Liu, X; Sun, L; Webster, TJ; Zhang, Y; Zheng, C, 2016)		0.67
"Anticoagulation in patients with impaired kidney function can be challenging since drugs' pharmacokinetics and bioavailability are altered in this setting."( Chronic kidney disease and anticoagulation: from vitamin K antagonists and heparins to direct oral anticoagulant agents.
Baldovino, S; Fenoglio, R; Radin, M; Roccatello, D; Schreiber, K; Sciascia, S, 2017)		0.46
" In 5-FU-treated rats, the maximum plasma concentration, the area under the concentration-time curve of DAB after the oral administration of DABE, and the oral bioavailability of DABE were significantly decreased to 18."( 5-Fluororacil-Induced Gastrointestinal Damage Impairs the Absorption and Anticoagulant Effects of Dabigatran Etexilate.
Akiyoshi, T; Hattori, T; Imaoka, A; Ohtani, H; Tsujii, K, 2018)		0.7
" This review summarizes the discovery and optimization of representative novel oral anticoagulants with the aim to improve selectivity and bioavailability of compounds."( The selectivity and bioavailability improvement of novel oral anticoagulants: An overview.
Cheng, K; Li, S; Liao, C; Lv, X; Tian, Y; Xiao, X; Xie, Z; Zhan, M, 2018)		0.48
" However, due to altered pharmacokinetics and bioavailability of these drugs in CKD, a significant risk of bleeding exists."( [The Multimorbid Patient: Use of New Oral Anticoagulants in Patients with Chronic Kidney Disease].
Mohebbi, N, 2018)		0.48
" Consequently, food does not influence its bioavailability and the efficacy and safety of dabigatran are similar with or without concomitant intake of proton pump inhibitors (PPIs)."( Establishing Therapeutic Equivalence of Complex Pharmaceuticals: The Case of Dabigatran.
Earl, KM; Jamali, F; Leblanc, K; Semchuk, W; Weitz, JI, 2018)		0.93
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019)		0.51
" Dabigatran etexilate (DABE), an oral anticoagulant and substrate of P-glycoprotein (P-gp), is poorly absorbed and exhibits low bioavailability in humans."( Irinotecan-induced gastrointestinal damage impairs the absorption of dabigatran etexilate.
Akiyoshi, T; Hattori, T; Imaoka, A; Ohtani, H, 2019)		1.66
"For weakly basic drugs, the sharp decrease of drug solubility and the following drug precipitation after drugs transferring from the gastric fluid to the intestinal fluid in the gastrointestinal (GI) tract is a main reason for the poor oral bioavailability of drugs."( A composite nanocarrier to inhibit precipitation of the weakly basic drug in the gastrointestinal tract.
Ge, L; He, X; Li, Y; Peng, Z; Sun, Y; Tao, J; Wu, Y; Zheng, C, 2020)		0.56

Dosage Studied

Dabigatran is the first of four direct-acting oral anticoagulants approved to prevent stroke in adult patients with atrial fibrillation. However, dosing based on coagulation parameters can be difficult because available assays may not provide adequate sensitivity and specificity.

ExcerptRelevanceReference
" In experimental models of thrombosis, melagatran has been shown to have a shallower dose-response curve than warfarin and, therefore, a better separation between efficacy and bleeding."( Oral direct thrombin inhibitors in clinical development.
Gustafsson, D, 2003)		0.32
" A dose-response was demonstrated for minor bleeding events."( Dose escalating safety study of a new oral direct thrombin inhibitor, dabigatran etexilate, in patients undergoing total hip replacement: BISTRO I.
Ahnfelt, L; Dahl, OE; Eriksson, BI; Hermansson, K; Kälebo, P; Kohlbrenner, V; Nehmiz, G; Stangier, J, 2004)		0.56
" These pharmacokinetic characteristics confirm the suitability of this oral solid dosage form for use in future clinical trials."( Pharmacokinetic profile of the oral direct thrombin inhibitor dabigatran etexilate in healthy volunteers and patients undergoing total hip replacement.
Ahnfelt, L; Dahl, OE; Eriksson, BI; Nehmiz, G; Rathgen, K; Stähle, H; Stangier, J; Svärd, R, 2005)		0.57
" A total of 4604 BIBR 953 ZW plasma concentrations, obtained from 287 patients after once- or twice-daily oral dosing for up to 10 days after surgery in the dose range 12."( Population pharmacokinetic analysis of the new oral thrombin inhibitor dabigatran etexilate (BIBR 1048) in patients undergoing primary elective total hip replacement surgery.
Liesenfeld, KH; Schäfer, HG; Stangier, J; Tillmann, C; Trocóniz, IF, 2007)		0.57
" There are numerous drug/drug and drug/food interactions, and there is difficulty in dosing for one-third of patients."( The new anticoagulants.
Money, SR; Stone, WM; Tonnessen, BH, 2007)		0.34
" 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
" Dosing stopped at contrast venography, 12 to 15 days after surgery."( Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery.
Caprini, JA; Clements, ML; Comp, PC; Davidson, BL; Francis, CW; Friedman, RJ; Ginsberg, JS; Hantel, S; Huo, MH; Lieberman, JR; Muntz, JE; Raskob, GE; Schnee, JM, 2009)		0.66
" Dabigatran etexilate pharmacokinetics were linear across a wide dosage range."( Dabigatran etexilate.
Plosker, GL; Sanford, M, 2008)		2.7
" The use of algorithms for dosing that incorporate pharmacogenomic information perform better than those using clinical data alone."( New issues in oral anticoagulants.
Francis, CW, 2008)		0.35
" It is unique because it includes equal numbers of VKA-experienced and naive patients and evaluates 2 different dosages of dabigatran, which may allow tailoring of dosing to individual patient needs."( Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran.
Connolly, S; Ezekowitz, MD; Oldgren, J; Parekh, A; Reilly, PA; Themeles, E; Varrone, J; Wallentin, L; Wang, S; Yusuf, S, 2009)		0.77
" Dabigatran is mainly eliminated by renal excretion (a fact which affects the dosage in elderly and in moderate-severe renal failure patients), and no hepatic metabolism by cytochrome P450 isoenzymes has been observed, showing a good interaction profile."( [Pharmacokinetics and pharmacodynamics of the new oral anticoagulants dabigatran and rivaroxaban].
Climent Grana, E; Jover Botella, A; Ordovás Baines, JP; Valero García, I, )		1.28
" These drugs have predictable pharmacokinetics that allow fixed dosing without laboratory monitoring, and are being compared with vitamin K antagonists or aspirin in phase III clinical trials [corrected]."( New anticoagulants for atrial fibrillation.
Eikelboom, J; O'Donnell, M; Sobieraj-Teague, M, 2009)		0.35
"We assessed the efficacy, safety, and dose-response of dabigatran etexilate (DAB) in preventing venous thromboembolism (VTE) in Japanese patients undergoing total knee arthroplasty (TKA)."( Dabigatran etexilate prevents venous thromboembolism after total knee arthroplasty in Japanese patients with a safety profile comparable to placebo.
Fuijita, S; Fuji, T; Sato, T; Ujihira, T, 2010)		2.05
" All of these characteristics can be an obstacle to optimal patient care, particularly when outpatient dosing is required after early discharge."( [Dabigatran (Pradaxa): efficacy and safety].
Bellamy, L; Rosencher, N, 2009)		1.26
"The RE-LY study compared dabigatran in the dose of 150 mg and 110 mg twice daily, without laboratory monitoring, with the conventional treatment with warfarin dosed according to INR in 18,113 patients with non-valvular atrial fibrillation and high risk of embolisation."( [The results of the RE-lY study promise more effective, safer and easier prevention of embolic complications in patients with non-valvular atrial fibrillation].
Vojácek, J, 2009)		0.66
" Blood and urine samples were collected up to 96 hours after dosing for determination of dabigatran pharmacokinetic and pharmacodynamic parameters."( Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate: an open-label, parallel-group, single-centre study.
Mazur, D; Rathgen, K; Stähle, H; Stangier, J, 2010)		0.81
" Four isomeric acylglucuronides of dabigatran were isolated and purified from urine of dosed rhesus monkeys."( Dabigatran acylglucuronide, the major human metabolite of dabigatran: in vitro formation, stability, and pharmacological activity.
Ebner, T; Wagner, K; Wienen, W, 2010)		2.08
" Depending on its dosage its effectiveness in comparison with vitamin K antagonists is equal or even better without disadvantages in safety."( [New oral anticoagulants: better than vitamin K antagonists?].
Alban, S; Völler, H; Westermann, D, 2010)		0.36
" Efficacy and safety of oral anticoagulation is limited by a narrow therapeutical range as well as by inter- and intraindividual variability of INR-values due to genetic disposition, differences in alimentation, dosage errors, rare control of INR-levels and drug-interactions."( [Novel anticoagulants for stroke prevention in atrial fibrillation].
Baumhäkel, M; Böhm, M; Schirmer, SH, 2010)		0.36
" Moreover, the higher dosage was associated with significantly greater efficacy than warfarin in this regard."( Dabigatran etexilate: a review of its use in the prevention of stroke and systemic embolism in patients with atrial fibrillation.
Garnock-Jones, KP, 2011)		1.81
" Based on the RE-LY study we investigated the cost-effectiveness of Health Canada approved dabigatran etexilate dosing (150 mg bid for patients <80 years, 110 mg bid for patients ≥80 years) versus warfarin and "real-world" prescribing (i."( Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: a Canadian payer perspective.
Bradley-Kennedy, C; Connolly, S; Kansal, AR; Linnehan, J; Peng, S; Plumb, JM; Sorensen, SV, 2011)		0.9
" Disadvantages of dabigatran may include a higher frequency of dyspepsia compared with warfarin, lack of dosing information in severe renal impairment, possible missed opportunities for periodic health examinations and interventions due to elimination of regular physician's visit for international normalized ratio monitoring, and drug costs."( Dabigatran etexilate: the first oral anticoagulant available in the United States since warfarin.
Cheng-Lai, A; Tran, A, )		1.91
" The vitamin K antagonist warfarin has traditionally been used in these patients but presents challenges in dosing and monitoring in these patients."( Dabigatran: an oral direct thrombin inhibitor for use in atrial fibrillation.
Baker, WL; Bendel, SD; Bona, R, 2011)		1.81
" Although dabigatran is not approved for venous thromboembolism (VTE) prevention or treatment, results of the RE-MODEL and RE-NOVATE trials suggest similar efficacy to once-daily dosing of enoxaparin 40 mg but inferior efficacy to the FDA-approved twice-daily dosing of enoxaparin 30 mg in the RE-MOBILIZE trial."( Dabigatran etexilate: a novel oral thrombin inhibitor for thromboembolic disease.
Bovio, JA; Gums, JG; Smith, SM, 2011)		2.21
" 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)		0.79
"The pharmacology, pharmacokinetics, clinical efficacy, tolerability, dosage and administration, and place in therapy of dabigatran etexilate are reviewed."( Dabigatran etexilate: A novel oral direct thrombin inhibitor.
Blommel, AL; Blommel, ML, 2011)		2.02
" 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
" Exposure to dabigatran was not significantly altered with concomitant digoxin-the maximum concentration (Cmax,ss ) and area under the concentration-time curve at steady state over 1 dosing interval (AUCτ,ss ) of dabigatran with and without digoxin were essentially unchanged."( Pharmacokinetics and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor, with coadministration of digoxin.
Körnicke, T; Rathgen, K; Reseski, K; Roth, W; Stähle, H; Stangier, J, 2012)		1.01
" The aim of this analysis was to derive a modeling and simulation-based dose and dosing regimen for AF patients with severe renal failure who could potentially benefit from the use of DE."( Dabigatran etexilate in atrial fibrillation patients with severe renal impairment: dose identification using pharmacokinetic modeling and simulation.
Clemens, A; Friedman, J; Haertter, S; Lehr, T; Liesenfeld, KH; Reilly, PA; Staab, A, 2012)		1.82
"The objective of this work was to derive a dosing regimen for dabigatran in patients with severe renal impairment by modeling and simulation."( Clinical pharmacology basis of deriving dosing recommendations for dabigatran in patients with severe renal impairment.
Hariharan, S; Madabushi, R, 2012)		0.86
" The dosage of 110 mg bid should be preferably used in patients older than 75 years at a higher bleeding risk."( Preventing cardioembolic stroke in atrial fibrillation with dabigatran.
Diener, HC; Eikelboom, JW; Hohnloser, SH; Weimar, C, 2012)		0.62
" 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)		1.06
" This preliminary evidence, while intriguing, requires confirmation in post-stroke patients receiving orally dosed D in order to determine whether these findings are clinically relevant."( Effects of dabigatran in vitro on thrombin biomarkers by Calibrated Automated Thrombography in patients after ischemic stroke.
Fong, A; Hanley, D; Lynch, D; Sani, Y; Schevchuck, A; Serebruany, V; Svetlov, S; Thevathasan, L, 2012)		0.77
"The labeling of dabigatran etexilate (Pradaxa-Boehringer Ingelheim), an oral direct thrombin inhibitor, has recently been updated to include new dosing and monitoring recommendations and a warning on the risk of bleeding."( Bleeding with dabigatran (Pradaxa).
, 2011)		1.08
"For this paper the authors searched the literature for data on efficacy and bleeding rates with low-molecular-weight heparins and fondaparinux in routine clinical practice; and on the effects of standard or reduced dosing with these anticoagulants or with the oral direct thrombin inhibitor dabigatran etexilate in vulnerable patient groups."( A new approach with anticoagulant development: tailoring anticoagulant therapy with dabigatran etexilate according to patient risk.
Albaladejo, P; Rosencher, N, 2012)		0.78
" Heparin was not used postoperatively and transition dosing from dabigatran to warfarin was started on postoperative day 8, the day of discharge."( Dabigatran use in a postoperative coronary artery bypass surgery patient with nonvalvular atrial fibrillation and heparin-PF4 antibodies.
Fieland, D; Taylor, M, 2012)		2.06
" Based on its pharmacokinetic profile, dabigatran is dosed twice daily."( Twice daily dosing of dabigatran for stroke prevention in atrial fibrillation: a pharmacokinetic justification.
Brueckmann, M; Clemens, A; Friedman, J; Haertter, S; Lehr, T; Stangier, J; van Ryn, J, 2012)		0.96
" For patients who miss or delay taking one scheduled dabigatran dose, twice daily dosing maintained adequate minimum trough concentrations better than once daily dosing."( Twice daily dosing of dabigatran for stroke prevention in atrial fibrillation: a pharmacokinetic justification.
Brueckmann, M; Clemens, A; Friedman, J; Haertter, S; Lehr, T; Stangier, J; van Ryn, J, 2012)		0.94
" The efficacy and safety of this dosing regimen is supported by clinical data from the RE-LY trial."( Twice daily dosing of dabigatran for stroke prevention in atrial fibrillation: a pharmacokinetic justification.
Brueckmann, M; Clemens, A; Friedman, J; Haertter, S; Lehr, T; Stangier, J; van Ryn, J, 2012)		0.69
" However, one study failed to demonstrate noninferiority to subcutaneous enoxaparin dosed BID in the composite end point of VTE, and all-cause mortality."( Dabigatran etexilate: an oral direct thrombin inhibitor for the management of thromboembolic disorders.
Cheng, JW; Vu, H, 2012)		1.82
" The discussion of clinical trial data focuses on comparative trials with the EU approved dosage regimen of once-daily subcutaneous enoxaparin sodium 40 mg."( Dabigatran etexilate: a review of its use for the prevention of venous thromboembolism after total hip or knee replacement surgery.
Burness, CB; McKeage, K, 2012)		1.82
" The emergence of new anticoagulants that offer equal or superior efficacy, greater safety and the convenience of fixed oral dosing may make warfarin the less preferred option."( Prevention of stroke in patients with atrial fibrillation: anticoagulant and antiplatelet options.
Halperin, JL; Varughese, CJ, 2012)		0.38
" Dosed twice daily, dabigatran offers recipients the ability to forego regular international normalized ratio coagulation monitoring as well as eliminating dietary restrictions (i."( Dabigatran for the prevention of thromboembolic complications in the elderly: a RE-LY-able alternative to warfarin?
Freeman, MK; Hughes, PJ, 2012)		2.15
" These agents promise to be more convenient to administer with fixed dosing but still have equivalent efficacy and improved bleeding risk compared to warfarin."( Newer oral anticoagulant agents: a new era in medicine.
Goel, R; Srivathsan, K, 2012)		0.38
"This study aims to test a new dosing regimen for dabigatran etexilate in patients with a mechanical bileaflet valve."( A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: THE Randomized, phase II study to evaluate the safety and pharmacokinetics of oral dabigatran etexilate in patients after heart valve replacement (RE-ALIGN).
Brueckmann, M; Connolly, SJ; Eikelboom, JW; Friedman, J; Granger, CB; Harper, R; Härtter, S; Kappetein, AP; Lehr, T; Mack, MJ; Noack, H; Van de Werf, F, 2012)		0.98
" Dabigatran (110 or 150 mg twice daily) demonstrated noninferiority versus adjusted-dose warfarin with regard to the prevention of stroke and systemic embolism (primary endpoint) in patients with AF in the RE-LY trial, and the 150 mg twice-daily dosage was significantly more effective than warfarin for this endpoint, as well as most other efficacy endpoints."( Dabigatran etexilate: a pharmacoeconomic review of its use in the prevention of stroke and systemic embolism in patients with atrial fibrillation.
McKeage, K, 2012)		2.73
" The dosage of 110 mg BID should be preferably used in patients aged 75-80 years or older as the rate of extracranial bleeding events tends to increase with dabigatran 150 mg BID above this age limit."( Dabigatran for stroke prevention in atrial fibrillation.
Diener, HC; Hohnloser, SH, 2012)		2.02
" Genotype-guided warfarin dosing and management may improve patient-time in target range (TTR) and therefore affect the cost-effectiveness of dabigatran compared with warfain."( Cost-effectiveness of dabigatran versus genotype-guided management of warfarin therapy for stroke prevention in patients with atrial fibrillation.
Cheng, G; Tsui, KK; Wong, RS; You, JH, 2012)		0.89
" The approved dosing regimen for patients with creatinine clearance 15-30 mL/min (75 mg twice daily) was derived from PK modeling studies, limiting its applicability to the clinical setting."( Pharmacokinetic and clinical implications of dabigatran use in severe renal impairment for stroke prevention in nonvalvular atrial fibrillation.
Kim, JJ; Mack, DR, )		0.39
" Steady-state dosing of clopidogrel 75 mg qd and dabigatran etexilate 150 mg bid (part 2) demonstrated minor effects on dabigatran pharmacokinetics (AUC(τ,ss) ratio test/reference: 91."( Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers.
Baumann, S; Friedman, J; Fritsch, H; Härtter, S; Schepers, C; Sennewald, R, 2013)		0.87
" It is suggested to perform EXCA tests for each individual patient to determine the real drug dosage he needs to reach 10-20% of normal EXCA for therapy or 20-40% of normal EXCA for prophylaxis."( Determination of the anti-F10a or anti-F2a generation action of rivaroxaban or dabigatran.
Stief, TW, 2012)		0.61
" The requirement for a twice-daily dosage regimen, the lack of an anticoagulation monitoring option, the relatively short duration of action and the lack of an antidote may even prove to be crucial disadvantages in clinical practice in comparison to vitamin K antagonists."( [New oral anticoagulants for the prevention of stroke. Open questions in geriatric patients].
Berthold, HK, 2012)		0.38
" They have a slow onset and offset of action, narrow therapeutic window, marked dose-response variability, and multiple food and drug interactions, and require frequent coagulation monitoring and dose adjustments."( Emerging anticoagulant therapies for atrial fibrillation: new options, new challenges.
Mangiafico, M; Mangiafico, RA, 2012)		0.38
" These data suggest that direct thrombin inhibition in a relevant dosage improved endothelial function and reduced atherosclerotic lesion size, collagen content, and oxidative stress in hypercholesterolemic atherosclerosis."( The effects of direct thrombin inhibition with dabigatran on plaque formation and endothelial function in apolipoprotein E-deficient mice.
Baumhäkel, M; Böhm, M; Kratz, MT; Lee, IO; Schirmer, SH, 2012)		0.64
" Much of the literature associated with dabigatran encourages this view, stressing that dabigatran is a 'game changer' with the advantage of fixed dosing for most patients and no anticoagulation monitoring."( Dabigatran: rational dose individualisation and monitoring guidance is needed.
Al-Sallami, HS; Duffull, SB; Faed, JM; Wright, DF; Zufferey, PJ, 2012)		2.09
" Patients who met at least one caution or contraindication criteria were deemed "non-candidates"; potential dosage reductions of the new oral anticoagulants were not considered."( Analysis of the projected utility of dabigatran, rivaroxaban, and apixaban and their future impact on existing Hematology and Cardiology Anticoagulation Clinics at The Johns Hopkins Hospital.
Carter, KL; Kraus, PS; Ross, PA; Shermock, KM; Streiff, MB; Thomas, ML; Wellman, JC, 2012)		0.65
" Based on the RE-LY and ROCKET AF trial results, we investigated the cost-effectiveness of dabigatran (twice daily dosing of 150 mg or 110 mg based on patient age) versus rivaroxaban from a Canadian payer perspective."( Dabigatran versus rivaroxaban for the prevention of stroke and systemic embolism in atrial fibrillation in Canada. Comparative efficacy and cost-effectiveness.
Bradley-Kennedy, C; Clemens, A; Kansal, AR; Monz, BU; Peng, S; Roskell, N; Sharma, M; Sorensen, SV, 2012)		2.04
" These newer agents possess a highly predictable pharmacokinetic-pharmacodynamic relationship, allowing for fixed dosing and no necessity for routine laboratory monitoring; additionally these agents have minimal drug interactions."( New anticoagulants for stroke prophylaxis in atrial fibrillation: assessing the impact on medication adherence.
Kopecky, S, 2012)		0.38
" However, a delay in dosing could occur for clinical or logistical reasons."( Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis.
Clemens, A; Dahl, OE; Eriksson, BI; Hantel, S; Kurth, AA; Rosencher, N, 2012)		0.64
" Results in patients with dosing delayed more than 4h postsurgery were compared with those of patients without a delay."( Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis.
Clemens, A; Dahl, OE; Eriksson, BI; Hantel, S; Kurth, AA; Rosencher, N, 2012)		0.64
" Linearity of dose-response and responsiveness to increasing dose in addition to standardization are other important issues to consider."( Laboratory tests and the new oral anticoagulants.
Tripodi, A, 2012)		0.38
"This review provides recommendations for clinicians regarding dosing during invasive surgical procedures, transitioning off alternative anticoagulants, and a discussion of storage and handling of the drug."( Dabigatran in clinical practice.
Ellis, CR; Nagarakanti, R, 2012)		1.82
" The first, monitoring, implies laboratory testing to assess the drug's effect and to adjust the dosage to maintain anticoagulation within the therapeutic interval."( The laboratory and the new oral anticoagulants.
Tripodi, A, 2013)		0.39
" The choice of tests is based on such characteristics as availability, linearity of the dose-response curve, standardization, and responsiveness to increasing drug dosage."( The laboratory and the new oral anticoagulants.
Tripodi, A, 2013)		0.39
" Nineteen percent reported some difficulty with twice daily dosing adherence with 13 of 70 reporting missed doses."( Dabigatran for anticoagulation in atrial fibrillation - early clinical experience in a hospital population and comparison to trial data.
Boga, T; Michel, J; Mundell, D; Sasse, A, 2013)		1.83
" In addition, dabigatran significantly facilitates management of patients with atrial fibrillation as it does not require laboratory monitoring, has predictable pharmacokinetics, simple dosing regimen that does not require complicated dose adjustments, and does not interact with food."( [Dabigatran etexilate in clinical practice for prevention of thromboembolic events in patients with atrial fibrillation].
Heinc, P; Hrčková, Y; Táborský, M, 2012)		1.65
" A sequential dosage scheme, in which 150 mg are administered up to the age of 80 years and 110 mg thereafter, resulted in an ICER of CHF 10,215 per QALY."( Cost-effectiveness of dabigatran for stroke prevention in atrial fibrillation in Switzerland.
Eichler, K; Plessow, R; Pletscher, M; Wieser, S, 2013)		0.7
" In an open-label, single-centre phase I study with two fixed multiple dosing periods, we investigated the pharmacokinetics, pharmacodynamics and safety of dabigatran before, during and after 4 hour haemodialysis sessions with either 200 or 400 ml/min targeted blood flow in seven end-stage renal disease patients without atrial fibrillation."( Effective elimination of dabigatran by haemodialysis. A phase I single-centre study in patients with end-stage renal disease.
Clemens, A; Formella, S; Friedman, J; Härtter, S; Khadzhynov, D; Lehr, T; Liesenfeld, KH; Moschetti, V; Neumayer, HH; Peters, H; Slowinski, T; Wagner, F; Wiegert, E, 2013)		0.89
" DE was indicated by using the same selection criteria and dosing as in the RE-MODEL and RE-NOVATE studies."( [Dabigatran etexilate use among older adults in a home-care system after hip or knee replacement surgery].
La Valle, RÁ; Saimovici, JM; Silveira, M; Waisman, GD; Zunino, S, )		1.04
" These drugs have predictable pharmacokinetics that allow fixed dosing without routine laboratory monitoring."( Practical use of dabigatran etexilate for stroke prevention in atrial fibrillation.
Christory, F; Connolly, SJ; Dan, GA; Hatala, R; Huber, K; Kher, A; Kiss, RG; Klun, NV; Meier, B; Merkely, B; Pieske, B; Potpara, T; Stępińska, J; Vinereanu, D; Widimský, P, 2013)		0.73
"To determine the adherence to dabigatran etexilate renal dosing guidelines, the frequency of co-prescription of potentially interacting drugs in patients on dabigatran, and how these related to dabigatran dosing."( Dosing of dabigatran etexilate in relation to renal function and drug interactions at a tertiary hospital.
Barclay, ML; Begg, EJ; Chin, PK; Vella-Brincat, JW; Walker, SL, 2013)		1.08
"Few patients were dosed excessively in relation to creatinine clearance."( Dosing of dabigatran etexilate in relation to renal function and drug interactions at a tertiary hospital.
Barclay, ML; Begg, EJ; Chin, PK; Vella-Brincat, JW; Walker, SL, 2013)		0.79
" Rivaroxaban, apixaban, and dabigatran have different pharmacological characteristics, and guidance is needed on optimum doses and dosing intervals and the effects of renal or hepatic impairment, age, food, and other drugs."( Novel oral anticoagulants: clinical pharmacology, indications and practical considerations.
Graff, J; Harder, S, 2013)		0.68
" Dabigatran was granted marketing authorisation by the European Medicines Agency for a sequential dosing regimen (DBG sequential), in which patients under 80 years are treated with dabigatran 150 mg twice daily (DBG150) and patients 80 years and over are given dabigatran 110 mg twice daily (DBG110)."( Dabigatran for the prevention of stroke and systemic embolism in atrial fibrillation: A NICE single technology appraisal.
Burch, J; Corbacho, B; Faria, R; Palmer, S; Pepper, C; Spackman, E; Todd, D; Woolacott, N, 2013)		2.74
" Consequently, if renal function is impaired, there is a risk of drug accumulation that is highest for dabigatran followed by rivaroxaban and then apixaban and thus dosing recommendations are different."( Recommendations for the emergency management of complications associated with the new direct oral anticoagulants (DOACs), apixaban, dabigatran and rivaroxaban.
Böhm, M; Dichgans, M; Diener, HC; Ell, C; Endres, M; Epple, C; Grond, M; Laufs, U; Nickenig, G; Riess, H; Röther, J; Schellinger, PD; Spannagl, M; Steiner, T; Veltkamp, R, 2013)		0.81
" In this review, we outline key pharmacokinetic and pharmacodynamic features of each compound and provide guidance on selection and dosing of the 3 NOACs relative to warfarin when considering OAC therapy for AF patients."( Importance of pharmacokinetic profile and variability as determinants of dose and response to dabigatran, rivaroxaban, and apixaban.
Gong, IY; Kim, RB, 2013)		0.61
" Much remains to be learned about the optimal use of the novel oral anticoagulants in CKD patients; additional studies about optimal dosing of the novel oral anticoagulants and frequency of monitoring renal function in CKD patients with atrial fibrillation are needed."( Stroke prevention in atrial fibrillation patients with chronic kidney disease.
Brimble, KS; Eikelboom, JW; Hart, RG; Ingram, AJ; McMurtry, MS, 2013)		0.39
" If the anticoagulant dosage is not immediately available, worse propositions, based on the usual tests (prothrombin time and activated partial thromboplastin time), are presented."( Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors: proposals of the working group on perioperative haemostasis (GIHP) - March 2013.
Albaladejo, P; Blais, N; Cohen, A; de Maistre, E; Fontana, P; Godier, A; Gruel, Y; Llau, JV; Mismetti, P; Pernod, G; Rosencher, N; Samama, CM; Samama, MM; Schved, JF; Sié, P; Susen, S, )		0.13
" However the choice of dosing regimens in different clinical conditions has been different for the various NOACs, and has been established on the basis of widely different considerations, including the clinical setting (venous versus arterial thrombosis), the indications (prophylaxis versus treatment), the likelihood of concomitant antiplatelet drugs, and marketing opportunities; these latter were based on the knowledge that patients' compliance is generally better with once daily than with twice daily dosing."( The new oral anticoagulants in atrial fibrillation: once daily or twice daily?
De Caterina, R; Renda, G, )		0.13
" These new anticoagulants do not require strict and frequent laboratory monitoring, dosing adjustments, or dietary restrictions, and they incur fewer drug-drug interactions than warfarin."( Novel oral anticoagulants: a review of new agents.
Wanat, MA, 2013)		0.39
" If the dosage of the drug is not immediately available, proposals only based on the usual tests, PT and aPTT, also are presented."( [Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors. Proposals of the Working Group on Perioperative Haemostasis (GIHP) - March 2013].
Albaladejo, P; Blais, N; Cohen, A; de Maistre, E; Fontana, P; Godier, A; Gruel, Y; Llau, JV; Mismetti, P; Pernod, G; Rosencher, N; Samama, CM; Samama, MM; Schved, JF; Sié, P; Susen, S, 2013)		0.39
" The authors recommend caution while dosing dabigatran in the Asian population, as the estimates of kidney functioning vary substantially depending on the formula used to estimate GFR, which may in turn lead in some cases of inadequate dosing of dabigatran."( A comparison of methods for estimating glomerular filtration rate for a population in Hawai'i with non-valvular atrial fibrillation.
Azuma, S; Lum, CJ, 2013)		0.65
"Pharmacogenetics-guided warfarin dosing is an alternative to standard clinical algorithms and new oral anticoagulants for patients with nonvalvular atrial fibrillation."( Cost-effectiveness of pharmacogenetics-guided warfarin therapy vs. alternative anticoagulation in atrial fibrillation.
Hughes, DA; Lane, S; Pink, J; Pirmohamed, M, 2014)		0.4
" Adjusted dosage of dabigatran to 110 mg/bid according to renal clearance in combination with 150 mg/day aspirin was started."( [Severe thrombosis of bioprosthesis mitral valve after dabigatran].
Akgüllü, C; Eryılmaz, U; Kurtoğlu, T, 2013)		0.96
" Advantages and disadvantages to using these newer agents are presented, as are dosing adjustments for renal and hepatic impairment."( Outpatient management of oral anticoagulation in atrial fibrillation.
Manning, JA, 2013)		0.39
" These data suggest cautious early uptake of dabigatran, and more careful attention to dosing adjustments is warranted."( Early adoption of dabigatran and its dosing in US patients with atrial fibrillation: results from the outcomes registry for better informed treatment of atrial fibrillation.
Ansell, J; Chang, P; Ezekowitz, MD; Fonarow, GC; Gersh, B; Holmes, DN; Hylek, EM; Kowey, PR; Mahaffey, KW; Peterson, ED; Piccini, JP; Singer, DE; Steinberg, BA; Thomas, L, 2013)		0.98
" These drugs differ in a several important respects from warfarin; most notably they have a reliable dose-response effect which means they can be given without the need for monitoring."( New oral anticoagulants: their role and future.
Laffan, M; Shapiro, S, 2013)		0.39
" The dose of dabigatran was appropriate in 90% of the patients, with the most common cause of inappropriate dosing due to perceived bleeding risk."( Dabigatran Use in the Real World: A Multihospital System Experience.
Davis, M; Kabra, R; Kimmons, LA; Oliphant, CS; Segars, BV, 2014)		2.21
" In contrast to warfarin, most NOACs need dosage adjustments in renal impairment and are contraindicated in severe liver impairment, and there are no specific antidotes for treating NOAC-related over-anticoagulation."( New oral anticoagulants in practice: pharmacological and practical considerations.
Bajorek, B; Wang, Y, 2014)		0.4
" The HTI dosage could help managing the treatment in case of severe bleeding event."( Impaired renal function and bleeding in elderly treated with dabigatran.
Assayag, P; Berthelot, E; Desconclois, C; Lavenu-Bombled, C; Orostegui-Giron, L, 2014)		0.64
" They are at least as effective and as safe as conventional therapy (heparins and vitamin-K inhibitors) and have practical advantages, such as fixed dosing and no need for laboratory monitoring."( Direct oral anticoagulants in the treatment and long-term prevention of venous thrombo-embolism.
Bounameaux, H; Fontana, P; Goldhaber, SZ, 2014)		0.4
" Dabigatran was given through sequential dosing, where patients<80 years old received 150 mg of dabigatran twice a day and the dosage was reduced to 110 mgs for patients ≥ 80 years old."( Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation in Taiwan.
Chang, CH; Chen, JH; Lin, LJ; Yang, YH, 2014)		1.63
" However, in elderly patients with impaired renal function or considerable bleeding risks, label advice regarding dosing needs strict observation."( Benefit-risk assessment of dabigatran in the treatment of stroke prevention in non-valvular atrial fibrillation.
Harder, S; Meyer Dos Santos, S, 2014)		0.7
"Clinical results of the European Action on Anticoagulation (EAA) computer-assisted dosage study and the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial have been compared."( Warfarin or dabigatran for treatment of atrial fibrillation.
Ibrahim, S; Jespersen, J; Poller, L, 2014)		0.78
" Current dabigatran dosing guidelines use the Cockcroft-Gault (CG) equation to gauge renal function, instead of contemporary equations including the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations employing creatinine (CKD-EPI_Cr), cystatin C (CKD-EPI_Cys) and both renal biomarkers (CKD-EPI_CrCys)."( Correlation between trough plasma dabigatran concentrations and estimates of glomerular filtration rate based on creatinine and cystatin C.
Barclay, ML; Begg, EJ; Chin, PK; Jensen, BP; Patterson, DM; Roberts, RL; Wallace, MC; Wright, DF; Zhang, M, 2014)		1.1
" In the studied dosing regimens, these drugs failed to show a net clinical benefit in addition to dual antiplatelet therapy."( Direct oral anticoagulants in acute coronary syndrome.
Ahrens, I; Bode, C, 2014)		0.4
" The results of the 110-mg BID dosage were mainly driven by the RE-LY trial."( Dabigatran etexilate and risk of myocardial infarction, other cardiovascular events, major bleeding, and all-cause mortality: a systematic review and meta-analysis of randomized controlled trials.
Bruyère, O; Buckinx, F; Dogné, JM; Douxfils, J; Hainaut, P; Minet, V; Mullier, F; Rabenda, V; Reginster, JY, 2014)		1.85
" The most frequent inappropriate criteria were inappropriate choice (28% of patients), wrong dosage (26%), and impractical modalities of administration (26%)."( Appropriateness of prescribing dabigatran etexilate and rivaroxaban in patients with nonvalvular atrial fibrillation: a prospective study.
Chatelain, C; Devalet, B; Dogné, JM; Douxfils, J; Larock, AS; Mullier, F; Sennesael, AL; Spinewine, A, 2014)		0.69
" Other reasons included dosing frequency (5."( Continuation of dabigatran therapy in "real-world" practice in Hong Kong.
Chan, EW; Chan, KH; Chan, PH; Cheung, E; Hai, JJ; Ho, CW; Ho, MH; Leung, GK; Siu, CW; Tse, HF, 2014)		0.75
"Compared to Vitamin K antagonists (VKA), novel oral anticoagulants (NOACs) appear to be safer in terms of major bleeding risks with added advantage of having fixed dosing schedules when used in patients with non-valvular atrial fibrillation (AF)."( Evaluation of Trends of Inpatient Hospitalisation for Significant Haemorrhage in Patients Anticoagulated for Atrial Fibrillation before and after the Release of Novel Anticoagulants.
Aryal, MR; Badal, M; Chaudhary, A; Donato, AA; Mege, J, 2015)		0.42
"Ease of dosing and simplicity of monitoring make new oral anticoagulants an attractive therapy in a growing range of clinical conditions."( Management of the bleeding patient receiving new oral anticoagulants: a role for prothrombin complex concentrates.
Baumann Kreuziger, LM; Dries, DJ; Keenan, JC; Morton, CT, 2014)		0.4
" Coagulation biomarkers in shed blood were assessed at 3 h after monotherapy with the medicines under study, at 3 h after triple therapy dosing and at steady state trough conditions."( Antithrombotic triple therapy and coagulation activation at the site of thrombus formation: a randomized trial in healthy subjects.
Eichinger, S; Gouya, G; Kapiotis, S; Kyrle, PA; Litschauer, B; Mayer, P; Smerda, L; Weisshaar, S; Wolzt, M, 2014)		0.4
"Dabigatran is available on formulary with a dosing and monitoring policy developed by a multidisciplinary subcommittee of the formulary and therapeutics committee."( Bleeding incidence and real-life prescribing practices with dabigatran use in an acute care setting.
Campbell, P; Lam, T; Nguyen, C; Tran, TH, 2014)		2.09
" Practical advantages of NOACs over warfarin include fixed once- or twice-daily oral dosing without the need for coagulation monitoring, and few known or defined drug or food interactions."( Approach to the new oral anticoagulants in family practice: part 1: comparing the options.
Bell, AD; Douketis, J; Eikelboom, J; Liew, A, 2014)		0.4
" This study examines the relative cost-effectiveness of dabigatran (BID dosing of 150 mg or 110 mg based on patient age), rivaroxaban, and apixaban from a UK payer perspective."( Comparison of the cost-effectiveness of new oral anticoagulants for the prevention of stroke and systemic embolism in atrial fibrillation in a UK setting.
Gonschior, AK; Heinrich-Nols, J; Kansal, AR; Noack, H; Sorensen, SV; Sunderland, T; Zheng, Y, 2014)		0.65
"New oral anticoagulants require dosing adjustment according to renal function."( Comparison of estimated glomerular filtration rate equations for dosing new oral anticoagulants in patients with atrial fibrillation.
Andreu-Cayuelas, JM; Gallego, P; Lip, GY; Manzano-Fernández, S; Marín, F; Orenes-Piñero, E; Roldán, V; Valdés, M; Vicente, V, 2015)		0.42
"Among the overall population, relative to Cockcroft-Gault, discordance in dabigatran dosage was 11."( Comparison of estimated glomerular filtration rate equations for dosing new oral anticoagulants in patients with atrial fibrillation.
Andreu-Cayuelas, JM; Gallego, P; Lip, GY; Manzano-Fernández, S; Marín, F; Orenes-Piñero, E; Roldán, V; Valdés, M; Vicente, V, 2015)		0.65
" It has also been used in patients for other indications as a substitute for warfarin therapy because it requires no monitoring; one group being patients undergoing radiofrequency (RF), ablation for AF, although there have been no consensus guidelines with regards to dosage and timing of dose."( Left atrial appendage thrombus with resulting stroke post-RF ablation for atrial fibrillation in a patient on dabigatran.
Hussaini, A; Kiernan, TJ; Lobo, R; McCann, C; Meany, TB, )		0.34
" Vitamin K antagonists require regular monitoring and dosage adjustment."( Dabigatran etexilate as second-line therapy in patients with a left ventricular assist device.
Charitos, C; Diakos, N; Kaldara, E; Kapelios, CJ; Katsaros, L; Nanas, JN; Ntalianis, A; Terrovitis, JV; Tsamatsoulis, M; Vakrou, S, )		1.57
" The RapidTEG activated clotting time test allowed the creation of a dose-response curve for all 3 NOACs."( Use of Thromboelastography (TEG) for Detection of New Oral Anticoagulants.
Dias, JD; Doorneweerd, DD; Norem, K; Omert, LA; Popovsky, MA; Thurer, RL, 2015)		0.42
" 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, )		0.38
" The mean dosage of dabigatran was 211."( Efficacy of Dabigatran for Dissolving Deep Vein Thromboses in Outpatients With a Deteriorated General Condition.
Fujino, T; Ikeda, T; Kabuki, T; Kiuchi, S; Kobayashi, K; Yamazaki, A; Yamazaki, J; Yamazaki, Y, 2015)		1.12
"To review current literature for target-specific oral anticoagulants (TSOACs) and provide critical analysis for dosing recommendations in special population groups."( Dosing of Target-Specific Oral Anticoagulants in Special Populations.
Ge, D; Morrill, AM; Willett, KC, 2015)		0.42
" It is valuable to understand the rationale for labeled dosing recommendations in nonvalvular atrial fibrillation and venous thromboembolism treatment and prevention, particularly in patients that fall into special population groups."( Dosing of Target-Specific Oral Anticoagulants in Special Populations.
Ge, D; Morrill, AM; Willett, KC, 2015)		0.42
" In this regard, novel oral anticoagulants (NOACs) have shown promise in the shift toward the "ideal" anticoagulant therapy, in that fixed dosing is the norm, drug interactions are few, food interactions are absent, onset is fairly immediate and offset predictable, and, in the majority of patients, therapeutic monitoring is not required."( Novel Anticoagulants in Atrial Fibrillation: A Primer for the Primary Physician.
Mookadam, F; Mookadam, M; Shamoun, FE, )		0.13
" Rivaroxaban is the only DOAC that has once-daily dosing while apixaban is the only DOAC that has lower risk of overall, major, and gastrointestinal bleeding compared with VKA."( Differential benefit risk assessment of DOACs in the treatment of venous thromboembolism: focus on dabigatran.
Law, EH; Leung, TS, 2015)		0.63
" NOACs overcome these difficulties; however, physicians' hesitation to use NOACs with the optimal dosage may be another limitation in real-world practice."( A new gap in the novel anticoagulants' era: undertreatment.
Bayyigit, A; Belen, E; Canbolat, IP; Helvaci, A; Kilickesmez, K; Pusuroglu, H, 2015)		0.42
"The dabigatran dose-response is predictable; however, it is necessary to measure plasma levels in a variety of clinical conditions."( Measuring dabigatran with the dilute Russell viper venom confirm assay in an anticoagulation clinic population.
Fritsma, GA; McGlasson, DL, 2016)		1.39
"Once daily dosing schedule is associated with increased adherence to and persistence with cardiovascular therapies."( Adherence to and persistence with non-vitamin K-antagonist oral anticoagulants: does the number of pills per day matter?
Rubboli, A, 2015)		0.42
" Thrombin time and anti-IIa activity were dosed for each patient."( Thrombin time and anti-IIa dabigatran's activity: hypothesis of thrombin time's predictive value.
Kaabar, M; Le Guyader, M; Lemaire, P; Pineau Vincent, F, )		0.43
" The patient tolerated the combination, with dabigatran blood levels within the expected range at a standard dosing regimen, without evidence of bleeding or other adverse outcomes."( Novel oral anticoagulants and HIV: dabigatran use with antiretrovirals.
Holloway, C; Joseph, J; Perram, J, 2015)		0.95
" The aim of the present study was to evaluate the hypothetical need for dosage adjustment (based on fluctuations in kidney function) of dabigatran, rivaroxaban and apixaban during the first 6 months after hospital discharge in patients with concomitant atrial fibrillation and heart failure."( Impact of Variations in Kidney Function on Nonvitamin K Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Recent Acute Heart Failure.
Andreu-Cayuelas, JM; Flores-Blanco, PJ; García-Alberola, A; Lip, GY; Manzano-Fernández, S; Mateo-Martínez, A; Pastor-Pérez, FJ; Puche, CM; Roldán, V; Valdés, M, 2016)		0.64
" The hypothetical recommended dosage of dabigatran, rivaroxaban and apixaban according to renal function was determined at discharge."( Impact of Variations in Kidney Function on Nonvitamin K Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Recent Acute Heart Failure.
Andreu-Cayuelas, JM; Flores-Blanco, PJ; García-Alberola, A; Lip, GY; Manzano-Fernández, S; Mateo-Martínez, A; Pastor-Pérez, FJ; Puche, CM; Roldán, V; Valdés, M, 2016)		0.7
"Among the overall study population, 44% of patients would have needed dabigatran dosage adjustment during follow-up, 35% would have needed rivaroxaban adjustment, and 29% would have needed apixaban dosage adjustment."( Impact of Variations in Kidney Function on Nonvitamin K Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Recent Acute Heart Failure.
Andreu-Cayuelas, JM; Flores-Blanco, PJ; García-Alberola, A; Lip, GY; Manzano-Fernández, S; Mateo-Martínez, A; Pastor-Pérez, FJ; Puche, CM; Roldán, V; Valdés, M, 2016)		0.67
"The need for dosage adjustment of nonvitamin K oral anticoagulants during follow-up is frequent in patients with atrial fibrillation after acute decompensated heart failure, especially among older patients and those with renal impairment."( Impact of Variations in Kidney Function on Nonvitamin K Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Recent Acute Heart Failure.
Andreu-Cayuelas, JM; Flores-Blanco, PJ; García-Alberola, A; Lip, GY; Manzano-Fernández, S; Mateo-Martínez, A; Pastor-Pérez, FJ; Puche, CM; Roldán, V; Valdés, M, 2016)		0.43
" However, the short half-life of NOAC means that twice-a-day dosing is needed and there is higher risk of a prothrombotic state when doses are missed."( Novel oral anticoagulants for atrial fibrillation.
How, CH, 2015)		0.42
" Dabigatran patients resumed medication 8 h after the procedure, resuming usual dosage (every 12 h) the day after surgery."( Dental implant surgery in patients in treatment by dabigatran.
Aguilar-Salvatierra, A; Calvo-Guirado, JL; de Carlos, F; Delgado-Ruiz, RA; Fernández-Cejas, E; Gómez-Moreno, G, 2018)		1.64
" Normal dosage can be resumed 8 h after implant surgery."( Dental implant surgery in patients in treatment by dabigatran.
Aguilar-Salvatierra, A; Calvo-Guirado, JL; de Carlos, F; Delgado-Ruiz, RA; Fernández-Cejas, E; Gómez-Moreno, G, 2018)		0.73
" If a pericardial effusion is newly diagnosed in a patient during anticoagulant therapy, the pharmacotherapy should be revised concerning potentially interacting drugs, like nonsteroidal anti-inflammatory drugs, and dosage of the anticoagulant drug."( Hemopericardium under dabigatran for stroke prevention in atrial fibrillation.
Finsterer, J; Heger, M; Stöllberger, C, 2017)		0.77
"Following enteric dabigatran dosing in vitro assessment of thrombin clotting times (TCT) was undertaken in rabbit plasma spiked with incremental liposome concentrations."( Reversal of lipophilic weak bases using pH gradient acidic centre liposomes: demonstration of effect in dabigatran-induced anticoagulation.
Cave, G; Chauhan, A; Damitz, R; Harvey, M; Hunter, N; Wu, Z, 2016)		0.98
"All the newer oral anticoagulants compared were more effective than adjusted dosed warfarin."( Cost-Effectiveness of Oral Anticoagulants for Ischemic Stroke Prophylaxis Among Nonvalvular Atrial Fibrillation Patients.
Hayes, CJ; Martin, BC; Shah, A; Shewale, A, 2016)		0.43
" However, dosing based on coagulation parameters can be difficult because available assays may not provide adequate sensitivity and specificity for measuring anticoagulation induced by dabigatran or the countering effects of PCCs/aPCCs."( Efficacy of prothrombin complex concentrates for the emergency reversal of dabigatran-induced anticoagulation.
Aisenberg, J; Bernstein, R; Del Zoppo, GJ; Eikelboom, J; Goldstein, P; Grottke, O; Huisman, MV; Jamieson, DG; Levy, JH; Pollack, CV; Spyropoulos, AC; Steiner, T, 2016)		0.86
" However the peri-procedural dosing protocols used in various studies especially in terms of whether NOAC use is interrupted or uninterrupted during AF ablation, have significant inter-operator and inter-institution variability."( Are Some Anticoagulants More Equal Than Others? - Evaluating the Role of Novel Oral Anticoagulants in AF Ablation.
Fox, DJ; Sankaranarayanan, R, )		0.13
"The standard dabigatran etexilate dosage for prevention of venous thromboembolism (VTE) after elective total hip or knee replacement (THR/TKR) is 220mg once daily (qd), with 150mg qd for patients with moderate renal impairment."( Observational study of dabigatran etexilate 150mg in patients with moderate renal impairment undergoing elective total hip or knee replacement.
Brueckmann, M; Clemens, A; Feuring, M; Frostick, SP; Gullberg, J; Kleine, E; Rosencher, N; Samama, CM, 2016)		1.11
" Susoctocog alfa offers the ability to effectively titrate and monitor dosing based on factor VIII activity levels."( [Coagulation disorders in the intensive care unit - what is new?].
Hart, C; Schmid, S, 2016)		0.43
"Direct oral anticoagulants (DOACs) offer clinical advantages over warfarin, such as minimal medication and food interactions and fixed dosing without the need for routine monitoring of coagulation status."( Emergent Bleeding in Patients Receiving Direct Oral Anticoagulants.
Sterling, SA; Summers, RL, )		0.13
" In the patients of both groups the product dabigatran etexilate in the standard dosage (220 mg/day) was used for specific prevention."( [Substantiation of the system of thrombus formation prevention in treatment of patients with hip joint pathology against the background of arterial insufficiency of the lower extremities].
Akhtyamov, IF; Shigaev, ES; Ziatdinov, BG, 2016)		0.7
" Nonetheless, the absence of the ability for clinicians to assess compliance or washout with a simple laboratory test (or to adjust dosing with a similar assessment) and the absence of an antidote to rapidly stop major hemorrhage or to enhance safety in the setting of emergent or urgent surgery/procedures have been limitations to greater non-vitamin K antagonist oral anticoagulant usage and better thromboembolic prevention."( NOAC monitoring, reversal agents, and post-approval safety and effectiveness evaluation: A cardiac safety research consortium think tank.
Kaminskas, E; Reiffel, JA; Reilly, P; Sager, P; Sarich, T; Seltzer, J; Weitz, JI, 2016)		0.43
" Differences in the ACT before ablation and adequate initial heparin dosing in patients receiving non-vitamin K antagonist oral anticoagulants (NOACs) were examined."( Adequate Initial Heparin Dosage for Atrial Fibrillation Ablation in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants.
Higashiya, S; Hina, K; Kamikawa, S; Kawamura, H; Komtasubara, I; Kusachi, S; Murakami, M; Murakami, T; Yamaji, H, 2016)		0.43
" In addition to familiarity with the dosing and monitoring of vitamin K antagonists, clinicians are accustomed to using vitamin K if there is a need to reverse the anticoagulant effect of vitamin K antagonists."( Management of Bleeding With Non-Vitamin K Antagonist Oral Anticoagulants in the Era of Specific Reversal Agents.
Antman, EM; Giugliano, RP; Ruff, CT, 2016)		0.43
" If the dosage of the drug is not available, proposals are based on the combination of a PT ≥80% and an aPTT ≤1."( PT, aPTT, TT and the hemostatic safety threshold of dabigatran and rivaroxaban.
Calmette, L; Flaujac, C; Gouin-Thibault, I; Horellou, MH; Ibrahim, F; Layka, A; Mazoyer, É, 2016)		0.68
" We suggest that repeated dosing may lead to higher concentrations, but this should be further explored."( Vitreous and subretinal fluid concentrations of orally administered dabigatran in patients with rhegmatogenous retinal detachment.
Kluft, C; Mulder, VC; van Meurs, JC, 2016)		0.67
" Outcome measures were dosing errors if GFR were to be substituted for CrCL-CG."( Potential Effect of Substituting Estimated Glomerular Filtration Rate for Estimated Creatinine Clearance for Dosing of Direct Oral Anticoagulants.
Schwartz, JB, 2016)		0.43
" At a CrCL-CG of less than 30 mL/min, GFR estimates missed indicated dosage reductions for dabigatran in 18% to 21% of NHANES subjects and 57% to 86% of research subjects."( Potential Effect of Substituting Estimated Glomerular Filtration Rate for Estimated Creatinine Clearance for Dosing of Direct Oral Anticoagulants.
Schwartz, JB, 2016)		0.65
"A recommendation for dosage adjustment of dabigatran etexilate, a prodrug of dabigatran, seems to be desirable based on creatinine clearance to avoid bleeding and stroke."( Dosage Adjustment of Dabigatran Etexilate Based on Creatinine Clearance in Patients With Cardioembolic Stroke or Atrial Fibrillation.
Imazu, T; Kimura, R; Maeda, Y; Matsuda, S; Matsumoto, A; Murakami, T; Nakamura, M, 2016)		1.02
" Since there was no dose-response for bleeding, the switch from VKA to dabigatran in itself was not a risk factor for bleeding."( Risk of Ischemic Stroke, Hemorrhagic Stroke, Bleeding, and Death in Patients Switching from Vitamin K Antagonist to Dabigatran after an Ablation.
Gislason, GH; Lee, CJ; Lindhardt, TB; Olesen, JB; Pallisgaard, JL; Sindet-Pedersen, C; Staerk, L; Torp-Pedersen, C, 2016)		0.88
" To our knowledge, this is the first case report to describe the successful use of repeat dosing of idarucizumab with hemodialysis to reverse the anticoagulant effects of dabigatran."( Management of Dabigatran-Associated Bleeding with Two Doses of Idarucizumab Plus Hemodialysis.
Berliner, N; Connell, NT; Connors, JM; Dew, RB; Marino, KK; Santiago, RA; Tucker, JK, 2016)		0.99
" With similar efficacy, better safety, and the convenience of fixed dosing without the need for routine coagulation monitoring, guidelines now recommend DOACs over VKAs for VTE treatment in patients without active cancer."( Optimizing the safety of treatment for venous thromboembolism in the era of direct oral anticoagulants.
Jaffer, IH; Weitz, JI, 2016)		0.43
" The article addresses some crucial aspects of NOAC therapy such as measurement of anticoagulant effects, transition between different agents, ensuring drug intake compliance, dealing with dosing errors, management of bleeding complications etc based on the guidance offered by the European Heart Rhythm Association in 2013."( Current Perspective on Use of NOAC in Clinical Practice in India.
Bhave, A; Dalal, JJ; Dhall, A, 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
"Direct oral anticoagulants currently have no indication for monitoring even though there are data that imply that individual dosing can improve and add safety to the therapy."( Development of an UHPLC-UV-Method for Quantification of Direct Oral Anticoagulants: Apixaban, Rivaroxaban, Dabigatran, and its Prodrug Dabigatran Etexilate in Human Serum.
Boehr, S; Haen, E, 2017)		0.67
" DOACs have a wide therapeutic range that allows fixed dosing determined based on studies conducted in healthy subjects with normal absorptive capacity."( Effect of major gastrointestinal tract surgery on the absorption and efficacy of direct acting oral anticoagulants (DOACs).
Al-Sanea, N; Hakeam, HA, 2017)		0.46
"Surgical procedures under NOACS can be scheduled at the beginning of next dosing interval or omitted in low/minimal bleeding risk patients, so that only 2-3 NOAC doses are not administered."( [Management of NOAK administration during invasive or surgical interventions : When and how to pause and when to restart?]
Buerke, M; Hoffmeister, HM, 2017)		0.46
" To ensure responsible use of these agents, every hospital needs a bleeding management algorithm that identifies patients eligible for reversal and outlines appropriate dosing regimens."( Reversal of Direct Oral Anticoagulants: Current Status and Future Directions.
Weitz, JI, 2017)		0.46
"Pre-existing and treatment-emergent ADA were present at extremely low levels relative to the idarucizumab dosage under evaluation."( Evaluation of the immunogenicity of the dabigatran reversal agent idarucizumab during Phase I studies.
Glund, S; Haazen, W; Harada, A; Ikushima, I; Imazu, S; Lang, B; Moschetti, V; Norris, S; Ramael, S; Reilly, PA; Stangier, J, 2017)		0.72
" The fact that the NOACs don't require routine monitoring to assure that patients remain within the therapeutic range and have relatively simple dosing requirements and a safer risk profile makes them attractive substitutes to warfarin in HF patients with atrial fibrillation and other conditions (e."( Anticoagulation Therapy and NOACs in Heart Failure.
EncisoSilva, J; Greenberg, B; Schlueter, M; Thomas, I, 2017)		0.46
" A single 5 g dose is usually sufficient, but higher doses may sometimes be required and optimum dosing has not been defined."( Dose requirements for idarucizumab reversal of dabigatran in a lethal porcine trauma model with continuous bleeding.
Grottke, O; Honickel, M; Rossaint, R; Spronk, HM; Stoppe, C; Ten Cate, H; van Ryn, J, 2017)		0.71
"The superiority of dabigatran has been well proven in the standard dosing regimen in prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and extended venous thromboembolism (VTE) treatment."( Dabigatran - Metabolism, Pharmacologic Properties and Drug Interactions.
Antonijevic, NM; Culafic, MD; Jovanovic, LM; Kanjuh, VI; Kocica, MJ; Matic, DM; Mrdovic, IB; Zivkovic, ID, 2017)		2.23
"We compared NOACs (as a group) to warfarin in non-valvular atrial fibrillation, studying all 12,694 patients starting NOAC treatment within the Swedish clinical register and dosing system Auricula, from July 1, 2011 to December 31, 2014, and matching them to 36,317 patients starting warfarin using propensity scoring."( Non-vitamin K oral anticoagulants are non-inferior for stroke prevention but cause fewer major bleedings than well-managed warfarin: A retrospective register study.
Byström, B; Norrving, B; Oldgren, J; Renlund, H; Själander, A; Sjögren, V; Svensson, PJ, 2017)		0.46
" Therefore, it is likely safe to coadminister ritonavir with DE, while there is a potential need for reduced dosing and prudent clinical monitoring with the coadministration of cobicistat due to the greater net inhibition of intestinal P-gp transport and increased bioavailability."( Differential Influence of the Antiretroviral Pharmacokinetic Enhancers Ritonavir and Cobicistat on Intestinal P-Glycoprotein Transport and the Pharmacokinetic/Pharmacodynamic Disposition of Dabigatran.
Alfaro, RM; Brooks, KM; George, JM; Gordon, LA; Hadigan, C; Kellogg, A; Kumar, P; Lozier, J; McManus, M; Nghiem, K; Penzak, SR, 2017)		0.65
" Off-label indications and dosage too low were the most common not per protocol reasons for apixaban and rivaroxaban prescriptions."( Comparison of Prescribing Practices with Direct Acting Oral Anticoagulant Protocols.
Carley, B; Draper, E; Griesbach, S; Krueger, K; Larson, T; Parkhurst, B, 2017)		0.46
"Once-daily dosing of non-vitamin K antagonist oral anticoagulants (NOACs) may increase patient adherence to treatment but may also be associated with a higher risk of bleeding."( Safety of once- or twice-daily dosing of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with nonvalvular atrial fibrillation: A NOAC-TR study.
Akyüz, A; Başaran, Ö; Berilgen, R; Çelik, O; Çetin, N; Coşar, S; Dereli, Y; Doğan, T; Doğan, V; Emren, SV; Enhoş, A; Ergene, O; Gürsul, E; İnci, S; Karaca, I; Karaca, Ö; Köseoğlu, C; Levent, F; Onrat, E; Otlu, YÖ; Özdemir, İH; Özmen, Ç; Sümerkan, M; Zoghi, M, 2018)		0.48
" Appropriateness was evaluated based on approved dosing and indications in Canada and the United States."( Appropriateness of Dabigatran and Rivaroxaban Prescribing in Qatar: A 5-Year Experience.
Ali, Z; El-Makaty, H; Elewa, H, 2018)		0.81
"3%) patients, while inappropriate dosing was found in 352 (33."( Appropriateness of Dabigatran and Rivaroxaban Prescribing in Qatar: A 5-Year Experience.
Ali, Z; El-Makaty, H; Elewa, H, 2018)		0.81
" While efficacious, they are difficult to use due to interpatient dose-response variability and the risks of bleeding."( Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
Fischer, PM, 2018)		0.48
"The direct oral anticoagulants (DOACs), also referred to as novel (or non-vitamin K antagonist) oral anticoagulants (NOACs), represent a major development in anticoagulation therapy due to their rapid onset of action, predictable dose-response with fixed doses and limited interactions with food and drugs."( An update on the bleeding risks associated with DOACs.
, 2017)		0.46
" However, further prospective randomized trials are needed in order to comprehensively evaluate whether D150 or D110 is the optimal dosage in Asian patients with AF."( Optimal dose of dabigatran for the prevention of thromboembolism with minimal bleeding risk in Korean patients with atrial fibrillation.
Ahn, Y; Cho, JG; Cho, JY; Hong, YJ; Hyun, DY; Jeong, MH; Kim, JH; Kim, KH; Kim, MC; Kim, Y; Lee, KH; Lee, N; Oh, SS; Park, HJ; Park, HW; Park, JC; Sim, DS; Won, J; Yoon, HJ; Yoon, NS, 2017)		0.8
"In this review we present comparison of pharmacokinetics of novel oral anticoagulants (NOAC) dabigatran, rivaroxaban, apixaban, and edoxaban, principles of selection of a regimen of their dosing for phase III clinical trials in patients with atrial fibrillation."( [Clinico-Pharmacological and Clinical Basis of Multiplicity of Intake of Novel Oral Anticoagulants].
Levanov, AN; Sinitsina, II; Sychev, DA; Tsomaya, IV; Vardanyan, AV, 2017)		0.67
"Pradaxa (dabigatrani etexilati mesilas) belongs to a new group of anticoagulants, its pharmacological properties enabling uniform dosage without a need for monitoring the anticoagulant effect."( [Bleeding during anticoagulant and antiaggregation therapy as a cause of acute abdomen].
Hekerová, M, )		0.55
" Drug dosage changes and serum creatinine determinations were recorded during 1-year follow-up."( Kidney function monitoring and nonvitamin K oral anticoagulant dosage in atrial fibrillation.
Albendin Iglesias, H; Andreu Cayuelas, JM; Bailen Lorenzo, JL; Caro Martínez, C; Cerezo Manchado, JJ; Elvira Ruiz, G; Flores Blanco, PJ; García Alberola, A; Januzzi, JL; Manzano-Fernández, S, 2018)		0.48
" Compliance with kidney function monitoring recommendations was associated with adequate NOAC dosage at 1-year follow-up."( Kidney function monitoring and nonvitamin K oral anticoagulant dosage in atrial fibrillation.
Albendin Iglesias, H; Andreu Cayuelas, JM; Bailen Lorenzo, JL; Caro Martínez, C; Cerezo Manchado, JJ; Elvira Ruiz, G; Flores Blanco, PJ; García Alberola, A; Januzzi, JL; Manzano-Fernández, S, 2018)		0.48
"There is limited evidence on patients' adherence and the impact of the prescribed dosing regimen in non-vitamin-K oral anticoagulants (NOACs)."( Secondary adherence to non-vitamin-K antagonist oral anticoagulants in patients with atrial fibrillation in Sweden and the Netherlands.
de Boer, PT; Hoffmann, M; Jacobs, MS; Levin, LÅ; Postma, MJ; Schouten, JF, 2018)		0.48
" Patients using a consistent dosage for at least 180 consecutive days were included."( Secondary adherence to non-vitamin-K antagonist oral anticoagulants in patients with atrial fibrillation in Sweden and the Netherlands.
de Boer, PT; Hoffmann, M; Jacobs, MS; Levin, LÅ; Postma, MJ; Schouten, JF, 2018)		0.48
"Direct acting non-Vitamin K antagonist oral anticoagulants (NOAC) are characterized by a fixed dosing regimen."( Impact of BMI on clinical outcomes of NOAC therapy in daily care - Results of the prospective Dresden NOAC Registry (NCT01588119).
Beyer-Westendorf, I; Beyer-Westendorf, J; Endig, S; Marten, S; Reitter, A; Tittl, L, 2018)		0.48
" Future directions include identification of clinically relevant SNPs, and change in optimum dosage for patients who are carriers of significant variants."( Pharmacogenetics of novel oral anticoagulants: a review of identified gene variants & future perspectives.
Ašić, A; Marjanović, D; Mirat, J; Primorac, D, 2018)		0.48
" In addition, we have shown that this increase is affected by dabigatran dosage and concomitant treatment with proton-pump inhibitor and digoxin."( Effect of Bisoprolol on the Level of Dabigatran.
Ivankova, J; Mokan, M; Nehaj, F; Sokol, J, )		0.64
"This study demonstrated the interaction between dabigatran and bisoprolol, which is modulated with dabigatran dosage and concomitant treatment with proton-pump inhibitor and digoxin."( Effect of Bisoprolol on the Level of Dabigatran.
Ivankova, J; Mokan, M; Nehaj, F; Sokol, J, )		0.66
" Dosing schedule is dabigatran 150mg BID patients with normal renal function."( Dabigatran - the First Approved DTI for SPAF.
Hiremath, JS; Trailokya, A, 2018)		2.25
" Multivariable adjusted Cox models stratified by dosage estimated hazard ratios (aHR)."( Dabigatran Versus Rivaroxaban for Secondary Stroke Prevention in Patients with Atrial Fibrillation Rehabilitated in Skilled Nursing Facilities.
Alcusky, M; Fisher, M; Goldberg, RJ; Hume, AL; Lapane, KL; McManus, DD; Tjia, J, 2018)		1.92
" The goal of our study was to evaluate the outcomes of our reduced dosing strategy with FEIBA in patients experiencing a DOAC-related bleeding event."( Effect of low and moderate dose FEIBA to reverse major bleeding in patients on direct oral anticoagulants.
Dager, WE; Nishijima, DK; Roberts, AJ, 2019)		0.51
" Monitoring the effects of the targeted anticoagulant demonstrated the need for correction of dosage and discrete use of the drug in prevention and treatment for thrombohemorrhagic complications in this category of patients."( Features of Pharmacodynamics of the Anticoagulant Dabigatran in Secondary Thrombophilia.
Kairov, GT; Kotlovskaya, LY; Solovev, MA; Udut, VV, 2018)		0.73
" The observed effect could be a secondary consequence of dosage control or alternatively a result of different anticoagulant effects among the different medications."( Higher Incidence of Ischemic Stroke in Patients Taking Novel Oral Anticoagulants.
Cowperthwaite, M; Fanale, C; Nadasdy, Z; Ramakrishnan, A; Shpak, M, 2018)		0.48
" The intake of Dabigatran etexilate in fixed dosage does not exclude development of thrombosis of deep veins of lower extremities that substantiates point of view concerning usefulness of individualization of anti-thrombotic prevention in case of application of new oral anti-coagulants."( [The clotting tests and molecular markers in evaluating of coagulation alterations against the background of anti-thrombotic prevention by Dabigatran after large orthopedic operations].
Antropova, IP; Reino, EV; Yushkov, BG, 2017)		1.01
" Because the combined effects of drug-drug interactions and RI have not been evaluated by means of clinical studies, the decision of DABE dosing for RI patients receiving P-glycoprotein inhibitors is empirical at its best."( Assessing Potential Drug-Drug Interactions Between Dabigatran Etexilate and a P-Glycoprotein Inhibitor in Renal Impairment Populations Using Physiologically Based Pharmacokinetic Modeling.
Doki, K; Homma, M; Neuhoff, S; Rostami-Hodjegan, A, 2019)		0.77
"In the past decade, direct-acting oral anticoagulants (DOAC) have been introduced to medical practice for several indications, with a wide range of dosing regimens."( Clinical pharmacist led hospital-wide direct oral anticoagulant stewardship program.
Aldouby-Bier, G; Fisher Negev, T; Hirsh-Raccah, B; Hochberg-Klein, S; Horwitz, E; Kalish, Y; Muszkat, M; Perlman, A, 2019)		0.51
" dosing interval) or patient experiences while on treatment."( Real-world adherence for direct oral anticoagulants in a newly diagnosed atrial fibrillation cohort: does the dosing interval matter?
Brown, JD; Pham, PN, 2019)		0.51
"Apixaban users had the highest overall adherence despite twice-daily dosing versus once-daily dosing for rivaroxaban."( Real-world adherence for direct oral anticoagulants in a newly diagnosed atrial fibrillation cohort: does the dosing interval matter?
Brown, JD; Pham, PN, 2019)		0.51
" Benefits of direct oral anticoagulants include a rapid onset of therapeutic effect, fixed dose-response relationships without the need for routine monitoring, a short half-life, and infrequent need for periprocedural bridging with a parenteral agent."( Direct Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation: Update and Periprocedural Management.
Pickett, JD, 2019)		0.51
"To describe heparin dosing requirements in patients who underwent catheter ablation of atrial fibrillation with uninterrupted anticoagulation using dabigatran etexilate (dabigatran) or warfarin to attain therapeutic activated clotting time (ACT) in the RE-CIRCUIT® study."( Heparin dosing in uninterrupted anticoagulation with dabigatran vs. warfarin in atrial fibrillation ablation: RE-CIRCUIT study.
Bis, B; Calkins, H; Gerstenfeld, EP; Hohnloser, SH; Kleine, E; Nordaby, M; Okumura, K; Schilling, R; Verma, A; Willems, S, 2019)		0.96
" Heparin dosing requirement to reach therapeutic ACT was lowest when time from last dose of dabigatran to septal puncture was 0 to <4 h."( Heparin dosing in uninterrupted anticoagulation with dabigatran vs. warfarin in atrial fibrillation ablation: RE-CIRCUIT study.
Bis, B; Calkins, H; Gerstenfeld, EP; Hohnloser, SH; Kleine, E; Nordaby, M; Okumura, K; Schilling, R; Verma, A; Willems, S, 2019)		0.98
"Background The direct oral anticoagulants (DOACs) offer several advantages over warfarin in the management atrial fibrillation, including the provision of fixed dosing without a requirement for regular monitoring."( The acceptability of a direct oral anticoagulant monitoring regimen among patients with atrial fibrillation: a pilot study.
Aslani, P; Brieger, D; D'Souza, M; Mourad, AP, 2019)		0.51
" The prothrombin time (PT) and activated partial thromboplastin time (APTT) were averaged if they were measured more than twice depending on the respective DOAC and dosage across individuals."( Excessive Prolongation of Coagulation Time During Treatment With Direct Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation.
Akiyoshi, K; Goya, M; Hirao, K; Kawabata, M; Koyama, T; Maeda, S; Sekigawa, M; Takahashi, Y; Yagishita, A; Yamamoto, T, 2019)		0.51
"8%), was found to be significantly associated with inappropriately high DOAC dosage and body weight (≤ 60 kg)."( Excessive Prolongation of Coagulation Time During Treatment With Direct Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation.
Akiyoshi, K; Goya, M; Hirao, K; Kawabata, M; Koyama, T; Maeda, S; Sekigawa, M; Takahashi, Y; Yagishita, A; Yamamoto, T, 2019)		0.51
" Patients with the body weight of <60 kg should be considered for dosage reduction or DOAC withdrawal."( Excessive Prolongation of Coagulation Time During Treatment With Direct Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation.
Akiyoshi, K; Goya, M; Hirao, K; Kawabata, M; Koyama, T; Maeda, S; Sekigawa, M; Takahashi, Y; Yagishita, A; Yamamoto, T, 2019)		0.51
"Appropriate dosing of direct oral anticoagulants (DOACs) requires consideration of renal function."( Renal Function Estimates and Dosing of Direct Oral Anticoagulants in Stroke Patients with Atrial Fibrillation: An Observational Study.
Chen, YT; Lin, HJ, 2018)		0.48
"Although substituting eGFR for CrCl carries potential risks of DOAC overdosing in patients with AF, the effect might be offset by clinicians' predilection for lower dosage in this stroke cohort."( Renal Function Estimates and Dosing of Direct Oral Anticoagulants in Stroke Patients with Atrial Fibrillation: An Observational Study.
Chen, YT; Lin, HJ, 2018)		0.48
" Therefore, although dosed as DABE, a P-gp drug-drug interaction (DDI) is reported as a dabigatran plasma concentration ratio (perpetrator versus placebo)."( Renal Excretion of Dabigatran: The Potential Role of Multidrug and Toxin Extrusion (MATE) Proteins.
Marathe, P; Rodrigues, AD; Shen, H; Sinz, M; Yao, M; Zhu, M, 2019)		1.06
" There was a low frequency of unapproved dabigatran dosage regimens (3."( Global Use of Idarucizumab in Clinical Practice: Outcomes of the RE-VECTO Surveillance Program.
Butcher, K; Fanikos, J; França, LR; Gruenenfelder, F; Kermer, P; Lane, DA; Murwin, D; Reilly, PA; Tartakovsky, I; Wowern, FV, 2020)		0.82
" Increasing the duration of anticoagulation, determining the optimal dosage of anticoagulants, and switching to another anticoagulant when necessary could be considered to improve treatment effectiveness."( Outcome of Anticoagulation Therapy of Left Atrial Thrombus or Sludge in Patients With Nonvalvular Atrial Fibrillation or Flutter.
Dong, J; Du, X; Ma, C; Yang, Y, 2019)		0.51
"Direct oral anticoagulants (DOACs) especially dabigatran, have gain popularity for their efficacy, fixed dosing and favourable safety profile."( A national audit on the utilisation and documentation of dabigatran checklist for patients initiated on dabigatran.
Devaraj, NK; Doris, G; Noraini, M; Sahimi, M; Shakirin, SR, 2019)		1.02
" Most patients who were taking NOACs had excellent adherence regardless of the dosing frequency."( NOAC Adherence of Patients with Atrial Fibrillation in the Real World: Dosing Frequency Matters?
Bae, HJ; Cho, YK; Choi, SW; Han, S; Hur, SH; Hwang, J; Jun, SW; Kim, H; Kim, IC; Lee, CH; Lee, SH; Nam, CW; Park, HS; Yoon, HJ, 2020)		0.56
" European guidelines criteria 2012 on dabigatran dosing were examined: age ≥80 years, HAS-BLED ≥3, estimated glomerular filtration rate (eGFR)<50 mL/min/1."( Switching from vitamin K antagonist to dabigatran in atrial fibrillation: differences according to dose.
Bonde, AN; Fosbøl, EL; Gislason, GH; Køber, L; Lee, CJ; Olesen, JB; Rørth, R; Staerk, L; Torp-Pedersen, C; Vinding, NE, 2021)		1.16
" The patient was taking an adequate dosage of dabigatran, thus dabigatran was thought to be overdosed due to its interaction with ranolazine because dabigatran is a p-glycoprotein substrate, whereas ranolazine is the inhibitor of this transporter."( Possible Interaction between Dabigatran and Ranolazine in Patients with Renal Failure.
Damulevičienė, G; Galaunė, V; Gumbrevičius, G; Gumbrevičiūtė, M, 2019)		1.06
"We evaluated adherence to dosing criteria for patients with atrial fibrillation (AF) taking dabigatran or rivaroxaban and the impact of off-label dosing on thromboembolic and bleeding risk."( Characteristics and outcomes in patients with atrial fibrillation receiving direct oral anticoagulants in off-label doses.
Alvarez, P; Asleh, R; Briasoulis, A; Chrischilles, E; Gao, Y; Inampudi, C; Leira, EC; Vaughan-Sarrazin, M, 2020)		0.78
"To review the literature on treatment of venous thromboembolism (VTE) and prevention of cardioembolic stroke with direct-acting oral anticoagulants (DOACs) in low- and high-body-weight patients and to make recommendations regarding agent selection and dosing in these patient populations."( Direct-acting oral anticoagulant use at extremes of body weight: Literature review and recommendations.
Branam, DL; Covert, K, 2020)		0.56
"The selection and optimal dosing of DOACs in low- and high-body-weight patients has not yet been fully elucidated by clinical trials; however, evidence suggests that issues of both safety and efficacy in patients at the extremes of body weight may warrant careful consideration when selecting a DOAC for such patients."( Direct-acting oral anticoagulant use at extremes of body weight: Literature review and recommendations.
Branam, DL; Covert, K, 2020)		0.56
" In elderly, renal dysfunction, co-morbidity, and concomitant intake of different drugs could make the dosage of Dabigatran challenging."( A Case of Liver Failure Due to Dabigatran Treated with Venovenous Hemodiafiltration and Idarucizumab.
Guglielmo, N; Mestroni, R; Montanari, G; Orso, D, 2020)		1.05
"Application of PGT on the carrier of allelic variant rs2244613 of CES1 gene for adjustment of dabigatrane etexilate dosage in patients with non - valve AF may be more cost - effective strategy for prevention of thromboembolic complications in patients with non - valve AF."( [Comparative clinical and economic evaluation of pharmacogenetic testing application for dabigatran in patients with atrial fibrillation].
Abdullaev, SP; Mirzaev, KB; Sychev, DA, 2019)		0.95
" Mean aPCC dosing was 2974 IU (SD ± 857 IU)."( Activated prothrombin complex concentrates for direct oral anticoagulant-associated bleeding or urgent surgery: Hemostatic and thrombotic outcomes.
Buyukdere, H; Carrier, M; Castellucci, LA; Chakraborty, S; Dowlatshahi, D; Shaw, JR; Tokessy, M, 2020)		0.56
" For low-risk procedures, age ≥75 years, female sex, a creatinine clearance (CrCl) <50 mL/min, and an interruption of <36 hours were associated with a greater likelihood of levels ≥30 ng/mL, whereas age ≥75 years, female sex, a CrCl of <50 mL/min, and standard DOAC dosing were associated with levels ≥50 ng/mL."( Predictors of preprocedural direct oral anticoagulant levels in patients having an elective surgery or procedure.
Coppens, M; Douketis, JD; Duncan, J; Li, N; Radwi, M; Schulman, S; Shaw, JR; Spyropoulos, AC; Syed, S; Vanassche, T, 2020)		0.56
" They have multiple advantages over vitamin K antagonists including fixed dosing without coagulation lab monitoring, rapid onset and offset of action, and fewer drug and food interactions."( Direct-Acting Oral Anticoagulants: A Resident-Based Workshop to Improve Knowledge and Confidence.
Anderson, I; Arora, VM, 2020)		0.56
" A growing body of evidence shows that once-daily dosing improves adherence and persistence to therapy, without having an impact on bleeding risk."( Non-Vitamin K Antagonist Oral Anticoagulants and Factors Influencing the Ischemic and Bleeding Risk in Elderly Patients With Atrial Fibrillation: A Review of Current Evidence.
Haas, S; Patti, G, 2020)		0.56
" Only 37% of patients on warfarin had optimal dosing control, and they did not differ significantly in TTB, TTT, and OS from patients on DOACs."( Patterns of anticoagulation therapy in atrial fibrillation: results from a large real-life single-center registry.
Atić, A; Hadžibegović, I; Hulak Karlak, V; Jurin, I; Lucijanić, M; Magličić, A; Šakić, Z; Starčević, B, 2020)		0.56
" Patients receiving warfarin rarely obtain optimal dosing control, and experience significantly shorter survival compared with patients receiving DOACs."( Patterns of anticoagulation therapy in atrial fibrillation: results from a large real-life single-center registry.
Atić, A; Hadžibegović, I; Hulak Karlak, V; Jurin, I; Lucijanić, M; Magličić, A; Šakić, Z; Starčević, B, 2020)		0.56
"The direct oral anticoagulants (DOAC) have similar half-lives, but the dosing regimen varies between once daily (QD) or twice daily (BID)."( Twice- or Once-Daily Dosing of Direct Oral Anticoagulants, a systematic review and meta-analysis.
Bertoletti, L; Cucherat, M; Durieu, I; Grange, C; Grenet, G; Gueyffier, F; Kilo, R; Laporte, S; Lega, JC; Mainbourg, S; Mismetti, P; Nony, P; Provencher, S, 2021)		0.62
" We evaluated the effect of PMT use on questionable DOAC dosing rates within 40 VHA medical centers and whether this effect differed by DOAC indication or agent."( Working smarter, not harder: evaluating a population health approach to anticoagulation therapy management.
Allen, A; Patterson, ME; Rossier, C; Schaefer, M; Spoutz, P, 2021)		0.62
"To evaluate the safety and efficacy of extended-interval dabigatran dosing in older Chinese patients with non-valvular atrial fibrillation."( Evaluation of Extended-Interval Dabigatran Dosing in Older Patients With Non-Valvular Atrial Fibrillation.
Chen, X; Fan, Y; Fu, Z; Liu, M; Ni, L; Sun, D; Zhao, Z, 2021)		1.15
"We conducted an observational study on non-valvular atrial fibrillation patients administered dabigatran at different dosing intervals at the Department of Geriatrics, Peking University First Hospital, China."( Evaluation of Extended-Interval Dabigatran Dosing in Older Patients With Non-Valvular Atrial Fibrillation.
Chen, X; Fan, Y; Fu, Z; Liu, M; Ni, L; Sun, D; Zhao, Z, 2021)		1.12
" Sixty-two patients received extended-interval dosing with dabigatran at a mean dose of 117."( Evaluation of Extended-Interval Dabigatran Dosing in Older Patients With Non-Valvular Atrial Fibrillation.
Chen, X; Fan, Y; Fu, Z; Liu, M; Ni, L; Sun, D; Zhao, Z, 2021)		1.15
"Extended-interval dabigatran dosing in older patients with non-valvular atrial fibrillation and lower creatinine clearance can maintain activated partial thromboplastin time trough and peak values comparable to the conventional low dose."( Evaluation of Extended-Interval Dabigatran Dosing in Older Patients With Non-Valvular Atrial Fibrillation.
Chen, X; Fan, Y; Fu, Z; Liu, M; Ni, L; Sun, D; Zhao, Z, 2021)		1.24
" The aims of this clinical trial were to study the appropriateness of a paediatric dabigatran dosing algorithm, and the efficacy and safety of dabigatran dosed according to that algorithm versus standard of care in treating children with venous thromboembolism."( Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial.
Albisetti, M; Bomgaars, L; Brandão, LR; Brueckmann, M; Chalmers, E; Gorbatikov, K; Gropper, S; Halton, J; Huang, F; Kreuzer, J; Luciani, M; Mitchell, LG; Nurmeev, I; Reilly, P; Sharathkumar, A; Simetzberger, M; Sun, Z; Svirin, P; Tartakovsky, I, 2021)		2.29
" Standard of care (low-molecular-weight heparins, unfractionated heparin, vitamin K antagonists or fondaparinux) was compared with a paediatric oral dabigatran dosing regimen (an age-adjusted and weight-adjusted nomogram) in children younger than 18 years with acute venous thromboembolism initially treated (5-21 days) with parenteral anticoagulation, requiring anticoagulation therapy for at least 3 months."( Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial.
Albisetti, M; Bomgaars, L; Brandão, LR; Brueckmann, M; Chalmers, E; Gorbatikov, K; Gropper, S; Halton, J; Huang, F; Kreuzer, J; Luciani, M; Mitchell, LG; Nurmeev, I; Reilly, P; Sharathkumar, A; Simetzberger, M; Sun, Z; Svirin, P; Tartakovsky, I, 2021)		2.26
"An age-adjusted and weight-adjusted dabigatran dosing algorithm was appropriate in children aged birth to less than 18 years with venous thromboembolism."( Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial.
Albisetti, M; Bomgaars, L; Brandão, LR; Brueckmann, M; Chalmers, E; Gorbatikov, K; Gropper, S; Halton, J; Huang, F; Kreuzer, J; Luciani, M; Mitchell, LG; Nurmeev, I; Reilly, P; Sharathkumar, A; Simetzberger, M; Sun, Z; Svirin, P; Tartakovsky, I, 2021)		2.34
"This study evaluated DE pharmacokinetics (PK) in children with VTE and the appropriateness of a DE pediatric age- and weight-based dosing algorithm."( Pharmacokinetic modeling and simulation support for age- and weight-adjusted dosing of dabigatran etexilate in children with venous thromboembolism.
Albisetti, M; Bergstrand, M; Bomgaars, L; Brandão, LR; Brueckmann, M; Chalmers, E; Gropper, S; Halton, J; Huang, F; Ibrahim, MMA; Joseph, D; Luciani, M; Mitchell, LG; Röshammar, D; Tartakovsky, I, 2021)		0.84
" The final model was used to evaluate the pediatric dosing algorithm, with simulations comparing pediatric trough exposure with reference exposure defined for the pediatric studies."( Pharmacokinetic modeling and simulation support for age- and weight-adjusted dosing of dabigatran etexilate in children with venous thromboembolism.
Albisetti, M; Bergstrand, M; Bomgaars, L; Brandão, LR; Brueckmann, M; Chalmers, E; Gropper, S; Halton, J; Huang, F; Ibrahim, MMA; Joseph, D; Luciani, M; Mitchell, LG; Röshammar, D; Tartakovsky, I, 2021)		0.84
" Simulations confirmed that for all DE formulations, the final pediatric dosing algorithms achieved reference exposure without dose adjustment."( Pharmacokinetic modeling and simulation support for age- and weight-adjusted dosing of dabigatran etexilate in children with venous thromboembolism.
Albisetti, M; Bergstrand, M; Bomgaars, L; Brandão, LR; Brueckmann, M; Chalmers, E; Gropper, S; Halton, J; Huang, F; Ibrahim, MMA; Joseph, D; Luciani, M; Mitchell, LG; Röshammar, D; Tartakovsky, I, 2021)		0.84
"Using a population PK model of DE for children with VTE, simulations showed that the final dosing algorithms were appropriate for all DE formulations; no dose titration was needed."( Pharmacokinetic modeling and simulation support for age- and weight-adjusted dosing of dabigatran etexilate in children with venous thromboembolism.
Albisetti, M; Bergstrand, M; Bomgaars, L; Brandão, LR; Brueckmann, M; Chalmers, E; Gropper, S; Halton, J; Huang, F; Ibrahim, MMA; Joseph, D; Luciani, M; Mitchell, LG; Röshammar, D; Tartakovsky, I, 2021)		0.84
"To clarify the appropriate initial dosage of heparin during radiofrequency catheter ablation (RFCA) in patients with atrial fibrillation (AF) receiving uninterrupted nonvitamin K antagonist oral anticoagulant (NOAC) treatment."( Appropriate intraprocedural initial heparin dosing in patients undergoing catheter ablation for atrial fibrillation receiving uninterrupted non-vitamin-K antagonist oral anticoagulant treatment.
Dong, YX; Gao, LJ; Li, WW; Ma, CM; Wang, N; Xia, YL; Xiao, XJ; Yang, MH; Yin, XM; Yu, XH; Zhang, RF, 2021)		0.62
"For patients with AF receiving uninterrupted NOAC treatment who underwent RFCA, an initial heparin dosage of 120 U/kg or 130 U/kg can provide an adequate intraprocedural anticoagulant effect, and 130 U/kg allowed ACT to reach the target earlier."( Appropriate intraprocedural initial heparin dosing in patients undergoing catheter ablation for atrial fibrillation receiving uninterrupted non-vitamin-K antagonist oral anticoagulant treatment.
Dong, YX; Gao, LJ; Li, WW; Ma, CM; Wang, N; Xia, YL; Xiao, XJ; Yang, MH; Yin, XM; Yu, XH; Zhang, RF, 2021)		0.62
" These differences between DOACs with almost equal half-life are probably partly due to the differences in dosing interval: twice a day (BID) versus once a day (QD)."( [Is one DOAC better than another?]
Pos, L, 2021)		0.62
" However, suboptimal adherence, variable dosing and use in patient populations that otherwise would have been excluded from clinical trials may impact the efficacy and safety profile of DOACs in a routine care setting."( Dose specific effectiveness and safety of DOACs in patients with non-valvular atrial fibrillation: A Canadian retrospective cohort study.
Dasgupta, K; Godin, R; Nedjar, H; Rahme, E; Tagalakis, V, 2021)		0.62
" US Food and Drug Administration-approved dosing was used in 91."( Evaluation of Prescribing Practices and Outcomes Using Direct-acting Oral Anticoagulants After Cardiac Surgery.
Cook, BM; Kanaan, DM; Kelly, J; Malloy, R, 2021)		0.62
"We aimed to assess differences in ACT values and UFH dosage during PVI in patients on different oral anticoagulants."( Differences in activated clotting time and total unfractionated heparin dose during pulmonary vein isolation in patients on different anticoagulation therapy.
Anic, A; Bakotic, Z; Benko, I; Bojko, A; Brusich, S; Jan, M; Manola, S; Pavlovic, N; Pernat, A; Pezo Nikolic, B; Radeljic, V; Scherr, D; Szavits Nossan, J; Traykov, V; Velagic, V; Zeljkovic, I, 2021)		0.62
" There is a paucity of data for rates of inappropriate inpatient DOAC dosing in Australia."( Appropriateness of inpatient dosing of direct oral anticoagulants for atrial fibrillation.
Caughey, GE; Li, RJ; Shakib, S, 2022)		0.72
" Results of clinical trials and real clinical practice studies have confirmed that rivaroxaban may provide a comprehensive protection for a senile patient with AF due to favorable indexes of efficiency and safety, beneficial effect on the risk of coronary events and impairment оf renal function, whereas once a day dosing of rivaroxaban improves the compliance with this treatment and its constancy."( [Atrial fibrillation in old age: risk management and features of the use of direct oral anticoagulants].
Kanorskii, SG, 2021)		0.62
"To analyse the appropriateness of direct oral anticoagulant (DOAC) dosing and determinants for under-and overdosing as well as acceptance and implementation rates of pharmacists' interventions."( Determinants for under- and overdosing of direct oral anticoagulants and physicians' implementation of clinical pharmacists' recommendations.
Cornu, P; Dupont, A; Moudallel, S; Steurbaut, S, 2022)		0.72
" In patients aged 80 years and over, however, the fear of DOAC-associated bleeding and the complexity of DOAC dosing regimes may prompt physicians to prescribe inappropriate dose levels."( Direct Oral Anticoagulants and Non-valvular Atrial Fibrillation: Compliance with Dose Level Guidelines in Patients Aged 80 Years and Over.
Cavillon Decaestecker, M; Decaestecker, K; Ferret, L; Gautier, S; Tsogli, ES; Verdun, S, 2021)		0.62
" In contrast, initial management in a neurology department was associated with appropriate dosing (p = 0."( Direct Oral Anticoagulants and Non-valvular Atrial Fibrillation: Compliance with Dose Level Guidelines in Patients Aged 80 Years and Over.
Cavillon Decaestecker, M; Decaestecker, K; Ferret, L; Gautier, S; Tsogli, ES; Verdun, S, 2021)		0.62
" It might be possible to reduce inappropriate dosing by raising awareness among hospital-based and private-practice prescribers, providing prescription support tools for DOACs, and performing medication reconciliations and reviews at hospital and in private practice."( Direct Oral Anticoagulants and Non-valvular Atrial Fibrillation: Compliance with Dose Level Guidelines in Patients Aged 80 Years and Over.
Cavillon Decaestecker, M; Decaestecker, K; Ferret, L; Gautier, S; Tsogli, ES; Verdun, S, 2021)		0.62
" Anticoagulant dosing may differ under special considerations."( An Update of the Efficacy and Comparative Characteristics of Direct (New) Oral Anticoagulants (DOACs).
Abuşka, D; Afacan, G; Ersan, E; Hosseinzadeh, M; Karcioglu, O; Ozkaya, B; Yeniocak, S; Yilmaz, S; Zengin, S, 2022)		0.72
"Ciraparantag provides a dose-related reversal of anticoagulation induced by steady-state dosing of apixaban or rivaroxaban."( Ciraparantag reverses the anticoagulant activity of apixaban and rivaroxaban in healthy elderly subjects.
Ansell, J; Bakhru, S; Freedman, D; Laulicht, BE; Tracey, G; Villano, S, 2022)		0.72
"Dabigatran, a novel oral anticoagulant, is a direct thrombin inhibitor and is being increasingly used owing to the advantage of dosing without the need for laboratory monitoring."( Extensive skin necrosis in an elderly woman on dabigatran.
Ahuja, N; Ashraf, R; Bharati, J; Rajarajen, AP, 2021)		2.32
" To what extent the observed increases in DOAC exposure in the older patients is the cause of their increased risk of bleeding, which could potentially be ameliorated by dosing titration, requires further investigation."( Assessment of exposure to direct oral anticoagulants in elderly hospitalised patients.
Avery, P; Biss, T; Kamali, F; Kampouraki, E; Wynne, H, 2021)		0.62
" Previous VKA dosage and creatinine clearance were inversely associated with DOAC trough concentrations."( Inter- and intra-individual concentrations of direct oral anticoagulants: The KIDOAC study.
Cannegieter, SC; Huisman, MV; Lijfering, WM; Nierman, MC; Toorop, MMA; van der Meer, FJM; van Rein, N; Vermaas, HW, 2022)		0.72
" Lower previous VKA dosage and creatinine clearance were associated with higher DOAC trough concentrations."( Inter- and intra-individual concentrations of direct oral anticoagulants: The KIDOAC study.
Cannegieter, SC; Huisman, MV; Lijfering, WM; Nierman, MC; Toorop, MMA; van der Meer, FJM; van Rein, N; Vermaas, HW, 2022)		0.72
" In these situations, the type, dosage or the time of last intake of anticoagulants is often unknown and single substance analysis by functional tests is only possible if the substance contained in the sample is known."( Development and validation of an analytical method for the determination of direct oral anticoagulants (DOAC) and the direct thrombin-inhibitor argatroban by HPLC-MS/MS.
Beyer-Westendorf, J; Brückner, L; Pietsch, J; Tiebel, O, 2022)		0.72
"Clear guidelines exist to guide the dosing of direct-acting oral anticoagulants (DOACs)."( Guideline-discordant dosing of direct-acting oral anticoagulants in the veterans health administration.
Berlowitz, DR; Lee, JS; Liu, W; Mitra, A; Rose, AJ; Yu, H, 2021)		0.62
" We examined how often patient dosing was concordant with these recommendations."( Guideline-discordant dosing of direct-acting oral anticoagulants in the veterans health administration.
Berlowitz, DR; Lee, JS; Liu, W; Mitra, A; Rose, AJ; Yu, H, 2021)		0.62
"A substantial portion of DOAC prescriptions in the VA system are dosed contrary to clinical guidelines."( Guideline-discordant dosing of direct-acting oral anticoagulants in the veterans health administration.
Berlowitz, DR; Lee, JS; Liu, W; Mitra, A; Rose, AJ; Yu, H, 2021)		0.62
" Child-appropriate formulations have been developed, age-specific dosing information generated, and safety and efficacy evaluated in ongoing phase 3 trials."( Anticoagulation in Pediatric Patients.
Male, C, 2022)		0.72
" Peak and trough drug plasma concentrations were collected based on the dosing interval and pharmacokinetics of the drugs and quantified using high performance liquid chromatography."( Simvastatin, but Not Atorvastatin, Is Associated with Higher Peak Rivaroxaban Serum Levels and Bleeding: an Asian Cohort Study from Singapore.
Chan, ECY; Soh, XQ; Tan, DS, 2023)		0.91
" As the overall effect of accumulation of several covariates could be difficult to apprehend for the clinicians, PopPK modeling could represent an interesting approach for informed precision dosing and to improve personalized prescription of DOACs."( Population Pharmacokinetic Models for Direct Oral Anticoagulants: A Systematic Review and Clinical Appraisal Using Exposure Simulation.
Csajka, C; Daali, Y; Fontana, P; Gaspar, F; Guidi, M; Reny, JL; Terrier, J, 2022)		0.72
"3 mL dosage of CFA into the rat's hind leg planter surface resulted in articular surface deformities, reduced cartilage thickness, loss of intercellular matrix, and inflammatory cell infiltration."( Ameliorative Effect of Dabigatran on CFA-Induced Rheumatoid Arthritis via Modulating Kallikrein-Kinin System in Rats.
Abdel-Reheim, MA; Ahmed Gaafar, AG; Atwa, GMK; Cavalu, S; El-Daly, M; Morsy, MA; Saber, S; Yahya, G; Youssef, ME, 2022)		1.03
" The dosage of dabigatran etexilate was 110 mg twice daily for adults and 55 mg twice daily for children."( Dabigatran etexilate is efficacious in consumptive coagulopathy and pain associated with venous malformations.
Chen, H; Gu, H; Hu, L; Lin, X; Liu, H; Xu, Z; Yang, X, 2023)		2.71
" However, there remain gaps in our understanding of dosage and disparities in use."( Trends in direct oral anticoagulant (DOAC) prescribing in English primary care (2014-2019).
Arora, J; de Lusignan, S; Delanerolle, G; Emanuel, S; Fan, X; Feher, M; Field, BC; Heiss, C; Hobbs, FR; Joy, M; Kar, D; Pollock, KG; Sandler, B; Sheppard, JP; Williams, J, 2023)		0.91
" Eventually, standard dosing regimens of DABE and digoxin were assessed in Chinese old-elderly patients with chronic heart failure (CHF) with different stages of renal impairment."( Assessment of Aging-Related Function Variations of P-gp Transporter in Old-Elderly Chinese CHF Patients Based on Modeling and Simulation.
Cui, C; Jiang, Y; Li, H; Ling, J; Liu, D; Pan, J; Qu, Y; Sia, JEV; Wang, Y; Zhu, Z, 2022)		0.72
"Per-label dosing of direct oral anticoagulants (DOACs) is important for the prevention of stroke and systemic embolism among patients with non-valvular atrial fibrillation (NVAF), especially those with poor renal function, advanced age, low body weight or concomitant P-glycoprotein inhibitors."( Direct Oral Anticoagulant (DOAC) Dosing in Patients with Non-valvular Atrial Fibrillation (NVAF) in the United Kingdom: A Retrospective Cohort Study Using CPRD Gold Database.
Anastassopoulou, A; Doobaree, IU; Fay, M; Gusto, G; Khachatryan, A; Manu, M; Mughal, F; Spentzouris, G; Zawaneh, Y, 2023)		0.91
"Although most patients received per-label dosing, ~ one in five patients was incorrectly dosed with DOAC, which may lead to serious clinical consequences and increased healthcare burden."( Direct Oral Anticoagulant (DOAC) Dosing in Patients with Non-valvular Atrial Fibrillation (NVAF) in the United Kingdom: A Retrospective Cohort Study Using CPRD Gold Database.
Anastassopoulou, A; Doobaree, IU; Fay, M; Gusto, G; Khachatryan, A; Manu, M; Mughal, F; Spentzouris, G; Zawaneh, Y, 2023)		0.91
" Hypothetically, an increased glomerular filtration rate (GFR) may lead to suboptimal dosing and a higher thromboembolic events incidence."( Impact of increased kidney function on clinical and biological outcomes in real-world patients treated with Direct Oral Anticoagulants.
Acosta-Isaac, R; Corrochano, M; Mojal, S; Moret, C; Muñoz, R; Plaza, M; Souto, JC, 2022)		0.72
" Importantly, no study has adequately accounted for warfarin dosing being continuously modified based on INR values while dosing of DOACs is fixed."( Comparison of medication adherence to different oral anticoagulants: population-based cohort study.
Ágústsson, AS; Björnsson, ES; Guðmundsdóttir, BR; Hreinsson, JP; Ingason, AB; Lund, SH; Önundarson, PT; Pálsson, DA; Reynisson, IE; Rumba, E, 2023)		0.91
" Additional data on safety, efficacy, and dosing strategies for reversal agents are also necessary, especially as the use of DOACs becomes more common in the pediatric population."( Just DOAC: Use of direct-acting oral anticoagulants in pediatrics.
Cober, MP; Fenn, NE; Hill, C; King, M; Mills, K; Omecene, NE; Pauley, JL; Sierra, CM; Smith, T, 2023)		0.91
" Our simulation results revealed that recommended reduced dosing regimen of dabigatran etexilate during comedication with verapamil and clarithromycin (110 and 75 mg BID for Chinese young and old older adults) will result in exposure (trough concentration) that was either slightly higher or similar to the trough concentration of patients with any bleeding events."( Physiologically-based pharmacokinetic modeling to predict drug-drug interactions of dabigatran etexilate and rivaroxaban in the Chinese older adults.
Cui, C; Lai, X; Li, H; Liu, D; Sia, JEV; Wu, X; Zhang, F, 2023)		1.36
" Nevertheless, high interindividual variability in DOAC exposure in older adults was noted, which can be explained by distinctive older patient characteristics, such as kidney function, changes in body composition (especially reduced muscle mass), and co-medication with P-gp inhibitors, which is in line with the current dosing reduction criteria of apixaban, edoxaban, and rivaroxaban."( Insights into the Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants in Older Adults with Atrial Fibrillation: A Structured Narrative Review.
Dia, N; Dreesen, E; Edwina, AE; Spriet, I; Tournoy, J; Van der Linden, L; Vanassche, T; Verhamme, P, 2023)		0.91
" Dosing was considered inappropriate when use of eGFR resulted in a lower (undertreatment) or higher (overtreatment) dose than that recommended by the eCrCl."( Variability in Nonvitamin K Oral Anticoagulant Dose Eligibility and Adjustment According to Renal Formulae and Clinical Outcomes in Patients With Atrial Fibrillation With and Without Chronic Kidney Disease: Insights From ORBIT-AF II.
Andrade, JG; Fordyce, CB; Holmes, DN; Levin, A; Piccini, JP; Yao, RJR, 2023)		0.91
"Twice-daily dosing of non-vitamin K antagonist oral anticoagulants (NOACs) may reduce drug adherence compared with once-daily dosing of NOACs in patients with atrial fibrillation (AF), thus worsening clinical outcomes."( Adherence and clinical outcomes for twice-daily versus once-daily dosing of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: Is dosing frequency important?
Bae, YJ; Hwang, HJ; Jin, ES; Sohn, IS, 2023)		0.91
" The proportion of patients with high adherence to NOACs was 95%, which did not significantly differ according to the dosing regimen."( Adherence and clinical outcomes for twice-daily versus once-daily dosing of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: Is dosing frequency important?
Bae, YJ; Hwang, HJ; Jin, ES; Sohn, IS, 2023)		0.91
"Adherence between once- and twice-daily dosing NOACs in patients with AF was high and similar among both dosing regimens."( Adherence and clinical outcomes for twice-daily versus once-daily dosing of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: Is dosing frequency important?
Bae, YJ; Hwang, HJ; Jin, ES; Sohn, IS, 2023)		0.91
"Dabigatran is the first of four direct-acting oral anticoagulants approved to prevent stroke in adult patients with atrial fibrillation using a fixed two-dose scheme compared with warfarin dosing adjusted to a prothrombin time range associated with optimal risk reduction in stroke and serious bleeding."( Dabigatran Dosing Proposal for Adults With Atrial Fibrillation: Stress-Testing Renal Function Range in Real World Patients.
Al Qaraghuli, F; Fiedler-Kelly, J; Gonzalez, D; Powell, JR; Weiner, D, 2023)		3.8
"26)), once daily DOAC dosing (OR = 3."( Impact of Direct Oral Anticoagulant Concentration on Clinical Outcomes in Asian Patients with Atrial Fibrillation.
Ho, LT; Huang, CF; Jeng, JS; Kuo, CH; Lin, SY; Liu, YB; Peng, YF; Tang, SC; Tsai, LK, 2023)		0.91
" The objectives of this study were to evaluate DOAC dosing discordance and to determine whether discordance based on various estimates of kidney function is associated with bleeding or thromboembolism."( DOAC Dosing Discordance Using Different Estimates of Kidney Function and Outcomes.
Achanta, A; Bhalodia, NJ; Cheng, J; Coons, JC; Deri, CR; Heiney, H; Iasella, CJ; Marchionda, O; Stahl, K; White, EM, 2023)		0.91
"Lower risks for bleed and mortality associated with reduced- versus standard-dose dabigatran in patients with AF and a high bleeding risk suggest a better dosing strategy."( Effectiveness and safety of Dabigatran 110 mg versus 150 mg for Stroke Prevention in Patients with Atrial Fibrillation at High Bleeding Risk.
An, J; Cheetham, TC; Lang, DT; Lee, MS; Luong, T; Reynolds, K, 2023)		1.43
" Inappropriate dosing was noted in 18% of the population."( Characteristics of patients with atrial fibrillation treated with direct oral anticoagulants and new insights into inappropriate dosing: results from the French National Prospective Registry: PAFF.
Assouline, S; Cohen, C; Cohen, S; Dhanjal, TS; Dib, JC; Dievart, F; Durand, P; Garban, T; Guedj-Meynier, D; Guenoun, M; Hoffman, O; Lellouche, N; Lequeux, B; Ouazana, L; Parrens, E; Pradeau, V; Sabouret, P; Schwartz, J; Sharareh, A; Villaceque, M, 2023)		0.91
"Within this large registry, DOACs were associated with inappropriate dosing in 18% of cases."( Characteristics of patients with atrial fibrillation treated with direct oral anticoagulants and new insights into inappropriate dosing: results from the French National Prospective Registry: PAFF.
Assouline, S; Cohen, C; Cohen, S; Dhanjal, TS; Dib, JC; Dievart, F; Durand, P; Garban, T; Guedj-Meynier, D; Guenoun, M; Hoffman, O; Lellouche, N; Lequeux, B; Ouazana, L; Parrens, E; Pradeau, V; Sabouret, P; Schwartz, J; Sharareh, A; Villaceque, M, 2023)		0.91
"This single-center, open-label, fixed-sequence study enrolled 24 healthy male subjects who were dosed orally with dabigatran etexilate 75 mg on days 1 (Treatment A1) and 9 (Treatment C1) as well as rosuvastatin 10 mg on days 3 (Treatment A2) and 11 (Treatment C2)."( Effect of Daridorexant on the Pharmacokinetics of P-Glycoprotein Substrate Dabigatran Etexilate and Breast Cancer Resistance Protein Substrate Rosuvastatin in Healthy Subjects.
Anliker-Ort, M; Dingemanse, J; Janů, L; Kaufmann, P, 2023)		1.35
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
anticoagulantAn agent that prevents blood clotting.
EC 3.4.21.5 (thrombin) inhibitorAn EC 3.4.21.* (serine endopeptidase) inhibitor that interferes with the action of thrombin (EC 3.4.21.5).
EC 1.10.99.2 [ribosyldihydronicotinamide dehydrogenase (quinone)] inhibitorAn EC 1.10.99.* (oxidoreductases acting on diphenols and related substances as donors, other acceptors) inhibitor that interferes with the action of ribosyldihydronicotinamide dehydrogenase (quinone), EC 1.10.99.2.
[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 (5)

ClassDescription
aromatic amideAn amide in which the amide linkage is bonded directly to an aromatic system.
benzimidazolesAn organic heterocyclic compound containing a benzene ring fused to an imidazole ring.
carboxamidineCompounds having the structure RC(=NR)NR2. The term is used as a suffix in systematic nomenclature to denote the -C(=NH)NH2 group including its carbon atom.
pyridinesAny organonitrogen heterocyclic compound based on a pyridine skeleton and its substituted derivatives.
beta-alanine derivative
[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 (23)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency10.68400.01237.983543.2770AID1645841
EWS/FLI fusion proteinHomo sapiens (human)Potency0.17950.001310.157742.8575AID1259253; AID1259256
GVesicular stomatitis virusPotency10.68400.01238.964839.8107AID1645842
cytochrome P450 2D6Homo sapiens (human)Potency37.90830.00108.379861.1304AID1645840
Interferon betaHomo sapiens (human)Potency10.68400.00339.158239.8107AID1645842
HLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)Potency10.68400.01238.964839.8107AID1645842
Inositol hexakisphosphate kinase 1Homo sapiens (human)Potency10.68400.01238.964839.8107AID1645842
cytochrome P450 2C9, partialHomo sapiens (human)Potency10.68400.01238.964839.8107AID1645842
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Solute carrier family 22 member 2Homo sapiens (human)IC50 (µMol)4.70000.40003.10009.7000AID721751
ProthrombinHomo sapiens (human)IC50 (µMol)0.00460.00000.710710.0000AID1202328; AID1254403; AID1266251; AID1299221; AID1315499; AID1332061; AID1381646; AID1436084; AID1681853; AID1871814; AID228064; AID719849
ProthrombinHomo sapiens (human)Ki0.00500.00000.78469.0000AID1057658; AID1393315; AID1681853; AID228213; AID645253; AID683501; AID753177
Coagulation factor XHomo sapiens (human)Ki2.85330.00000.47089.0000AID1057659; AID1681852; AID52166
PlasminogenHomo sapiens (human)Ki1.69500.01701.15604.4000AID225426
Coagulation factor XIIHomo sapiens (human)IC50 (µMol)33.00000.01043.889010.9666AID1681854
Tissue-type plasminogen activatorHomo sapiens (human)Ki45.36000.01703.71968.6000AID210579
Vitamin K-dependent protein CHomo sapiens (human)Ki20.93001.80002.10002.4000AID30726
Serine protease hepsinHomo sapiens (human)Ki0.83500.00050.19170.8350AID1195363
Trypsin-1Homo sapiens (human)Ki0.05010.00001.76768.9000AID1393316; AID228436
Trypsin-2Homo sapiens (human)Ki0.05010.00430.94873.2900AID1393316; AID228436
Muscarinic acetylcholine receptor M1Rattus norvegicus (Norway rat)IC50 (µMol)10.00000.00052.773925.1700AID719847
Ribosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)IC50 (µMol)10.50000.00271.62879.9000AID719845; AID719847
Ribosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)Ki60.00000.00650.04360.0880AID719846
Trypsin-3Homo sapiens (human)Ki0.05010.00430.94873.2900AID1393316; AID228436
Multidrug and toxin extrusion protein 2Homo sapiens (human)IC50 (µMol)25.30000.16003.95718.6000AID721752
Multidrug and toxin extrusion protein 1Homo sapiens (human)IC50 (µMol)8.10000.01002.765610.0000AID721754
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (169)

Processvia Protein(s)Taxonomy
activation of cysteine-type endopeptidase activity involved in apoptotic processSolute carrier family 22 member 2Homo sapiens (human)
positive regulation of gene expressionSolute carrier family 22 member 2Homo sapiens (human)
organic cation transportSolute carrier family 22 member 2Homo sapiens (human)
monoatomic cation transportSolute carrier family 22 member 2Homo sapiens (human)
neurotransmitter transportSolute carrier family 22 member 2Homo sapiens (human)
serotonin transportSolute carrier family 22 member 2Homo sapiens (human)
body fluid secretionSolute carrier family 22 member 2Homo sapiens (human)
organic cation transportSolute carrier family 22 member 2Homo sapiens (human)
quaternary ammonium group transportSolute carrier family 22 member 2Homo sapiens (human)
prostaglandin transportSolute carrier family 22 member 2Homo sapiens (human)
amine transportSolute carrier family 22 member 2Homo sapiens (human)
putrescine transportSolute carrier family 22 member 2Homo sapiens (human)
spermidine transportSolute carrier family 22 member 2Homo sapiens (human)
acetylcholine transportSolute carrier family 22 member 2Homo sapiens (human)
choline transportSolute carrier family 22 member 2Homo sapiens (human)
dopamine transportSolute carrier family 22 member 2Homo sapiens (human)
norepinephrine transportSolute carrier family 22 member 2Homo sapiens (human)
xenobiotic transportSolute carrier family 22 member 2Homo sapiens (human)
epinephrine transportSolute carrier family 22 member 2Homo sapiens (human)
histamine transportSolute carrier family 22 member 2Homo sapiens (human)
serotonin uptakeSolute carrier family 22 member 2Homo sapiens (human)
histamine uptakeSolute carrier family 22 member 2Homo sapiens (human)
norepinephrine uptakeSolute carrier family 22 member 2Homo sapiens (human)
thiamine transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
purine-containing compound transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
amino acid import across plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
dopamine uptakeSolute carrier family 22 member 2Homo sapiens (human)
L-arginine import across plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
export across plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
transport across blood-brain barrierSolute carrier family 22 member 2Homo sapiens (human)
L-alpha-amino acid transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
spermidine transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
L-arginine transmembrane transportSolute carrier family 22 member 2Homo sapiens (human)
cellular detoxificationSolute carrier family 22 member 2Homo sapiens (human)
xenobiotic transport across blood-brain barrierSolute carrier family 22 member 2Homo sapiens (human)
positive regulation of protein phosphorylationProthrombinHomo sapiens (human)
proteolysisProthrombinHomo sapiens (human)
acute-phase responseProthrombinHomo sapiens (human)
cell surface receptor signaling pathwayProthrombinHomo sapiens (human)
G protein-coupled receptor signaling pathwayProthrombinHomo sapiens (human)
blood coagulationProthrombinHomo sapiens (human)
positive regulation of cell population proliferationProthrombinHomo sapiens (human)
regulation of cell shapeProthrombinHomo sapiens (human)
response to woundingProthrombinHomo sapiens (human)
negative regulation of platelet activationProthrombinHomo sapiens (human)
platelet activationProthrombinHomo sapiens (human)
regulation of blood coagulationProthrombinHomo sapiens (human)
positive regulation of blood coagulationProthrombinHomo sapiens (human)
positive regulation of cell growthProthrombinHomo sapiens (human)
positive regulation of insulin secretionProthrombinHomo sapiens (human)
positive regulation of collagen biosynthetic processProthrombinHomo sapiens (human)
fibrinolysisProthrombinHomo sapiens (human)
negative regulation of proteolysisProthrombinHomo sapiens (human)
positive regulation of receptor signaling pathway via JAK-STATProthrombinHomo sapiens (human)
negative regulation of astrocyte differentiationProthrombinHomo sapiens (human)
positive regulation of release of sequestered calcium ion into cytosolProthrombinHomo sapiens (human)
regulation of cytosolic calcium ion concentrationProthrombinHomo sapiens (human)
cytolysis by host of symbiont cellsProthrombinHomo sapiens (human)
positive regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionProthrombinHomo sapiens (human)
negative regulation of fibrinolysisProthrombinHomo sapiens (human)
antimicrobial humoral immune response mediated by antimicrobial peptideProthrombinHomo sapiens (human)
neutrophil-mediated killing of gram-negative bacteriumProthrombinHomo sapiens (human)
positive regulation of lipid kinase activityProthrombinHomo sapiens (human)
negative regulation of cytokine production involved in inflammatory responseProthrombinHomo sapiens (human)
positive regulation of protein localization to nucleusProthrombinHomo sapiens (human)
positive regulation of phospholipase C-activating G protein-coupled receptor signaling pathwayProthrombinHomo sapiens (human)
ligand-gated ion channel signaling pathwayProthrombinHomo sapiens (human)
positive regulation of reactive oxygen species metabolic processProthrombinHomo sapiens (human)
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)
proteolysisPlasminogenHomo sapiens (human)
blood coagulationPlasminogenHomo sapiens (human)
negative regulation of cell population proliferationPlasminogenHomo sapiens (human)
negative regulation of cell-substrate adhesionPlasminogenHomo sapiens (human)
extracellular matrix disassemblyPlasminogenHomo sapiens (human)
tissue regenerationPlasminogenHomo sapiens (human)
fibrinolysisPlasminogenHomo sapiens (human)
positive regulation of blood vessel endothelial cell migrationPlasminogenHomo sapiens (human)
myoblast differentiationPlasminogenHomo sapiens (human)
muscle cell cellular homeostasisPlasminogenHomo sapiens (human)
tissue remodelingPlasminogenHomo sapiens (human)
biological process involved in interaction with symbiontPlasminogenHomo sapiens (human)
negative regulation of fibrinolysisPlasminogenHomo sapiens (human)
positive regulation of fibrinolysisPlasminogenHomo sapiens (human)
trophoblast giant cell differentiationPlasminogenHomo sapiens (human)
labyrinthine layer blood vessel developmentPlasminogenHomo sapiens (human)
mononuclear cell migrationPlasminogenHomo sapiens (human)
trans-synaptic signaling by BDNF, modulating synaptic transmissionPlasminogenHomo sapiens (human)
negative regulation of cell-cell adhesion mediated by cadherinPlasminogenHomo sapiens (human)
plasma kallikrein-kinin cascadeCoagulation factor XIIHomo sapiens (human)
Factor XII activationCoagulation factor XIIHomo sapiens (human)
blood coagulation, intrinsic pathwayCoagulation factor XIIHomo sapiens (human)
positive regulation of plasminogen activationCoagulation factor XIIHomo sapiens (human)
protein processingCoagulation factor XIIHomo sapiens (human)
protein autoprocessingCoagulation factor XIIHomo sapiens (human)
positive regulation of blood coagulationCoagulation factor XIIHomo sapiens (human)
zymogen activationCoagulation factor XIIHomo sapiens (human)
fibrinolysisCoagulation factor XIIHomo sapiens (human)
innate immune responseCoagulation factor XIIHomo sapiens (human)
response to misfolded proteinCoagulation factor XIIHomo sapiens (human)
positive regulation of fibrinolysisCoagulation factor XIIHomo sapiens (human)
blood coagulationCoagulation factor XIIHomo sapiens (human)
response to hypoxiaTissue-type plasminogen activatorHomo sapiens (human)
proteolysisTissue-type plasminogen activatorHomo sapiens (human)
blood coagulationTissue-type plasminogen activatorHomo sapiens (human)
negative regulation of plasminogen activationTissue-type plasminogen activatorHomo sapiens (human)
plasminogen activationTissue-type plasminogen activatorHomo sapiens (human)
protein modification processTissue-type plasminogen activatorHomo sapiens (human)
fibrinolysisTissue-type plasminogen activatorHomo sapiens (human)
negative regulation of proteolysisTissue-type plasminogen activatorHomo sapiens (human)
negative regulation of fibrinolysisTissue-type plasminogen activatorHomo sapiens (human)
prevention of polyspermyTissue-type plasminogen activatorHomo sapiens (human)
trans-synaptic signaling by BDNF, modulating synaptic transmissionTissue-type plasminogen activatorHomo sapiens (human)
platelet-derived growth factor receptor signaling pathwayTissue-type plasminogen activatorHomo sapiens (human)
smooth muscle cell migrationTissue-type plasminogen activatorHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
positive regulation of T cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
adaptive immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class I via ER pathway, TAP-independentHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of T cell anergyHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
defense responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
detection of bacteriumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-12 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-6 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protection from natural killer cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
innate immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of dendritic cell differentiationHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class IbHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
proteolysisVitamin K-dependent protein CHomo sapiens (human)
blood coagulationVitamin K-dependent protein CHomo sapiens (human)
negative regulation of blood coagulationVitamin K-dependent protein CHomo sapiens (human)
negative regulation of apoptotic processVitamin K-dependent protein CHomo sapiens (human)
negative regulation of inflammatory responseVitamin K-dependent protein CHomo sapiens (human)
negative regulation of coagulationVitamin K-dependent protein CHomo sapiens (human)
positive regulation of establishment of endothelial barrierVitamin K-dependent protein CHomo sapiens (human)
proteolysisSerine protease hepsinHomo sapiens (human)
regulation of cell shapeSerine protease hepsinHomo sapiens (human)
positive regulation of gene expressionSerine protease hepsinHomo sapiens (human)
negative regulation of epithelial to mesenchymal transitionSerine protease hepsinHomo sapiens (human)
positive regulation of plasminogen activationSerine protease hepsinHomo sapiens (human)
positive regulation of cell growthSerine protease hepsinHomo sapiens (human)
basement membrane disassemblySerine protease hepsinHomo sapiens (human)
negative regulation of apoptotic processSerine protease hepsinHomo sapiens (human)
positive regulation by host of viral transcriptionSerine protease hepsinHomo sapiens (human)
negative regulation of epithelial cell proliferationSerine protease hepsinHomo sapiens (human)
detection of mechanical stimulus involved in sensory perception of soundSerine protease hepsinHomo sapiens (human)
potassium ion transmembrane transportSerine protease hepsinHomo sapiens (human)
cochlea morphogenesisSerine protease hepsinHomo sapiens (human)
response to thyroid hormoneSerine protease hepsinHomo sapiens (human)
pilomotor reflexSerine protease hepsinHomo sapiens (human)
positive regulation of hepatocyte proliferationSerine protease hepsinHomo sapiens (human)
positive regulation of thyroid hormone generationSerine protease hepsinHomo sapiens (human)
digestionTrypsin-1Homo sapiens (human)
extracellular matrix disassemblyTrypsin-1Homo sapiens (human)
proteolysisTrypsin-1Homo sapiens (human)
proteolysisTrypsin-2Homo sapiens (human)
digestionTrypsin-2Homo sapiens (human)
antimicrobial humoral responseTrypsin-2Homo sapiens (human)
extracellular matrix disassemblyTrypsin-2Homo sapiens (human)
positive regulation of cell growthTrypsin-2Homo sapiens (human)
collagen catabolic processTrypsin-2Homo sapiens (human)
positive regulation of cell adhesionTrypsin-2Homo sapiens (human)
quinone catabolic processRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
proteolysisTrypsin-3Homo sapiens (human)
digestionTrypsin-3Homo sapiens (human)
antimicrobial humoral responseTrypsin-3Homo sapiens (human)
zymogen activationTrypsin-3Homo sapiens (human)
endothelial cell migrationTrypsin-3Homo sapiens (human)
organic cation transportMultidrug and toxin extrusion protein 2Homo sapiens (human)
transmembrane transportMultidrug and toxin extrusion protein 2Homo sapiens (human)
proton transmembrane transportMultidrug and toxin extrusion protein 2Homo sapiens (human)
xenobiotic detoxification by transmembrane export across the plasma membraneMultidrug and toxin extrusion protein 2Homo sapiens (human)
inositol phosphate metabolic processInositol hexakisphosphate kinase 1Homo sapiens (human)
phosphatidylinositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
negative regulation of cold-induced thermogenesisInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
xenobiotic transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
organic cation transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
putrescine transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
xenobiotic transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
thiamine transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
amino acid import across plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-arginine import across plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-alpha-amino acid transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
proton transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-arginine transmembrane transportMultidrug and toxin extrusion protein 1Homo sapiens (human)
xenobiotic detoxification by transmembrane export across the plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (71)

Processvia Protein(s)Taxonomy
amine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
acetylcholine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
neurotransmitter transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
monoamine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
organic anion transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
organic cation transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
prostaglandin transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
L-amino acid transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
pyrimidine nucleoside transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
choline transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
thiamine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
putrescine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
efflux transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
spermidine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
quaternary ammonium group transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
toxin transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
xenobiotic transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
L-arginine transmembrane transporter activitySolute carrier family 22 member 2Homo sapiens (human)
lipopolysaccharide bindingProthrombinHomo sapiens (human)
serine-type endopeptidase activityProthrombinHomo sapiens (human)
signaling receptor bindingProthrombinHomo sapiens (human)
calcium ion bindingProthrombinHomo sapiens (human)
protein bindingProthrombinHomo sapiens (human)
growth factor activityProthrombinHomo sapiens (human)
heparin bindingProthrombinHomo sapiens (human)
thrombospondin receptor activityProthrombinHomo sapiens (human)
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)
protease bindingPlasminogenHomo sapiens (human)
endopeptidase activityPlasminogenHomo sapiens (human)
serine-type endopeptidase activityPlasminogenHomo sapiens (human)
signaling receptor bindingPlasminogenHomo sapiens (human)
protein bindingPlasminogenHomo sapiens (human)
serine-type peptidase activityPlasminogenHomo sapiens (human)
enzyme bindingPlasminogenHomo sapiens (human)
kinase bindingPlasminogenHomo sapiens (human)
protein domain specific bindingPlasminogenHomo sapiens (human)
apolipoprotein bindingPlasminogenHomo sapiens (human)
protein-folding chaperone bindingPlasminogenHomo sapiens (human)
protein antigen bindingPlasminogenHomo sapiens (human)
serine-type endopeptidase activityCoagulation factor XIIHomo sapiens (human)
calcium ion bindingCoagulation factor XIIHomo sapiens (human)
protein bindingCoagulation factor XIIHomo sapiens (human)
misfolded protein bindingCoagulation factor XIIHomo sapiens (human)
serine-type endopeptidase activityTissue-type plasminogen activatorHomo sapiens (human)
signaling receptor bindingTissue-type plasminogen activatorHomo sapiens (human)
protein bindingTissue-type plasminogen activatorHomo sapiens (human)
phosphoprotein bindingTissue-type plasminogen activatorHomo sapiens (human)
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
signaling receptor bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
peptide antigen bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein-folding chaperone bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
serine-type endopeptidase activityVitamin K-dependent protein CHomo sapiens (human)
calcium ion bindingVitamin K-dependent protein CHomo sapiens (human)
protein bindingVitamin K-dependent protein CHomo sapiens (human)
serine-type endopeptidase activitySerine protease hepsinHomo sapiens (human)
protein bindingSerine protease hepsinHomo sapiens (human)
peptidase activitySerine protease hepsinHomo sapiens (human)
serine-type peptidase activitySerine protease hepsinHomo sapiens (human)
serine-type exopeptidase activitySerine protease hepsinHomo sapiens (human)
serine-type endopeptidase activityTrypsin-1Homo sapiens (human)
metal ion bindingTrypsin-1Homo sapiens (human)
metalloendopeptidase activityTrypsin-2Homo sapiens (human)
serine-type endopeptidase activityTrypsin-2Homo sapiens (human)
calcium ion bindingTrypsin-2Homo sapiens (human)
protein bindingTrypsin-2Homo sapiens (human)
serine-type peptidase activityTrypsin-2Homo sapiens (human)
dihydronicotinamide riboside quinone reductase activityRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
protein bindingRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
zinc ion bindingRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
electron transfer activityRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
oxidoreductase activityRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
oxidoreductase activity, acting on other nitrogenous compounds as donorsRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
chloride ion bindingRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
protein homodimerization activityRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
FAD bindingRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
melatonin bindingRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
resveratrol bindingRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
NAD(P)H dehydrogenase (quinone) activityRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
serine-type endopeptidase activityTrypsin-3Homo sapiens (human)
calcium ion bindingTrypsin-3Homo sapiens (human)
protein bindingTrypsin-3Homo sapiens (human)
serine-type peptidase activityTrypsin-3Homo sapiens (human)
organic cation transmembrane transporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
antiporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
transmembrane transporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
polyspecific organic cation:proton antiporter activityMultidrug and toxin extrusion protein 2Homo sapiens (human)
inositol-1,3,4,5,6-pentakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol heptakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
ATP bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 1-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 3-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol 5-diphosphate pentakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol diphosphate tetrakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingMultidrug and toxin extrusion protein 1Homo sapiens (human)
organic cation transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-amino acid transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
thiamine transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
antiporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
putrescine transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
L-arginine transmembrane transporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
polyspecific organic cation:proton antiporter activityMultidrug and toxin extrusion protein 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (44)

Processvia Protein(s)Taxonomy
plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
basal plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
membraneSolute carrier family 22 member 2Homo sapiens (human)
basolateral plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
apical plasma membraneSolute carrier family 22 member 2Homo sapiens (human)
extracellular exosomeSolute carrier family 22 member 2Homo sapiens (human)
presynapseSolute carrier family 22 member 2Homo sapiens (human)
external side of plasma membraneProthrombinHomo sapiens (human)
collagen-containing extracellular matrixProthrombinHomo sapiens (human)
extracellular regionProthrombinHomo sapiens (human)
extracellular spaceProthrombinHomo sapiens (human)
endoplasmic reticulum lumenProthrombinHomo sapiens (human)
Golgi lumenProthrombinHomo sapiens (human)
plasma membraneProthrombinHomo sapiens (human)
extracellular exosomeProthrombinHomo sapiens (human)
blood microparticleProthrombinHomo sapiens (human)
collagen-containing extracellular matrixProthrombinHomo sapiens (human)
extracellular spaceProthrombinHomo sapiens (human)
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)
extracellular regionPlasminogenHomo sapiens (human)
extracellular spacePlasminogenHomo sapiens (human)
plasma membranePlasminogenHomo sapiens (human)
external side of plasma membranePlasminogenHomo sapiens (human)
cell surfacePlasminogenHomo sapiens (human)
platelet alpha granule lumenPlasminogenHomo sapiens (human)
collagen-containing extracellular matrixPlasminogenHomo sapiens (human)
extracellular exosomePlasminogenHomo sapiens (human)
blood microparticlePlasminogenHomo sapiens (human)
Schaffer collateral - CA1 synapsePlasminogenHomo sapiens (human)
glutamatergic synapsePlasminogenHomo sapiens (human)
extracellular spacePlasminogenHomo sapiens (human)
extracellular regionCoagulation factor XIIHomo sapiens (human)
extracellular spaceCoagulation factor XIIHomo sapiens (human)
plasma membraneCoagulation factor XIIHomo sapiens (human)
collagen-containing extracellular matrixCoagulation factor XIIHomo sapiens (human)
extracellular exosomeCoagulation factor XIIHomo sapiens (human)
extracellular spaceCoagulation factor XIIHomo sapiens (human)
rough endoplasmic reticulumCoagulation factor XIIHomo sapiens (human)
collagen-containing extracellular matrixTissue-type plasminogen activatorHomo sapiens (human)
extracellular regionTissue-type plasminogen activatorHomo sapiens (human)
cytoplasmTissue-type plasminogen activatorHomo sapiens (human)
cell surfaceTissue-type plasminogen activatorHomo sapiens (human)
secretory granuleTissue-type plasminogen activatorHomo sapiens (human)
apical part of cellTissue-type plasminogen activatorHomo sapiens (human)
extracellular exosomeTissue-type plasminogen activatorHomo sapiens (human)
serine protease inhibitor complexTissue-type plasminogen activatorHomo sapiens (human)
Schaffer collateral - CA1 synapseTissue-type plasminogen activatorHomo sapiens (human)
glutamatergic synapseTissue-type plasminogen activatorHomo sapiens (human)
extracellular spaceTissue-type plasminogen activatorHomo sapiens (human)
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
Golgi membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
endoplasmic reticulumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
Golgi apparatusHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
cell surfaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
ER to Golgi transport vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
secretory granule membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
phagocytic vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
early endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
recycling endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular exosomeHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
lumenal side of endoplasmic reticulum membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
MHC class I protein complexHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular spaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
external side of plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular regionVitamin K-dependent protein CHomo sapiens (human)
endoplasmic reticulumVitamin K-dependent protein CHomo sapiens (human)
endoplasmic reticulum lumenVitamin K-dependent protein CHomo sapiens (human)
Golgi apparatusVitamin K-dependent protein CHomo sapiens (human)
Golgi lumenVitamin K-dependent protein CHomo sapiens (human)
extracellular spaceVitamin K-dependent protein CHomo sapiens (human)
nuclear membraneSerine protease hepsinHomo sapiens (human)
endoplasmic reticulum membraneSerine protease hepsinHomo sapiens (human)
plasma membraneSerine protease hepsinHomo sapiens (human)
cell-cell junctionSerine protease hepsinHomo sapiens (human)
cell surfaceSerine protease hepsinHomo sapiens (human)
membraneSerine protease hepsinHomo sapiens (human)
apical plasma membraneSerine protease hepsinHomo sapiens (human)
neuronal cell bodySerine protease hepsinHomo sapiens (human)
extracellular exosomeSerine protease hepsinHomo sapiens (human)
extracellular regionTrypsin-1Homo sapiens (human)
collagen-containing extracellular matrixTrypsin-1Homo sapiens (human)
blood microparticleTrypsin-1Homo sapiens (human)
extracellular spaceTrypsin-1Homo sapiens (human)
extracellular regionTrypsin-2Homo sapiens (human)
extracellular spaceTrypsin-2Homo sapiens (human)
extracellular matrixTrypsin-2Homo sapiens (human)
azurophil granule lumenTrypsin-2Homo sapiens (human)
extracellular spaceTrypsin-2Homo sapiens (human)
nucleoplasmRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
cytosolRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
extracellular exosomeRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
cytosolRibosyldihydronicotinamide dehydrogenase [quinone]Homo sapiens (human)
extracellular regionTrypsin-3Homo sapiens (human)
extracellular spaceTrypsin-3Homo sapiens (human)
tertiary granule lumenTrypsin-3Homo sapiens (human)
extracellular spaceTrypsin-3Homo sapiens (human)
plasma membraneMultidrug and toxin extrusion protein 2Homo sapiens (human)
apical plasma membraneMultidrug and toxin extrusion protein 2Homo sapiens (human)
membraneMultidrug and toxin extrusion protein 2Homo sapiens (human)
fibrillar centerInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
cytosolInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleusInositol hexakisphosphate kinase 1Homo sapiens (human)
cytoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
basolateral plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
apical plasma membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
membraneMultidrug and toxin extrusion protein 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (105)

Assay IDTitleYearJournalArticle
AID1436084Inhibition of human thrombin preincubated for 10 mins followed by Ac-FVR-AMC substrate addition measured every 20s for 10 mins by fluorescence assay2017European journal of medicinal chemistry, Jan-27, Volume: 126Novel dabigatran derivatives with a fluorine atom at the C-2 position of the terminal benzene ring: Design, synthesis and anticoagulant activity evaluation.
AID1681805Anticoagulant activity in human platelet-rich plasma assessed as reduction in TF-induced thrombin generation by measuring Tmax of clotting time at 1 uM preincubated for 15 mins followed by TF addition by Z-Gly-Gly-Arg-AMC substrate based calibrated automa2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID1681839Inhibition of human coagulation factor XIIA in presence of Boc-Gln-Gly-Arg-AMC as fluorogenic substrate at 1 uM measured at 1 min interval for 1 hr by fluorometric assay relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID1681830Inhibition of porcine trypsin using Z-Gly-Gly-Arg-AMC as fluorogenic substrate at 5 uM measured at 1 min interval for 1 hr by fluorometric assay relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID1266251Inhibition of thrombin (unknown origin)2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Molecular modeling studies, synthesis and biological evaluation of dabigatran analogues as thrombin inhibitors.
AID719844Displacement of (S)-N4-(2-(4-(4-(4-methyl-3-(4-(pyridin-3-yl)pyrimidin-2-ylamino)phenylcarbamoyl)benzyl)piperazin-1-yl)ethyl)-N1-(15-oxo-19-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-4,7,10-trioxa-14-azanonadecyl)-2-(4-(3-(trifluoromethyl2012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID719848Inhibition of human alpha thrombin using Boc-Val-Pro-Arg-AMC as substrate after 2 hrs by fluorometric analysis2012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID228213Inhibitory constant (Ki) was determined against human thrombin2002Journal of medicinal chemistry, Apr-25, Volume: 45, Issue:9
Structure-based design of novel potent nonpeptide thrombin inhibitors.
AID1681852Inhibition of human coagulation factor Xa using Boc-Ile-Glu-Gly-Arg-AMC as fluorogenic substrate measured at 1 min interval for 1 hr by fluorometric assay2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID1681853Inhibition of human coagulation factor alpha-thrombin using Boc-Val-Pro-Arg-AMC as fluorogenic substrate measured at 1 min interval for 1 hr by fluorometric assay2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID721752Inhibition of human MATE2K-mediated ASP+ uptake expressed in HEK293 cells after 1.5 mins by fluorescence assay2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID753175Displacement of biotinylated fibrinogen from human glycoprotein 2b/3a receptor after 2 hrs by chemiluminescence assay2013European journal of medicinal chemistry, Jun, Volume: 64Low molecular weight dual inhibitors of factor Xa and fibrinogen binding to GPIIb/IIIa with highly overlapped pharmacophores.
AID1681831Inhibition of human coagulation factor Xa using Boc-Ile-Glu-Gly-Arg-AMC as fluorogenic substrate at 1 uM measured at 1 min interval for 1 hr by fluorometric assay relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID1871814Inhibition of thrombin in human blood using fluorogenic Ac-FVR-AMC as substrate by chromogenic assay2022European journal of medicinal chemistry, Jan-15, Volume: 228Progress of thrombus formation and research on the structure-activity relationship for antithrombotic drugs.
AID1057646Reduction of thrombin generation time in human platelet-rich plasma by spectrophotometer analysis2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
5-Chlorothiophene-2-carboxylic acid [(S)-2-[2-methyl-3-(2-oxopyrrolidin-1-yl)benzenesulfonylamino]-3-(4-methylpiperazin-1-yl)-3-oxopropyl]amide (SAR107375), a selective and potent orally active dual thrombin and factor Xa inhibitor.
AID210579Inhibitory constant (Ki) was determined against human Tissue plasminogen activator (tissue plasminogen activator)2002Journal of medicinal chemistry, Apr-25, Volume: 45, Issue:9
Structure-based design of novel potent nonpeptide thrombin inhibitors.
AID719843Displacement of 3-(1-methyl-N-(pyridin-2-yl)-2-((4-(N-((S)-6,9,25-trioxo-29-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-8-(4-(3-(trifluoromethyl)-3H-diazirin-3-yl)benzamido)-14,17,20-trioxa-5,10,24-triazanonacosyl)carbamimidoyl)phenylamino2012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID1299221Inhibition of human thrombin preincubated for 10 mins followed by Ac-FVR-AMC substrate addition measured within 10 mins by fluorescence assay2016Bioorganic & medicinal chemistry, 06-15, Volume: 24, Issue:12
Molecular design, synthesis and anticoagulant activity evaluation of fluorinated dabigatran analogues.
AID228436Inhibitory constant (Ki) was determined against human trypsin2002Journal of medicinal chemistry, Apr-25, Volume: 45, Issue:9
Structure-based design of novel potent nonpeptide thrombin inhibitors.
AID1681851Inhibition of porcine trypsin using Z-Gly-Gly-Arg-AMC as fluorogenic substrate measured at 1 min interval for 1 hr by fluorometric assay2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID721751Inhibition of human OCT2-mediated ASP+ uptake expressed in HEK293 cells after 3 mins by fluorescence assay2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID1393316Inhibition of human trypsin2018Journal of medicinal chemistry, 05-10, Volume: 61, Issue:9
Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
AID1195363Inhibition of hepsin (unknown origin) using Boc-QAR-AMC as substrate after 30 mins prior to substrate addition by fluorescence assay2015Bioorganic & medicinal chemistry, May-15, Volume: 23, Issue:10
Structure-based discovery of small molecule hepsin and HGFA protease inhibitors: Evaluation of potency and selectivity derived from distinct binding pockets.
AID1681804Anticoagulant activity in human platelet-rich plasma assessed as reduction in TF-induced thrombin generation by measuring endogenous thrombin potential at 1 uM preincubated for 15 mins followed by TF addition by Z-Gly-Gly-Arg-AMC substrate based calibrate2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID1315500Anticoagulant activity in rat assessed as inhibition of arteriovenous thrombosis at 0.5 mg/ml after 15 mins relative to control2016European journal of medicinal chemistry, Sep-14, Volume: 120Design, synthesis, anticoagulant activity evaluation and molecular docking studies of a class of N-ethyl dabigatran derivatives.
AID1254403Inhibition of human thrombin using tosyl-glycyl-prolyl-arginine-4-nitranilide acetate as substrate preincubated for 10 mins by spectrophotometer analysis2015Bioorganic & medicinal chemistry, Dec-01, Volume: 23, Issue:23
Design, synthesis and antithrombotic evaluation of novel dabigatran etexilate analogs, a new series of non-peptides thrombin inhibitors.
AID1202328Inhibition of human thrombin using Ac-FVR-AMC as substrate incubated for 10 mins prior to substrate addition measured for 10 min by fluorescence assay2015European journal of medicinal chemistry, , Volume: 96Design, synthesis and structural exploration of novel fluorinated dabigatran derivatives as direct thrombin inhibitors.
AID1381646Inhibition of human thrombin using tosyl-glycyl-prolyl-arginine-4-nitranilide acetate as substrate preincubated for 10 mins followed by substrate addition by spectrophotometric method2018European journal of medicinal chemistry, Feb-25, Volume: 146The selectivity and bioavailability improvement of novel oral anticoagulants: An overview.
AID753176Inhibition of trypsin (unknown origin) using S-2222 as substrate incubated for 15 mins prior to substrate addition measured every 10 secs by spectrophotometric analysis2013European journal of medicinal chemistry, Jun, Volume: 64Low molecular weight dual inhibitors of factor Xa and fibrinogen binding to GPIIb/IIIa with highly overlapped pharmacophores.
AID645253Inhibition of thrombin using S-2238 as substrate preincubated for 15 mins prior substrate addition measured for every 10 secs by spectrophotometry2012European journal of medicinal chemistry, Apr, Volume: 50Fluorinated dual antithrombotic compounds based on 1,4-benzoxazine scaffold.
AID719845Displacement of (S)-N4-(4-(3-(2-((4-carbamimidoylphenylamino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanamido)butyl)-N1-(15-oxo-19-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-4,7,10-trioxa-14-azanonadecyl)-22012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID1681806Anticoagulant activity in human platelet-rich plasma assessed as reduction in TF-induced thrombin generation by measuring half life of clotting time at 1 uM preincubated for 15 mins followed by TF addition by Z-Gly-Gly-Arg-AMC substrate based calibrated a2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID228064Inhibition of human thrombin by chromogenic assay2002Journal of medicinal chemistry, Apr-25, Volume: 45, Issue:9
Structure-based design of novel potent nonpeptide thrombin inhibitors.
AID52166Inhibitory constant (Ki) was determined against human Coagulation factor Xa (fXa)2002Journal of medicinal chemistry, Apr-25, Volume: 45, Issue:9
Structure-based design of novel potent nonpeptide thrombin inhibitors.
AID719841Displacement of 3-(1-methyl-N-(pyridin-2-yl)-2-((4-(N-((S)-6,9,25-trioxo-29-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-8-(4-(3-(trifluoromethyl)-3H-diazirin-3-yl)benzamido)-14,17,20-trioxa-5,10,24-triazanonacosyl)carbamimidoyl)phenylamino2012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID1393315Inhibition of human thrombin using tosyl-glycyl-prolyl-arginine-4-nitranilide acetate as substrate preincubated for 10 mins followed by substrate addition by spectrophotometer2018Journal of medicinal chemistry, 05-10, Volume: 61, Issue:9
Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
AID719820Displacement of (S)-N4-(3-(3-(2-((4-carbamimidoylphenylamino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanamido)propyl)-N1-(15-oxo-19-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-4,7,10-trioxa-14-azanonadecyl)-2012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID1436086Oral bioavailability in human at 10 to 400 mg administered as single dose measured after 24 hrs2017European journal of medicinal chemistry, Jan-27, Volume: 126Novel dabigatran derivatives with a fluorine atom at the C-2 position of the terminal benzene ring: Design, synthesis and anticoagulant activity evaluation.
AID1436085Anti-thrombotic activity in Sprague-Dawley rat assessed as inhibition of arteriovenous thrombosis weight at 0.5 mg/ml relative to control2017European journal of medicinal chemistry, Jan-27, Volume: 126Novel dabigatran derivatives with a fluorine atom at the C-2 position of the terminal benzene ring: Design, synthesis and anticoagulant activity evaluation.
AID721754Inhibition of human MATE1-mediated ASP+ uptake expressed in HEK293 cells after 1.5 mins by fluorescence assay2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Discovery of potent, selective multidrug and toxin extrusion transporter 1 (MATE1, SLC47A1) inhibitors through prescription drug profiling and computational modeling.
AID719836Displacement of (S)-N4-(4-(3-(2-((4-carbamimidoylphenylamino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanamido)butyl)-N1-(15-oxo-19-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-4,7,10-trioxa-14-azanonadecyl)-22012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID1332061Inhibition of human thrombin assessed as reduction in release of free nitroaniline using tosyl-glycyl-prolyl-arginine-4-nitranilide acetate as substrate preincubated for 10 mins followed by substrate addition by spectrophotometer2017Bioorganic & medicinal chemistry, 01-15, Volume: 25, Issue:2
Design, synthesis and antithrombotic evaluation of novel non-peptide thrombin inhibitors.
AID1871825Anticoagulant activity in mouse plasma assessed inhibition of thrombin-induced platelet aggregation2022European journal of medicinal chemistry, Jan-15, Volume: 228Progress of thrombus formation and research on the structure-activity relationship for antithrombotic drugs.
AID1681838Inhibition of human coagulation factor alpha thrombin in presence of Boc-Val-Pro-Arg-AMC as fluorogenic substrate at 1 uM measured at 1 min interval for 1 hr by fluorometric assay relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID1299222Anticoagulant activity in Sprague-Dawley rat assessed as inhibition of arteriovenous thrombosis at 0.5 mg/ml administered 3 days prior to testing measured on day 4 relative to control2016Bioorganic & medicinal chemistry, 06-15, Volume: 24, Issue:12
Molecular design, synthesis and anticoagulant activity evaluation of fluorinated dabigatran analogues.
AID719834Displacement of (S)-N4-(4-(3-(2-((4-carbamimidoylphenylamino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanamido)butyl)-N1-(15-oxo-19-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-4,7,10-trioxa-14-azanonadecyl)-22012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID1681826Non-covalent inhibition of human coagulation factor XIIA using Boc-Gln-Gly-Arg-AMC as fluorogenic substrate measured every 87 sec for 180 mins by time-dependent fluorescence assay2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID719822Displacement of 3-(1-methyl-N-(pyridin-2-yl)-2-((4-(N-((S)-6,9,25-trioxo-29-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-8-(4-(3-(trifluoromethyl)-3H-diazirin-3-yl)benzamido)-14,17,20-trioxa-5,10,24-triazanonacosyl)carbamimidoyl)phenylamino2012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID1681854Inhibition of human coagulation factor XIIA using Boc-Gln-Gly-Arg-AMC as fluorogenic substrate measured at 1 min interval for 1 hr by fluorometric assay2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID719824Displacement of 3-(1-methyl-N-(pyridin-2-yl)-2-((4-(N-((S)-6,9,25-trioxo-29-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-8-(4-(3-(trifluoromethyl)-3H-diazirin-3-yl)benzamido)-14,17,20-trioxa-5,10,24-triazanonacosyl)carbamimidoyl)phenylamino2012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID753178Inhibition of F10a (unknown origin) using S-2222 as substrate incubated for 15 mins prior to substrate addition measured every 10 secs by spectrophotometric analysis2013European journal of medicinal chemistry, Jun, Volume: 64Low molecular weight dual inhibitors of factor Xa and fibrinogen binding to GPIIb/IIIa with highly overlapped pharmacophores.
AID719838Displacement of (S)-N4-(4-(3-(2-((4-carbamimidoylphenylamino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanamido)butyl)-N1-(15-oxo-19-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-4,7,10-trioxa-14-azanonadecyl)-22012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID719821Displacement of 3-(1-methyl-N-(pyridin-2-yl)-2-((4-(N-((S)-6,9,25-trioxo-29-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-8-(4-(3-(trifluoromethyl)-3H-diazirin-3-yl)benzamido)-14,17,20-trioxa-5,10,24-triazanonacosyl)carbamimidoyl)phenylamino2012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID719847Competitive inhibition of human recombinant NQO2-mediated mitomycin C metabolism using NADH as cosubstrate incubated for 5 mins prior to NADH addition measured after 30 mins by Michaelis-Menten plot analysis2012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID89068Effective dose was determined against human plasma using PTT reagent2002Journal of medicinal chemistry, Apr-25, Volume: 45, Issue:9
Structure-based design of novel potent nonpeptide thrombin inhibitors.
AID683501Binding affinity to human thrombin2012European journal of medicinal chemistry, Nov, Volume: 57Synthesis and antithrombotic evaluation of novel dabigatran prodrugs containing a cleavable moiety with anti-platelet activity.
AID1057649Reduction of thrombin generation time in human platelet-poor plasma by spectrophotometer analysis2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
5-Chlorothiophene-2-carboxylic acid [(S)-2-[2-methyl-3-(2-oxopyrrolidin-1-yl)benzenesulfonylamino]-3-(4-methylpiperazin-1-yl)-3-oxopropyl]amide (SAR107375), a selective and potent orally active dual thrombin and factor Xa inhibitor.
AID719840Displacement of (S)-N4-(4-(3-(2-((4-carbamimidoylphenylamino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanamido)butyl)-N1-(15-oxo-19-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-4,7,10-trioxa-14-azanonadecyl)-22012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID1057650Reduction of thrombin generation time in rat platelet-poor plasma by spectrophotometer analysis2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
5-Chlorothiophene-2-carboxylic acid [(S)-2-[2-methyl-3-(2-oxopyrrolidin-1-yl)benzenesulfonylamino]-3-(4-methylpiperazin-1-yl)-3-oxopropyl]amide (SAR107375), a selective and potent orally active dual thrombin and factor Xa inhibitor.
AID1315499Inhibition of human thrombin pre-incubated for 10 mins before Ac-FVR-AMC substrate addition and measured after 10 mins by fluorescence based assay2016European journal of medicinal chemistry, Sep-14, Volume: 120Design, synthesis, anticoagulant activity evaluation and molecular docking studies of a class of N-ethyl dabigatran derivatives.
AID30726Inhibitory constant (Ki) was determined against human Activated protein C2002Journal of medicinal chemistry, Apr-25, Volume: 45, Issue:9
Structure-based design of novel potent nonpeptide thrombin inhibitors.
AID719842Displacement of (S)-N4-(4-(3-(2-((4-carbamimidoylphenylamino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanamido)butyl)-N1-(15-oxo-19-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-4,7,10-trioxa-14-azanonadecyl)-22012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID719849Inhibition of human thrombin-mediated platelet aggregation in cell-based assay2012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID225426Inhibitory constant (Ki) was determined against human plasmin2002Journal of medicinal chemistry, Apr-25, Volume: 45, Issue:9
Structure-based design of novel potent nonpeptide thrombin inhibitors.
AID1681850Effect on blood coagulation in human blood assessed as increase in prothrombin time at 300 uM incubated for 3 mins followed by CaCl2 addition by PT reagent based assay relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID1681807Anticoagulant activity in human platelet-rich plasma assessed as reduction in TF-induced thrombin generation by measuring amplitude of thrombin peak at 1 uM preincubated for 15 mins followed by TF addition by Z-Gly-Gly-Arg-AMC substrate based calibrated a2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID753177Inhibition of thrombin (unknown origin) using S-2238 as substrate incubated for 15 mins prior to substrate addition measured every 10 secs by spectrophotometric analysis2013European journal of medicinal chemistry, Jun, Volume: 64Low molecular weight dual inhibitors of factor Xa and fibrinogen binding to GPIIb/IIIa with highly overlapped pharmacophores.
AID719846Inhibition of human recombinant NQO2-mediated mitomycin C metabolism using NADH as cosubstrate incubated for 5 mins prior to NADH addition measured after 30 mins by spectrophotometric analysis2012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID1057658Inhibition of thrombin (unknown origin)2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
5-Chlorothiophene-2-carboxylic acid [(S)-2-[2-methyl-3-(2-oxopyrrolidin-1-yl)benzenesulfonylamino]-3-(4-methylpiperazin-1-yl)-3-oxopropyl]amide (SAR107375), a selective and potent orally active dual thrombin and factor Xa inhibitor.
AID719823Displacement of 3-(1-methyl-N-(pyridin-2-yl)-2-((4-(N-((S)-6,9,25-trioxo-29-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)-8-(4-(3-(trifluoromethyl)-3H-diazirin-3-yl)benzamido)-14,17,20-trioxa-5,10,24-triazanonacosyl)carbamimidoyl)phenylamino2012Journal of medicinal chemistry, Apr-26, Volume: 55, Issue:8
Dabigatran and dabigatran ethyl ester: potent inhibitors of ribosyldihydronicotinamide dehydrogenase (NQO2).
AID1057659Inhibition of factor-10a (unknown origin)2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
5-Chlorothiophene-2-carboxylic acid [(S)-2-[2-methyl-3-(2-oxopyrrolidin-1-yl)benzenesulfonylamino]-3-(4-methylpiperazin-1-yl)-3-oxopropyl]amide (SAR107375), a selective and potent orally active dual thrombin and factor Xa inhibitor.
AID1681849Anticoagulant activity in human blood assessed as increase in activated partial thromboplastin time at 300 uM incubated for 1 min by aPTT reagent based assay relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347159Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347160Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1345816Human coagulation factor II, thrombin (S1: Chymotrypsin)2002Journal of medicinal chemistry, Apr-25, Volume: 45, Issue:9
Structure-based design of novel potent nonpeptide thrombin inhibitors.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (3,685)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's98 (2.66)29.6817
2010's2819 (76.50)24.3611
2020's768 (20.84)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 103.76

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 Index103.76 (24.57)
Research Supply Index8.33 (2.92)
Research Growth Index6.05 (4.65)
Search Engine Demand Index191.05 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (103.76)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials261 (6.71%)5.53%
Reviews976 (25.11%)6.00%
Case Studies458 (11.78%)4.05%
Observational192 (4.94%)0.25%
Other2,000 (51.45%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (268)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Assessment of Electrophysiological Effects of 150 mg and 600 mg of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind Three-way Crossover Study With an Open Label Posi [NCT02170987]Phase 140 participants (Actual)Interventional2006-03-31Completed
Safety, Pharmacodynamics and Pharmacokinetics After Single Oral Administration of 600 mg, 750 mg and 900 mg Dabigatran Etexilate as Capsule in Healthy Subjects. A Randomised, Placebo-controlled Study, Double Blind at Each Dose Level [NCT02171455]Phase 110 participants (Actual)Interventional2006-01-31Completed
Safety, Tolerability and Pharmacokinetics Study After Single and Multiple Oral Doses of Dabigatran Etexilate Capsule (110mg,150 mg b.i.d., 7 Days) in Healthy Chinese Subjects (Open Label Study) [NCT02171572]Phase 128 participants (Actual)Interventional2009-10-31Completed
Bioavailability of BIBR 953 ZW After 50 mg of BIBR 1048 MS (Oral Prodrug of BIBR 953) in 4 Experimental Formulations Relative to Drinking Solution of BIBR 1048 MS, Each Treatment Given Bid Over 3 Days, in Healthy Subjects. Intraindividual Comparison (5-wa [NCT02170636]Phase 115 participants (Actual)Interventional2002-01-31Completed
Comparative Effectiveness and Safety Between Warfarin and Dabigatran Using Real World Claims Data of Japanese Non-valvular Atrial Fibrillation Patients [NCT03254134]22,490 participants (Actual)Observational2017-10-20Completed
Post-Marketing Surveillance on the Use of Prazaxa® Capsules in Japanese Patients With Nonvalvular Atrial Fibrillation After the Availability of Idarucizumab [NCT03175198]5,660 participants (Actual)Observational2017-07-05Completed
A 24-month, Randomized-control, Double-blind, Multi-center, Delayed-start, Pilot Study Evaluating Thrombin Inhibitions Alzheimer's Disease Using 150mg Dabigatran Daily: A Novel Therapeutic Target for Alzheimer's Disease [NCT03752294]Phase 140 participants (Anticipated)Interventional2018-11-30Not yet recruiting
Safety of Dabigatran Etexilate (DE) for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Paediatric Patients From Birth to Less Than 2 Years of Age: a Prospective European Non-interventional Cohort Study Based on New Data Colle [NCT05536791]50 participants (Anticipated)Observational2022-11-24Recruiting
Treatment Patterns and Clinical Outcomes Among Venous Thromboembolism Patients Treated With Anticoagulants After the Entry of Non-vitamin K Antagonist Oral Anticoagulants in Korea [NCT05022563]55,759 participants (Actual)Observational2021-08-31Completed
Identification of Clinical and Pharmacogenetic Factors Predictive of Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation. [NCT04297150]700 participants (Anticipated)Observational2020-06-18Active, not recruiting
Reversion of the Anticoagulant Effect of the New Antithrombotic Agents Anti-Xa and Anti IIa by Specific and Non-specific Haemostatic Drugs,: an Ex-Vivo Study in Healthy Volunteers [NCT01210755]Phase 410 participants (Anticipated)Interventional2010-11-30Completed
"RE-ELECT Study: Randomized Evaluation of Changing Kidney Function Over a Time in Patients With Atrial Fibrillation (AF), Concomitant T2DM and Existing Chronic Kidney Disease (CKD) Treated With Dabigatran or Warfarin for Stroke Prevention" [NCT03789695]Phase 4200 participants (Anticipated)Interventional2018-11-14Recruiting
A Single-center, Open-label, Three-period, Fixed-sequence Design Study to Investigate the Effect of Daridorexant on the Pharmacokinetics of Dabigatran and Rosuvastatin in Healthy Male Subjects [NCT05480475]Phase 124 participants (Actual)Interventional2022-09-03Completed
Pattern of Use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation Patients in UK General Practices [NCT03119116]31,336 participants (Actual)Observational2017-05-15Completed
Phase II, Randomized, Crossover, Single Blind, Safety Trial of DABIGATRAN Versus ASA for Preventing Ischaemic Brain Lesions in Patients Affected by CADASIL [NCT01361763]Phase 250 participants (Anticipated)Interventional2011-06-30Recruiting
RE-SPECT CVT: a Randomised, Open-label, Exploratory Trial With Blinded Endpoint Adjudication (PROBE), Comparing Efficacy and Safety of Oral Dabigatran Etexilate Versus Oral Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis Over a 24-wee [NCT02913326]Phase 3120 participants (Actual)Interventional2016-12-13Completed
Prospective Study of the Assessment of the Dental Protocol for Tooth Extraction in Patients With Atrial Fibrillation in Continuous Use of New Oral Anticoagulants: A Pilot Study [NCT03181386]Phase 360 participants (Actual)Interventional2017-05-03Completed
Effects of LMWH Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease [NCT02389582]Phase 429 participants (Actual)Interventional2014-05-31Completed
A Phase 1, Multi-center, Open-label, 3-arm, Fixed Sequence Study to Assess the Effect of Co-administration of AZD9833 on the Pharmacokinetics of Midazolam (CYP3A4/5 Substrate), of Omeprazole (CYP2C19 Substrate), of Celecoxib (CYP2C9 Substrate) and of Dabi [NCT05438303]Phase 159 participants (Actual)Interventional2022-06-13Completed
Intracerebral Hemorrhage Due to Oral Anticoagulants in the Secondary Prevention of Ischemic Stroke: Prediction of the Risk by the Detection of Leukoaraiosis and Microbleeding With Magnetic Resonance [NCT02238470]1,000 participants (Actual)Observational [Patient Registry]2012-04-30Completed
Impact of Dabigatran and Phenprocoumon on ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation [NCT01339819]Phase 470 participants (Actual)Interventional2011-04-30Completed
Open-label, Fixed Sequence Crossover Study to Determine the Effects of a Single Dose of Elinzanetant (BAY 3427080) on the Pharmacokinetics of Dabigatran Etexilate in Healthy Participants [NCT05471817]Phase 120 participants (Actual)Interventional2022-08-05Completed
Evaluation of Non-Vitamin K Antagonist Oral Anticoagulants Concentration Among Patients With Acute Stroke (The Direct Oral AntiCoagulant Registry in Taiwan-Emergent Department, DOACT-ED) [NCT06144866]1,000 participants (Anticipated)Observational [Patient Registry]2020-05-01Recruiting
Safety and Effectiveness of Direct Oral Anticoagulants for Stroke Prevention in Non-valvular Atrial Fibrillation: a Multi-database Cohort Study With Meta-analysis (DOACs vs DOACs) [NCT03568916]227,579 participants (Actual)Observational2016-11-30Completed
Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban. [NCT02085824]60 participants (Anticipated)Interventional2012-07-31Recruiting
A Phase 1, 2-part, Open-label, Fixed-sequence Study Evaluating Potential Drug-drug Interactions Between Gemfibrozil (Part 1) or Dabigatran Etexilate (Part 2) and Camlipixant (BLU-5937) 50 mg Tablet in Healthy Participants Under Fasting Conditions [NCT05959447]Phase 136 participants (Anticipated)Interventional2023-08-31Not yet recruiting
Safety, Pharmacokinetics and Pharmacodynamics After Single Rising Oral Doses of 50, 150 and 350 mg BIBR 1048 MS as Capsules in Healthy Subjects of Japanese and Caucasian Origin. Double-blind at Each Dose Level, Placebo-controlled, Randomised Study [NCT02170844]Phase 140 participants (Actual)Interventional2004-06-30Completed
Relative Bioavailability of 200 mg Film Coated Tablets of BIBR 1048 MS With or Without Food Compared to 200 mg Solution of BIBR 1048 MS Given as Single Oral Administrations to Healthy Subjects. A 3-way Crossover, Open, Partly Randomized Study. [NCT02170922]Phase 16 participants (Actual)Interventional1999-07-31Completed
Safety, Pharmacokinetics and Pharmacodynamics After Multiple Oral Doses of BIBR 1048 MS Capsule (150 mg b.i.d., 7 Days) in Healthy Japanese Male Subjects (Open Label Study) [NCT02171000]Phase 17 participants (Actual)Interventional2005-04-30Completed
Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule (110 mg and 150 mg b.i.d., 7 Days) in Healthy Japanese and Caucasian Male Subjects (Open Label Study) [NCT02171468]Phase 148 participants (Actual)Interventional2006-05-31Completed
A Two-part Study to Determine the Relative Bioavailability of Dabigatran Etexilate 150 mg Bid (Capsules) With and Without 600 mg Quinidine Sulfate Tablets (Part 1) and to Measure the Effect of Quinidine as a Probe Inhibitor of P-glycoprotein on the Absorp [NCT02171546]Phase 142 participants (Actual)Interventional2007-11-30Terminated
A Two-way Crossover Study to Evaluate the Safety and Pharmacokinetics of Quinidine Sulfate Alone (200 mg Orally q2h to a Maximum of 1,000 mg), Dabigatran Etexilate Alone (150 mg BID for Three Days), and the Co-administration of Dabigatran Etexilate (150 m [NCT02171624]Phase 142 participants (Actual)Interventional2009-03-31Completed
Bioavailability of BIBR 953 ZW After 150 mg of BIBR 1048 (Oral Pro-drug of BIBR 953) Administered as Capsule With and Without Coadministration of Pantoprazole as Well as Under the Influence of Food in Healthy Subjects. A Threeway Crossover, Randomised, Op [NCT02170610]Phase 118 participants (Actual)Interventional2002-03-31Completed
Bioavailability of BIBR 953 ZW After Single Oral Doses of 12.5, 25, 50 or 100 mg BIBR 1048 MS Film-coated Tablet With and Without Pre-treatment With Pantoprazole to Healthy Subjects. Four Groups, 2-way Crossover, Randomised, Open Trial. [NCT02170766]Phase 148 participants (Actual)Interventional2000-10-31Completed
Pharmacokinetics of BIBR 953 ZW After 150 mg of BIBR 1048 (Oral Pro-drug of BIBR 953) Administered as Capsule Twice Daily Over Seven Days With or Without Pantoprazole Co-treatment to Healthy Male and Female Elderly Subjects [NCT02173730]Phase 136 participants (Actual)Interventional2002-11-30Completed
Effect of Inhibitors of the Proton Pump on Intestinal Transporters and Their Impact on the Pharmacokinetics of Dabigatran - Mechanistic and Clinical Approach -BIPP Study [NCT02524210]Phase 112 participants (Actual)Interventional2014-05-31Completed
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Patients With Venous Thromboembolism. [NCT03129555]Phase 45,000 participants (Anticipated)Interventional2023-04-01Recruiting
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Atrial Fibrillation (DANNOAC-AF). [NCT03129490]Phase 411,000 participants (Anticipated)Interventional2023-04-01Recruiting
Multicenter, Open-label-study to Assess PK Profile of a Single Oral Dose of 150 mg BIBR 1048 (Capsule) in Patients Shortly After Primary Elective Total Hip Replacement Surgery. [NCT02170935]Phase 262 participants (Actual)Interventional2002-04-30Completed
Bioequivalence of Two Different Drug Product Batches of 150 mg of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers (Double Blind, Randomised, Single-dose, Replicate Design in a Two-treatments, Four Periods Crossover [NCT02171013]Phase 166 participants (Actual)Interventional2006-04-30Completed
Bioequivalence of Two Different Polymorphs of 150 mg Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers (Double-blind, Randomised, Single Dose, Replicate Design in a Two Treatments, Four Periods Crossover Phase I Stud [NCT02171481]Phase 166 participants (Actual)Interventional2008-05-31Completed
Relative Bioavailability and Pharmacodynamics of Dabigatran After a Single Dose of 220 mg Dabigatran Etexilate and After 40 mg Enoxaparin s.c. for 3 Days Followed by a Single Dose of 220 mg Dabigatran Etexilate in Healthy Male and Female Volunteers (an Op [NCT02171559]Phase 129 participants (Actual)Interventional2008-08-31Completed
Bioavailability of BIBR 953 ZW After 50 mg of BIBR 1048 MS (Oral Prodrug of BIBR 953) in 2 Experimental Formulations Relative to Drinking Solution of BIBR 1048 MS, Each Treatment Given Bid Over 3 Days in Healthy Subjects. Intraindividual Comparison (3-way [NCT02170623]Phase 112 participants (Actual)Interventional2002-02-28Completed
Multicenter, Open-label, Ascending Dose Study of BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery. Bistro I [NCT02170701]Phase 2289 participants (Actual)Interventional2000-10-31Completed
A Phase I, Non-randomized, Open-label, Fixed-sequence Study to Investigate the Effect of Darolutamide (ODM-201) on the Pharmacokinetics of a Probe Substrate of CYP3A4 and P-gp in Healthy Male Volunteers [NCT03237416]Phase 115 participants (Actual)Interventional2017-08-02Completed
Association Between Socioeconomic Factors and Use of Direct Oral Anticoagulants Versus Standard of Care (Warfarin) in Patients With Non-valvular Atrial Fibrillation in Sweden [NCT03684395]68,056 participants (Actual)Observational2016-06-15Completed
Validation of Predictors for Oral Anticoagulant Medication Choice Using EMR Data [NCT03006341]140,187 participants (Actual)Observational2017-02-28Completed
Development of Precision Medicine Platform for Pharmacogenomics of Novel Oral Anticoagulants (NOACs) [NCT04056143]500 participants (Anticipated)Observational2019-01-02Recruiting
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy: a Prospective Randomized Clinical Trial [NCT03463317]Phase 41,512 participants (Anticipated)Interventional2018-02-28Recruiting
RandomizEd Dabigatran Etexilate Dose Finding Study in Patients With Acute Coronary Syndromes Post Index Event With Additional Risk Factors for Cardiovascular Complications Also Receiving Aspirin and Clopidogrel: Multi-centre, Prospective, Placebo Controll [NCT00621855]Phase 21,878 participants (Actual)Interventional2008-03-31Completed
Comparison of Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran in Patients With Non-valvular Atrial Fibrillation (RIVAL-AF Study) -Multicenter Randomized Study- [NCT02331602]Phase 4200 participants (Anticipated)Interventional2013-07-31Recruiting
SIFNOS STUDY: RETROSPECTIVE STUDY IN PATIENTS WITH ATRIAL FIBRILLATION (AF) EXPOSED AND UNEXPOSED TO AN ORAL ANTICOAGULANT THERAPY BETWEEN 2014-2020 IN FRANCE [NCT05838664]1 participants (Anticipated)Observational2023-07-07Active, not recruiting
Anticoagulant Treatment Patterns and Outcomes Among Non-valvular Atrial Fibrillation Patients With High Risk of Gastrointestinal Bleeding in France: a Retrospective Cohort Analysis Using SNDS Database [NCT05038228]1 participants (Actual)Observational2022-08-01Active, not recruiting
Bioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Replicate Design in a Two-treatment, Four-period, Two-s [NCT03070171]Phase 1160 participants (Actual)Interventional2017-03-21Completed
Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ADONIS-PCI) [NCT04695106]Phase 42,230 participants (Anticipated)Interventional2021-10-25Recruiting
[NCT02313584]Phase 3464 participants (Anticipated)Interventional2014-12-31Not yet recruiting
Bioavailability of BIBR 953 ZW After 50 mg of BIBR 1048 MS (Oral Prodrug of BIBR 953) in 4 Experimental Formulations Relative to Drinking Solution of BIBR 1048 MS, Each Treatment Given Bid Over 3 Days, in Healthy Subjects. Intraindividual Comparison (5-wa [NCT02170896]Phase 116 participants (Actual)Interventional2001-10-31Completed
Bioavailability of BIBR 953 ZW After 150 mg of BIBR 1048 (Oral Pro-drug of BIBR 953 ZW) Administered as HPMC Polymorph II Capsule Relative to 150 mg HPMC Polymorph I Capsule in Healthy Subjects. A Two-way Crossover, Randomised, Open Trial [NCT02170974]Phase 128 participants (Actual)Interventional2004-07-31Completed
Relative Bioavailability of Dabigatran and Digoxin After 150 mg BID Dabigatran Etexilate and Digoxin at 0.25 mg QD Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers (an Open Label, Randomised, Multiple-dose [NCT02171052]Phase 124 participants (Actual)Interventional2006-06-30Completed
Pharmacodynamics, Safety and Pharmacokinetics After Single Oral Administration of 10, 30, 100, 200 and 400 mg BIBR 1048 MS as Drinking Solution in Healthy Subjects. An Open Study, Placebo Randomized Double Blind at Each Dose Level. [NCT02170116]Phase 140 participants (Actual)Interventional1998-11-30Completed
Metabolism and Pharmacokinetics of [14C]-BIBR 953 ZW After Administration of Single Doses of 5 mg [14C]-BIBR 953 ZW Intravenously or 200 mg [14C]-BIBR 1048 Oral Solution in a Group Comparison Design in 12 Healthy Male Volunteers. [NCT02171442]Phase 110 participants (Actual)Interventional2002-04-30Completed
Tolerability of Single Rising Doses of 0.1 mg, 1 mg, and 5 mg BIBR 953 ZW IV (Placebo-controlled in Each Dose Group; Substudy 1) and Absolute and Relative Bioavailability of 100mg BIBR 1048 Tablet and of Solution and of 1 mg or 5 mg BIBR 953 ZW IV (Random [NCT02170584]Phase 130 participants (Actual)Interventional2001-01-31Completed
Bioequivalence of Two Different Generations of Drug Product of 150 mg Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers (Double-blind, Randomised, Single Dose, Replicate Design in a Two Treatments, Four Periods Cross [NCT02171520]Phase 166 participants (Actual)Interventional2008-05-31Completed
Bioavailability of BIBR 953 ZW After Multiple Oral Doses of 50 and 200 mg BIBR 1048 MS Film-coated Tablet Administered BIDfor 3 Days or 200 mg BIBR 1048 MS With and Without Pre-treatment With Pantoprazole to Healthy Volunteer Subjects. Two Groups, 2-way C [NCT02170740]Phase 126 participants (Actual)Interventional1999-11-30Completed
Randomised, Open Label, 3-way Cross Over Phase I Study to Investigate the Impact of Concomitant Use of Multiple Doses of Clopidogrel (75 mg qd After a Loading Dose of 300 mg) With Multiple Doses of Dabigatran Etexilate (150 mg Bid) on the Pharmacokinetic [NCT02171598]Phase 144 participants (Actual)Interventional2009-02-28Completed
Safety and Efficacy of Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk (HBR) Patients With History of Paroxysmal Atrial Fibrillation [NCT04151680]100 participants (Anticipated)Observational [Patient Registry]2019-12-01Recruiting
Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation (CAF Trial) [NCT03061006]Phase 4101 participants (Actual)Interventional2017-04-03Completed
Long-term, Open-label Follow-up Treatment of Patients With Atrial Fibrillation Who Have Been Previously Treated With BIBR 1048 in the PETRO Trial (Trial 1160.20 - NCT01227629). (PETRO Extension Trial: PETRO-Ex) [NCT00157248]Phase 2361 participants (Actual)Interventional2003-12-31Terminated
[NCT02309970]90 participants (Anticipated)Observational2014-12-31Not yet recruiting
A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 [NCT00168818]Phase 33,494 participants (Actual)Interventional2004-11-30Completed
Bioavailability of BIBR 953 ZW After Single Oral Doses of 12.5, 50 or 200 mg BIBR 1048 MS Film-coated Tablet Over 2 Days With and Without Coadministration of Ranitidine to Healthy Subjects. Three Groups, 2-way Crossover, Randomised, Open Trial. [NCT02170792]Phase 130 participants (Actual)Interventional2001-02-28Completed
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of 150 mg Dabigatran Etexilate p.o. in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open, Parallel-group Trial [NCT02182024]Phase 135 participants (Actual)Interventional2005-04-30Completed
Novel Oral Anticoagulants in Oral and Maxillofacial Surgery: Impact on Bleeding Tendency, Surgical Difficulty and Post-operative Complications [NCT04662515]300 participants (Anticipated)Observational2016-06-01Recruiting
Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation. A Multicenter Randomized Clinical Trial. (Occlusion-AF) [NCT03642509]750 participants (Anticipated)Interventional2019-01-01Recruiting
Impact of Dabigatran and Phenprocoumon on Clopidogrel Mediated ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation [NCT01352702]Phase 446 participants (Actual)Interventional2011-05-31Terminated(stopped due to Slow recruitment; Study was terminated for futility reasons)
Dabigatran Following Transient Ischemic Attack and Minor Stroke [NCT02295826]Phase 2300 participants (Actual)Interventional2015-01-31Completed
A PHASE 1, OPEN-LABEL, 3-TREATMENT, 6-SEQUENCE, 3-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF PF-07321332/RITONAVIR AND RITONAVIR ON THE PHARMACOKINETICS OF DABIGATRAN IN HEALTHY PARTICIPANTS [NCT05064800]Phase 124 participants (Actual)Interventional2021-09-21Completed
A Post-marketing Retrospective Non-interventional Study Using Nationwide Registries and Electronic Medical Records to Investigate the Real-life Effectiveness and Major Bleeding Complications of Oral Anticoagulants in Norwegian Non-valvular Atrial Fibrilla [NCT03715725]70,000 participants (Actual)Observational2018-10-31Terminated(stopped due to After feasibility assessment and due to delays in data receipt study was terminated)
A Study to Assess the Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin Administered as Microdoses in Subjects With Varying Degrees of Renal Insufficiency in the Presence and Absence of Rifampin [NCT03311841]Phase 132 participants (Actual)Interventional2018-03-01Completed
A Randomized Clinical Trial to Validate Novel Biomarker Approaches After Single Doses of Anticoagulants in Healthy Young Male Subjects and in Healthy Elderly Subjects [NCT01379300]Phase 142 participants (Actual)Interventional2011-05-31Completed
Patients Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation Impact of Conventional Oral Anticoagulant (OAC) Compared With Novel Oral Anticoagulant (NOAC) [NCT03187197]1,315 participants (Actual)Observational2017-06-20Completed
A Clinical Trial to Evaluate the Effect of Simvastatin on the Pharmacokinetics and Pharmacodynamics of Dabigatran in Healthy Male Adults [NCT03728101]Phase 112 participants (Actual)Interventional2018-11-16Completed
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial) [NCT02744092]811 participants (Actual)Interventional2016-12-13Completed
Observational Cohort Study to Evaluate the Safety and Efficacy of Switching From Lovenox (Enoxaparin) 40mg to Pradaxa (Dabigatran Etexilate) 220mg in Patients Undergoing Elective Total Hip or Knee Replacement Surgery [NCT01153698]167 participants (Actual)Observational2010-08-31Terminated(stopped due to This trial was prematurely discontinued due to low enrolment.)
Relative Bioavailability of Tablet Formulation of Dabigatran Etexilate With and Without Co-administration of Rabeprazole in Healthy Male Subjects (an Open-label, Single-dose, Two-period, Single-arm Study) [NCT03143166]Phase 136 participants (Actual)Interventional2017-05-22Completed
Relative Bioavailability of Rosuvastatin (Part 1) and Dabigatran (Part 2) Given Alone and Together With BI 1358894 in Healthy Male Subjects (Open, Single-dose, Fixed Sequence, Two-period Crossover Design in Each Trial Part) [NCT04099732]Phase 126 participants (Actual)Interventional2019-10-07Completed
Pilot-Trial: Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device [NCT02872649]Phase 216 participants (Actual)Interventional2013-01-31Terminated(stopped due to safety reasons)
A Phase 1, 2-Panel, Fixed-Sequence, Open-Label Single-Center Study to Assess the Effect of Single and Multiple Doses of Darunavir in Combination With Cobicistat or Ritonavir on the Pharmacokinetics of Single Dose Dabigatran Etexilate in Healthy Subjects [NCT04208061]Phase 128 participants (Actual)Interventional2019-12-18Completed
Comparison of Efficacy and Safety Among DAbigatran, RIvaroxaban, and ApixabaN in Patients HavinG Non-Valvular Atrial Fibrillation in Taiwan (DARING-AF Study) [NCT02666157]Phase 43,672 participants (Anticipated)Interventional2016-01-31Recruiting
The Efficacy and Safety of Dabigatran Etexilate and Different Intensity Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation [NCT02646267]Phase 4210 participants (Anticipated)Interventional2016-03-31Enrolling by invitation
Relative Bioavailability of Rosuvastatin (Part 1) and Dabigatran (Part 2) Given Alone and Together With BI 1323495 in Healthy Male Subjects (Open, Single-dose, Randomised, Two-period Crossover Design in Each Trial Part) [NCT04257032]Phase 128 participants (Actual)Interventional2020-02-13Completed
Rationale and Design of Dabigatran for Mitral Stenosis Atrial Fibrillation Trial [NCT04045093]Phase 4686 participants (Anticipated)Interventional2020-10-22Recruiting
Relationship of Advanced Holding Education and ADherence on Antithrombotic in Younger SPAF Patients [NCT04532528]898 participants (Actual)Observational2020-08-27Completed
AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study. [NCT02611635]382 participants (Actual)Observational2016-02-02Completed
Phase I, Open-label, Single Sequence, Two-Period Study to Evaluate the Effect of Tepotinib on P-gp by Investigating the PK of the P-gp Probe Substrate Dabigatran Etexilate in Healthy Subjects [NCT03492437]Phase 120 participants (Actual)Interventional2018-05-17Completed
Study on the Pharmacokinetics and Point of Care Testing After a Single Dose of 150 mg Dabigatran, 20 mg Rivaroxaban, 5 mg Apixaban, and 60 mg Edoxaban in Healthy Male Subjects [NCT05491460]Phase 124 participants (Anticipated)Interventional2022-07-01Active, not recruiting
An Open-label, Single-center, Three-part Study in Healthy Subjects to Investigate the Effect of Givinostat on the Pharmacokinetics of Midazolam and Dabigatran, the Effect of Clarithromycin on the Pharmacokinetics of Givinostat and the Pharmacokinetics of [NCT05492318]Phase 154 participants (Actual)Interventional2022-03-21Completed
A Phase III, Randomized, Parallel-group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens (75mg Day 1 Followed by 150 mg Day 2-completion, and 110 mg Day 1 Followed by 220 mg Day 2-completion) of [NCT00152971]Phase 32,615 participants (Actual)Interventional2004-11-30Completed
OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs [NCT04262492]500 participants (Anticipated)Observational [Patient Registry]2020-10-21Recruiting
Relative Bioavailability of Dabigatran and Atorvastatin After 150 mg BID Dabigatran Etexilate and Atorvastatin at 80 mg QD Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers (an Open-label, Randomised, Multi [NCT02171039]Phase 124 participants (Actual)Interventional2006-06-30Completed
Relative Bioavailability of Dabigatran and Diclofenac After 150 mg b.i.d. Dabigatran Etexilate and Diclofenac at 50 mg Single Dose Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers (an Open Label, Randomise [NCT02171507]Phase 124 participants (Actual)Interventional2006-05-31Completed
Relative Bioavailability of Dabigatran After Single Oral Administration of 150 mg Dabigatran Etexilate (Capsule) With or Without Multiple Oral Administration of 500 mg Clarithromycin (Tablet) Bid in Healthy Male and Female Volunteers (an Open Label, Fixed [NCT02171585]Phase 120 participants (Actual)Interventional2008-06-30Completed
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of 150 mg Dabigatran Etexilate p.o. in Patients With Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function in a Monocentric, Open, Parallel-group Design [NCT02170571]Phase 124 participants (Actual)Interventional2005-07-31Completed
Bioavailability of BIBR 953 ZW After Single Oral Doses of Two Different 50 mg Capsules of BIBR 1048 MS With and Without Coadministration of Pantoprazole to Healthy Subjects Relative to Solution. Two Groups, 3-way Crossover, Randomised, Open Trial [NCT02170805]Phase 124 participants (Actual)Interventional2001-04-30Completed
Effects of Dabigatran in Patients With AF - A Prospective, Randomized, Open-label, Explorative, Blinded-endpoint Trial to Compare the Efficacy of Dabigatran With Phenprocoumon for the Resolution of LAA Thrombus in Patients With AF [NCT02256683]Phase 264 participants (Actual)Interventional2014-07-31Terminated(stopped due to Recruiting problems)
Non-interventional Study Describing Patients' Perception on Anticoagulant Treatment and Treatment Convenience When Treated With Pradaxa or Vitamin K Antagonist for Stroke Prophylaxis in Atrial Fibrillation. [NCT02849509]1,313 participants (Actual)Observational2016-06-20Completed
The Role of D-dimer in Patients With Atrial Fibrillation Receiving Anticoagulation Therapy [NCT03280641]1,194 participants (Actual)Observational2015-08-09Completed
An Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of A Single Oral Dose Of Bosutinib On The Pharmacokinetics Of Dabigatran Etexilate Mesylate Administered Orally To Healthy Subjects [NCT02102633]Phase 127 participants (Actual)Interventional2014-05-31Completed
Real-World Comparisons of Bleeding Among Novel Oral Anticoagulant (NOAC)-Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage, Who Newly Initiated Novel Oral Anticoagulation Therapies or Were Treated With Warfarin [NCT03189069]36,000 participants (Actual)Observational2016-10-06Completed
The Use of Dabigatran Etexilate in Patients With Atrial Fibrillation After Mitral Valve Prosthetic Replacement [NCT03183843]Phase 440 participants (Actual)Interventional2016-06-29Enrolling by invitation
Safety & Suitability of Dabigatran to Inhibit Thrombin in Scleroderma [NCT02426229]Phase 115 participants (Actual)Interventional2016-02-29Completed
Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LT3001 Drug Product and Drug-Drug Interaction in Healthy Adult Subjects [NCT04809818]Phase 164 participants (Anticipated)Interventional2021-03-21Recruiting
Safety, Pharmacokinetics and Pharmacodynamics After Single (150 mg, 220 mg and 300 mg) and Multiple (150 mg and 220 mg q.d. and 150 mg b.i.d.) Rising Oral Doses of BIBR 1048 MS/Capsules in Healthy Male Subjects of Japanese and Caucasian Origin. (Open Labe [NCT02170909]Phase 142 participants (Actual)Interventional2004-12-31Completed
Relative Bioavailability of Single Oral Doses of 150 mg Dabigatran Etexilate With or Without Oral Administration of Verapamil in Two Different Dosages (240 mg and 480 mg Daily) (Open-label, Fixed-sequence Design), and Relative Bioavailability of Single Or [NCT02171533]Phase 140 participants (Actual)Interventional2008-06-30Completed
Bioavailability of BIBR 953 ZW After 150 mg of BIBR 1048 (Oral Pro-drug of BIBR 953 ZW) Administered as HPMC Capsule Relative to a Gelatine Capsule, and Bioavailability of the HPMC Capsule Under the Influence of Food in Healthy Subjects. A Three-way Cross [NCT02170597]Phase 112 participants (Actual)Interventional2003-08-31Completed
Relative Bioavailability of Single Doses of 150 mg Dabigatran Etexilate (Capsule) When Administered Alone or in Combination With a Single Dose of 400 mg Ketoconazole (Tablet) or in Combination With 400 mg q.d. Ketoconazole (Tablet) at Steady State in Heal [NCT02170675]Phase 124 participants (Actual)Interventional2009-06-30Completed
Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Oral Doses of 50, 100, 200, and 400 mg BIBR 1048 MS Solution Administered TID for 7 Days to Healthy Volunteer Subjects. An Open Study, Placebo-controlled Randomised Double Blind at Each Dose Le [NCT02170831]Phase 140 participants (Actual)Interventional1999-05-31Completed
Relative Bioavailability of Single Doses of 150 mg Dabigatran Etexilate (Capsule)When Administered Alone, After Seven Days of Dosing With 600 mg Rifampicin(Tablet), and Seven Days and Fourteen Days After Last Administration of Rifampicin in Healthy Male a [NCT02173717]Phase 124 participants (Actual)Interventional2009-06-30Completed
A Randomized Study Comparing Dabigatran Etexilate Versus Warfarin in Chinese Patients With Nonvalvular Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention With Stenting (DES) [NCT03536611]Phase 41,120 participants (Anticipated)Interventional2018-09-01Recruiting
RE-MODEL (Thromboembolism Prevention After Knee Surgery). Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With a Half Dose (i.e.75 or 110 mg) on the Day of Surgery] Compared to Subcutaneo [NCT00168805]Phase 32,101 participants (Actual)Interventional2004-11-30Completed
THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) - a Multi-centre Assessor-blind Randomised-controlled Trial [NCT05735639]Phase 46,660 participants (Anticipated)Interventional2024-01-01Not yet recruiting
"Prospective Open Label Randomized Evaluation of Abbreviated Course of Dabigatran Etexilate With tranSesophageal echOcardiography (TEE) Control vs Conventional 3-week coUrse With dabigatraN Etexilate Before Cardioversion: Analysis of MRI-detecteD Cerebral [NCT03975062]Phase 4400 participants (Anticipated)Interventional2017-12-28Recruiting
Replication Of An Early Evaluation Of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin In The U.S [NCT02769078]14,201 participants (Actual)Observational2014-11-30Completed
Dabigatran Study in the Early Phase of Stroke. New Neuroimaging Markers and Biomarkers Study (SEDMAN STUDY) [NCT02742480]500 participants (Anticipated)Observational2016-06-28Recruiting
AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY TO EVALUATE THE EFFECT OF A SINGLE ORAL DOSE OF ARV-471 (PF-07850327) ON THE PHARMACOKINETICS OF DABIGATRAN IN HEALTHY PARTICIPANTS [NCT05673889]Phase 124 participants (Actual)Interventional2023-01-27Completed
A PHASE 1, RANDOMIZED, 2-WAY CROSSOVER, SINGLE DOSE, OPEN LABEL STUDY TO ESTIMATE THE EFFECT OF PF-04965842 ON DABIGATRAN PHARMACOKINETICS IN HEALTHY PARTICIPANTS [NCT03742336]Phase 120 participants (Actual)Interventional2018-11-21Completed
Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES Trial [NCT03568890]Phase 4510 participants (Anticipated)Interventional2018-09-01Recruiting
Clinical Application Model of Direct Oral Anticoagulants (MACACOD). Comprehensive Management of ACOD From a Specialized Center in Antithrombotic Therapy and Its Area of Influence [NCT04042155]1,600 participants (Anticipated)Observational [Patient Registry]2019-07-29Recruiting
Relative Bioavailability of Dabigatran and Amiodarone After Multiple Oral Administrations of 150 mg Dabigatran Etexilate b.i.d. With or Without 600 mg Amiodarone as Single Dose in Healthy Male and Female Volunteers (an Open-Label, Multiple-Dose, Group-Com [NCT02171026]Phase 124 participants (Actual)Interventional2006-04-30Completed
Real-world Comparative Effectiveness of Dabigatran Versus VKA [NCT02687867]56,039 participants (Actual)Observational2016-02-12Completed
Open-label Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given for 3 Days at the End of Standard Anticoagulant Therapy in Children Aged 12 Years to Less Than 18 Years [NCT00844415]Phase 29 participants (Actual)Interventional2009-06-30Completed
The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization [NCT00818753]Phase 253 participants (Actual)Interventional2009-01-31Completed
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Trial [NCT03968393]Phase 42,800 participants (Anticipated)Interventional2019-06-14Recruiting
RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes [NCT00808067]Phase 35,897 participants (Actual)Interventional2008-11-30Completed
AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study [NCT02607371]198 participants (Actual)Observational2015-08-27Completed
Burden of Ischemic Stroke and Adherence to Oral Anticoagulants in Atrial Fibrillation in the UK Primary Care [NCT04099238]3,739 participants (Actual)Observational2019-10-01Completed
Investigation Drug-drug Interaction Between Dabigatran and Clarithromycin [NCT01385683]Phase 110 participants (Actual)Interventional2011-06-30Completed
Evaluation of the Potential Action of Coagulation Factors Concentrates in the Reversal of the Antithrombotic Action of New Oral Anticoagulants: Studies ex Vivo in Blood Samples From Healthy Volunteers [NCT01478282]Phase 410 participants (Anticipated)Interventional2012-01-31Recruiting
Open Label, Randomised Exploratory Dose Response Study in Pharmacodynamics and Safety of BIBR 1048 (110 mg Twice Daily (b.i.d.) and 150 mg b.i.d.) for 12 Weeks in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin [NCT01136408]Phase 2174 participants (Actual)Interventional2005-11-30Completed
APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study [NCT02640222]321,501 participants (Actual)Observational2014-01-01Completed
A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatm [NCT00680186]Phase 32,589 participants (Actual)Interventional2008-04-30Completed
A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Orally Administered 220 mg Dabigatran Etexilate Capsules (110 mg Administered on the Day of Surgery Followed by 220 mg Once Daily) Comp [NCT00657150]Phase 32,055 participants (Actual)Interventional2008-03-31Completed
The Comparative Effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism [NCT03292666]39,603 participants (Actual)Observational2010-01-01Completed
The Effect of Dicloxacillin on Oral Absorption of Drugs [NCT05073627]Phase 112 participants (Actual)Interventional2022-02-07Completed
A Phase 1, Open-label, Sequential Study to Investigate the Pharmacokinetic Interaction Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Subjects [NCT02945020]Phase 115 participants (Actual)Interventional2016-11-10Completed
Efficacy and Safety of Non-vitamin K Oral Anticoagulants and Vitamin K Oral Anticoagulants on Some Metabolic and Coagulation Parameters in Diabetic and Nondiabetic Patients With First Diagnosis of Non-valvular Atrial Fibrillation [NCT02935855]Phase 4300 participants (Actual)Interventional2015-09-30Completed
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atria [NCT00262600]Phase 318,113 participants (Actual)Interventional2005-12-31Completed
Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in the Treatment of Non Valvular Atrial Fibrillation in Patients Aged 80 Years and Over, Living at Home or in Nursing Home. A Prospective Cohort Study [NCT02286414]159 participants (Actual)Observational2015-02-28Completed
A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembo [NCT00329238]Phase 32,867 participants (Actual)Interventional2006-05-31Completed
A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following In [NCT00291330]Phase 32,564 participants (Actual)Interventional2006-02-28Completed
Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia. A Prospective Randomized Controlled Academic Single-centre Feasibility Study. [NCT01911624]Phase 294 participants (Actual)Interventional2013-01-31Completed
Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study). [NCT03539055]Phase 4100 participants (Anticipated)Interventional2018-09-01Active, not recruiting
Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin [NCT01994265]Phase 4200 participants (Actual)Interventional2014-11-07Completed
Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data [NCT04735523]5,350 participants (Actual)Observational2020-09-22Completed
Investigating the Role of the Coagulation Cascade in Idiopathic Pulmonary Fibrosis [NCT02885961]12 participants (Anticipated)Interventional2016-08-31Not yet recruiting
Safety and Efficacy of Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for the Treatment of Acute Intermediate-Risk Pulmonary Embolism [NCT02596555]Phase 4400 participants (Actual)Interventional2016-01-31Terminated(stopped due to "Interim results suggested a reduction of sample size.~Anticipated length of enrolment period with resulting funding issues to pose a threat to the study.")
Closure of Patent Foramen Ovale or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence [NCT00562289]Phase 3664 participants (Actual)Interventional2007-12-31Completed
A Single Dose, Randomized, Open Label, Two-Treatment, Two-Sequence, Two-Period, Crossover Bioequivalence Study of WD-1602 Versus Pradaxa® in Healthy Subjects Under Fed Condition [NCT04592822]Phase 120 participants (Anticipated)Interventional2021-01-06Not yet recruiting
Prospective, Multi-centre, Randomized, Parallel Comparison to Evaluate the Safety and Efficacy of the Abluminal Sirolimus Coated Bio-engineered Stent (COMBO Stent) in Association With Short-term Single Antiplatelet Therapy in Patients With Coronary Artery [NCT02723981]Phase 40 participants (Actual)Interventional2016-04-30Withdrawn(stopped due to Regulatory authority approval for the initial study design could not be obtained)
The Comparative Safety of Direct Oral Anticoagulants Versus Warfarin for the Treatment of Venous Thromboembolism [NCT02833987]59,525 participants (Actual)Observational2015-03-31Completed
Dose Exploration in Patients With Atrial Fibrillation [NCT01227629]Phase 2502 participants (Actual)Interventional2003-09-30Completed
Oral Anticoagulant Bleeding Rate and Discontinuation and Adherence Patterns in Non-Valvular Atrial Fibrillation (NVAF) Patients [NCT02792335]28,000 participants (Actual)Observational2012-01-31Completed
A Randomized Pilot Study Comparing the Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery [NCT01431456]Phase 3148 participants (Actual)Interventional2013-09-30Completed
Use of Public Health Surveillance Models in the French National Health System Database: A Tool for an Ongoing Monitoring of Adverse Drug Reaction? The Case of Dabigatran [NCT02904499]814,446 participants (Actual)Observational2013-12-31Completed
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial [NCT03961334]Phase 3620 participants (Anticipated)Interventional2019-12-05Recruiting
Prospective Randomized Study for Evaluating Vascular Protective Effects of New Oral Anticoagulants in High Risk Patients With Atrial Fibrillation [NCT02544932]Phase 355 participants (Anticipated)Interventional2015-10-31Not yet recruiting
Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation Using Healthcare Data for Pragmatic Research: A Randomised Controlled Trial [NCT04700826]Phase 43,000 participants (Anticipated)Interventional2021-06-01Recruiting
RE-DUAL PCI Real Life Registry Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI [NCT04688723]Phase 41,000 participants (Anticipated)Interventional2020-12-23Recruiting
A Phase 1, Open-Label, Fixed Sequence Drug Interaction Study to Evaluate the Potential Intestinal Inhibitory Effect of Quizartinib on the Pharmacokinetics of a Pgp Substrate Dabigatran Etexilate in Healthy Subjects [NCT04459585]Early Phase 120 participants (Actual)Interventional2020-08-28Completed
Start or STop Anticoagulants Randomised Trial (SoSTART) After Spontaneous Intracranial Haemorrhage [NCT03153150]Phase 3203 participants (Actual)Interventional2018-03-28Completed
Bioequivalence of Two Different Capsule Types of 150 mg Dabigatran Etexilate Made From Two Different Drug Product Batches, Following Oral Administration in Healthy Male and Female Volunteers (Open-label, Randomised, Single Dose, Replicate Design in a Two [NCT01290757]Phase 1180 participants (Actual)Interventional2011-01-31Completed
BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery [NCT01225822]Phase 21,973 participants (Actual)Interventional2002-11-30Completed
An Open Label, Non-comparative, Pharmacokinetic and Pharmacodynamic Study to Evaluate the Effect of Dabigatran Etexilate on Coagulation Parameters Including a Calibrated Thrombin Time Test in Patients With Moderate Renal Impairment (Creatinine Clearance 3 [NCT01184989]Phase 4142 participants (Actual)Interventional2010-08-31Completed
A Phase 1, Open-label, 2-part, 2-period Fixed-sequence Study to Evaluate the Effect of Fruquintinib on the Pharmacokinetics of Dabigatran Etexilate (A P-GP Substrate) and Rosuvastatin (A BCRP Substrate) in Healthy Subjects [NCT05368805]Phase 132 participants (Actual)Interventional2022-03-02Completed
Safety and Effectiveness Study Comparing Dabigatran, Rivaroxaban & Apixaban in Non-valvular Atrial Fibrillation Patients Enrolled in the US Department of Defense Military Health System [NCT03026556]42,534 participants (Actual)Observational2016-12-29Completed
PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation (PRESTIGE-AF) [NCT03996772]Phase 3350 participants (Anticipated)Interventional2019-06-03Recruiting
The Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin Comparative Effectiveness Research Study [NCT03271450]416,000 participants (Anticipated)Observational2017-07-01Enrolling by invitation
Oral Anticoagulation After Cardiac Surgery in the Era of Direct Oral Anticoagulants: is Large Use of Vitamin K Antagonists Still Justified? [NCT04002011]Phase 20 participants (Actual)Interventional2022-03-09Withdrawn(stopped due to Submission process abandoned. No patient enrolled.)
Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Successive Groups of Children Aged 2 Years to Less Than 12 Years Followed by 1 Year to Less Than 2 Years [NCT01083732]Phase 218 participants (Actual)Interventional2010-03-31Completed
Relative Bioavailability of a Single Dose of 150 mg Dabigatran Etexilate (Capsule) When Administered Alone or in Combination With a Single Dose of 400 mg Dronedarone Tablet) or in Combination With 400 mg Bid Dronedarone (Tablet) at Steady State in Healthy [NCT01306162]Phase 136 participants (Actual)Interventional2011-02-28Completed
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of RDG-17012(Dabigatran Etexilate Tosylate) With Pradaxa® Capsule(Dabigatran Etexilate Mesylate) in Healthy Male Volunteers [NCT03495739]Phase 164 participants (Actual)Interventional2018-02-01Active, not recruiting
OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke: a Randomised Controlled Trial [NCT03759938]3,478 participants (Anticipated)Interventional2019-06-18Recruiting
Relative Bioavailability of Dabigatran After Administration of Different Dosage Forms of Multiple Doses of 150 mg Dabigatran Etexilate (Hard Capsule, Granules Resolved in Reconstitution Solution, Pellets on Food) in Healthy Male Volunteers (an Open-label, [NCT02044367]Phase 154 participants (Actual)Interventional2014-01-31Completed
An Open-Label, Drug-Drug Interaction Study Designed to Evaluate the Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy Subjects [NCT05347979]Phase 130 participants (Actual)Interventional2022-05-25Completed
Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms [NCT04192916]442 participants (Actual)Observational2019-09-01Completed
A Randomized Controlled Trial to Investigate Whether a Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at the Time of Device Surgery, in Patients With Moderate to High Risk of Arterial Thrombo-embolic Events, Leads to a Reduction in the [NCT01675076]Phase 3663 participants (Actual)Interventional2013-01-31Completed
A Retrospective Cohort Study With Chart Review to Assess the Management of Major Bleeding Events in NVAF Patients Treated With Dabigatran Etexilate [NCT02149303]191 participants (Actual)Observational2014-06-30Completed
A Cohort (Follow Up) Study With 100 Subjects Having a Primary Total Knee Replacement, Taking Pradax (Tablet) Post Discharge for Ten Days, Without the Need for Routine Coagulation Monitoring and Dose Adjustment [NCT00868179]Phase 40 participants (Actual)Interventional2009-04-30Withdrawn(stopped due to study never started)
Relative Bioavailability of Dabigatran After Single Oral Administration of Five Different Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Six-period, [NCT02710630]Phase 135 participants (Actual)Interventional2016-03-22Completed
Validation of a Novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy [NCT01810237]0 participants (Actual)Interventional2013-03-31Withdrawn(stopped due to No patients recruited)
Randomised, Double-blind Within Dose Groups, Placebo-controlled Phase I Trial in Healthy Japanese Male Volunteers to Investigate Safety, Tolerability and Pharmacokinetics of Different Doses of BI 655075 (Part 1) and to Explore the Effective Dose of BI 655 [NCT02028780]Phase 180 participants (Actual)Interventional2014-01-31Completed
Relative Bioavailability of Dabigatran After Administration of Different Application Forms of a Single Oral Dose of 150 mg Dabigatran Etexilate (Capsule, Powder for Reconstitution Into Solution, Pellets on Food) in Healthy Male and Female Volunteers (an O [NCT02171611]Phase 130 participants (Actual)Interventional2009-03-31Completed
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS) [NCT02701062]Phase 4562 participants (Actual)Interventional2016-02-29Completed
A Randomised, Parallel-group, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery [NCT00246025]Phase 2512 participants (Actual)Interventional2005-10-31Completed
APIXABAN DRUG UTILIZATION STUDY IN STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF) [NCT03441633]51,690 participants (Actual)Observational2016-02-18Completed
Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants [NCT02754154]321,182 participants (Actual)Observational2014-12-31Completed
Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF: The CORRAL-AF Study [NCT04684212]2,931 participants (Anticipated)Interventional2023-12-01Not yet recruiting
A Large, International, Randomized, Placebo-controlled Trial to Assess the Impact of Dabigatran (a Direct Thrombin Inhibitor) and Omeprazole (a Proton-pump Inhibitor) in Patients Suffering Myocardial Injury After Noncardiac Surgery [NCT01661101]Phase 31,754 participants (Actual)Interventional2013-01-31Completed
Impact of Rabeprazole-induced Elevated Gastric pH on APO-Dabigatran Exposure in Healthy Volunteers [NCT04157881]Phase 446 participants (Actual)Interventional2020-01-03Completed
Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients [NCT01727427]695 participants (Actual)Observational2012-11-30Completed
Dabigatran Treatment Following Transient Ischemic Attack and Minor Stroke [NCT01769703]Phase 253 participants (Actual)Interventional2012-02-29Completed
Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Children Aged 1 Year to Less Than 2 Years in Conjunction With Study 1160.89 [NCT01773174]Phase 20 participants (Actual)Interventional2013-01-31Withdrawn
A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Pradaxa (Dabigatran Etexilate Mesilate, 110 mg or 150 mg b.i.d.) in Korean Patients With Non-valvular Atrial Fibrillation(SPARK: Safety Study of Pradaxa in AF Pat [NCT01774370]3,182 participants (Actual)Observational2013-01-14Completed
Treating Acute Pancreatitis With Dabigatran, a Pilot Study [NCT03807856]Phase 12 participants (Actual)Interventional2019-06-24Terminated(stopped due to Difficult recruitment)
A Prospective, Randomized, Controlled, Analyst-blinded, Parallel Group Study to Investigate the Effect of Antithrombotic Triple Therapy With Ticagrelor and Acetylsalicylic Acid in Combination With Dabigatran or Rivaroxaban or Phenprocoumon on Markers of C [NCT01812200]Phase 460 participants (Actual)Interventional2012-10-31Completed
Comparison of the Length of Stay in Patients Hospitalized and Initiated With Dabigatran or Warfarin for a Concomitant Non-Valvular Atrial Fibrillation in Real-world Japanese Therapeutic Practice (SHORT-J) [NCT02631057]4,313 participants (Actual)Observational2016-09-01Completed
Open-label, Single Dose, Tolerability, Pharmacokinetic/Pharmacodynamics and Safety Study of Dabigatran Etexilate Given at the End of Standard Anticoagulant Therapy in Children Aged Less Than 1 Year Old [NCT02223260]Phase 28 participants (Actual)Interventional2014-09-30Completed
Pradaxa Initiation Post-Stroke Study: SITS-Pradaxa 1. A Retrospective Analysis From the SITS-AF Registry on Treatment Initiation of Dabigatran Etexilate in Non-valvular Atrial Fibrillation Patients Hospitalized With Acute Ischemic Stroke [NCT03258645]1,489 participants (Actual)Observational2018-11-15Completed
A Clinical Study to Evaluate the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Healthy Volunteers and Renal Impairment Patients [NCT05747768]Phase 460 participants (Anticipated)Interventional2022-07-15Recruiting
Efficacy and Safety of Vascular Boot Warming Program After Acute DVT±PE for Earlier Resolution of Venous Thromboembolism (VTE) and Prevention of Post Thrombotic Syndrome: A Pilot Study. [NCT03465735]15 participants (Actual)Interventional2017-01-13Terminated(stopped due to Due to lack of recruitment of eligible participants)
Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation [NCT02067182]Phase 4200 participants (Actual)Interventional2015-08-31Completed
Replication of the RELY Anticoagulant Trial in Healthcare Claims Data [NCT04593043]78,140 participants (Actual)Observational2020-01-01Completed
Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation [NCT01468155]Phase 450 participants (Actual)Interventional2011-07-13Completed
A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF PF-07081532 ADMINISTRATION ON THE SINGLE-DOSE PHARMACOKINETICS OF DABIGATRAN AND ROSUVASTATIN IN OVERWEIGHT OR OBESE ADULT PARTICIPANTS [NCT05788328]Phase 116 participants (Actual)Interventional2023-03-27Terminated(stopped due to The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.)
Stroke/Systemic Embolism and Major Bleeding in Patients Newly Treated With Oral Anticoagulants: a Real World Study From Portuguese Administrative Claims Data [NCT04808934]0 participants (Actual)Observational2020-06-01Withdrawn(stopped due to Withdrawn due to COVID19 pandemic. Several delays affected this study, therefore company decided to not conduct the study. It was cancelled prior to any enrollment.)
Open Label Phase I Trial in Healthy Chinese Male and Female Volunteers to Investigate Pharmacokinetics and Pharmacodynamics of Idarucizumab to Reverse Dabigatran Anticoagulant Activity [NCT03086356]Phase 112 participants (Actual)Interventional2017-05-10Completed
Open Label, Non Randomized, Multiple Dose Phase I Study to Investigate the Elimination, Pharmacokinetics, Pharmacodynamics and Safety of Dabigatran Etexilate (Pradaxa) Under Steady State Conditions Before, During and After Haemodialysis in Patients With E [NCT01241539]Phase 17 participants (Actual)Interventional2010-11-30Completed
Early Versus Late Initiation of Direct Oral Anticoagulants in Post-ischaemic Stroke Patients With Atrial fibrillatioN (ELAN): an International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial [NCT03148457]2,013 participants (Actual)Interventional2017-11-06Completed
A Prospective Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism [NCT03240120]Phase 399 participants (Anticipated)Interventional2017-09-01Recruiting
Drug Persistence/Adherence in Patients Being Treated With Dabigatran Etexilate or VKA for Stroke Prevention in Non-valvular Atrial Fibrillation (SPAF) [NCT02240667]1,506 participants (Actual)Observational2014-09-18Completed
The Direct Oral Anticoagulation Versus Warfarin After Cardiac Surgery Trial [NCT04284839]Phase 36,215 participants (Anticipated)Interventional2021-07-18Recruiting
Dabigatran Versus Warfarin After Mitral and Aortic Bioprosthesis Replacement for the Management of Atrial Fibrillation Postoperatively: Pilot Study [NCT01868243]Phase 2/Phase 327 participants (Actual)Interventional2013-08-31Terminated(stopped due to because a significant decrease of viable candidates for the study.)
A Pilot Trial of Restarting Direct Oral Anticoagulants After Traumatic Intracranial Hemorrhage [NCT04891861]Phase 3100 participants (Anticipated)Interventional2021-07-01Not yet recruiting
Phase 1 Study of the Pharmacokinetics and Pharmacodynamics of Oral Dabigatran Etexilate in Hemodialysis Patients [NCT01590823]Phase 110 participants (Actual)Interventional2012-07-31Completed
Early Versus Late DC-cardioversion of Persistent Atrial Fibrillation. Effect on Atrial Remodeling,Inflammatory and Neurohumoral Markers and Recurrence of Atrial Fibrillation. [NCT01593150]141 participants (Actual)Interventional2011-11-30Completed
SafeTy and Efficacy of Direct Oral Anticoagulant Versus Aspirin for Reduction Of RisK of CErebrovascular Events in Patients Undergoing Ventricular Tachycardia Ablation (STROKE-VT) [NCT02666742]Phase 4246 participants (Actual)Interventional2017-02-16Completed
VICTORIE (VTE In Cancer - Treatment, Outcomes and Resource Use In Europe) [NCT04618913]1 participants (Anticipated)Observational2020-12-14Active, not recruiting
Pharmacodynamic Effects of Dabigatran in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel [NCT01852162]35 participants (Actual)Interventional2012-02-29Completed
Pilot Study of Post-thrombotic Syndrome & Predictors of Recurrence in Cancer Patients With Catheter-related Thrombosis [NCT01999179]27 participants (Actual)Interventional2014-06-30Completed
Registration of Idarucizumab for Patients With IntraCranial Hemorrhage (RIC-ICH) [NCT04062097]104 participants (Actual)Observational2019-09-19Completed
Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor (Part 1 and 2, Open, Non-randomised, 2 Parallel Groups) and Assessment of Ticagrelor Interaction Potential With Dabigatran (Part 3, Open, Randomised, Two-period Cross-over) in Healthy M [NCT01595854]Phase 136 participants (Actual)Interventional2012-05-31Completed
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism. [NCT00558259]Phase 31,353 participants (Actual)Interventional2007-11-30Completed
Randomised, Double-blind, Placebo-controlled Phase I Study in Healthy Male Volunteers. to Investigate Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BI 655075 (Part 1) and to Explore the Dose of BI 655075 Effective to Reverse Dabigatr [NCT01688830]Phase 1157 participants (Actual)Interventional2012-09-30Completed
A Prospective Randomised Controlled Study to Evaluate Outcomes of the Treatment With Pradaxa or Warfarin for Prevention of Recurrent VTE in Patients With Angiographically Confirmed Acute Massive Pulmonary Embolism Undergoing Endovascular Mechanical Fragme [NCT02979561]Phase 4200 participants (Anticipated)Interventional2016-10-31Recruiting
Medical Need of Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Head Trauma, Fracture, and Emergency Surgery Using Large Scale Claims Database (Please Note That This Study Contains no Patients Treated With Idarucizumab Although the St [NCT03254147]53,969 participants (Actual)Observational2017-10-15Completed
Prospective, Observational, Non-interventional Open-label Multicenter Registry Regarding the Incidence of Heavy Menstrual Bleeding in Women of Reproductive Age Treated With Direct Oral Anticoagulants Because of Venous Thromboembolism [NCT04477837]150 participants (Anticipated)Observational [Patient Registry]2020-10-15Recruiting
Open Label, Single Arm Safety Prospective Cohort Study of Dabigatran Etexilate for Secondary Prevention of Venous Thromboembolism in Children From 0 to Less Than 18 Years [NCT02197416]Phase 3214 participants (Actual)Interventional2014-09-29Completed
THE REAL WORLD EVIDENCE ON TREATMENT PATTERNS, EFFECTIVENESS, AND SAFETY OF DRUGS FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS IN KOREA [NCT03572972]64,684 participants (Actual)Observational2018-01-31Completed
Dabigatran-related Effect on Progression of Atrial Fibrosis in Patients With Atrial Fibrillation [NCT01546883]Phase 414 participants (Actual)Interventional2012-02-29Terminated(stopped due to Not enough patients in time period allotted for study)
Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve [NCT01505881]Phase 2158 participants (Actual)Interventional2011-12-31Terminated
A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt [NCT01452347]Phase 2328 participants (Actual)Interventional2011-10-31Terminated
A Prospective, Open Label Study Evaluating the Efficacy of Two Management Strategies (Pantoprazole 40 mg q.a.m. and Taking Pradaxa® With Food (Within 30 Minutes After a Meal) on Gastrointestinal Symptoms (GIS) in Patients Newly on Treatment With Pradaxa® [NCT01493557]Phase 41,067 participants (Actual)Interventional2011-12-31Completed
Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty [NCT04878497]1,000,000 participants (Anticipated)Observational2021-03-30Active, not recruiting
Efficacy and Safety of Dabigatran in Patients With Cirrhosis and Portal Vein Thrombosis-A Randomized Placebo Controlled Trial [NCT04433481]84 participants (Anticipated)Interventional2020-06-20Recruiting
Effect of LY3314814 on the Pharmacokinetics of Dabigatran in Healthy Subjects [NCT02568397]Phase 160 participants (Actual)Interventional2015-10-31Completed
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in Daily Clinical Practice - A French Cohort Within the Nationwide Claims and Hospital Database [NCT02864758]99,999 participants (Actual)Observational2016-09-08Completed
Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE [NCT03965741]97,765 participants (Actual)Observational2019-05-30Completed
An Open-label Crossover Trial Assessing the Value of Dabigatran in a Drug Interaction Cocktail in Healthy Young Volunteers [NCT02361619]Phase 116 participants (Actual)Interventional2015-02-28Completed
A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of EDP-938 on the Pharmacokinetics of Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects [NCT04498741]Phase 189 participants (Actual)Interventional2020-07-08Completed
The Efficacy and Safety of Dabigatran Etexilate Comparing With Warfarin for the Anticoagulation Treatment of Cerebral Venous Thrombosis :a Pilot Study [NCT03217448]Phase 380 participants (Anticipated)Interventional2017-10-30Recruiting
Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor Under Steady State Conditions in Healthy Male Subjects [NCT01734772]Phase 148 participants (Actual)Interventional2012-11-30Completed
Canadian Pradaxa Acute Stroke Safety Study [NCT02415855]101 participants (Actual)Observational [Patient Registry]2015-03-31Completed
Randomized Evaluation of Dabigatran Etexilate Compared to warfarIn in pulmonaRy Vein Ablation: Assessment of an Uninterrupted periproCedUral alntIcoagulation sTrategy (The RE-CIRCUIT Trial) [NCT02348723]Phase 4678 participants (Actual)Interventional2015-04-28Completed
A Prospective Observational Cohort Study of Predictive Factors Related to Prognosis of In-hosiptal Patients With Ischemic Stroke Due to Large-artery Atherosclerosis [NCT04847752]1,000 participants (Anticipated)Observational2021-03-01Recruiting
An Open-Label Study to Investigate the Effect of Selpercatinib on the Pharmacokinetics of Dabigatran in Healthy Volunteers [NCT04782076]Phase 136 participants (Actual)Interventional2021-03-05Completed
Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism in Patients Undergoing Left Atrial Catheter Ablation Procedures for Paroxysmal or Persistent (Non-permanent) Atrial Fibrillation and Left Atrial Flutter [NCT01976507]Phase 4101 participants (Actual)Interventional2013-10-31Completed
Effectiveness of Dabigatran Versus Conventional Treatment for Prevention of Silent Cerebral Infarct in Aortic and Mitral Valvular Atrial Fibrillation Patients [NCT02982850]Phase 4120 participants (Actual)Interventional2016-12-31Completed
Open-label, Randomized, Parallel-group, Active-controlled, Multi-centre Non-inferiority Study of Dabigatran Etexilate Versus Standard of Care for Venous Thromboembolism Treatment in Children From Birth to Less Than 18 Years of Age [NCT01895777]Phase 3267 participants (Actual)Interventional2013-09-25Completed
A Randomized Trial of the Safety of Non-vitamin K Oral Anticoagulants Compared to Warfarin Early After Cardiac Surgery: a Pilot Study [NCT05006287]Phase 2100 participants (Anticipated)Interventional2021-10-01Not yet recruiting
An Open-Label, 2-Part Study to Investigate the Effect of Lasmiditan on the Pharmacokinetics of Dabigatran and Rosuvastatin in Healthy Volunteers [NCT04749914]Phase 196 participants (Actual)Interventional2021-02-15Completed
Real-world Evidence for Non-valvular Atrial Fibrillation Patients Treated With Oral Anticoagulation in the Nordics [NCT04249401]134,897 participants (Actual)Observational2020-03-01Completed
International Registry on the Use of the Direct Oral Anticoagulants for the Treatment of Unusual Site Venous Thromboembolism [NCT03778502]300 participants (Anticipated)Observational [Patient Registry]2019-10-01Recruiting
Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embol [NCT02239120]Phase 35,390 participants (Actual)Interventional2014-11-27Completed
A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus C [NCT02164864]Phase 32,725 participants (Actual)Interventional2014-07-22Completed
A Prospective, Open Label Study to Evaluate the Pharmacokinetics of Dabigatran in Non-valvular Atrial Fibrillation (NVAF) Patients With Severely Impaired Renal Function on Dabigatran Etexilate 75 mg BID Therapy [NCT01896297]Phase 463 participants (Actual)Interventional2013-07-31Completed
An Exploratory Study to Investigate the Pharmacokinetics and Effects of DABIgatran Etexilate in Patients With Stable Severe RENAL Disease: DabiRenal [NCT01711853]Phase 119 participants (Actual)Interventional2012-10-31Completed
A Study Evaluating the Pharmacokinetics of Dabigatran Etexilate in Adult Healthy Subjects, Elderly Healthy Subjects, and Elderly Patients With Atrial Fibrillation [NCT05715658]36 participants (Anticipated)Interventional2022-08-15Recruiting
Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring [NCT01706146]Phase 459 participants (Actual)Interventional2012-10-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00152971 (9) [back to overview]Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
NCT00152971 (9) [back to overview]Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
NCT00152971 (9) [back to overview]Number of Participants With Total Deep Vein Thrombosis During Treatment Period
NCT00152971 (9) [back to overview]Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
NCT00152971 (9) [back to overview]Number of Participants Who Died During Treatment Period
NCT00152971 (9) [back to overview]Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
NCT00152971 (9) [back to overview]Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
NCT00152971 (9) [back to overview]Number of Participants With Pulmonary Embolism During Treatment Period
NCT00152971 (9) [back to overview]Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
NCT00157248 (16) [back to overview]Severe Adverse Event
NCT00157248 (16) [back to overview]Yearly Event Rate of Haemorrhagic Stroke
NCT00157248 (16) [back to overview]Yearly Event Rate of Death
NCT00157248 (16) [back to overview]Yearly Event Rate for Transient Ischaemic Attacks
NCT00157248 (16) [back to overview]Yearly Event Rate for Systemic Thromboembolism
NCT00157248 (16) [back to overview]Yearly Event Rate for Stroke
NCT00157248 (16) [back to overview]Yearly Event Rate for Major Bleeding
NCT00157248 (16) [back to overview]Yearly Event Rate for Major + Minor/Relevant Bleeding
NCT00157248 (16) [back to overview]Yearly Event Rate for Composite Secondary Endpoint of Ischaemic Stroke, Transient Ischaemic Attacks, Non-central Nervous System Systemic Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and All-cause Mortality
NCT00157248 (16) [back to overview]Yearly Event Rate for Minor Bleeding
NCT00157248 (16) [back to overview]Laboratory Analyses
NCT00157248 (16) [back to overview]Yearly Event Rate of Other Major Adverse Cardiac Events
NCT00157248 (16) [back to overview]Yearly Event Rate of Myocardial Infarction
NCT00157248 (16) [back to overview]Yearly Event Rate of Ischaemic Stroke
NCT00157248 (16) [back to overview]Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.
NCT00157248 (16) [back to overview]Yearly Event Rate for Any Bleeding
NCT00168805 (12) [back to overview]Blood Transfusion
NCT00168805 (12) [back to overview]Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
NCT00168805 (12) [back to overview]Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
NCT00168805 (12) [back to overview]Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
NCT00168805 (12) [back to overview]Number of Participants Who Died During Treatment Period
NCT00168805 (12) [back to overview]Laboratory Analyses
NCT00168805 (12) [back to overview]Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
NCT00168805 (12) [back to overview]Number of Participants With Pulmonary Embolism During Treatment Period
NCT00168805 (12) [back to overview]Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
NCT00168805 (12) [back to overview]Number of Participants With Total Deep Vein Thrombosis During Treatment Period
NCT00168805 (12) [back to overview]Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
NCT00168805 (12) [back to overview]Volume of Blood Loss
NCT00168818 (12) [back to overview]Laboratory Analyses
NCT00168818 (12) [back to overview]Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
NCT00168818 (12) [back to overview]Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
NCT00168818 (12) [back to overview]Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
NCT00168818 (12) [back to overview]Symptomatic Deep Vein Thrombosis During Treatment Period
NCT00168818 (12) [back to overview]Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
NCT00168818 (12) [back to overview]Total Deep Vein Thrombosis During Treatment Period
NCT00168818 (12) [back to overview]Proximal Deep Vein Thrombosis During Treatment Period
NCT00168818 (12) [back to overview]Pulmonary Embolism During Treatment Period
NCT00168818 (12) [back to overview]Volume of Blood Loss
NCT00168818 (12) [back to overview]Blood Transfusion
NCT00168818 (12) [back to overview]Death During Treatment Period
NCT00246025 (11) [back to overview]Number of Participants With Bleeding Events During Treatment Period
NCT00246025 (11) [back to overview]Laboratory Analyses
NCT00246025 (11) [back to overview]Blood Transfusion
NCT00246025 (11) [back to overview]Volume of Blood Loss
NCT00246025 (11) [back to overview]Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)
NCT00246025 (11) [back to overview]Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period
NCT00246025 (11) [back to overview]Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period
NCT00246025 (11) [back to overview]Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality
NCT00246025 (11) [back to overview]Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.
NCT00246025 (11) [back to overview]Number of Participants With Pulmonary Embolism During Treatment Period
NCT00246025 (11) [back to overview]Number of Participants Who Died During Treatment Period
NCT00262600 (6) [back to overview]Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death
NCT00262600 (6) [back to overview]Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death
NCT00262600 (6) [back to overview]Bleeding Events (Major and Minor)
NCT00262600 (6) [back to overview]Abnormal Liver Function Test
NCT00262600 (6) [back to overview]Yearly Event Rate for Composite Endpoint of Stroke/SEE
NCT00262600 (6) [back to overview]Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)
NCT00291330 (9) [back to overview]Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE
NCT00291330 (9) [back to overview]Number of Participants With Bleeding Events
NCT00291330 (9) [back to overview]Laboratory Analyses
NCT00291330 (9) [back to overview]Number of Participants Who Died (Any Cause)
NCT00291330 (9) [back to overview]Number of Participants Who Died Due to VTE
NCT00291330 (9) [back to overview]Number of Participants With Acute Coronary Syndrome (ACS)
NCT00291330 (9) [back to overview]Number of Participants With Recurrent Symptomatic DVT
NCT00291330 (9) [back to overview]Number of Participants With Recurrent Symptomatic Non-fatal PE
NCT00291330 (9) [back to overview]Number of Participants With Recurrent Symptomatic VTE and All Deaths
NCT00329238 (15) [back to overview]DVT at 18 Months
NCT00329238 (15) [back to overview]Deep Vein Thrombosis (DVT) at 36 Months
NCT00329238 (15) [back to overview]Symptomatic Pulmonary Embolism (PE) at 18 Months
NCT00329238 (15) [back to overview]Number of Participants With Definite Acute Coronary Syndrome (ACS)
NCT00329238 (15) [back to overview]Number of Participants With Bleeding Events
NCT00329238 (15) [back to overview]Laboratory Analysis
NCT00329238 (15) [back to overview]Deaths Related to VTE at 18 Months
NCT00329238 (15) [back to overview]Deaths of All Causes at 36 Months
NCT00329238 (15) [back to overview]Deaths of All Causes at 18 Months
NCT00329238 (15) [back to overview]Composite of Recurrent VTE or VTE Death at 36 Months
NCT00329238 (15) [back to overview]Composite of Recurrent VTE or VTE Death at 18 Months
NCT00329238 (15) [back to overview]Composite of Recurrent VTE or All Cause Death at 36 Months
NCT00329238 (15) [back to overview]Composite of Recurrent VTE or All Cause Death at 18 Months
NCT00329238 (15) [back to overview]Deaths Related to VTE at 36 Months
NCT00329238 (15) [back to overview]Symptomatic Pulmonary Embolism (PE) at 36 Months
NCT00558259 (8) [back to overview]Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period
NCT00558259 (8) [back to overview]Centrally Confirmed Unexplained Deaths During the Intended Treatment Period
NCT00558259 (8) [back to overview]Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period
NCT00558259 (8) [back to overview]Centrally Confirmed Bleeding Event During the Treatment Period
NCT00558259 (8) [back to overview]Laboratory Measures, Especially Liver Function Tests (LFTs)
NCT00558259 (8) [back to overview]Centrally Confirmed Cardiovascular Events During the Treatment Period
NCT00558259 (8) [back to overview]Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period
NCT00558259 (8) [back to overview]Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period
NCT00621855 (7) [back to overview]Laboratory Analyses
NCT00621855 (7) [back to overview]Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time
NCT00621855 (7) [back to overview]Composite of Cardiovascular Death (CVD) With Non Fatal Myocardial Infarction (MI) and Non Haemorrhagic Stroke and All Cause Death (ACD), Non Fatal MI, Severe Recurrent Ischaemia (SRI) and Non Haemorrhagic Stroke During Six Months Treatment
NCT00621855 (7) [back to overview]Number of Participants With Bleeding Events During Total Observation Time
NCT00621855 (7) [back to overview]Change From Baseline in log10 D-dimer After 1 and 4 Weeks
NCT00621855 (7) [back to overview]Number of Participants With Any Reduction of D-dimer Concentration
NCT00621855 (7) [back to overview]Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment
NCT00657150 (12) [back to overview]Volume of Blood Loss
NCT00657150 (12) [back to overview]Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
NCT00657150 (12) [back to overview]Number of Participants With Total Deep Vein Thrombosis During Treatment Period
NCT00657150 (12) [back to overview]Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
NCT00657150 (12) [back to overview]Number of Participants With Pulmonary Embolism During Treatment Period
NCT00657150 (12) [back to overview]Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
NCT00657150 (12) [back to overview]Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
NCT00657150 (12) [back to overview]Number of Participants Who Died During Treatment Period
NCT00657150 (12) [back to overview]Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
NCT00657150 (12) [back to overview]Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
NCT00657150 (12) [back to overview]Laboratory Analyses
NCT00657150 (12) [back to overview]Blood Transfusion
NCT00680186 (10) [back to overview]Number of Participants With Recurrent Symptomatic VTE and All Deaths
NCT00680186 (10) [back to overview]Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events
NCT00680186 (10) [back to overview]Number of Participants With Acute Coronary Syndrome (ACS)
NCT00680186 (10) [back to overview]Number of Participants Who Died Due to VTE
NCT00680186 (10) [back to overview]Number of Participants Who Died (Any Cause)
NCT00680186 (10) [back to overview]Laboratory Analyses
NCT00680186 (10) [back to overview]Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE
NCT00680186 (10) [back to overview]Number of Participants With Recurrent Symptomatic Non-fatal PE
NCT00680186 (10) [back to overview]Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE
NCT00680186 (10) [back to overview]Number of Participants With Recurrent Symptomatic DVT
NCT00808067 (14) [back to overview]Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death
NCT00808067 (14) [back to overview]Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed
NCT00808067 (14) [back to overview]Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death
NCT00808067 (14) [back to overview]Annualized Rate of Subjects With Minor Bleeds
NCT00808067 (14) [back to overview]Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)
NCT00808067 (14) [back to overview]Pulmonary Embolism (PE), Annualized Rate of Subjects With PE
NCT00808067 (14) [back to overview]Stroke, Annualized Rate of Subjects With Stroke
NCT00808067 (14) [back to overview]Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE
NCT00808067 (14) [back to overview]Major Bleeding, Annualized Rate of Subjects With Major Bleeds
NCT00808067 (14) [back to overview]Deep Vein Thrombosis, Annualized Rate of Subjects With DVT
NCT00808067 (14) [back to overview]Death, Annualized Rate of Subject Death
NCT00808067 (14) [back to overview]Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI
NCT00808067 (14) [back to overview]Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)
NCT00808067 (14) [back to overview]Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)
NCT00818753 (5) [back to overview]Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow
NCT00818753 (5) [back to overview]Number of Participants With Bleeding Events
NCT00818753 (5) [back to overview]Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy
NCT00818753 (5) [back to overview]Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis
NCT00818753 (5) [back to overview]Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis
NCT00844415 (11) [back to overview]TT Locally Measured
NCT00844415 (11) [back to overview]Thrombin Time (TT) Centrally Measured
NCT00844415 (11) [back to overview]Number of Patients With Bleeding Events (Major and Minor)
NCT00844415 (11) [back to overview]Plasma Concentration of Total Dabigatran
NCT00844415 (11) [back to overview]Ecarin Clotting Time (ECT)
NCT00844415 (11) [back to overview]Plasma Concentration of Free Dabigatran
NCT00844415 (11) [back to overview]Occurences of Clinical Outcome
NCT00844415 (11) [back to overview]Number of Patients With Adverse Events
NCT00844415 (11) [back to overview]Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs
NCT00844415 (11) [back to overview]Activated Partial Thromboplastin Time (aPTT) Centrally Measured
NCT00844415 (11) [back to overview]aPTT Locally Measured
NCT01083732 (19) [back to overview]Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma)
NCT01083732 (19) [back to overview]Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma)
NCT01083732 (19) [back to overview]Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period.
NCT01083732 (19) [back to overview]Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination
NCT01083732 (19) [back to overview]Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma)
NCT01083732 (19) [back to overview]AUC0-tz (Area Under the Concentration Time Curve of the Total Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)
NCT01083732 (19) [back to overview]AUC0-tz (Area Under the Concentration Time Curve of the Free Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)
NCT01083732 (19) [back to overview]Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.
NCT01083732 (19) [back to overview]Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.
NCT01083732 (19) [back to overview]Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.
NCT01083732 (19) [back to overview]Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma)
NCT01083732 (19) [back to overview]Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)
NCT01083732 (19) [back to overview]Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)
NCT01083732 (19) [back to overview]Plasma Concentration of Metabolite BIBR 951 BS
NCT01083732 (19) [back to overview]Plasma Concentration of Metabolite BIBR 1087 SE
NCT01083732 (19) [back to overview]Plasma Concentration of Free Dabigatran (BIBR 953 ZW).
NCT01083732 (19) [back to overview]Global Assessment of Tolerability of Study Medication- Taste Assessment
NCT01083732 (19) [back to overview]Percentage of Patients With Any Adverse Events During the Treatment Period
NCT01083732 (19) [back to overview]Global Assessment of Tolerability of Study Medication
NCT01136408 (18) [back to overview]Discontinuation of the Study Drug Due to Adverse Events
NCT01136408 (18) [back to overview]Frequency (Occurrence Rates) of a Composite Clinical Endpoint.
NCT01136408 (18) [back to overview]Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event
NCT01136408 (18) [back to overview]Changes in Laboratory Test Values
NCT01136408 (18) [back to overview]Anticoagulation Effects Trough INR (International Normalised Ratio)
NCT01136408 (18) [back to overview]Frequency (Occurrence Rates) of Major Bleeding Event
NCT01136408 (18) [back to overview]Anticoagulation Effects Trough aPTT (Activated Partial Thromboplastin Time)
NCT01136408 (18) [back to overview]Anticoagulation Effects Trough 11-dehydrothromboxane B2
NCT01136408 (18) [back to overview]Frequency (Occurrence Rates) of Transient Ischemic Attack
NCT01136408 (18) [back to overview]Frequency (Occurrence Rates) of Ischemic or Haemorrhagic Stroke (Fatal or Non-fatal)
NCT01136408 (18) [back to overview]Frequency (Occurrence Rates) of Systemic Embolism
NCT01136408 (18) [back to overview]Anticoagulation Effects Trough ECT (Ecarin Clotting Time)
NCT01136408 (18) [back to overview]Frequency (Occurrence Rates) of Nuisance Bleeding Event
NCT01136408 (18) [back to overview]Frequency (Occurrence Rates) of Myocardial Infarction (Fatal or Non-fatal)
NCT01136408 (18) [back to overview]Frequency (Occurrence Rates) of Death
NCT01136408 (18) [back to overview]Steady-state Pharmacokinetics of Total Dabigatran Trough Plasma Concentration
NCT01136408 (18) [back to overview]Incidence and Severity of Adverse Events
NCT01136408 (18) [back to overview]Frequency (Occurrence Rates) of Other Major Adverse Cardiac Events
NCT01153698 (10) [back to overview]Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All-cause Mortality Events During the Switch-/ Post-switch Treatment Period
NCT01153698 (10) [back to overview]Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period
NCT01153698 (10) [back to overview]Volume of Wound Drainage (Post-operative)
NCT01153698 (10) [back to overview]Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period
NCT01153698 (10) [back to overview]Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period
NCT01153698 (10) [back to overview]Percentage of Patients With MBE During Pre-switch Treatment Period
NCT01153698 (10) [back to overview]Percentage of Patients With MBE During Total Treatment Period
NCT01153698 (10) [back to overview]Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period
NCT01153698 (10) [back to overview]Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period
NCT01153698 (10) [back to overview]Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period
NCT01184989 (3) [back to overview]Dabigatran Concentration in Plasma, Estimated From Local Hemoclot®
NCT01184989 (3) [back to overview]Dabigatran Concentration in Plasma, Estimated From Central Hemoclot®
NCT01184989 (3) [back to overview]Dabigatran Concentration in Plasma, Measured With HPLC-MS/MS
NCT01225822 (11) [back to overview]Plasma Concentration (Cmax) of Dabigatran
NCT01225822 (11) [back to overview]Number of Participants With Clinically Significant, Minor or Any Bleeding Events
NCT01225822 (11) [back to overview]Laboratory Analyses
NCT01225822 (11) [back to overview]Area Under the Plasma Concentration-time Curve During a Dosing Interval
NCT01225822 (11) [back to overview]Number of Participants With Major Bleeding Events (MBE)
NCT01225822 (11) [back to overview]Rate of Transfusions Due to Bleedings
NCT01225822 (11) [back to overview]Number of Participants With VTE Events and All Cause Mortality
NCT01225822 (11) [back to overview]Number of Participants With Venous Thromboembolic (VTE) Events
NCT01225822 (11) [back to overview]Volume of Blood Loss
NCT01225822 (11) [back to overview]Number of Participants With Proximal DVT, PE (Pulmonary Embolism) and VTE Related Mortality
NCT01225822 (11) [back to overview]Number of Participants With Proximal DVT
NCT01227629 (21) [back to overview]Number of Participants With Thromboembolic Events: Ischemic Stroke
NCT01227629 (21) [back to overview]Thromboembolic Events: Number of Participants With Myocardial Infarction
NCT01227629 (21) [back to overview]Number of Participants With Increase of Bilirubin to >2*Baseline
NCT01227629 (21) [back to overview]Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline
NCT01227629 (21) [back to overview]Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline
NCT01227629 (21) [back to overview]Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline
NCT01227629 (21) [back to overview]Trough Plasma Concentration of Dabigatran (BIBR 953)
NCT01227629 (21) [back to overview]Thromboembolic Events: Number of Participants With Transient Ischemic Attack
NCT01227629 (21) [back to overview]Thromboembolic Events: Number of Participants With Systemic Thromboembolism
NCT01227629 (21) [back to overview]Thromboembolic Events: Number of Participants With Other Major Cardiac Events
NCT01227629 (21) [back to overview]Thromboembolic Events: Number of Participants Who Died
NCT01227629 (21) [back to overview]Soluble Fibrin: Difference From Baseline
NCT01227629 (21) [back to overview]Number of Participants With Thromboembolic Events: Composite Endpoint
NCT01227629 (21) [back to overview]D-dimer: Difference From Baseline
NCT01227629 (21) [back to overview]Ecarin Clotting Time (ECT): Difference From Baseline
NCT01227629 (21) [back to overview]Severity of Adverse Events
NCT01227629 (21) [back to overview]Number of Participants With Minor/Relevant Bleeding Events
NCT01227629 (21) [back to overview]Number of Participants With Minor/Nuisance Bleeding Events
NCT01227629 (21) [back to overview]11-dehydrothromboxane B2 (TXB2): Difference From Baseline
NCT01227629 (21) [back to overview]Activated Partial Thromboplastin Time (aPTT): Difference From Baseline
NCT01227629 (21) [back to overview]Number of Participants With Fatal or Life-threatening Major Bleeding Events
NCT01241539 (9) [back to overview]Safety and Tolerability
NCT01241539 (9) [back to overview]Additional Safety Parameters
NCT01241539 (9) [back to overview]Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)
NCT01241539 (9) [back to overview]Coagulation Parameters
NCT01241539 (9) [back to overview]Dialysis Clearance of Dabigatran
NCT01241539 (9) [back to overview]Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis
NCT01241539 (9) [back to overview]Maximum Plasma Concentrations of Dabigatran (Cmax)
NCT01241539 (9) [back to overview]Plasma Concentration Extraction Ratio
NCT01241539 (9) [back to overview]Time to Maximum Plasma Concentration (Tmax)
NCT01290757 (6) [back to overview]Cmax of Free Dabigatran in Plasma.
NCT01290757 (6) [back to overview]Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran.
NCT01290757 (6) [back to overview]AUC0-∞ of Free Dabigatran.
NCT01290757 (6) [back to overview]AUC0-tz of Free Dabigatran.
NCT01290757 (6) [back to overview]Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran
NCT01290757 (6) [back to overview]Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma
NCT01306162 (4) [back to overview]Free Dabigatran: Maximum Measured Concentration (Cmax)
NCT01306162 (4) [back to overview]Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)
NCT01306162 (4) [back to overview]Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)
NCT01306162 (4) [back to overview]Total Dabigatran: Maximum Measured Concentration (Cmax)
NCT01452347 (8) [back to overview]Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12
NCT01452347 (8) [back to overview]Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4
NCT01452347 (8) [back to overview]Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2
NCT01452347 (8) [back to overview]Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1
NCT01452347 (8) [back to overview]Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12
NCT01452347 (8) [back to overview]Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1
NCT01452347 (8) [back to overview]Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4
NCT01452347 (8) [back to overview]Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2
NCT01493557 (10) [back to overview]Rate of Partial Effectiveness of Combined GIS Management Strategies
NCT01493557 (10) [back to overview]Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom
NCT01493557 (10) [back to overview]Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies
NCT01493557 (10) [back to overview]Rates of Complete Effectiveness of GIS at Each Visit.
NCT01493557 (10) [back to overview]Rate of Complete Effectiveness of Combined GIS Management Strategies
NCT01493557 (10) [back to overview]The Rate of Complete Effectiveness of Initial GIS Management Strategy
NCT01493557 (10) [back to overview]Rate of Partial Effectiveness of Initial GIS Management Strategies
NCT01493557 (10) [back to overview]Rates of Complete or Partial Effectiveness of GIS at Each Visit.
NCT01493557 (10) [back to overview]Rates of Partial Effectiveness of GIS at Each Visit.
NCT01493557 (10) [back to overview]Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies
NCT01505881 (4) [back to overview]Percentage of Patients With Serious AEs
NCT01505881 (4) [back to overview]Percentage of Patients With Any Adverse Event (AE)
NCT01505881 (4) [back to overview]Percentage of Patients With AEs Leading to Discontinuation of Trial Drug
NCT01505881 (4) [back to overview]Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
NCT01595854 (3) [back to overview]Total Dabigatran: Maximum Measured Concentration (Cmax)
NCT01595854 (3) [back to overview]Number of Participants With Drug Related Adverse Events
NCT01595854 (3) [back to overview]Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)
NCT01688830 (10) [back to overview]AUCt1-t2,ss (Area Under the Concentration-time Curve for the Unbound Sum Dabigatran in Plasma From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4
NCT01688830 (10) [back to overview]Number of Subjects With Drug Related Adverse Events (AE)
NCT01688830 (10) [back to overview]AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 3 of the Study
NCT01688830 (10) [back to overview]AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab
NCT01688830 (10) [back to overview]Aet1-t2,ss (Amount of Dabigatran Etexilate Eliminated in Urine From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4 for Sum Dabigatran
NCT01688830 (10) [back to overview]Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab
NCT01688830 (10) [back to overview]Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2)
NCT01688830 (10) [back to overview]AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study
NCT01688830 (10) [back to overview]C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)
NCT01688830 (10) [back to overview]Cmax (Maximum Measured Concentration) for Idarucizumab
NCT01706146 (2) [back to overview]Number of Days on Anticoagulation
NCT01706146 (2) [back to overview]Bleeding Incidence
NCT01711853 (2) [back to overview]Cmax,ss
NCT01711853 (2) [back to overview]AUCtau,ss
NCT01734772 (2) [back to overview]Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)
NCT01734772 (2) [back to overview]Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)
NCT01774370 (3) [back to overview]Percentage of Participants With Stroke
NCT01774370 (3) [back to overview]Occurrence of Adverse Events(Including Unexpected Adverse Events, Serious Adverse Events, Drug-related Adverse Events, Adverse Events Leading to Discontinuation and Adverse Events by Intensity, Outcome of the Event, Causality)
NCT01774370 (3) [back to overview]Percentage of Participants With Systemic Embolism
NCT01852162 (5) [back to overview]TRAP-induced Platelet Aggregation
NCT01852162 (5) [back to overview]Clot Kinetic: Clot Stength
NCT01852162 (5) [back to overview]Clot Kinetic: Thrombin Activity
NCT01852162 (5) [back to overview]Platelet Reactivity Measured by Multiple Electrode Aggregometry.
NCT01852162 (5) [back to overview]Platelet Reactivity Measured by LTA
NCT01868243 (2) [back to overview]Spontaneous Echo Contrast
NCT01868243 (2) [back to overview]Intracardiac Thrombus
NCT01895777 (13) [back to overview]Frequency of Dose Adjustment During the Treatment Phase
NCT01895777 (13) [back to overview]Composite Primary Endpoint
NCT01895777 (13) [back to overview]Assessment of the Acceptability of an Age-appropriate Formulation at End of Therapy (Pellets)
NCT01895777 (13) [back to overview]Assessment of the Acceptability of an Age-appropriate Formulation at End of Therapy (Oral Liquid Formulation - OLF)
NCT01895777 (13) [back to overview]Assessment of the Acceptability of an Age-appropriate Formulation at End of Therapy (Capsules)
NCT01895777 (13) [back to overview]All Components of the Primary Efficacy Endpoint
NCT01895777 (13) [back to overview]All Bleeding Events
NCT01895777 (13) [back to overview]Steady State Plasma Concentrations of Total Dabigatran at Visit 3
NCT01895777 (13) [back to overview]Frequency of Patients Switching the Type of Anti-coagulation Therapy Including Dabigatran Etexilate to Standard of Care Treatment and Switching From One Standard of Care Treatment to Another
NCT01895777 (13) [back to overview]Freedom From Thrombus Progression at End of Therapy Compared With Baseline
NCT01895777 (13) [back to overview]Freedom From Major Bleeding Events (MBEs)
NCT01895777 (13) [back to overview]All-cause Mortality
NCT01895777 (13) [back to overview]Steady State Plasma Concentrations After at Least 3 Days Following Any Dabigatran Etexilate Dose Adjustment
NCT01896297 (2) [back to overview]Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose
NCT01896297 (2) [back to overview]Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose
NCT01976507 (3) [back to overview]Number of Participants With Minor Bleeding Events
NCT01976507 (3) [back to overview]Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation.
NCT01976507 (3) [back to overview]Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation.
NCT01999179 (5) [back to overview]PTS Assessment Completion
NCT01999179 (5) [back to overview]Biomarker Sample Collection
NCT01999179 (5) [back to overview]Number of Participants With Major Bleeding
NCT01999179 (5) [back to overview]Number of Participants With Recurrent Thrombosis
NCT01999179 (5) [back to overview]Number of Participants With Post-thrombotic Syndrome
NCT02028780 (8) [back to overview]AUEC2-12
NCT02028780 (8) [back to overview]AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II).
NCT02028780 (8) [back to overview]Ae0-74,ss on Days 4 and 11 for Sum Dabigatran (Part II)
NCT02028780 (8) [back to overview]Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2
NCT02028780 (8) [back to overview]Ae0-73 for the Dose Group 4 in the Part I
NCT02028780 (8) [back to overview]Ae0-72 for Idarucizumab in the Part I & Part II.
NCT02028780 (8) [back to overview]Cmax for Idarucizumab in the Part I & Part II.
NCT02028780 (8) [back to overview]AUC0-inf for Idarucizumab in the Part I & Part II.
NCT02044367 (6) [back to overview]Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.
NCT02044367 (6) [back to overview]Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.
NCT02044367 (6) [back to overview]Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.
NCT02044367 (6) [back to overview]Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.
NCT02044367 (6) [back to overview]Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.
NCT02044367 (6) [back to overview]Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.
NCT02149303 (3) [back to overview]Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release.
NCT02149303 (3) [back to overview]Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
NCT02149303 (3) [back to overview]Index Event Characteristics (i.e. Type of Bleeding and Anatomic Locations of the Index Event) at the Time of the ED / ER Presentation or Hospitalization
NCT02164864 (13) [back to overview]Time to Adjudicated Non-CV
NCT02164864 (13) [back to overview]Time to Adjudicated All Cause Death
NCT02164864 (13) [back to overview]Time to Composite Endpoint of Death or First Thrombotic Event
NCT02164864 (13) [back to overview]Time to Adjudicated Undetermined Cause of Death
NCT02164864 (13) [back to overview]Time to Composite Endpoint of Death + MI + Stroke
NCT02164864 (13) [back to overview]Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG
NCT02164864 (13) [back to overview]Time to First Adjudicated ISTH MBE or CRNMBE
NCT02164864 (13) [back to overview]Time to First Adjudicated MI
NCT02164864 (13) [back to overview]Time to First Adjudicated SE
NCT02164864 (13) [back to overview]Time to First Adjudicated ST
NCT02164864 (13) [back to overview]Time to First Adjudicated Stroke
NCT02164864 (13) [back to overview]Time to First Adjudicated Unplanned Revascularisation by PCI/CABG
NCT02164864 (13) [back to overview]Time to Adjudicated CV
NCT02171611 (21) [back to overview]MRTpo for Free Dabigatran
NCT02171611 (21) [back to overview]Cmax for Total Dabigatran
NCT02171611 (21) [back to overview]Cmax for Free Dabigatran
NCT02171611 (21) [back to overview]CL/F for Free Dabigatran
NCT02171611 (21) [back to overview]AUC0-tz for Total Dabigatran
NCT02171611 (21) [back to overview]AUC0-tz for Free Dabigatran
NCT02171611 (21) [back to overview]AUC0-inf for Total Dabigatran
NCT02171611 (21) [back to overview]λz for Total Dabigatran
NCT02171611 (21) [back to overview]Percentage of Participants With Drug-related Adverse Events
NCT02171611 (21) [back to overview]Tmax for Total Dabigatran
NCT02171611 (21) [back to overview]Assessment of Tolerability by Investigator.
NCT02171611 (21) [back to overview]λz for Free Dabigatran
NCT02171611 (21) [back to overview]Vz/F for Total Dabigatran
NCT02171611 (21) [back to overview]Vz/F for Free Dabigatran
NCT02171611 (21) [back to overview]Tmax for Free Dabigatran
NCT02171611 (21) [back to overview]t1/2 for Total Dabigatran
NCT02171611 (21) [back to overview]t1/2 for Free Dabigatran
NCT02171611 (21) [back to overview]Percentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests.
NCT02171611 (21) [back to overview]CL/F for Total Dabigatran
NCT02171611 (21) [back to overview]AUC0-inf for Free Dabigatran
NCT02171611 (21) [back to overview]MRTpo for Total Dabigatran
NCT02197416 (11) [back to overview]Central Measurement of Diluted Thrombin Time (dTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
NCT02197416 (11) [back to overview]Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
NCT02197416 (11) [back to overview]Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months
NCT02197416 (11) [back to overview]Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
NCT02197416 (11) [back to overview]Central Measurement of Ecarin Clotting Time (ECT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
NCT02197416 (11) [back to overview]Central Measurement of Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
NCT02197416 (11) [back to overview]Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment Period
NCT02197416 (11) [back to overview]Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 Months
NCT02197416 (11) [back to overview]Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months
NCT02197416 (11) [back to overview]Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months
NCT02197416 (11) [back to overview]Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
NCT02223260 (13) [back to overview]Central Measurement: The Mean of dTT Ratio at 2h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
NCT02223260 (13) [back to overview]Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
NCT02223260 (13) [back to overview]Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
NCT02223260 (13) [back to overview]Central Measurement: The Mean ECT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
NCT02223260 (13) [back to overview]Incidence of All AEs During the Treatment Period
NCT02223260 (13) [back to overview]Incidence of All Bleeding Events (Major, CRNM and Minor) During the Treatment Period.
NCT02223260 (13) [back to overview]PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters APTT Values.
NCT02223260 (13) [back to overview]PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters dTT Values.
NCT02223260 (13) [back to overview]PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters ECT Values.
NCT02223260 (13) [back to overview]Global Assessment of Acceptability and Tolerability of Study Medication
NCT02223260 (13) [back to overview]Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
NCT02223260 (13) [back to overview]Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate
NCT02223260 (13) [back to overview]Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
NCT02239120 (10) [back to overview]Adjudicated Ischaemic Stroke
NCT02239120 (10) [back to overview]Adjudicated Recurrent Stroke
NCT02239120 (10) [back to overview]All-cause Death
NCT02239120 (10) [back to overview]Disabling Stroke
NCT02239120 (10) [back to overview]First Major Bleed (Adjudicated)
NCT02239120 (10) [back to overview]Adjudicated Life-threatening Bleed
NCT02239120 (10) [back to overview]Any Bleed (Investigator-reported)
NCT02239120 (10) [back to overview]Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death
NCT02239120 (10) [back to overview]Adjudicated Fatal Bleed
NCT02239120 (10) [back to overview]Adjudicated Intracranial Hemorrhage
NCT02240667 (3) [back to overview]Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.
NCT02240667 (3) [back to overview]Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month
NCT02240667 (3) [back to overview]Number of Patients With the Reason for Definitive Treatment Discontinuation
NCT02348723 (4) [back to overview]Incidence of ISTH MBE, Stroke, Systemic Embolism, or TIA (Composite Endpoint Combining Safety and Efficacy
NCT02348723 (4) [back to overview]Incidence of Minor Bleeding Events
NCT02348723 (4) [back to overview]Incidence of the Composite of Stroke, Systemic Embolism, or Transient Ischemic Attack (TIA)
NCT02348723 (4) [back to overview]Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH)
NCT02415855 (5) [back to overview]Any Parenchymal Haemorrhage (PH1 or PH2)
NCT02415855 (5) [back to overview]Recurrent TIA/Ischemic Stroke
NCT02415855 (5) [back to overview]Symptomatic Hemorrhagic Transformation Rate
NCT02415855 (5) [back to overview]Symptomatic Hemorrhagic Transformation Rate (PH2)
NCT02415855 (5) [back to overview]Systemic Hemorrhagic Complication Rate
NCT02568397 (6) [back to overview]Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time
NCT02568397 (6) [back to overview]Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran
NCT02568397 (6) [back to overview]Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity)
NCT02568397 (6) [back to overview]Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau)
NCT02568397 (6) [back to overview]Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat
NCT02568397 (6) [back to overview]Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time
NCT02631057 (1) [back to overview]Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline
NCT02666742 (12) [back to overview]Number of Participants With Transient Ischemic Attack
NCT02666742 (12) [back to overview]Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours
NCT02666742 (12) [back to overview]Number of Participants With Stroke
NCT02666742 (12) [back to overview]Number of Participants With Retroperitoneal Bleed
NCT02666742 (12) [back to overview]Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD)
NCT02666742 (12) [back to overview]Number of Participants With In-hospital Mortality
NCT02666742 (12) [back to overview]Number of Participants With Heart Block
NCT02666742 (12) [back to overview]Number of Participants With Groin Hematoma
NCT02666742 (12) [back to overview]Number of Participants With Fatal Pulmonary Embolism
NCT02666742 (12) [back to overview]Number of Participants With Cardiac Tamponade
NCT02666742 (12) [back to overview]Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days
NCT02666742 (12) [back to overview]Number of Participants With Acute Procedure Related Complications
NCT02701062 (8) [back to overview]Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates)
NCT02701062 (8) [back to overview]Number of Perioperative Complications Associated With AtriClip Placement
NCT02701062 (8) [back to overview]Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days
NCT02701062 (8) [back to overview]Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)
NCT02701062 (8) [back to overview]Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)
NCT02701062 (8) [back to overview]Number of Subjects With Intraoperative Successful Exclusion of LAA.
NCT02701062 (8) [back to overview]Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values)
NCT02701062 (8) [back to overview]Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values)
NCT02710630 (6) [back to overview]Cmax (Maximum Plasma Concentration of Total Dabigatran)
NCT02710630 (6) [back to overview]Cmax (Maximum Concentration of Free Dabigatran)
NCT02710630 (6) [back to overview]AUC0-tz (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
NCT02710630 (6) [back to overview]AUC0-tz (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
NCT02710630 (6) [back to overview]AUC0-infinity (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)
NCT02710630 (6) [back to overview]AUC0-infinity (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)
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]Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Cumulative Non-Fatal VTE Recurrence at 6 Months (%)
NCT02744092 (11) [back to overview]Cumulative Rates of Major Bleeding
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]Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 6-months
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]Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)
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
NCT02849509 (12) [back to overview]Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B
NCT02849509 (12) [back to overview]Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups
NCT02849509 (12) [back to overview]Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups
NCT02849509 (12) [back to overview]Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment
NCT02849509 (12) [back to overview]Patient Characterization at Baseline - Categorical Parameters
NCT02849509 (12) [back to overview]Patient Characterization at Baseline - Categorical Parameters
NCT02849509 (12) [back to overview]Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score
NCT02849509 (12) [back to overview]Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
NCT02849509 (12) [back to overview]Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment
NCT02849509 (12) [back to overview]Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A
NCT02849509 (12) [back to overview]Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score
NCT02849509 (12) [back to overview]Patient Characteristics at Baseline - Creatinine Clearance
NCT02913326 (8) [back to overview]Cerebral Venous Recanalisation as Measured by the Change in Number of Occluded Cerebral Veins and Sinuses at Week 24
NCT02913326 (8) [back to overview]Percentage of Participants With Clinically Relevant Non-major Bleeding Events in Full Observation Period.
NCT02913326 (8) [back to overview]Percentage of Participants With Composite of Venous Thrombotic Event (VTE) or Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period.
NCT02913326 (8) [back to overview]Percentage of Participants With Major Bleeding According to ISTH Criteria in Full Observation Period
NCT02913326 (8) [back to overview]Percentage of Participants With Major Bleeding According to ISTH Criteria or CRNMBEs After up to 24 Weeks
NCT02913326 (8) [back to overview]Percentage of Participants With Recurring Cerebral Venous and Dural Sinus Thrombosis; DVT of Any Limb, PE or Splanchnic Vein Thrombosis in Full Observation Period
NCT02913326 (8) [back to overview]Percentage of Participants With Any Bleeding Event After up to 24 Weeks
NCT02913326 (8) [back to overview]Composite Endpoint of Percentage of Participants With New Intracranial Haemorrhage or Worsening of the Haemorrhagic Component of a Previous Lesion After up to 24 Weeks
NCT03006341 (17) [back to overview]Percentage of Patients With Obesity
NCT03006341 (17) [back to overview]Percentage of Patients With Uncontrolled Hypertension
NCT03006341 (17) [back to overview]Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs
NCT03006341 (17) [back to overview]Percentage of Patients With Prior Transient Ischemic Attack
NCT03006341 (17) [back to overview]EMR Characteristic: Duration of Atrial Fibrillation
NCT03006341 (17) [back to overview]EMR Characteristic: History/Duration of Congestive Heart Failure (CHF)
NCT03006341 (17) [back to overview]EMR Characteristic: History/Duration of Hypertension
NCT03006341 (17) [back to overview]EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score
NCT03006341 (17) [back to overview]EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR)
NCT03006341 (17) [back to overview]EMR Characteristic: Serum Creatinine
NCT03006341 (17) [back to overview]Percentage of Patients Smoking
NCT03006341 (17) [back to overview]Percentage of Patients With Abnormal Liver Function
NCT03006341 (17) [back to overview]Percentage of Patients With Abnormal Renal Function
NCT03006341 (17) [back to overview]Percentage of Patients With Alcohol Consumption
NCT03006341 (17) [back to overview]Percentage of Patients With Bleeding History or Predisposition
NCT03006341 (17) [back to overview]Percentage of Patients With Diabetes
NCT03006341 (17) [back to overview]Percentage of Patients With Hyperlipidemia
NCT03026556 (13) [back to overview]Hemorrhagic Stroke
NCT03026556 (13) [back to overview]Major Urogenital Bleeding
NCT03026556 (13) [back to overview]Major GI Bleeding
NCT03026556 (13) [back to overview]All-cause Mortality
NCT03026556 (13) [back to overview]Major Intracranial Bleeding
NCT03026556 (13) [back to overview]Ischemic Stroke
NCT03026556 (13) [back to overview]Lower GI Bleeding
NCT03026556 (13) [back to overview]Major Extracranial Bleeding
NCT03026556 (13) [back to overview]Major Other Bleeding
NCT03026556 (13) [back to overview]TIA
NCT03026556 (13) [back to overview]Overall Major Bleeding
NCT03026556 (13) [back to overview]Stroke Overall (Hemorrhagic, Ischemic, Uncertain)
NCT03026556 (13) [back to overview]Upper GI Bleeding
NCT03070171 (6) [back to overview]Cmax of Total Dabigatran
NCT03070171 (6) [back to overview]AUC0-∞ of Free Dabigatran
NCT03070171 (6) [back to overview]AUC0-∞ of Total Dabigatran
NCT03070171 (6) [back to overview]AUC0-tz of Free Dabigatran
NCT03070171 (6) [back to overview]AUC0-tz of Total Dabigatran
NCT03070171 (6) [back to overview]Cmax of Free Dabigatran
NCT03086356 (6) [back to overview]Amount of Idarucizumab Eliminated in Urine Over the Time Interval From 0 to 72 Hours (h) (Ae0-72)
NCT03086356 (6) [back to overview]Area Under the Concentration-time Curve of Idarucizumab in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
NCT03086356 (6) [back to overview]Maximum Measured Concentration of Idarucizumab in Plasma (Cmax)
NCT03086356 (6) [back to overview]For Diluted Thrombin Time: Area After Subtraction of Baseline Area From Area Under the Effect Curve Over the Time Interval From 2 - 12 Hours (AUEC Above,2-12) on Day 4 and Day 11
NCT03086356 (6) [back to overview]For Sum Dabigatran: Amount of the Analyte Excreted in Urine at Steady State Over the Time Interval 0-74 Hours (Ae0-74,ss ) on Day 4 and Day 11
NCT03086356 (6) [back to overview]For Unbound Sum Dabigatran: Area Under the Concentration-time Curve of the Dabigatran in Plasma at Steady State Over the Time Interval 2 Hours-12 Hours
NCT03143166 (6) [back to overview]Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
NCT03143166 (6) [back to overview]Maximum Concentration of Total Dabigatran in Plasma (Cmax).
NCT03143166 (6) [back to overview]Maximum Concentration of Free Dabigatran in Plasma (Cmax).
NCT03143166 (6) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Total Dabigatran (AUC0-tz).
NCT03143166 (6) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Free Dabigatran (AUC0-tz).
NCT03143166 (6) [back to overview]Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
NCT03175198 (1) [back to overview]Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
NCT03187197 (4) [back to overview]Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
NCT03187197 (4) [back to overview]Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
NCT03187197 (4) [back to overview]Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
NCT03187197 (4) [back to overview]Description of PACT-Q1 Items for Patients in Cohort B at Baseline
NCT03254134 (2) [back to overview]Incidence Rate of Major Bleeding
NCT03254134 (2) [back to overview]Incidence Rate of Stroke and Systemic Embolism (SE)
NCT03254147 (2) [back to overview]The Number of Patients With Cardiac Tamponade and Pericardiocentesis.
NCT03254147 (2) [back to overview]The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.
NCT03258645 (12) [back to overview]Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event)
NCT03258645 (12) [back to overview]Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
NCT03258645 (12) [back to overview]Age of Patients According to Dabigatran Initiation Time Period
NCT03258645 (12) [back to overview]CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period
NCT03258645 (12) [back to overview]Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period
NCT03258645 (12) [back to overview]HAS-BLED of Patients According to Dabigatran Initiation Time Period
NCT03258645 (12) [back to overview]National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
NCT03258645 (12) [back to overview]Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period
NCT03258645 (12) [back to overview]Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
NCT03258645 (12) [back to overview]Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
NCT03258645 (12) [back to overview]Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
NCT03258645 (12) [back to overview]Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
NCT03311841 (18) [back to overview]Apparent Volume of Distribution During the Terminal Phase (Vz/F) Post-dose Period 1
NCT03311841 (18) [back to overview]Apparent Plasma Terminal Half-life (t1/2) Post-dose Period 1
NCT03311841 (18) [back to overview]Apparent Clearance After Extravascular Administration (CL/F) Post-dose Period 1
NCT03311841 (18) [back to overview]Time to Maximum Plasma Concentration (Tmax) Post-dose Period 1
NCT03311841 (18) [back to overview]Plasma Concentration at 24 Hours (C24) Post-dose Period 1
NCT03311841 (18) [back to overview]Maximum Plasma Concentration (Cmax) Post-dose Period 1
NCT03311841 (18) [back to overview]Effect of Rifampin on Vz/F Post-dose Period 2
NCT03311841 (18) [back to overview]Effect of Rifampin on Tmax Post-dose Period 2
NCT03311841 (18) [back to overview]Effect of Rifampin on t1/2 Post-dose Period 2
NCT03311841 (18) [back to overview]Effect of Rifampin on Cmax Post-dose Period 2
NCT03311841 (18) [back to overview]Effect of Rifampin on CL/F Post-dose Period 2
NCT03311841 (18) [back to overview]Effect of Rifampin on C24 Post-dose Period 2
NCT03311841 (18) [back to overview]Effect of Rifampin on AUC0-last Post-dose Period 2
NCT03311841 (18) [back to overview]Effect of Rifampin on AUC0-inf Post-dose Period 2
NCT03311841 (18) [back to overview]Effect of Rifampin on AUC0-24 Post-dose Period 2
NCT03311841 (18) [back to overview]Area Under the Plasma Concentration-time Curve From Time 0 to Last (AUC0-last) Post-dose Period 1
NCT03311841 (18) [back to overview]Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) Post-dose Period 1
NCT03311841 (18) [back to overview]Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) Post-dose Period 1
NCT03441633 (10) [back to overview]International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
NCT03441633 (10) [back to overview]Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)
NCT03441633 (10) [back to overview]Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
NCT03441633 (10) [back to overview]Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)
NCT03441633 (10) [back to overview]Risk of Thromboembolic Events: CHADS2 Score
NCT03441633 (10) [back to overview]Risk of Thromboembolic Events: CHA2DS2Vasc Score
NCT03441633 (10) [back to overview]Risk of Bleeding Events: HAS-BLED Score
NCT03441633 (10) [back to overview]Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year
NCT03441633 (10) [back to overview]Number of Participants by Comorbidity
NCT03441633 (10) [back to overview]Number of Participants by Comedications
NCT03492437 (12) [back to overview]Apparent Volume of Distribution During Terminal Phase (Vz/f) of Total Dabigatran
NCT03492437 (12) [back to overview]Area Under Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Total Dabigatran
NCT03492437 (12) [back to overview]Number of Participants With Clinically Significant Changes in Laboratory Values
NCT03492437 (12) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Total Dabigatran
NCT03492437 (12) [back to overview]Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total Dabigatran
NCT03492437 (12) [back to overview]Elimination Half Life (t1/2) of Total Dabigatran
NCT03492437 (12) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
NCT03492437 (12) [back to overview]Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Findings
NCT03492437 (12) [back to overview]Apparent Clearance (CL/f) of Total Dabigatran
NCT03492437 (12) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of Total Dabigatran
NCT03492437 (12) [back to overview]Percentage of Area Under the Plasma Concentration-Time Curve From Time Tlast Extrapolated to Infinity (AUC0-inf) Obtained by Extrapolation (AUCextra%) of Total Dabigatran
NCT03492437 (12) [back to overview]Number of Participants With Clinically Significant Changes in Vital Signs
NCT03572972 (16) [back to overview]Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT04459585 (9) [back to overview]Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants
NCT04459585 (9) [back to overview]Time of Maximum Plasma Concentration (Tmax) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib
NCT04459585 (9) [back to overview]Maximum Plasma Concentration (Cmax) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants
NCT04459585 (9) [back to overview]Area Under the Plasma Concentration-Time Curve From Time 0 to 74 Hours (AUClast,74) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants
NCT04459585 (9) [back to overview]Area Under the Plasma Concentration-Time Curve up to Infinity (AUCinf) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib
NCT04459585 (9) [back to overview]Area Under the Plasma Concentration-Time Curve up to the Last Quantifiable Concentration Post-Dose (AUClast) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib
NCT04459585 (9) [back to overview]Maximum Plasma Concentration (Cmax) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib
NCT04459585 (9) [back to overview]Number of Participants Reporting Treatment-Emergent Adverse Events (TEAE) Relatedness to Study Medication Following Single Dose of Dabigatran Without and With Quizartinib in Participants
NCT04459585 (9) [back to overview]Terminal Elimination Half-Life (T1/2) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation
NCT05022563 (60) [back to overview]Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months
NCT05022563 (60) [back to overview]Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months
NCT05022563 (60) [back to overview]Number of Participants Who Switched to Another Anticoagulant Therapy
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Interruption in Index Anticoagulant Treatment
NCT05022563 (60) [back to overview]Time to Treatment Discontinuation
NCT05022563 (60) [back to overview]Time to Treatment Interruption
NCT05022563 (60) [back to overview]Time to Treatment Switch
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants Who Completely Discontinued Index Anticoagulant Treatment
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Overall Index Anticoagulant Treatment Duration
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event

Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period

"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma greater than or equal to 25 cm²~wound hematoma greater than or equal to 100 cm²~spontaneous nose bleed lasting longer than 5 min~macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding lasting longer than 5 min~any other bleeding event considered clinically relevant by the investigator~Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above." (NCT00152971)
Timeframe: First administration until 12-15 days

,,
InterventionParticipants (Number)
MajorClinically relevantMinorNone
Dabigatran 150mg52245799
Dabigatran 220mg52346783
Enoxaparin122151784

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Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period

Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee (NCT00152971)
Timeframe: First administration until 12-15 days

InterventionParticipants (Number)
Dabigatran 220mg7
Dabigatran 150mg6
Enoxaparin5

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Number of Participants With Total Deep Vein Thrombosis During Treatment Period

Total Deep Vein Thrombosis as adjudicated by the VTE events committee (NCT00152971)
Timeframe: First administration until 12-15 days

InterventionParticipants (Number)
Dabigatran 220mg184
Dabigatran 150mg218
Enoxaparin158

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Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period

"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients." (NCT00152971)
Timeframe: First administration until 12-15 days

InterventionParticipants (Number)
Dabigatran 220mg188
Dabigatran 150mg219
Enoxaparin163

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Number of Participants Who Died During Treatment Period

All cause death, as adjudicated by the VTE events committee (NCT00152971)
Timeframe: First administration until 12-15 days

InterventionParticipants (Number)
Dabigatran 220mg1
Dabigatran 150mg1
Enoxaparin0

[back to top] [back to top]

Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period

Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee (NCT00152971)
Timeframe: First administration until 12-15 days

InterventionParticipants (Number)
Dabigatran 220mg15
Dabigatran 150mg20
Enoxaparin10

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Number of Participants With Pulmonary Embolism During Treatment Period

Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee (NCT00152971)
Timeframe: First administration until 12-15 days

InterventionParticipants (Number)
Dabigatran 220mg6
Dabigatran 150mg0
Enoxaparin5

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Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period

Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). (NCT00152971)
Timeframe: 3 months

,,
InterventionParticipants (Number)
Total VTE and all-cause mortalityasymptotic Deep Vein Thrombosissymptotic Deep Vein ThrombosisPulmonary Embolismdeath
Dabigatran 150mg71402
Dabigatran 220mg72221
Enoxaparin104222

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Severe Adverse Event

Frequency of patients with severe adverse events. (NCT00157248)
Timeframe: 5 years

Interventionparticipants (Number)
50 mg Once Daily0
50 mg Twice Daily5
150 mg Once Daily13
150 mg Twice Daily96
300 mg Once Daily28
300 mg Twice Daily16

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Yearly Event Rate of Haemorrhagic Stroke

Time to first occurrence of any haemorrhagic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25 (NCT00157248)
Timeframe: 5 years

Interventionyearly event rate (percentage) (Number)
50 mg Once Daily0.0
50 mg Twice Daily0.0
150 mg Once Daily0.0
150 mg Twice Daily0.6
300 mg Once Daily0.0
300 mg Twice Daily0.0

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Yearly Event Rate of Death

Time to death of any cause. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25 (NCT00157248)
Timeframe: 5 years

Interventionyearly event rate (percentage) (Number)
50 mg Once Daily0.0
50 mg Twice Daily0.0
150 mg Once Daily0.0
150 mg Twice Daily2.7
300 mg Once Daily2.1
300 mg Twice Daily0.0

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Yearly Event Rate for Transient Ischaemic Attacks

Time to first occurrence of any transient ischaemic attacks. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25 (NCT00157248)
Timeframe: 5 years

Interventionyearly event rate (percentage) (Number)
50 mg Once Daily0.0
50 mg Twice Daily0.0
150 mg Once Daily0.0
150 mg Twice Daily0.2
300 mg Once Daily0.4
300 mg Twice Daily0.0

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Yearly Event Rate for Systemic Thromboembolism

"Time to first occurrence of any non-central nervous system systemic thromboembolism.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25" (NCT00157248)
Timeframe: 5 years

Interventionyearly event rate (percentage) (Number)
50 mg Once Daily0.0
50 mg Twice Daily8.5
150 mg Once Daily0.0
150 mg Twice Daily0.2
300 mg Once Daily0.4
300 mg Twice Daily1.2

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Yearly Event Rate for Stroke

Time to first occurrence of any fatal or non-fatal stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25 (NCT00157248)
Timeframe: 5 years

Interventionyearly event rate (percentage) (Number)
50 mg Once Daily0.0
50 mg Twice Daily4.3
150 mg Once Daily5.0
150 mg Twice Daily1.1
300 mg Once Daily1.7
300 mg Twice Daily0.0

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Yearly Event Rate for Major Bleeding

"Time to first occurrence of fatal or life-threatening, retroperitoneal, intracranial, intraocular, or intraspinal bleeding, which required surgical treatment, led to a transfusion of a minimum of 2 units of packed cells or whole blood, or led to a fall in hemoglobin of 20g/L or less.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25" (NCT00157248)
Timeframe: 5 years

Interventionyearly event rate (percentage) (Number)
50 mg Once Daily0.0
50 mg Twice Daily0.0
150 mg Once Daily6.6
150 mg Twice Daily3.1
300 mg Once Daily0.8
300 mg Twice Daily7.3

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Yearly Event Rate for Major + Minor/Relevant Bleeding

Time to first occurrence of either major or minor/relevant bleeding. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25 (NCT00157248)
Timeframe: 5 years

Interventionyearly event rate (percentage) (Number)
50 mg Once Daily0.0
50 mg Twice Daily8.5
150 mg Once Daily11.6
150 mg Twice Daily7.6
300 mg Once Daily6.6
300 mg Twice Daily26.8

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Yearly Event Rate for Composite Secondary Endpoint of Ischaemic Stroke, Transient Ischaemic Attacks, Non-central Nervous System Systemic Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and All-cause Mortality

"Time to first occurrence of ischaemic stroke, transient ischaemic attacks, non-central nervous system systemic thromboembolism, myocardial infarction, other major adverse cardiac events and all-cause mortality.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25" (NCT00157248)
Timeframe: 5 years

Interventionyearly event rate (percentage) (Number)
50 mg Once Daily0.0
50 mg Twice Daily17.0
150 mg Once Daily5.0
150 mg Twice Daily5.5
300 mg Once Daily4.5
300 mg Twice Daily2.4

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Yearly Event Rate for Minor Bleeding

"Time to first occurrence of minor bleeding. A minor bleeding event is any bleed that does not qualify as a major bleed. All minor bleeding events not fulfilling one of the criteria for clinically relevant were classified as nuisance bleeds.~Clinically-relevant was defined as spontaneous skin hematoma ≥25 cm², spontaneous nose bleed >5 min, macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention, spontaneous rectal bleeding, gingival bleeding >5 min, leading to hospitalization, leading to a transfusion of <2 units of packed cells or whole blood and any other bleeding event considered clinically relevant by the investigator.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25" (NCT00157248)
Timeframe: 5 years

,,,,,
Interventionyearly event rate (percentage) (Number)
Clinically relevantNuisance only
150 mg Once Daily5.09.9
150 mg Twice Daily4.57.1
300 mg Once Daily5.88.3
300 mg Twice Daily19.531.7
50 mg Once Daily0.00.0
50 mg Twice Daily8.517.0

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Laboratory Analyses

"Frequency of patients with possible clinically significant abnormalities, i.e. with values out of normal range.~Normal ranges are defined as:~Alanine aminotransferase (ALT): 5-45 [U/L]~Aspartate aminotransferase (AST): 10-40 [U/L]~Bilirubin, total: 0.2-1.0 [mg/dL]" (NCT00157248)
Timeframe: 5 years

,,,,,
Interventionparticipants (Number)
AST > 3*ULNALT > 3*ULNBilirubin > 2*ULN
150 mg Once Daily000
150 mg Twice Daily1095
300 mg Once Daily342
300 mg Twice Daily120
50 mg Once Daily000
50 mg Twice Daily000

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Yearly Event Rate of Other Major Adverse Cardiac Events

Time to first occurrence of any other major adverse cardiac events. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25 (NCT00157248)
Timeframe: 5 years

Interventionyearly event rate (percentage) (Number)
50 mg Once Daily0.0
50 mg Twice Daily8.5
150 mg Once Daily0.0
150 mg Twice Daily1.1
300 mg Once Daily0.8
300 mg Twice Daily1.2

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Yearly Event Rate of Myocardial Infarction

Time to first occurrence of any myocardial infarction. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25 (NCT00157248)
Timeframe: 5 years

Interventionyearly event rate (percentage) (Number)
50 mg Once Daily0.0
50 mg Twice Daily0.0
150 mg Once Daily0.0
150 mg Twice Daily1.1
300 mg Once Daily0.4
300 mg Twice Daily0.0

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Yearly Event Rate of Ischaemic Stroke

Time to first occurrence of any ischaemic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25 (NCT00157248)
Timeframe: 5 years

Interventionyearly event rate (percentage) (Number)
50 mg Once Daily0.0
50 mg Twice Daily4.3
150 mg Once Daily5.0
150 mg Twice Daily0.5
300 mg Once Daily1.7
300 mg Twice Daily0.0

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Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.

Time to first occurrence of stroke, transient ischaemic attacks, system thromboembolism, myocardial infarction, other major adverse cardiac events and mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25 (NCT00157248)
Timeframe: 5 years

Interventionyearly event rate (percentage) (Number)
50 mg Once Daily0.0
50 mg Twice Daily17.0
150 mg Once Daily5.0
150 mg Twice Daily5.7
300 mg Once Daily4.5
300 mg Twice Daily2.4

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Yearly Event Rate for Any Bleeding

Time to first occurrence of any bleeding event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25 (NCT00157248)
Timeframe: 5 years

Interventionyearly event rate (percentage) (Number)
50 mg Once Daily0.0
50 mg Twice Daily25.5
150 mg Once Daily21.5
150 mg Twice Daily14.7
300 mg Once Daily14.9
300 mg Twice Daily58.5

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Blood Transfusion

Blood transfusion for treated and operated patients on Day of surgery. (NCT00168805)
Timeframe: Day 1

,,
Interventionparticipants (Number)
Patients with >=1 transfusionsPatients with >=1 non-autologous transfusions
Dabigatran 150mg25386
Dabigatran 220mg24287
Enoxaparin265120

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Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period

Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). (NCT00168805)
Timeframe: 3 months

,,
InterventionParticipants (Number)
Total VTE and all-cause mortalityasymptotic Deep Vein Thrombosissymptotic Deep Vein ThrombosisPulmonary Embolismdeath
Dabigatran 150mg31200
Dabigatran 220mg40121
Enoxaparin20002

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Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period

"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma greater than or equal to 25 cm²~wound hematoma greater than or equal to 100 cm²~spontaneous nose bleed lasting longer than 5 min~macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding lasting longer than 5 min~any other bleeding event considered clinically relevant by the investigator~Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above." (NCT00168805)
Timeframe: First administration until 6-10 days

,,
InterventionParticipants (Number)
MajorClinically relevantMinorNone
Dabigatran 150mg94859587
Dabigatran 220mg104060569
Enoxaparin93769579

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Number of Participants Who Died During Treatment Period

All cause death, as adjudicated by the VTE events committee (NCT00168805)
Timeframe: First administration until 6-10 days

InterventionParticipants (Number)
Dabigatran 220mg1
Dabigatran 150mg1
Enoxaparin1

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Laboratory Analyses

Frequency of patients with possible clinically significant abnormalities. (NCT00168805)
Timeframe: First administration to end of study

,,
Interventionparticipants (Number)
AST increase N=(620;645;636)AST decrease N=(620;645;636)ALT increase N=(621;645;637)ALT decrease N=(621;645;637)Bilirubin increase N=(619;644;635)Bilirubin decrease N=(619;644;635)
Dabigatran 150mg60210230
Dabigatran 220mg90160190
Enoxaparin90240140

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Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period

Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee (NCT00168805)
Timeframe: First administration until 6-10 days

InterventionParticipants (Number)
Dabigatran 220mg13
Dabigatran 150mg18
Enoxaparin17

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Number of Participants With Pulmonary Embolism During Treatment Period

Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee (NCT00168805)
Timeframe: First administration until 6-10 days

InterventionParticipants (Number)
Dabigatran 220mg0
Dabigatran 150mg1
Enoxaparin1

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Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period

Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee (NCT00168805)
Timeframe: First administration until 6-10 days

InterventionParticipants (Number)
Dabigatran 220mg1
Dabigatran 150mg3
Enoxaparin8

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Number of Participants With Total Deep Vein Thrombosis During Treatment Period

Total Deep Vein Thrombosis as adjudicated by the VTE events committee (NCT00168805)
Timeframe: First administration until 6-10 days

InterventionParticipants (Number)
Dabigatran 220mg182
Dabigatran 150mg211
Enoxaparin192

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Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period

"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients." (NCT00168805)
Timeframe: First administration until 6-10 days

InterventionParticipants (Number)
Dabigatran 220mg183
Dabigatran 150mg213
Enoxaparin193

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Volume of Blood Loss

Volume of blood loss for treated and operated patients during surgery. (NCT00168805)
Timeframe: Day 1

InterventionmL (Mean)
Dabigatran 220mg187
Dabigatran 150mg190
Enoxaparin191

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Laboratory Analyses

Frequency of patients with possible clinically significant abnormalities. (NCT00168818)
Timeframe: First administration to end of study

,,
Interventionparticipants (Number)
AST increase N=(1103;1097;1103)AST decrease N=(1103;1097;1103)ALT increase N=(1103;1098;1103)ALT decrease N=(1103;1098;1103)Bilirubin increase N=(1102;1094;1102)Bilirubin decrease N=(1102;1094;1102)
Dabigatran 150mg160290240
Dabigatran 220mg110280250
Enoxaparin290590340

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Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period

"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma greater than or equal to 25 cm²~wound hematoma greater than or equal to 100 cm²~spontaneous nose bleed lasting longer than 5 min~macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding lasting longer than 5 min~any other bleeding event considered clinically relevant by the investigator~Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above." (NCT00168818)
Timeframe: First administration until 31-38 days

,,
InterventionParticipants (Number)
MajorClinical relevantMinorNone
Dabigatran 150mg1555721021
Dabigatran 220mg2348701005
Enoxaparin1840741022

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Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period

Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). (NCT00168818)
Timeframe: end of treatment to day 91±7

,,
InterventionParticipants (Number)
Total VTE and all-cause mortalityasymptotic Deep Vein Thrombosissymptotic Deep Vein ThrombosisPulmonary Embolismdeath
Dabigatran 150mg41102
Dabigatran 220mg10100
Enoxaparin53011

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Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period

"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients." (NCT00168818)
Timeframe: First administration until 31-38 days

InterventionParticipants (Number)
Dabigatran 220mg53
Dabigatran 150mg75
Enoxaparin60

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Symptomatic Deep Vein Thrombosis During Treatment Period

Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee (NCT00168818)
Timeframe: First administration until 31-38 days

InterventionParticipants (Number)
Dabigatran 220mg6
Dabigatran 150mg9
Enoxaparin1

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Total Deep Vein Thrombosis During Treatment Period

Total Deep Vein Thrombosis as adjudicated by the VTE events committee (NCT00168818)
Timeframe: First administration until 31-38 days

InterventionParticipants (Number)
Dabigatran 220mg46
Dabigatran 150mg72
Enoxaparin57

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Proximal Deep Vein Thrombosis During Treatment Period

Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee (NCT00168818)
Timeframe: First administration until 31-38 days

InterventionParticipants (Number)
Dabigatran 220mg23
Dabigatran 150mg35
Enoxaparin33

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Pulmonary Embolism During Treatment Period

Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee (NCT00168818)
Timeframe: First administration until 31-38 days

InterventionParticipants (Number)
Dabigatran 220mg5
Dabigatran 150mg1
Enoxaparin3

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Volume of Blood Loss

Volume of blood loss for treated and operated patients during surgery. (NCT00168818)
Timeframe: Day 1

InterventionmL (Mean)
Dabigatran 220mg457
Dabigatran 150mg435
Enoxaparin463

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Blood Transfusion

Blood transfusion for treated and operated patients on Day of surgery. (NCT00168818)
Timeframe: Day 1

,,
Interventionparticipants (Number)
Patients with >=1 transfusionsPatients with >=1 non-autologous transfusions
Dabigatran 150mg531266
Dabigatran 220mg517259
Enoxaparin542286

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Death During Treatment Period

All cause death, as adjudicated by the VTE events committee (NCT00168818)
Timeframe: First administration until 31-38 days

InterventionParticipants (Number)
Dabigatran 220mg3
Dabigatran 150mg3
Enoxaparin0

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Number of Participants With Bleeding Events During Treatment Period

"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=2g/dL in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding >5 min~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above." (NCT00246025)
Timeframe: 2 weeks

,,,
Interventionparticipants (Number)
Major bleeding eventsMajor and clinically relevant bleeding eventsAny bleeding events
Dabigatran Etexilate 110 mg1113
Dabigatran Etexilate 150 mg0113
Dabigatran Etexilate 220 mg3514
Treatment Group With Placebo1410

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Laboratory Analyses

Frequency of patients with possible clinically significant abnormalities. (NCT00246025)
Timeframe: First administration to end of study

,,,
Interventionparticipants (Number)
AST increase N=(120;131;122;126)AST decrease N=(120;131;122;126)ALT increase N=(120;131;122;126)ALT decrease N=(120;131;122;126)Bilirubin increase N=(120;130;122;127)Bilirubin decrease N=(120;130;122;127)
Dabigatran Etexilate 110 mg100010
Dabigatran Etexilate 150 mg001000
Dabigatran Etexilate 220 mg000000
Treatment Group With Placebo202000

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Blood Transfusion

Blood transfusion for treated and operated patients on Day of surgery. (NCT00246025)
Timeframe: Day 0

,,,
Interventionparticipants (Number)
AutologousHomologousAutologous and homologous
Dabigatran Etexilate 110 mg8240
Dabigatran Etexilate 150 mg7740
Dabigatran Etexilate 220 mg7623
Treatment Group With Placebo7550

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Volume of Blood Loss

Volume of blood loss for treated and operated patients during surgery. (NCT00246025)
Timeframe: Day 0

InterventionmL (Mean)
Treatment Group With Placebo82.8
Dabigatran Etexilate 110 mg90.5
Dabigatran Etexilate 150 mg67.5
Dabigatran Etexilate 220 mg77.3

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Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)

Number of Participants expressing DVT with symptoms (NCT00246025)
Timeframe: 2 weeks

InterventionPercentage of participants (Number)
Treatment Group With Placebo1.6
Dabigatran Etexilate 110 mg0.8
Dabigatran Etexilate 150 mg1.6
Dabigatran Etexilate 220 mg0.8

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Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period

Number of participants who have Total DVT during treatment period (NCT00246025)
Timeframe: 2 weeks

Interventionpercentage of participants (Number)
Treatment Group With Placebo56.4
Dabigatran Etexilate 110 mg39.6
Dabigatran Etexilate 150 mg32.7
Dabigatran Etexilate 220 mg24.0

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Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period

Number of participants who have Proximal DVT during treatment period (NCT00246025)
Timeframe: 2 weeks

Interventionpercentage of participants (Number)
Treatment Group With Placebo5.8
Dabigatran Etexilate 110 mg1.7
Dabigatran Etexilate 150 mg1.8
Dabigatran Etexilate 220 mg0

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Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.

number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality (NCT00246025)
Timeframe: 2 weeks study medication

Interventionpercentage of participants (Number)
Treatment Group With Placebo56.4
Dabigatran Etexilate 110 mg39.6
Dabigatran Etexilate 150 mg32.7
Dabigatran Etexilate 220 mg24

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Number of Participants With Pulmonary Embolism During Treatment Period

Pulmonary embolism confirmed by pulmonary scintigraphy, pulmonary angiography or contrast CT. (NCT00246025)
Timeframe: 2 weeks

Interventionpercentage of participants (Number)
Treatment Group With Placebo0.0
Dabigatran Etexilate 110 mg0.0
Dabigatran Etexilate 150 mg0.0
Dabigatran Etexilate 220 mg0.0

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Number of Participants Who Died During Treatment Period

All cause death, as adjudicated by the VTE events committee. (NCT00246025)
Timeframe: 2 weeks

Interventionpercentage of participants (Number)
Treatment Group With Placebo0.0
Dabigatran Etexilate 110 mg0.0
Dabigatran Etexilate 150 mg0.0
Dabigatran Etexilate 220 mg0.0

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Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death

Time to first occurrence of stroke, SEE or all cause death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25 (NCT00262600)
Timeframe: 36 months

Interventionyearly event rate (percentage) (Number)
Dabigatran 110 mg4.85
Dabigatran 150 mg4.32
Warfarin5.20

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Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death

Time to first occurrence of stroke, systemic embolic event, pulmonary embolism, myocardial infarction including silent myocardial infarction or vascular death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25 (NCT00262600)
Timeframe: 36 months

Interventionyearly event rate (percentage) (Number)
Dabigatran 110 mg4.26
Dabigatran 150 mg3.68
Warfarin4.35

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Bleeding Events (Major and Minor)

"Yearly event rate of bleeds. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25~Major bleeds are adjudicated, whereas minor bleeds are investigator reported." (NCT00262600)
Timeframe: 36 months

,,
Interventionyearly event rate (percentage) (Number)
Major bleedsMinor bleeds
Dabigatran 110 mg2.9913.16
Dabigatran 150 mg3.5514.85
Warfarin3.8116.37

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Abnormal Liver Function Test

Number of subjects with abnormal liver function test (LFT), i.e., ALT/AST>3xULN and total bilirubin > 2 x ULN (NCT00262600)
Timeframe: 36 months

Interventionparticipants (Number)
Dabigatran 110 mg11
Dabigatran 150 mg14
Warfarin21

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Yearly Event Rate for Composite Endpoint of Stroke/SEE

Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25 (NCT00262600)
Timeframe: 36 months

Interventionyearly event rate (percentage) (Number)
Dabigatran 110 mg1.54
Dabigatran 150 mg1.11
Warfarin1.71

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Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)

Patients with clinical relevant abnormalities for intracerebral hemorrhage, other intracranial hemorrhage (ICH) (NCT00262600)
Timeframe: 36 months

,,
Interventionyearly event rate (percentage)] (Number)
intracerebral hemorrhageintracranial hemorrhage (ICH)
Dabigatran 110 mg0.120.23
Dabigatran 150 mg0.100.32
Warfarin0.380.76

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Number of Participants With Bleeding Events

"Major bleeding events (MBE) were defined as~Fatal bleeding~Symptomatic bleeding in a critical area or organ~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells~Clinically-relevant bleeding events (CRBE) was defined as~spontaneous skin hematoma >=25 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding (more than spotting on toilet paper)~gingival bleeding >5 min~leading to hospitalisation and / or requiring surgical treatment~leading to a transfusion of <2 units of whole blood or red cells~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above." (NCT00291330)
Timeframe: From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)

,
Interventionparticipants (Number)
Major bleeding eventsMBE and/or CRBEAny bleeding events
Dabigatran 150 mg2071207
Warfarin24111280

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Laboratory Analyses

Frequency of patients with possible clinically significant abnormalities. (NCT00291330)
Timeframe: From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)

,
Interventionparticipants (Number)
AST increaseAST decreaseALT increaseALT decreaseBilirubin increaseBilirubin decrease
Dabigatran 150 mg21026070
Warfarin220380130

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Number of Participants Who Died (Any Cause)

Any deaths which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00291330)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.

,
Interventionparticipants (Number)
Participants with event (up to day 180)Participants with event (up to end of ptp)
Dabigatran 150 mg2125
Warfarin2125

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Number of Participants Who Died Due to VTE

"VTE - related deaths which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee." (NCT00291330)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.

,
Interventionparticipants (Number)
Participants with event (up to day 180)Participants with event (up to end of ptp)
Dabigatran 150 mg11
Warfarin33

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Number of Participants With Acute Coronary Syndrome (ACS)

"Any ACS occurring during the conduct of the study (centrally adjudicated as definite).~Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee." (NCT00291330)
Timeframe: From first intake of study drug to end of study conduct

,
Interventionparticipants (Number)
During intake of active study drugAfter stopping active study drugBefore/without intake of active study drug
Dabigatran 150 mg542
Warfarin320

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Number of Participants With Recurrent Symptomatic DVT

"Symptomatic DVT which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee." (NCT00291330)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.

,
Interventionparticipants (Number)
Participants with event (up to day 180)Participants with event (up to end of ptp)
Dabigatran 150 mg1617
Warfarin1822

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Number of Participants With Recurrent Symptomatic Non-fatal PE

"Symptomatic non-fatal PE which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee." (NCT00291330)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.

,
Interventionparticipants (Number)
Participants with event (up to day 180)Participants with event (up to end of ptp)
Dabigatran 150 mg1316
Warfarin78

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Number of Participants With Recurrent Symptomatic VTE and All Deaths

"VTE or any death which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee." (NCT00291330)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.

,
InterventionParticipants (Number)
Participants with event (up to day 180)Participants with event (up to end of ptp)
Dabigatran 150 mg4855
Warfarin4453

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DVT at 18 Months

Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation. (NCT00329238)
Timeframe: 18 months

,
InterventionParticipants (Number)
Number of participants with eventNumber of participants with no event
Dabigatran151415
Warfarin121414

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Deep Vein Thrombosis (DVT) at 36 Months

Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation. (NCT00329238)
Timeframe: 36 months

,
InterventionParticipants (Number)
Number of participants with eventNumber of participants with no event
Dabigatran171413
Warfarin131413

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Symptomatic Pulmonary Embolism (PE) at 18 Months

Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography. (NCT00329238)
Timeframe: 18 months

,
InterventionParticipants (Number)
Number of participants with eventNumber of participants with no event
Dabigatran81422
Warfarin51421

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Number of Participants With Definite Acute Coronary Syndrome (ACS)

All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner. (NCT00329238)
Timeframe: day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination

,
Interventionparticipants (Number)
During intake of study drug, N=1430 , N=1415After stopping study drug, N=1426, N=1400
Dabigatran121
Warfarin25

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Number of Participants With Bleeding Events

"MBE (major bleeding event) if it fulfilled at least one of the following criteria~Fatal bleeding~Symptomatic bleeding in a critical area or organ.~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.~Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs~CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria~Spontaneous skin haematoma ≥25 cm2~Spontaneous nose bleed >5 min duration~Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h~Spontaneous rectal bleeding~Gingival bleeding >5 min~Bleeding leading to hospitalisation or requiring surgical treatment~Bleeding leading to a transfusion of <2 units of whole blood or red cells~Any other bleeding event considered clinically relevant by the investigator" (NCT00329238)
Timeframe: first intake of study drug until 6 days following last intake of study drug

,
Interventionparticipants (Number)
patients with MBEpatients with MBE and /or CRBEpatients with any bleeding event
Dabigatran1380277
Warfarin25145373

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Laboratory Analysis

Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality). (NCT00329238)
Timeframe: 18 months + 30 days follow up

,
Interventionparticipants (Number)
ALT increaseAST increaseAlkaline phosphataseTotal bilirubin
Dabigatran262399
Warfarin3023148

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Deaths of All Causes at 36 Months

Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments. (NCT00329238)
Timeframe: 36 months

,
InterventionParticipants (Number)
Number of participants with eventNumber of participants with no event
Dabigatran171413
Warfarin191407

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Deaths of All Causes at 18 Months

Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments. (NCT00329238)
Timeframe: 18 months

,
InterventionParticipants (Number)
Number of participants with eventNumber of participants with no event
Dabigatran151415
Warfarin161410

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Composite of Recurrent VTE or VTE Death at 36 Months

Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE. (NCT00329238)
Timeframe: 36 months

,
InterventionParticipants (Number)
Number of participants with eventNumber of participants with no event
Dabigatran261404
Warfarin181408

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Composite of Recurrent VTE or VTE Death at 18 Months

Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE. (NCT00329238)
Timeframe: 18 months

,
InterventionParticipants (Number)
Number of participants with eventNumber of participants with no event
Dabigatran221408
Warfarin171409

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Composite of Recurrent VTE or All Cause Death at 36 Months

Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. (NCT00329238)
Timeframe: 36 months

,
InterventionParticipants (Number)
Number of participants with eventNumber of participants with no event
Dabigatran421388
Warfarin361390

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Composite of Recurrent VTE or All Cause Death at 18 Months

Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. (NCT00329238)
Timeframe: 18 months

,
InterventionParticipants (Number)
Number of participants with eventNumber of participants with no event
Dabigatran361394
Warfarin321394

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Symptomatic Pulmonary Embolism (PE) at 36 Months

Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography. (NCT00329238)
Timeframe: 36 months

,
InterventionParticipants (Number)
Number of participants with eventNumber of participants with no event
Dabigatran101420
Warfarin51421

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Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period

Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event. (NCT00558259)
Timeframe: 6 months

InterventionParticipants (Number)
Dabigatran3
Placebo37

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Centrally Confirmed Unexplained Deaths During the Intended Treatment Period

Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described. (NCT00558259)
Timeframe: 6 months

Interventionparticipants (Number)
Dabigatran0
Placebo2

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Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period

Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described. (NCT00558259)
Timeframe: 6 months

InterventionParticipants (Number)
Dabigatran1
Placebo14

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Centrally Confirmed Bleeding Event During the Treatment Period

"Major bleeding events (MBE) had to fulfil at least 1 of the following criteria:~Fatal bleeding~Associated with a fall in haemoglobin of ≥2 g/dL~Led to the transfusion of ≥2 units packed cells or whole blood~Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal~Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.~Examples of these bleedings were:~Bleeding that compromised haemodynamics~Bleeding that led to hospitalisation~Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.~All bleeding events include MBEs, CRBEs, and trivial bleeding events." (NCT00558259)
Timeframe: 6 months

,
Interventionparticipants (Number)
MBEMBE or CRBEAll Bleeding
Dabigatran23672
Placebo01239

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Laboratory Measures, Especially Liver Function Tests (LFTs)

Number of participants with possible clinically significant abnormalities during the treatment period. (NCT00558259)
Timeframe: 6 months

,
Interventionparticipants (Number)
AST increase (N=655, 629)ALT increase (N=655, 629)Alkaline phosphatase increase (N=658, 629)Total bilirubin increase (N=658, 628)
Dabigatran2301
Placebo2501

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Centrally Confirmed Cardiovascular Events During the Treatment Period

Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups. (NCT00558259)
Timeframe: 6 months

Interventionparticipants (Number)
Dabigatran3
Placebo2

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Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period

Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described. (NCT00558259)
Timeframe: 6 months

InterventionParticipants (Number)
Dabigatran2
Placebo23

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Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period

Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event. (NCT00558259)
Timeframe: 6 months

InterventionParticipants (Number)
Dabigatran3
Placebo35

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Laboratory Analyses

Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline. (NCT00621855)
Timeframe: 6 month treatment period + 2 week post treatment follow up

,,,,
Interventionparticipants (Number)
AST increase N=(359;359;388;329;356)AST decrease N=(359;359;388;329;356)ALT increase N=(359;359;388;329;356)ALT decrease N=(359;359;388;329;356)Bilirubin increase N=(359;360;388;329;355)Bilirubin decrease N=(359;360;388;329;355)
110mg Dabigatran Etexilate504020
150mg Dabigatran Etexilate207000
50mg Dabigatran Etexilate8010010
75mg Dabigatran Etexilate504010
Placebo404000

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Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time

"International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.~A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.~All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug)." (NCT00621855)
Timeframe: 6 month treatment period + 2 week post treatment follow up

,,,,
Interventionparticipants (Number)
Major and clinically relevant minor bleed eventsNo major or clinically relevant minor bleed events
110mg Dabigatran Etexilate32374
150mg Dabigatran Etexilate27320
50mg Dabigatran Etexilate13356
75mg Dabigatran Etexilate16352
Placebo8363

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Composite of Cardiovascular Death (CVD) With Non Fatal Myocardial Infarction (MI) and Non Haemorrhagic Stroke and All Cause Death (ACD), Non Fatal MI, Severe Recurrent Ischaemia (SRI) and Non Haemorrhagic Stroke During Six Months Treatment

Number of Participants with Composite of Cardiovascular death (CVD) with non fatal myocardial infarction (MI) and non haemorrhagic stroke and All cause death (ACD), non fatal MI, severe recurrent ischaemia (SRI) and non haemorrhagic stroke during six months treatment (NCT00621855)
Timeframe: 6 month treatment period + 2 week post treatment follow up

,,,,
Interventionparticipants (Number)
CVD, non-fatal MI, non-haemorrhagic strokeACD, non-fatal MI, SRI, non-haemorrhagic stroke
110mg Dabigatran Etexilate1221
150mg Dabigatran Etexilate1225
50mg Dabigatran Etexilate1725
75mg Dabigatran Etexilate1827
Placebo1426

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Number of Participants With Bleeding Events During Total Observation Time

"International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.~A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.~All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds (CRBE) and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug)." (NCT00621855)
Timeframe: 6 month treatment period + 2 week post treatment follow up

,,,,
Interventionparticipants (Number)
Major bleeding eventsClinically relevant bleeding eventsNot clinically relevant bleeding eventsAny bleeding events
110mg Dabigatran Etexilate8243560
150mg Dabigatran Etexilate4232042
50mg Dabigatran Etexilate3103242
75mg Dabigatran Etexilate1162945
Placebo261725

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Change From Baseline in log10 D-dimer After 1 and 4 Weeks

Change from baseline in log10 D-dimer concentration after 1 and 4 weeks of dabigatran etexilate treatment compared to placebo. The standard deviation is the geometric standard deviation. (NCT00621855)
Timeframe: Baseline and at 1 week and 4 weeks

,,,,
Interventionratio (Geometric Mean)
Ratio of week 4 to baselineRatio of week 1 to baseline
110mg Dabigatran Etexilate0.290.52
150mg Dabigatran Etexilate0.310.55
50mg Dabigatran Etexilate0.330.58
75mg Dabigatran Etexilate0.310.52
Placebo0.570.87

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Number of Participants With Any Reduction of D-dimer Concentration

(NCT00621855)
Timeframe: at 1 week and 4 weeks

,,,,
Interventionparticipants (Number)
Number of Patients with any reductionNumber of Patients with no reductionMissing data
110mg Dabigatran Etexilate3334114
150mg Dabigatran Etexilate296288
50mg Dabigatran Etexilate2904820
75mg Dabigatran Etexilate2934916
Placebo2647715

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Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment

Number of Participants with individual occurrence of death (cardiovascular and all-cause), non-fatal MI, severe recurrent ischaemia and non-haemorrhagic stroke during six months of treatment. (NCT00621855)
Timeframe: 6 month treatment period + 2 week post treatment follow up

,,,,
Interventionparticipants (Number)
Cardiovascular deathNon-fatal myocardial infarctionSevere recurrent ischaemiaNon-haemorrhagic strokeAll cause death
110mg Dabigatran Etexilate57907
150mg Dabigatran Etexilate481107
50mg Dabigatran Etexilate89908
75mg Dabigatran Etexilate9811110
Placebo949314

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Volume of Blood Loss

Volume of blood loss for treated and operated patients during surgery. (NCT00657150)
Timeframe: Day 1

InterventionmL (Mean)
Dabigatran 220mg404.9
Enoxaparin411.0

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Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period

"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients." (NCT00657150)
Timeframe: 28-35 days

InterventionParticipants (Number)
Dabigatran 220mg61
Enoxaparin69

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Number of Participants With Total Deep Vein Thrombosis During Treatment Period

Total Deep Vein Thrombosis as adjudicated by the VTE events committee (NCT00657150)
Timeframe: 28-35 days

InterventionParticipants (Number)
Dabigatran 220mg60
Enoxaparin67

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Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period

Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee (NCT00657150)
Timeframe: 28-35 days

InterventionParticipants (Number)
Dabigatran 220mg0
Enoxaparin4

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Number of Participants With Pulmonary Embolism During Treatment Period

Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee (NCT00657150)
Timeframe: 28-35 days

InterventionParticipants (Number)
Dabigatran 220mg1
Enoxaparin2

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Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period

Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee (NCT00657150)
Timeframe: 28-35 days

InterventionParticipants (Number)
Dabigatran 220mg17
Enoxaparin31

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Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period

"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding~gingival bleeding >5 min~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above." (NCT00657150)
Timeframe: 28-35 days

,
InterventionParticipants (Number)
Major bleeding eventsMajor and clinically relevant bleeding eventsAny bleeding events
Dabigatran 220mg143798
Enoxaparin92983

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Number of Participants Who Died During Treatment Period

All cause death, as adjudicated by the VTE events committee (NCT00657150)
Timeframe: 28-35 days

InterventionParticipants (Number)
Dabigatran 220mg0
Enoxaparin1

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Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period

Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). (NCT00657150)
Timeframe: 3 months

,
InterventionParticipants (Number)
Total VTE and all-cause mortalityasymptomatic Deep Vein Thrombosissymptomatic Deep Vein ThrombosisPulmonary Embolismdeath
Dabigatran 220mg20110
Enoxaparin41021

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Laboratory Analyses

Frequency of patients with possible clinically significant abnormalities. (NCT00657150)
Timeframe: First administration to end of study

,
Interventionparticipants (Number)
AST increase N=(964;962)AST decrease N=(964;962)ALT increase N=(966;962)ALT decrease N=(966;962)Bilirubin increase N=(966;962)Bilirubin decrease N=(966;962)
Dabigatran 220mg28034030
Enoxaparin44067010

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Blood Transfusion

Number of treated and operated patients with required blood transfusion on day of surgery. (NCT00657150)
Timeframe: Day 1

,
Interventionparticipants (Number)
Transfusions requiredMissing
Dabigatran 220mg2464
Enoxaparin2377

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Number of Participants With Recurrent Symptomatic VTE and All Deaths

VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00680186)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.

,
Interventionparticipants (Number)
Participants with event (up to day 180)Participants with event (up to end of ptp)
Dabigatran 150 mg5157
Warfarin4851

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Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events

"Major bleeding events (MBE) are defined as~Fatal bleeding~Symptomatic bleeding in a critical area or organ~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells~Clinically-relevant bleeding events (CRBE) are defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding~gingival bleeding >5 min~leading to hospitalisation and / or requiring surgical treatment~leading to a transfusion of <2 units of whole blood or red cells~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above." (NCT00680186)
Timeframe: From first intake of study drug to last intake of study drug + 6 days washout

,
Interventionparticipants (Number)
MBEMBE and/or CRBEAny bleeding event
Dabigatran 150 mg1564200
Warfarin22102285

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Number of Participants With Acute Coronary Syndrome (ACS)

Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings. (NCT00680186)
Timeframe: From first intake of study drug to last contact date

,
Interventionparticipants (Number)
During intake of study drugAfter stopping study drug
Dabigatran 150 mg32
Warfarin01

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Number of Participants Who Died Due to VTE

VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Hazard ratios and 95% CI were not calculated because of insufficient number of events. (NCT00680186)
Timeframe: From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)

,
Interventionparticipants (Number)
Participants with event (up to day 180)Participants with event (up to end of ptp)
Dabigatran 150 mg33
Warfarin00

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Number of Participants Who Died (Any Cause)

Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00680186)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.

,
Interventionparticipants (Number)
Participants with event (up to day 180)Participants with event (up to end of ptp)
Dabigatran 150 mg2529
Warfarin2526

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Laboratory Analyses

Frequency of patients with possible clinically significant abnormalities. (NCT00680186)
Timeframe: From first intake of study drug to last intake of study drug + 6 days washout

,
Interventionparticipants (Number)
AST increaseAST decreaseALT increaseALT decreaseBilirubin increaseBilirubin decrease
Dabigatran 150 mg29031080
Warfarin27040060

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Number of Participants With Recurrent Symptomatic Non-fatal PE

Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00680186)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.

,
Interventionparticipants (Number)
Participants with event (up to day 180)Participants with event (up to end of ptp)
Dabigatran 150 mg79
Warfarin1315

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Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE

Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00680186)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.

,
Interventionparticipants (Number)
Participants with event (up to day 180)Participants with event (up to end of ptp)
Dabigatran 150 mg810
Warfarin1315

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Number of Participants With Recurrent Symptomatic DVT

Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00680186)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.

,
Interventionparticipants (Number)
Participants with event (up to day 180)Participants with event (up to end of ptp)
Dabigatran 150 mg2528
Warfarin1717

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Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg4.40
Dabigatran 150 mg4.02

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Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg6.65
Dabigatran 150 mg7.14

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Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg3.51
Dabigatran 150 mg3.32

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Annualized Rate of Subjects With Minor Bleeds

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not." (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg7.49
Dabigatran 150 mg8.98

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Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg0.28
Dabigatran 150 mg0.33

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Pulmonary Embolism (PE), Annualized Rate of Subjects With PE

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Pulmonary Embolism was generally documented by one of the following:~an intraluminal filling defect in segmental or more proximal branches on spiral CT scan~an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram~a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)~inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography." (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg0.10
Dabigatran 150 mg0.12

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Stroke, Annualized Rate of Subjects With Stroke

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital" (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg1.39
Dabigatran 150 mg1.26

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Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy." (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg0.25
Dabigatran 150 mg0.23

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Major Bleeding, Annualized Rate of Subjects With Major Bleeds

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Major bleeding must have satisfied one or more of the following criteria:~Bleeding associated with a reduction in hemoglobin of at least 20 g/L~Required transfusion of at least 2 units of blood or packed cells~Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal~Major bleed were classified as life-threatening if they met one or more of the following criteria:~Reduction in hemoglobin of at least 50 g/L~Transfusion of at least 4 units of blood or packed cells~Symptomatic intracranial bleeding, either subdural or intracerebral~Associated with hypotension requiring use of intravenous inotropic agents~Required surgical intervention to stop bleeding~Resulted in death" (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg2.79
Dabigatran 150 mg3.59

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Deep Vein Thrombosis, Annualized Rate of Subjects With DVT

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Deep Vein Thrombosis (DVT) was generally documented by one of the following:~abnormal compression ultrasound (CUS),~an intraluminal filling defect on venography." (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg0.06
Dabigatran 150 mg0.11

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Death, Annualized Rate of Subject Death

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology." (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg3.18
Dabigatran 150 mg2.99

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Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy." (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg0.72
Dabigatran 150 mg0.66

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Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg9.44
Dabigatran 150 mg11.20

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Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. (NCT00808067)
Timeframe: up to 43 months

Interventionpercentage of subject-years (Number)
Dabigatran 110 mg1.60
Dabigatran 150 mg1.47

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Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow

Investigator reported outcome (NCT00818753)
Timeframe: From 22 to 165 minutes

InterventionPercentage of participants (Number)
Dabigatran 110mg Bis in Die (BID)10.5
Dabigatran 150mg Bis in Die (BID)4.8
Heparin0

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Number of Participants With Bleeding Events

Bleeding is categorized using the TIMI criteria as major or minor bleeding. The time window for inclusion of bleeding events was up until 3 days post-procedure or discharge (whichever occurred first). (NCT00818753)
Timeframe: First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)

Interventionparticipants (Number)
Dabigatran 110mg Bis in Die (BID)0
Dabigatran 150mg Bis in Die (BID)0
Heparin1

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TT Locally Measured

Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay. (NCT00844415)
Timeframe: Day 3

Interventionseconds (Mean)
Patients with 75mg dose followed by 100mg (N=3)Patients with 100mg dose followed by 125mg (N=3)
All Patients33.536.8

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Thrombin Time (TT) Centrally Measured

Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay. (NCT00844415)
Timeframe: Day 3

Interventionseconds (Mean)
Patients with 75mg dose followed by 100mg (N=3)Patients with 100mg dose followed by 125mg (N=3)
All Patients36.937.4

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Number of Patients With Bleeding Events (Major and Minor)

"Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria:~Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds." (NCT00844415)
Timeframe: From Screening until 30 days after first drug administration (end of trial visit)

InterventionParticipants (Number)
All Patients0

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Plasma Concentration of Total Dabigatran

Plasma concentration of total dabigatran measured at 72 hours after first dose (NCT00844415)
Timeframe: Day 3

Interventionng/ml (Geometric Mean)
Patients with 75mg dose followed by 100mg (N=3)Patients with 100mg dose followed by 125mg (N=3)
All Patients34.258.2

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Ecarin Clotting Time (ECT)

Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT. (NCT00844415)
Timeframe: Day 3

Interventionseconds (Mean)
Patients with 75mg dose followed by 100mg (N=3)Patients with 100mg dose followed by 125mg (N=3)
All Patients43.349.6

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Plasma Concentration of Free Dabigatran

Plasma concentration of free dabigatran measured at 72 hours after first dose (NCT00844415)
Timeframe: 3 days

Interventionng/ml (Geometric Mean)
Patients with 75mg dose followed by 100mg (N=3)Patients with 100mg dose followed by 125mg (N=3)
All Patients28.041.6

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Occurences of Clinical Outcome

Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location). Number of patients with particular clinical outcome are reported. (NCT00844415)
Timeframe: 3 days

InterventionParticipants (Number)
Patients with recurrent VTEPatients with PTSPatients with PEPatients with VTE related deathPatients with other deathPatients with other clinical outcome
All Patients100000

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Number of Patients With Adverse Events

"Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered on-treatment if occurring within 72 hours after last drug administration." (NCT00844415)
Timeframe: From Screening until 30 days after first drug administration (end of trial visit)

InterventionParticipants (Number)
DRAEs on-treatmentSAEs on-treatmentDRAEs post-treatmentSAEs post-treatment
All Patients2001

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Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs

Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator. (NCT00844415)
Timeframe: Baseline and 3 days

InterventionParticipants (Number)
All Patients0

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Activated Partial Thromboplastin Time (aPTT) Centrally Measured

Measurement of aPTT was performed locally and centrally using validated assays. (NCT00844415)
Timeframe: Day 3

Interventionseconds (Mean)
Patients with 75mg dose followed by 100mg (N=3)Patients with 100mg dose followed by 125mg (N=3)
All Patients38.647.4

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aPTT Locally Measured

Measurement of aPTT was performed locally and centrally using validated assays. (NCT00844415)
Timeframe: Day 3

Interventionseconds (Mean)
Patients with 75mg dose followed by 100mg (N=3)Patients with 100mg dose followed by 125mg (N=3)
All Patients29.933.6

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Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma)

"tmax (time from dosing to maximum measured concentration of total dabigatran in plasma).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)." (NCT01083732)
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate

Interventionhours (Median)
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)1.99
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)2.00

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Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma)

"tmax (time from dosing to maximum measured concentration of free dabigatran in plasma).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)." (NCT01083732)
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate

Interventionhours (Median)
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)1.99
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)2.00

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Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period.

Major: Fatal bleeding, Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL in 24-h-period,bleeding that was retroperitoneal,pulmonary,intracranial,or otherwise involved the central nervous system,bleeding that required surgical intervention in an operating suite. CRNM: Overt bleeding for which a blood product was administered & which was not directly attributable to the patient's underlying medical condition,bleeding that required medical or surgical intervention to restore haemostasis,other than in an operating suite. Minor: Any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding. For multiple dosing,all events with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment and for single dosing,all events with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period. (NCT01083732)
Timeframe: Up to 6 days

InterventionPercentage of participants (Number)
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)0.0
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)0.0
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)0.0

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Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination

"Percentage of patients with changes in laboratory and clinical parameters such as liver enzymes and physical examination.~Clinically Relevant Abnormalities for Laboratory Parameters were reported." (NCT01083732)
Timeframe: During the treatment period, Up to 6 days

InterventionPercentage of participants (Number)
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)0.0
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)0.0
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)0.0

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Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma)

Cmax (maximum measured concentration of total dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2). (NCT01083732)
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate

Interventionng/mL (Geometric Mean)
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)129
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)116

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AUC0-tz (Area Under the Concentration Time Curve of the Total Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)

"AUC0-tz (area under the concentration time curve of the total dabigatran in plasma over the time interval 0 up to the last quantifiable data point).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)." (NCT01083732)
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate

Interventionng*h/mL (Geometric Mean)
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)715
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)658

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AUC0-tz (Area Under the Concentration Time Curve of the Free Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)

"AUC0-tz (area under the concentration time curve of the free dabigatran in plasma over the time interval 0 up to the last quantifiable data point).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)." (NCT01083732)
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate

Interventionng*h/mL (Geometric Mean)
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)581
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)566

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Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.

Central measurement of ECT (ecarin clotting time) at predose and 2 and 10 h after intake of study medication. ECT was not planned to be measured in the multiple dose group. The Standard Deviation presented below are actually the % coefficient of variation (NCT01083732)
Timeframe: at predose and 2 and 10 h after intake of study medication.

,
Interventionseconds (Mean)
Ebase (N=6, 6)E2 (N=6, 7)E10 (N=5, 7)
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)36.979.849.7
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)36.873.652.2

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Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.

Central measurement of dTT (diluted thrombin time) at predose and 2 and 10 h after intake of study medication. The Standard Deviation presented below are actually the % coefficient of variation (NCT01083732)
Timeframe: at predose and 2 and 10 h after intake of study medication.

,,
Interventionseconds (Mean)
Ebase (N=6, 9, 2)E2 (N=6, 9, 2)E10 (N=6, 9, NA)
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)32.934.3NA
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)31.946.635.5
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)35.653.639.7

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Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.

Central measurement of aPTT (activated partial thromboplastin time) at predose and 2 and 10 h after intake of study medication. For multiple dose patients only local measurements were planned. The Standard Deviation presented below is actually the % coefficient of variation. (NCT01083732)
Timeframe: at predose and 2 and 10 h after intake of study medication.

,
Interventionseconds (Mean)
Ebase (N=6, 7)E2 (N=6, 9)E10 (N=5, 8)
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)32.347.540.3
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)34.977.058.4

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Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma)

Cmax (maximum measured concentration of free dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2). (NCT01083732)
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate

Interventionng/mL (Geometric Mean)
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)101
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)102

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Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)

"Plasma concentration of unchanged dabigatran etexilate (BIBR 1048 BS).~Some values are NA because Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the Geometric Mean (gMean) and Geometric Coefficient of Variation (gCV) is not calculated according to internal rules." (NCT01083732)
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate

,
Interventionng/mL (Geometric Mean)
1h (N= 13, NA)2h (N=5, 2)4h (N=15, NA)6h (N=1, NA)10h (N=15, NA)50h (N=NA, 2)72h (N=NA, 3)
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)NANANANANANANA
Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)3.823.23NA1.05NANANA

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Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)

Plasma concentration of total dabigatran (SUM BIBR 953 ZW) (NCT01083732)
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate

,,
Interventionng/mL (Geometric Mean)
1h (N= 4, 9, NA)2h (N=6, 9, 2)4h (N=6, 9, NA)6h (N=6, 9, NA)10h (N=6, 9, NA)50h (N=NA, NA, 2)72h (N=NA, NA, 3)
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)NA26.0NANANA46.011.9
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)79.4129.091.062.934.8NANA
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)90.6114.087.756.228.2NANA

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Plasma Concentration of Metabolite BIBR 951 BS

Plasma concentration of metabolite BIBR 951 BS (NCT01083732)
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate

,
Interventionng/mL (Geometric Mean)
1h (N=13, NA)2h (N=15, 2)4h (N=4, NA)6h (N=15, NA)10h (N=15, NA)50h (N=NA, 2)72h (N=NA, 3)
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)NANANANANANANA
Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)4.883.551.71NANANANA

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Plasma Concentration of Metabolite BIBR 1087 SE

Plasma concentration of metabolite BIBR 1087 SE (NCT01083732)
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate

,
Interventionng/mL (Geometric Mean)
1h (N=12, NA)2h (N=8, 2)4h (N=1, NA)6h (N=15, NA)10h (N=15, NA)50h (N=NA, 2)72h (N=NA, 3)
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)NANANANANANANA
Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)2.311.511.18NANANANA

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Plasma Concentration of Free Dabigatran (BIBR 953 ZW).

Plasma concentration of free dabigatran (BIBR 953 ZW) (NCT01083732)
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate

,,
Interventionng/mL (Geometric Mean)
1h (N= 4, 9, NA)2h (N=6, 9, 2)4h (N=6, 9, NA)6h (N=6, 9, NA)10h (N=6, 9, NA)50h (N=NA, NA, 2)72h (N=NA, NA, 3)
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)NA23.4NANANA37.38.43
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)68.5101.075.351.628.1NANA
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)80.098.574.548.423.7NANA

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Global Assessment of Tolerability of Study Medication- Taste Assessment

The investigator was to provide a global clinical assessment of tolerability including patient taste assessment.This assessment was based on 6-point scale (Very good, good, satisfactory, bad, very bad, missing). The taste assessment was only provided when the patient was old enough to evaluate the taste. (NCT01083732)
Timeframe: Day 1 (immediately after dosing)

,,
InterventionPercentage of participants (Number)
Very GoodGoodSatisfactoryBadVery BadMissing
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)0033.3366.6700
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)00000100.00
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)0044.44033.3322.22

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Percentage of Patients With Any Adverse Events During the Treatment Period

Percentage of patients with any adverse events during the treatment period. For patients with multiple dosing, all AEs with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment were assigned to the on-treatment period. For patients with single dosing, all AEs with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period. (NCT01083732)
Timeframe: Up to 6 days

InterventionPercentage of participants (Number)
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)0.0
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)0.0
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)33.3

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Global Assessment of Tolerability of Study Medication

The investigator was to provide a global clinical assessment of tolerability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable). (NCT01083732)
Timeframe: Day 1 (immediately after dosing)

,,
InterventionPercentage of participants (Number)
GoodSatisfactoryNot satisfactoryBadNot assessable
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)100.000000
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)33.3316.6733.33016.67
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)11.1122.2244.4422.220

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Discontinuation of the Study Drug Due to Adverse Events

Discontinuation of the study drug due to adverse events. (NCT01136408)
Timeframe: Upto 15 weeks

Interventionparticipants (Number)
Dabigatran Etexilate 220 mg Daily4
Dabigatran Etexilate 300 mg Daily8
Warfarin4

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Frequency (Occurrence Rates) of a Composite Clinical Endpoint.

Percentage of patients with the composite clinical endpoint (ischemic or haemorrhagic stroke (fatal or non-fatal), transient ischemic attacks, systemic embolism, myocardial infarction (fatal or non-fatal), other major adverse cardiac events, and death) (NCT01136408)
Timeframe: Upto 15 weeks

InterventionPercentage of patients (Number)
Dabigatran Etexilate 220 mg Daily0
Dabigatran Etexilate 300 mg Daily0
Warfarin1.6

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Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event

"The percentage of patients with clinically relevant bleeding event.~Any bleed that did not qualify as a major bleed was defined as a minor bleed; minor bleed which fulfilled one of the criteria below was defined as a clinically relevant bleeding event:~A skin haematoma of at least 25 sqcm~Spontaneous nose bleed lasting for more than 5 minutes~Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)~Spontaneous rectal bleeding (more than spotting on toilet paper)~Gingival bleeding lasting for more than 5 minutes~Bleeding leading to hospitalisation~Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)~Any other bleeding considered clinically relevant by the investigator" (NCT01136408)
Timeframe: upto 15 weeks

InterventionPercentage of patients (Number)
Dabigatran Etexilate 220 mg Daily4.3
Dabigatran Etexilate 300 mg Daily8.6
Warfarin8.1

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Changes in Laboratory Test Values

The number of patients with ALT, AST, alkaline phosphatase, or bilirubin exceeded the upper limit of normal (ULN) range (NCT01136408)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
ALT > 1 x ULNAST > 1 x ULNAlkaline phosphatase > 1 x ULNTotal bilirubin > 1 x ULN
Dabigatran Etexilate 220 mg Daily1026
Dabigatran Etexilate 300 mg Daily4437
Warfarin4518

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Anticoagulation Effects Trough INR (International Normalised Ratio)

The blood coagulation parameter INR was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12. (NCT01136408)
Timeframe: Week 0,1,4 and 12

,
Interventionratio (Geometric Mean)
week 0, N=46 , N=58week 1, N=41, N=55week 4, N=40, N=50week 12, N=39, N=49
Dabigatran Etexilate 220 mg Daily1.871.351.351.43
Dabigatran Etexilate 300 mg Daily2.031.491.461.49

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Frequency (Occurrence Rates) of Major Bleeding Event

"The percentage of patients with major bleeding event.~Major bleeding was defined as any bleed fulfilling one of the following conditions:~Fatal or life-threatening~Retroperitoneal, intracranial, intraocular, or intraspinal bleeding (verified by objective testing)~Bleeding requiring surgical treatment~Clinically overt bleeding leading to a transfusion (erythrocyte component transfusion or whole blood transfusion) of 4.5 units (equal to 2 units in EU/US) or more~Clinically overt bleeding leading to a fall in haemoglobin of at least 2 g/dL" (NCT01136408)
Timeframe: upto 15 weeks

InterventionPercentage of patients (Number)
Dabigatran Etexilate 220 mg Daily0
Dabigatran Etexilate 300 mg Daily1.7
Warfarin3.2

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Anticoagulation Effects Trough aPTT (Activated Partial Thromboplastin Time)

The blood coagulation parameter aPTT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12. (NCT01136408)
Timeframe: Week 0,1,4 and 12

,
Interventionseconds (Geometric Mean)
week 0, N=46 , N=58week 1, N=41, N=55week 4, N=40, N=50week 12, N=40, N=48
Dabigatran Etexilate 220 mg Daily32.440.240.941.8
Dabigatran Etexilate 300 mg Daily34.045.045.044.1

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Anticoagulation Effects Trough 11-dehydrothromboxane B2

Analysis based on concomitant use of aspirin compared to no aspirin users. 11-dehydrothromboxane B2 is measured in urine of patients. (NCT01136408)
Timeframe: Week 0 and 12

,,
Interventionpg/mg creatinine (Geometric Mean)
week 0 without aspirin, N=34, N=43, N=37week 0 with aspirin, N=9, N=12, N=20week 12 without aspirin, N=34, N=42, N=37week 12 with aspirin, N=9, N=13, N=21
Dabigatran Etexilate 220 mg Daily2730189033502380
Dabigatran Etexilate 300 mg Daily3190148034301830
Warfarin3080166035201420

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Frequency (Occurrence Rates) of Transient Ischemic Attack

The percentage of patients with transient ischemic attack (NCT01136408)
Timeframe: Upto 15 weeks

InterventionPercentage of patients (Number)
Dabigatran Etexilate 220 mg Daily0
Dabigatran Etexilate 300 mg Daily0
Warfarin0

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Frequency (Occurrence Rates) of Ischemic or Haemorrhagic Stroke (Fatal or Non-fatal)

The percentage of patients with ischemic or haemorrhagic stroke (fatal or non-fatal) (NCT01136408)
Timeframe: Upto 15 weeks

InterventionPercentage of patients (Number)
Dabigatran Etexilate 220 mg Daily0
Dabigatran Etexilate 300 mg Daily0
Warfarin1.6

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Frequency (Occurrence Rates) of Systemic Embolism

The percentage of patients with systemic embolism (NCT01136408)
Timeframe: Upto 15 weeks

InterventionPercentage of patients (Number)
Dabigatran Etexilate 220 mg Daily0
Dabigatran Etexilate 300 mg Daily0
Warfarin0

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Anticoagulation Effects Trough ECT (Ecarin Clotting Time)

The blood coagulation parameter ECT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12. (NCT01136408)
Timeframe: Week 0,1,4 and 12

,
Interventionseconds (Geometric Mean)
week 0, N=46 , N=58week 1, N=41, N=55week 4, N=40, N=50week 12, N=40, N=48
Dabigatran Etexilate 220 mg Daily35.653.451.452.7
Dabigatran Etexilate 300 mg Daily36.363.258.956.9

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Frequency (Occurrence Rates) of Nuisance Bleeding Event

"The percentage of patients with nuisance bleeding event~Any bleed that did not qualify as a major bleed was defined as a minor bleed; all minor bleeding events not fulfilling one of the criteria below was defined as a nuisance bleeding event:~A skin haematoma of at least 25 sqcm~Spontaneous nose bleed lasting for more than 5 minutes~Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)~Spontaneous rectal bleeding (more than spotting on toilet paper)~Gingival bleeding lasting for more than 5 minutes~Bleeding leading to hospitalisation~Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)~Any other bleeding considered clinically relevant by the investigator" (NCT01136408)
Timeframe: Upto 15 weeks

InterventionPercentage of patients (Number)
Dabigatran Etexilate 220 mg Daily19.6
Dabigatran Etexilate 300 mg Daily29.3
Warfarin19.4

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Frequency (Occurrence Rates) of Myocardial Infarction (Fatal or Non-fatal)

The percentage of patients with myocardial infarction (fatal or non-fatal) (NCT01136408)
Timeframe: Upto 15 weeks

InterventionPercentage of patients (Number)
Dabigatran Etexilate 220 mg Daily0
Dabigatran Etexilate 300 mg Daily0
Warfarin0

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Frequency (Occurrence Rates) of Death

The percentage of patients with death (NCT01136408)
Timeframe: Upto 15 weeks

InterventionPercentage of patients (Number)
Dabigatran Etexilate 220 mg Daily0
Dabigatran Etexilate 300 mg Daily0
Warfarin0

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Steady-state Pharmacokinetics of Total Dabigatran Trough Plasma Concentration

(NCT01136408)
Timeframe: Week 1,4 and 12

,
Interventionng/mL (Geometric Mean)
week 1, N=41, N=55week 4, N=40, N=50week 12, N=39, N=49
Dabigatran Etexilate 220 mg Daily53.155.663.0
Dabigatran Etexilate 300 mg Daily78.178.275.1

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Incidence and Severity of Adverse Events

Intensity of event is categorised as mild, moderate and severe. (NCT01136408)
Timeframe: Upto 15 weeks

,,
Interventionparticipants (Number)
MildModerateSevere
Dabigatran Etexilate 220 mg Daily2810
Dabigatran Etexilate 300 mg Daily4612
Warfarin3542

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Frequency (Occurrence Rates) of Other Major Adverse Cardiac Events

The percentage of patients with other major adverse cardiac events (NCT01136408)
Timeframe: Upto 15 weeks

InterventionPercentage of patients (Number)
Dabigatran Etexilate 220 mg Daily0
Dabigatran Etexilate 300 mg Daily0
Warfarin0

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Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All-cause Mortality Events During the Switch-/ Post-switch Treatment Period

sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE). (NCT01153698)
Timeframe: From last enoxaparin administration until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)

InterventionPercentage of participants (Number)
All Patients0

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Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period

Total treatment period is defined from first enoxaparin administration to 24h after last Pradaxa intake or to 35h after last enoxaparin administration if no switch was performed. (NCT01153698)
Timeframe: From first enoxaparin administration until 24 hours after last Pradaxa intake ( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)

InterventionNumber of participants (Number)
Documented symptomatic proximal DVTDocumented symptomatic distal DVTDocumented symptomatic non-fatal PEAll-cause mortality
All Patients0000

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Volume of Wound Drainage (Post-operative)

Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards. (NCT01153698)
Timeframe: From end of surgery (before first dosing) until 24 hours after last Pradaxa intake

Interventionml (Mean)
All Patients462.1

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Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period

Major bleeding events were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation. (NCT01153698)
Timeframe: From last enoxaparin administration until 24 hours after last Pradaxa intake( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)

InterventionPercentage of participants (Number)
All Patients0.61

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Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period

Major extra-surgical site bleedings include all major bleedings not occurred at surgical site (NCT01153698)
Timeframe: From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed

InterventionPercentage of participants (Number)
All Patients0

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Percentage of Patients With MBE During Pre-switch Treatment Period

MBEs were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation. (NCT01153698)
Timeframe: From first enoxaparin administration until last enoxaparin administration

InterventionPercentage of participants (Number)
All Patients0

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Percentage of Patients With MBE During Total Treatment Period

MBEs were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation. (NCT01153698)
Timeframe: From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed

InterventionPercentage of participants (Number)
All Patients0.60

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Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period

sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE. (NCT01153698)
Timeframe: From first enoxaparin administration until last enoxaparin administration

InterventionPercentage of participants (Number)
All Patients0

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Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period

"sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.~Symptomatic DVT is defined as clinically symptomatic venous thromboembolic event and symptomatic non-fatal PE is defined as symptomatic pulmonary embolism" (NCT01153698)
Timeframe: From last enoxaparin administration until first Pradaxa intake

InterventionPercentage of participants (Number)
All Patients0

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Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period

sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE. (NCT01153698)
Timeframe: From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed

InterventionPercentage of participants (Number)
All Patients0

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Dabigatran Concentration in Plasma, Estimated From Local Hemoclot®

"The Hemoclot® test kit measures the dTT (diluted Thrombin time). In the present trial, as a first step, the dTT in calibration samples that had known Dabigatran concentrations was measured locally with the Hemoclot® test kit, and a linear calibration curve was fitted to the data from the calibration samples. Thereafter, for each patient at each time-point, the dTT was measured with the Hemoclot® kit and the Dabigatran concentration was read off from the calibration curve.~These estimated concentrations are compared with concentrations measured in parallel with HPLC-MS/MS.~As the trial objective is the method comparison and not the detection of the absolute concentrations of either of the methods, the result is reported as a relative bioavailability [%], see Statistical Analysis 1 below. Only concentrations >= LLOQ (Lower Limit of concentration) are included in the quantitative comparison." (NCT01184989)
Timeframe: Screening, day of surgery 1 hour (h) and 2h after drug intake (di) for late finalization of surgery, 4h and 8h after di for early finalization of surgery, 15 minutes (min) before di at days 2, 3, 4, 5 and 6, at day 6 also 1h, 2h, 4h, 8h and 24 after di

Interventionmeasurements estimated as above LLOQ (Number)
Patients Treated With Dabigatran Etexilate136

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Dabigatran Concentration in Plasma, Estimated From Central Hemoclot®

"The Hemoclot® test kit measures the dTT (diluted Thrombin time). In the present trial, as a first step, the dTT in calibration samples that had known Dabigatran concentrations was measured centrally with the Hemoclot® test kit, and a linear calibration curve was fitted to the data from the calibration samples. Thereafter, for each patient at each time-point, the dTT was measured with the Hemoclot® kit and the Dabigatran concentration was read off from the calibration curve.~These estimated concentrations are compared with concentrations measured in parallel with HPLC-MS/MS.~As the trial objective is the method comparison and not the detection of the absolute concentrations of either of the methods, the result is reported as a relative bioavailability [%], see Statistical Analysis 1 below. Only concentrations >= LLOQ (Lower Limit of concentration) are included in the quantitative comparison." (NCT01184989)
Timeframe: Screening, day of surgery 1 hour (h) and 2h after drug intake (di) for late finalization of surgery, 4h and 8h after di for early finalization of surgery, 15 minutes (min) before di at days 2, 3, 4, 5 and 6, at day 6 also 1h, 2h, 4h, 8h and 24 after di

Interventionmeasurements estimated as above LLOQ (Number)
Patients Treated With Dabigatran Etexilate468

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Dabigatran Concentration in Plasma, Measured With HPLC-MS/MS

Dabigatran Concentration in Plasma, measured with HPLC-MS/MS - Most relevant timepoints are reported here, ie timepoints of day 6 (NCT01184989)
Timeframe: At day 6 before drug intake (di), at 1h, 2h, 4h, 8h and 24h after di

Interventionng/mL (Geometric Mean)
before intake(N=96)after 1h(N=93)after 2h(N=91)after 4h(N=88)after 8h(N=93)after 24h(N=86)
Patients Treated With Dabigatran Etexilate47.587.814715711947.7

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Plasma Concentration (Cmax) of Dabigatran

"Maximum plasma concentration of Dabigatran (at steady-state) and Pre-dose plasma concentrations at steady state.~Cmax represents the maximum concentration of Dabigatran in plasma. Cmax,ss represents the maximum concentration of Dabigatran in plasma at steady state.~Cpre,ss represents pre-dose concentration of Dabigatran in plasma at steady state" (NCT01225822)
Timeframe: Day 1 to end of treatment

,,,
Interventionng/mL (Geometric Mean)
Cmax (N=88, 83, 84, 96, 0)Cmax at steady-state (N=87, 74, 79, 85, 0)Cpre at steady-state
BIBR 1048 150 mg Bid60.516570.3
BIBR 1048 225 mg Bid79.9257113
BIBR 1048 300 mg qd13227138.0
BIBR 1048 50 mg Bid24.548.019.6

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Number of Participants With Clinically Significant, Minor or Any Bleeding Events

"Number of participants with Clinically Significant, minor or any bleeding events. Clinically significant bleeding events are defined as~Spontaneous skin haematoma larger than >25 cm²~Wound haematoma >100 cm²~Spontaneous nose bleed >5 minutes~Macroscopic haematurea, either spontaneous or lasting more than 24 hours if associated with an intervention~Spontaneous rectal bleeding (more than spot on toilet paper)~Gingival bleeding >5 minutes~Any other bleeding event considered as clinically significant by the investigator All other bleeding events that did not fulfil the criteria of MBE or clinically significant bleeding event were classified as minor bleeding events." (NCT01225822)
Timeframe: Treatment period (up to day 8+/-2 days visit)

,,,,
Interventionparticipants (Number)
Clinically significant bleeding eventsMinor bleeding eventsAny bleeding events
BIBR 1048 150 mg Bid163161
BIBR 1048 225 mg Bid203865
BIBR 1048 300 mg qd193762
BIBR 1048 50 mg Bid91826
Enoxaparin 40 mg qd102543

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Laboratory Analyses

"Number of patients with possible clinically significant abnormalities, i.e. with values out of normal range.~Normal ranges are defined as:~Haematocrit [%]: (0.35-0.45) for women and (0.39-0.51) for men Haemoglobin [g/dL]: (11.6-15.4) for women and (13.2-17.3) for men White Blood Cell count [10^9/L]: (4-10.3) for women and (3.9-10.3) for men Platelets [10^9/L]: (145-420) for women and men Sodium [mmol/L]: (135-146) for women and men Potassium [mmol/L]: (3.5-5) for women and men Aspartate aminotransferase (AST) [U/L]: (11-37) for women and (11-39) for men Alanine aminotransferase (ALT) [U/L]: (8-43) for women and (8-45) for men Alkaline Phosphatase [U/L]: (36-118) for women and (35-123) for men Creatinine [mg/dL]: (0.57-1.06)for women and (0.72-1.3) for men Bilirubin, total [mg/dL]: (0.22-1.28) for women and men Uric acid [mg/dL]: (2.4-6.47) for women and men" (NCT01225822)
Timeframe: Screening to end of treatment

,,,,
Interventionparticipants (Number)
Haematocrit decrease (N=325,324,339,320,340)Haemoglobin decrease (N=325,324,339,320,340)White blood cell ct. decr.(N=325,324,339,320,340)Platelets decrease (N=325,324,339,320,340)Platelets increase (N=325,324,339,320,340)Sodium decrease (N=340,334,344,327,352)Potassium decrease (N=340,334,344,326,352)Potassium increase (N=340,334,344,326,352)AST increase (N=340,334,344,327,352)ALT increase (N=340,334,344,327,352)Alkaline phosphatase incr. (N=340,334,344,327,352)Creatinine increase (N=340,334,344,327,352)Bilirubin, total increase (N=340,334,344,327,352)Uric Acid increase (N=340,334,344,327,352)
BIBR 1048 150 mg Bid15129001202052204
BIBR 1048 225 mg Bid14148201011230004
BIBR 1048 300 mg qd14129100102380112
BIBR 1048 50 mg Bid16122000000161003
Enoxaparin 40 mg qd221420100219203103

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Area Under the Plasma Concentration-time Curve During a Dosing Interval

Area under the plasma concentration-time curve during a dosing interval (at steady-state). The AUC0-12h (for b.i.d. treatment regimens) and AUC0-24h (300 mg q.d.) after the first dose on day of surgery calculated by extrapolation using the elimination rate constant, reported only if the extrapolated fraction of AUC was less than 30 % of the total AUC. (NCT01225822)
Timeframe: up to day 8+/-2 days visit

,,,
Interventionng*h/mL (Geometric Mean)
AUC during a dosing interval (N=13,12,21,72,0)AUC during a dosing interval at steady-state
BIBR 1048 150 mg Bid6361250
BIBR 1048 225 mg Bid6051910
BIBR 1048 300 mg qd16102450
BIBR 1048 50 mg Bid229350

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Number of Participants With Major Bleeding Events (MBE)

(NCT01225822)
Timeframe: From approximately 14 days prior to surgery to 4-6 weeks post surgery

Interventionparticipants (Number)
BIBR 1048 50 mg Bid1
BIBR 1048 150 mg Bid16
BIBR 1048 225 mg Bid15
BIBR 1048 300 mg qd18
Enoxaparin 40 mg qd8

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Rate of Transfusions Due to Bleedings

Percentage of patients requiring transfusions due to bleeding .Rate of need of transfusion were to be analysed using a logistic regression with treatment and centre. (NCT01225822)
Timeframe: Day 1 (Day of surgery)

InterventionPercentage of patients (Number)
BIBR 1048 50 mg Bid0.26
BIBR 1048 150 mg Bid5.38
BIBR 1048 225 mg Bid4.07
BIBR 1048 300 mg qd4.94
Enoxaparin 40 mg qd3.57

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Number of Participants With VTE Events and All Cause Mortality

Deep venous thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or Pulmonary Embolism (PE) confirmed by objective testing and all deaths. (NCT01225822)
Timeframe: Treatment period (up to day 8+/-2 days visit)

Interventionparticipants (Number)
BIBR 1048 50 mg Bid86
BIBR 1048 150 mg Bid49
BIBR 1048 225 mg Bid39
BIBR 1048 300 mg qd47
Enoxaparin 40 mg qd72

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Number of Participants With Venous Thromboembolic (VTE) Events

Deep vein thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or PE confirmed by objective testing (NCT01225822)
Timeframe: Treatment period (up to day 8+/-2 days visit)

Interventionparticipants (Number)
BIBR 1048 50 mg Bid86
BIBR 1048 150 mg Bid49
BIBR 1048 225 mg Bid39
BIBR 1048 300 mg qd47
Enoxaparin 40 mg qd72

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Volume of Blood Loss

Volume of blood loss was to be analysed using an analysis of variance (ANOVA), which included treatment and centre. (NCT01225822)
Timeframe: Day 1 (Day of surgery)

Interventionml (Mean)
BIBR 1048 50 mg Bid523.3
BIBR 1048 150 mg Bid1538.4
BIBR 1048 225 mg Bid631.4
BIBR 1048 300 mg qd910.3
Enoxaparin 40 mg qd945.5

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Number of Participants With Proximal DVT

Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period (NCT01225822)
Timeframe: Treatment period (up to day 8+/-2 days visit)

Interventionparticipants (Number)
BIBR 1048 50 mg Bid15
BIBR 1048 150 mg Bid9
BIBR 1048 225 mg Bid5
BIBR 1048 300 mg qd6
Enoxaparin 40 mg qd17

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Number of Participants With Thromboembolic Events: Ischemic Stroke

Occurence of an ischemic stroke (fatal or non-fatal) (NCT01227629)
Timeframe: 12 weeks

,,,,,,,,,
InterventionParticipants (Number)
NoneFatalNon-FatalBoth
BIBR 1048 150 mg b.i.d99000
BIBR 1048 150 mg b.i.d + ASA 325 mg qd33000
BIBR 1048 150 mg b.i.d + ASA 81 mg qd34000
BIBR 1048 300 mg b.i.d98000
BIBR 1048 300 mg b.i.d + ASA 325 mg qd30000
BIBR 1048 300 mg b.i.d + ASA 81 mg qd33000
BIBR 1048 50 mg b.i.d58000
BIBR 1048 50 mg b.i.d + ASA 325 mg qd27000
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.19010
Warfarin, Dosed to Target INR 2.0 to 3.070000

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Thromboembolic Events: Number of Participants With Myocardial Infarction

Occurence of a myocardial infarction (NCT01227629)
Timeframe: 12 weeks

,,,,,,,,,
InterventionParticipants (Number)
NoneFatalNon-FatalBoth
BIBR 1048 150 mg b.i.d99000
BIBR 1048 150 mg b.i.d + ASA 325 mg qd33000
BIBR 1048 150 mg b.i.d + ASA 81 mg qd34000
BIBR 1048 300 mg b.i.d98000
BIBR 1048 300 mg b.i.d + ASA 325 mg qd30000
BIBR 1048 300 mg b.i.d + ASA 81 mg qd33000
BIBR 1048 50 mg b.i.d58000
BIBR 1048 50 mg b.i.d + ASA 325 mg qd27000
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.20000
Warfarin, Dosed to Target INR 2.0 to 3.070000

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Number of Participants With Increase of Bilirubin to >2*Baseline

Increase of Bilirubin to more than two times the baseline value (NCT01227629)
Timeframe: 12 weeks

,,,,,,,,,
InterventionParticipants (Number)
MissingNoYes
BIBR 1048 150 mg b.i.d08613
BIBR 1048 150 mg b.i.d + ASA 325 mg qd0330
BIBR 1048 150 mg b.i.d + ASA 81 mg qd0313
BIBR 1048 300 mg b.i.d1889
BIBR 1048 300 mg b.i.d + ASA 325 mg qd0291
BIBR 1048 300 mg b.i.d + ASA 81 mg qd1293
BIBR 1048 50 mg b.i.d0553
BIBR 1048 50 mg b.i.d + ASA 325 mg qd0252
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.0182
Warfarin, Dosed to Target INR 2.0 to 3.01636

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Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline

Increase of AST to more than two times the baseline value (NCT01227629)
Timeframe: 12 weeks

,,,,,,,,,
InterventionParticipants (Number)
MissingNoYes
BIBR 1048 150 mg b.i.d0936
BIBR 1048 150 mg b.i.d + ASA 325 mg qd0312
BIBR 1048 150 mg b.i.d + ASA 81 mg qd0322
BIBR 1048 300 mg b.i.d1952
BIBR 1048 300 mg b.i.d + ASA 325 mg qd0300
BIBR 1048 300 mg b.i.d + ASA 81 mg qd1311
BIBR 1048 50 mg b.i.d0571
BIBR 1048 50 mg b.i.d + ASA 325 mg qd0243
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.0200
Warfarin, Dosed to Target INR 2.0 to 3.01681

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Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline

Increase of AP to more than two times the baseline value (NCT01227629)
Timeframe: 12 weeks

,,,,,,,,,
InterventionParticipants (Number)
MissingNoYes
BIBR 1048 150 mg b.i.d0981
BIBR 1048 150 mg b.i.d + ASA 325 mg qd0330
BIBR 1048 150 mg b.i.d + ASA 81 mg qd0331
BIBR 1048 300 mg b.i.d1970
BIBR 1048 300 mg b.i.d + ASA 325 mg qd0291
BIBR 1048 300 mg b.i.d + ASA 81 mg qd1320
BIBR 1048 50 mg b.i.d0580
BIBR 1048 50 mg b.i.d + ASA 325 mg qd0270
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.0200
Warfarin, Dosed to Target INR 2.0 to 3.01690

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Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline

Number of Participants with Increase of ALT to more than two times the baseline value (NCT01227629)
Timeframe: 12 weeks

,,,,,,,,,
InterventionParticipants (Number)
MissingNoYes
BIBR 1048 150 mg b.i.d0954
BIBR 1048 150 mg b.i.d + ASA 325 mg qd0321
BIBR 1048 150 mg b.i.d + ASA 81 mg qd0331
BIBR 1048 300 mg b.i.d1934
BIBR 1048 300 mg b.i.d + ASA 325 mg qd0300
BIBR 1048 300 mg b.i.d + ASA 81 mg qd1311
BIBR 1048 50 mg b.i.d0553
BIBR 1048 50 mg b.i.d + ASA 325 mg qd0261
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.0182
Warfarin, Dosed to Target INR 2.0 to 3.01645

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Trough Plasma Concentration of Dabigatran (BIBR 953)

The values of the trough plasma concentration of dabigatran (BIBR 953) are the by-patient geometric means of week 1, 4 and 12. (NCT01227629)
Timeframe: 12 weeks

Interventionng/ml (Mean)
BIBR 1048 50 mg b.i.d29.1
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.30.4
BIBR 1048 50 mg b.i.d + ASA 325 mg qd31.8
BIBR 1048 150 mg b.i.d82.8
BIBR 1048 150 mg b.i.d + ASA 81 mg qd103.2
BIBR 1048 150 mg b.i.d + ASA 325 mg qd90.1
BIBR 1048 300 mg b.i.d188.0
BIBR 1048 300 mg b.i.d + ASA 81 mg qd203.7
BIBR 1048 300 mg b.i.d + ASA 325 mg qd207.6
Warfarin, Dosed to Target INR 2.0 to 3.0NA

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Thromboembolic Events: Number of Participants With Transient Ischemic Attack

Occurence of a transient ischemic attack (NCT01227629)
Timeframe: 12 weeks

InterventionParticipants (Number)
BIBR 1048 50 mg b.i.d0
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.0
BIBR 1048 50 mg b.i.d + ASA 325 mg qd0
BIBR 1048 150 mg b.i.d0
BIBR 1048 150 mg b.i.d + ASA 81 mg qd0
BIBR 1048 150 mg b.i.d + ASA 325 mg qd0
BIBR 1048 300 mg b.i.d0
BIBR 1048 300 mg b.i.d + ASA 81 mg qd0
BIBR 1048 300 mg b.i.d + ASA 325 mg qd0
Warfarin, Dosed to Target INR 2.0 to 3.00

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Thromboembolic Events: Number of Participants With Systemic Thromboembolism

Occurence of a systemic thromboembolism (NCT01227629)
Timeframe: 12 weeks

InterventionParticipants (Number)
BIBR 1048 50 mg b.i.d1
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.1
BIBR 1048 50 mg b.i.d + ASA 325 mg qd0
BIBR 1048 150 mg b.i.d0
BIBR 1048 150 mg b.i.d + ASA 81 mg qd0
BIBR 1048 150 mg b.i.d + ASA 325 mg qd0
BIBR 1048 300 mg b.i.d0
BIBR 1048 300 mg b.i.d + ASA 81 mg qd0
BIBR 1048 300 mg b.i.d + ASA 325 mg qd0
Warfarin, Dosed to Target INR 2.0 to 3.00

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Thromboembolic Events: Number of Participants With Other Major Cardiac Events

Occurence of other major adverse cardiac events (NCT01227629)
Timeframe: 12 weeks

InterventionParticipants (Number)
BIBR 1048 50 mg b.i.d0
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.1
BIBR 1048 50 mg b.i.d + ASA 325 mg qd1
BIBR 1048 150 mg b.i.d0
BIBR 1048 150 mg b.i.d + ASA 81 mg qd0
BIBR 1048 150 mg b.i.d + ASA 325 mg qd0
BIBR 1048 300 mg b.i.d0
BIBR 1048 300 mg b.i.d + ASA 81 mg qd0
BIBR 1048 300 mg b.i.d + ASA 325 mg qd0
Warfarin, Dosed to Target INR 2.0 to 3.00

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Thromboembolic Events: Number of Participants Who Died

Occurence of death by all causes (NCT01227629)
Timeframe: 12 weeks

InterventionParticipants (Number)
BIBR 1048 50 mg b.i.d0
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.0
BIBR 1048 50 mg b.i.d + ASA 325 mg qd0
BIBR 1048 150 mg b.i.d0
BIBR 1048 150 mg b.i.d + ASA 81 mg qd0
BIBR 1048 150 mg b.i.d + ASA 325 mg qd0
BIBR 1048 300 mg b.i.d0
BIBR 1048 300 mg b.i.d + ASA 81 mg qd0
BIBR 1048 300 mg b.i.d + ASA 325 mg qd0
Warfarin, Dosed to Target INR 2.0 to 3.00

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Soluble Fibrin: Difference From Baseline

Difference from baseline to visit 7 (NCT01227629)
Timeframe: baseline and 12 weeks

Interventionµg/ml (Mean)
BIBR 1048 50 mg b.i.d3.2
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.0.9
BIBR 1048 50 mg b.i.d + ASA 325 mg qd1.2
BIBR 1048 150 mg b.i.d0.3
BIBR 1048 150 mg b.i.d + ASA 81 mg qd-2.0
BIBR 1048 150 mg b.i.d + ASA 325 mg qd-1.3
BIBR 1048 300 mg b.i.d2.3
BIBR 1048 300 mg b.i.d + ASA 81 mg qd-0.7
BIBR 1048 300 mg b.i.d + ASA 325 mg qd-1.9
Warfarin, Dosed to Target INR 2.0 to 3.00.1

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Number of Participants With Thromboembolic Events: Composite Endpoint

Combination of ischemic stroke (fatal or non fatal), transient ischemic attack, systemic thromboembolism, myocardial infarction (fatal or non fatal), other major adverse cardiac event and all cause mortality (NCT01227629)
Timeframe: 12 weeks

InterventionParticipants (Number)
BIBR 1048 50 mg b.i.d1
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.2
BIBR 1048 50 mg b.i.d + ASA 325 mg qd1
BIBR 1048 150 mg b.i.d0
BIBR 1048 150 mg b.i.d + ASA 81 mg qd0
BIBR 1048 150 mg b.i.d + ASA 325 mg qd0
BIBR 1048 300 mg b.i.d0
BIBR 1048 300 mg b.i.d + ASA 81 mg qd0
BIBR 1048 300 mg b.i.d + ASA 325 mg qd0
Warfarin, Dosed to Target INR 2.0 to 3.00

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D-dimer: Difference From Baseline

Difference in D-dimer from baseline to last available value (NCT01227629)
Timeframe: baseline and 12 weeks

Interventionng/ml (Mean)
BIBR 1048 50 mg b.i.d22.3
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.12.3
BIBR 1048 50 mg b.i.d + ASA 325 mg qd50.2
BIBR 1048 150 mg b.i.d8.1
BIBR 1048 150 mg b.i.d + ASA 81 mg qd29.1
BIBR 1048 150 mg b.i.d + ASA 325 mg qd8.6
BIBR 1048 300 mg b.i.d4.2
BIBR 1048 300 mg b.i.d + ASA 81 mg qd11.3
BIBR 1048 300 mg b.i.d + ASA 325 mg qd-7.9
Warfarin, Dosed to Target INR 2.0 to 3.0-5.8

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Ecarin Clotting Time (ECT): Difference From Baseline

(NCT01227629)
Timeframe: baseline and 12 weeks

Interventionseconds (Mean)
BIBR 1048 50 mg b.i.d9.7
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.12.0
BIBR 1048 50 mg b.i.d + ASA 325 mg qd12.0
BIBR 1048 150 mg b.i.d31.9
BIBR 1048 150 mg b.i.d + ASA 81 mg qd42.5
BIBR 1048 150 mg b.i.d + ASA 325 mg qd32.7
BIBR 1048 300 mg b.i.d63.6
BIBR 1048 300 mg b.i.d + ASA 81 mg qd70.8
BIBR 1048 300 mg b.i.d + ASA 325 mg qd74.0
Warfarin, Dosed to Target INR 2.0 to 3.03.1

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Severity of Adverse Events

Total number of patients with any adverse event of worst intensity 'mild', 'moderate' and 'severe'. (NCT01227629)
Timeframe: 12 weeks

,,,,,,,,,,,,,,,,
Interventionparticipants (Number)
MildModerateSevere
D150bid54194
D150bid + ASA325qd1741
D150bid + ASA81qd2392
D150qd100
D150qd + ASA325qd000
D150qd + ASA81qd000
D300bid47236
D300bid + ASA325qd23112
D300bid + ASA81qd2351
D300qd100
D300qd + ASA325qd110
D300qd + ASA81qd210
D50bid24133
D50bid + ASA325qd1671
D50bid + ASA81qd961
D50qd000
Warfarin, Dosed to Target INR 2.0 to 3.030142

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Number of Participants With Minor/Relevant Bleeding Events

Haematuria, rectal bleeding, gingival bleeding, skin hematoma of 25cm^2 or more, nose bleed of more than 5 minutes duration, bleeding leading to a hospitalization, leading to a transfusion of less than 2 units or any other clinically relevant bleeding (NCT01227629)
Timeframe: 12 weeks

InterventionParticipants (Number)
BIBR 1048 50 mg b.i.d0
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.1
BIBR 1048 50 mg b.i.d + ASA 325 mg qd1
BIBR 1048 150 mg b.i.d9
BIBR 1048 150 mg b.i.d + ASA 81 mg qd2
BIBR 1048 150 mg b.i.d + ASA 325 mg qd2
BIBR 1048 300 mg b.i.d6
BIBR 1048 300 mg b.i.d + ASA 81 mg qd4
BIBR 1048 300 mg b.i.d + ASA 325 mg qd3
Warfarin, Dosed to Target INR 2.0 to 3.04

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Number of Participants With Minor/Nuisance Bleeding Events

All bleeding events not fulfilling one of the criteria for major bleeding event or minor/relevant bleeding events. (NCT01227629)
Timeframe: 12 weeks

InterventionParticipants (Number)
BIBR 1048 50 mg b.i.d2
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.1
BIBR 1048 50 mg b.i.d + ASA 325 mg qd2
BIBR 1048 150 mg b.i.d6
BIBR 1048 150 mg b.i.d + ASA 81 mg qd6
BIBR 1048 150 mg b.i.d + ASA 325 mg qd5
BIBR 1048 300 mg b.i.d9
BIBR 1048 300 mg b.i.d + ASA 81 mg qd7
BIBR 1048 300 mg b.i.d + ASA 325 mg qd9
Warfarin, Dosed to Target INR 2.0 to 3.09

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11-dehydrothromboxane B2 (TXB2): Difference From Baseline

Difference from baseline to visit 7 (NCT01227629)
Timeframe: baseline and 12 weeks

Interventionpg/mg Creatinine (Mean)
BIBR 1048 50 mg b.i.d596.5
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.-1816.8
BIBR 1048 50 mg b.i.d + ASA 325 mg qd-2779.8
BIBR 1048 150 mg b.i.d922.0
BIBR 1048 150 mg b.i.d + ASA 81 mg qd-1988.6
BIBR 1048 150 mg b.i.d + ASA 325 mg qd-1125.9
BIBR 1048 300 mg b.i.d1059.7
BIBR 1048 300 mg b.i.d + ASA 81 mg qd-1822.6
BIBR 1048 300 mg b.i.d + ASA 325 mg qd-1337.8
Warfarin, Dosed to Target INR 2.0 to 3.0203.5

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Activated Partial Thromboplastin Time (aPTT): Difference From Baseline

(NCT01227629)
Timeframe: baseline and 12 weeks

Interventionseconds (Mean)
BIBR 1048 50 mg b.i.d6.4
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.8.3
BIBR 1048 50 mg b.i.d + ASA 325 mg qd8.8
BIBR 1048 150 mg b.i.d13.5
BIBR 1048 150 mg b.i.d + ASA 81 mg qd24.9
BIBR 1048 150 mg b.i.d + ASA 325 mg qd14.5
BIBR 1048 300 mg b.i.d25.0
BIBR 1048 300 mg b.i.d + ASA 81 mg qd23.4
BIBR 1048 300 mg b.i.d + ASA 325 mg qd27.2
Warfarin, Dosed to Target INR 2.0 to 3.08.8

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Number of Participants With Fatal or Life-threatening Major Bleeding Events

Retroperitoneal, intracranial, intraocular, or intraspinal bleeding, or requiring surgical treatment, or leading to a transfusion of 2 units or more, or leading to a fall in hemoglobin of 20g/L or more (NCT01227629)
Timeframe: 12 weeks

InterventionParticipants (Number)
BIBR 1048 50 mg b.i.d0
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.0
BIBR 1048 50 mg b.i.d + ASA 325 mg qd0
BIBR 1048 150 mg b.i.d0
BIBR 1048 150 mg b.i.d + ASA 81 mg qd0
BIBR 1048 150 mg b.i.d + ASA 325 mg qd0
BIBR 1048 300 mg b.i.d0
BIBR 1048 300 mg b.i.d + ASA 81 mg qd1
BIBR 1048 300 mg b.i.d + ASA 325 mg qd3
Warfarin, Dosed to Target INR 2.0 to 3.00

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Safety and Tolerability

Tolerability refers to the number of non-tolerable patients as assessed through the subjective examination of adverse events (AE). Safety refers to the number of patients with treatment emergent AEs. These numbers are presented on the overall Dabigatran treatment. (NCT01241539)
Timeframe: 2 periods of 5 days each

InterventionParticipants (Number)
Treatment emergent adverse eventsAssessment of tolerability by the investigator
Dabigatran20

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Additional Safety Parameters

By study design abnormalities could be due to dialysis or Dabigatran. (NCT01241539)
Timeframe: 2 periods of 5 days each

InterventionParticipants (Number)
Electrocardiogram (ECG) abnormalitiesVital sign abnormalitiesPhysical finding abnormalitiesLaboratory abnormalities: HaematologyLaboratory abnormalities: Clinical chemistry
Dabigatran00000

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Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)

Area under the concentration-time curve of total and free dabigatran in plasma over the time interval from 0 to 8 hours after the second and third administration of dabigatran. (NCT01241539)
Timeframe: Days 2 and 3

,
Interventionng*hr/mL (Geometric Mean)
Total Dabigatran on Day 2Total Dabigatran on Day 3Free Dabigatran on Day 2Free Dabigatran on Day 3
Dabigatran P112301280907839
Dabigatran P211401180802752

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Coagulation Parameters

Assessment of blood coagulation parameters 'activated partial thromboplastin time' (aPTT) and 'factor IIa inhibition' (anti-FIIa) measured with the diluted thrombin time assay. Time to the formation of a fibrin clot (coagulation) is measured in seconds. (NCT01241539)
Timeframe: Day 3

,
Interventionsec (Mean)
Activated partial thromboplastin time (aPTT)Factor IIa inhibition (anti-FIIa)
Dabigatran P146.9143.27
Dabigatran P244.2643.09

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Dialysis Clearance of Dabigatran

Dialysis clearance of dabigatran from blood (CLD,b) and dialysis clearance of dabigatran from plasma (CLD) were calculated and indicate how quickly dabigatran is cleared out from blood or plasma. (NCT01241539)
Timeframe: 4 hours

,
InterventionmL/min (Geometric Mean)
Total dabigatran clearance (CLD,b) from bloodTotal dabigatran clearance (CLD) from plasmaFree dabigatran clearance (CLD,b) from bloodFree dabigatran clearance (CLD) from plasma
Dabigatran P1161120167124
Dabigatran P2241183251190

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Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis

Extent of dabigatran that is removed from blood during one complete 4-hour cycle of dialysis was computed by the difference of plasma concentration at the start and at the end of dialysis relative to the start concentration and is therefore measured as a percentage. (NCT01241539)
Timeframe: 4 hours

,
InterventionPercentage (Geometric Mean)
Total DabigatranFree Dabigatran
Dabigatran P148.849.7
Dabigatran P259.359.3

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Maximum Plasma Concentrations of Dabigatran (Cmax)

Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran. (NCT01241539)
Timeframe: Days 2 and 3

,
Interventionng/mL (Geometric Mean)
Total Dabigatran on Day 2Total Dabigatran on Day 3Free Dabigatran on Day 2Free Dabigatran on Day 3
Dabigatran P1194176150119
Dabigatran P2171159126105

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Plasma Concentration Extraction Ratio

Plasma concentration extraction ratio was measured directly at the dialysis machine and computed as the difference of the predialysis plasma concentration and the postdialysis plasma concentration relative to the predialysis concentration on the percentage scale (minimum: 0 percent of extraction (worst), maximum: 100 percent of extraction). (NCT01241539)
Timeframe: 4 hours

,
InterventionPercentage (Geometric Mean)
Total DabigatranFree Dabigatran
Dabigatran P179.982.6
Dabigatran P261.463.7

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Time to Maximum Plasma Concentration (Tmax)

Time to maximum plasma concentration of total and free dabigatran in plasma after the third administration of dabigatran. (NCT01241539)
Timeframe: Day 3

,
Interventionh (Geometric Mean)
Total DabigatranFree Dabigatran
Dabigatran P11.491.35
Dabigatran P22.131.83

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Cmax of Free Dabigatran in Plasma.

Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. (NCT01290757)
Timeframe: 60 hours

Interventionng/mL (Geometric Mean)
Capsugel106.66
Qualicaps85.12

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Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran.

Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. (NCT01290757)
Timeframe: 60 hours

Interventionng*hr/mL (Geometric Mean)
Capsugel1175.05
Qualicaps941.99

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AUC0-∞ of Free Dabigatran.

Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. (NCT01290757)
Timeframe: 60 hours

Interventionng*hr/mL (Geometric Mean)
Capsugel888.86
Qualicaps714.01

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AUC0-tz of Free Dabigatran.

Area under the concentration-time curve of free dabigatran in plasma from time 0 to the time of the last quantifiable data point. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. (NCT01290757)
Timeframe: 60 hours

Interventionng*hr/mL (Geometric Mean)
Capsugel856.31
Qualicaps678.43

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Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran

Area under the concentration-time curve of total dabigatran in plasma from time 0 to the time of the last quantifiable data point, adjusted for treatment, period and sequence (all fixed effects), and random subject effect. (NCT01290757)
Timeframe: 60 hours

Interventionng*hr/mL (Geometric Mean)
Capsugel1147.64
Qualicaps908.48

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Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma

Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. (NCT01290757)
Timeframe: 60 hours

Interventionng/mL (Geometric Mean)
Capsugel134.44
Qualicaps107.13

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Free Dabigatran: Maximum Measured Concentration (Cmax)

Maximum measured concentration of free dabigatran in plasma, per period. (NCT01306162)
Timeframe: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration

Interventionng/mL (Geometric Mean)
150mg DE (TrtA)126
150mg DE + 400mg DR (TrtB)239
150mg DE + 400mg DR 2h Later (TrtC)133
150mg DE + 400mg DR Bid Same Time (TrtD)241
150mg DE + 400mg DR Bid 2h Later (TrtE)138

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Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)

Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity. (NCT01306162)
Timeframe: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration

Interventionng*hr/mL (Geometric Mean)
150mg DE (TrtA)919
150mg DE + 400mg DR (TrtB)2110
150mg DE + 400mg DR 2h Later (TrtC)1110
150mg DE + 400mg DR Bid Same Time (TrtD)2100
150mg DE + 400mg DR Bid 2h Later (TrtE)1260

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Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)

Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity. (NCT01306162)
Timeframe: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration

Interventionng*hr/mL (Geometric Mean)
150mg DE (TrtA)1160
150mg DE + 400mg DR (TrtB)2520
150mg DE + 400mg DR 2h Later (TrtC)1440
150mg DE + 400mg DR Bid Same Time (TrtD)2570
150mg DE + 400mg DR Bid 2h Later (TrtE)1510

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Total Dabigatran: Maximum Measured Concentration (Cmax)

Maximum measured concentration of total dabigatran in plasma, per period. (NCT01306162)
Timeframe: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration

Interventionng/mL (Geometric Mean)
150mg DE (TrtA)149
150mg DE + 400mg DR (TrtB)282
150mg DE + 400mg DR 2h Later (TrtC)166
150mg DE + 400mg DR Bid Same Time (TrtD)288
150mg DE + 400mg DR Bid 2h Later (TrtE)163

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Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12

"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~(As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients)~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population." (NCT01452347)
Timeframe: Week 12

Interventionng/mL (Geometric Mean)
Observed108.21
Predicted104.80

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Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4

Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group. (NCT01452347)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Patients Evaluated9.8

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Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2

Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group. (NCT01452347)
Timeframe: Week 2

Interventionpercentage of participants (Number)
Patients Evaluated19.2

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Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1

Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group. (NCT01452347)
Timeframe: Week 1

Interventionpercentage of participants (Number)
Patients Evaluated26.9

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Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12

Percentage of patients with observed Ctrough,ss value < 50 ng/mL (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) This outcome measure was only analysed for all patients together and not by dose group. (NCT01452347)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Patients Evaluated7.4

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Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1

"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE) .~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population." (NCT01452347)
Timeframe: Week 1

Interventionng/mL (Geometric Mean)
Observed73.86
Predicted99.52

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Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4

"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population." (NCT01452347)
Timeframe: Week 4

Interventionng/mL (Geometric Mean)
Observed104.43
Predicted109.36

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Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2

"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population." (NCT01452347)
Timeframe: Week 2

Interventionng/mL (Geometric Mean)
Observed84.08
Predicted99.55

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Rate of Partial Effectiveness of Combined GIS Management Strategies

"The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS." (NCT01493557)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Pradaxa, 30 Minutes After a Meal (Randomized)42.9
Pantoprazole 40 mg (Randomized)46.7

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Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom

Time between symptom onset and first observed complete or partial effectiveness and between symptom onset and last observed symptom by management strategy. (NCT01493557)
Timeframe: Week 8

,
Interventiondays (Mean)
Duration of GIS (N= 58; 58)Time to first complete effectiveness (N= 43; 50)Time to first partial effectiveness(N= 6; 2)
Pantoprazole 40 mg (Randomized)23.910.73.5
Pradaxa, 30 Minutes After a Meal (Randomized)23.512.123.7

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Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies

"The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS." (NCT01493557)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Pradaxa, 30 Minutes After a Meal (Randomized)67.8
Pantoprazole 40 mg (Randomized)86.2

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Rates of Complete Effectiveness of GIS at Each Visit.

"The percentage of patients experiencing complete effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.~Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy." (NCT01493557)
Timeframe: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8

,
Interventionpercentage of participants (Number)
Baseline (n= 59 , 58)GIS 3 (Week 1, n= 59 , 58)GIS 4 (Week 2, n= 59 , 58)GIS 5 (Week 3, n= 59 , 58)GIS 6 (Week 4, n= 59 , 58)GIS 7 (Week 5, n= 14 , 15)GIS 8 (Week 6, n= 14 , 15)GIS 9 (Week 7, n= 14 , 15)GIS 10 (Week 8, n= 14 , 15)
Pantoprazole 40 mg (Randomized)0.051.755.260.367.240.040.033.333.3
Pradaxa, 30 Minutes After a Meal (Randomized)0.039.045.855.955.928.642.942.942.9

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Rate of Complete Effectiveness of Combined GIS Management Strategies

"The percentage of patients experiencing complete relief of combined gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved." (NCT01493557)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Pradaxa, 30 Minutes After a Meal (Randomized)42.9
Pantoprazole 40 mg (Randomized)33.3

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The Rate of Complete Effectiveness of Initial GIS Management Strategy

"The percentage of patients experiencing complete relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved." (NCT01493557)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Pradaxa, 30 Minutes After a Meal (Randomized)55.9
Pantoprazole 40 mg (Randomized)67.2

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Rate of Partial Effectiveness of Initial GIS Management Strategies

"The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) and patients taking Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS." (NCT01493557)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Pradaxa, 30 Minutes After a Meal (Randomized)11.9
Pantoprazole 40 mg (Randomized)19.0

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Rates of Complete or Partial Effectiveness of GIS at Each Visit.

"The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.~Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy." (NCT01493557)
Timeframe: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8

,
Interventionpercentage of participants (Number)
Baseline (n= 59 , 58)GIS 3 (Week 1, n= 59 , 58)GIS 4 (Week 2, n= 59 , 58)GIS 5 (Week 3, n= 59 , 58)GIS 6 (Week 4, n= 59 , 58)GIS 7 (Week 5, n= 14 , 15)GIS 8 (Week 6, n= 14 , 15)GIS 9 (Week 7, n= 14 , 15)GIS 10 (Week 8, n= 14 , 15)
Pantoprazole 40 mg (Randomized)0.065.579.382.886.280.080.080.080.0
Pradaxa, 30 Minutes After a Meal (Randomized)0.055.959.364.467.850.085.785.785.7

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Rates of Partial Effectiveness of GIS at Each Visit.

"The percentage of patients experiencing partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.~Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy." (NCT01493557)
Timeframe: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8

,
Interventionpercentage of participants (Number)
Baseline (n= 59 , 58)GIS 3 (Week 1, n= 59 , 58)GIS 4 (Week 2, n= 59 , 58)GIS 5 (Week 3, n= 59 , 58)GIS 6 (Week 4, n= 59 , 58)GIS 7 (Week 5, n= 14 , 15)GIS 8 (Week 6, n= 14 , 15)GIS 9 (Week 7, n= 14 , 15)GIS 10 (Week 8, n= 14 , 15)
Pantoprazole 40 mg (Randomized)0.013.824.122.419.040.040.046.746.7
Pradaxa, 30 Minutes After a Meal (Randomized)0.016.913.68.511.921.442.942.942.9

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Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies

"The percentage of patients experiencing combined of complete or partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS." (NCT01493557)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Pradaxa, 30 Minutes After a Meal (Randomized)85.7
Pantoprazole 40 mg (Randomized)80.0

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Percentage of Patients With Serious AEs

Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events. (NCT01505881)
Timeframe: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Interventionpercentage of participants (Number)
Dabigatran Etexilate (DE)3.0
Warfarin6.8

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Percentage of Patients With Any Adverse Event (AE)

Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events. (NCT01505881)
Timeframe: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Interventionpercentage of participants (Number)
Dabigatran Etexilate (DE)39.4
Warfarin37.3

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Percentage of Patients With AEs Leading to Discontinuation of Trial Drug

"Percentage of patients with Adverse Events leading to discontinuation of trial drug.~Prespecified clinical outcome events were not recorded as Adverse Events." (NCT01505881)
Timeframe: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Interventionpercentage of participants (Number)
Dabigatran Etexilate (DE)5.1
Warfarin1.7

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Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.

"Clinical efficacy outcome events presented are:~Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis" (NCT01505881)
Timeframe: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

,
Interventionpercentage of participants (Number)
DeathVenous thromboembolismMyocardial InfarctionTransient Ischaemic AttackStrokeSystemic embolismValve thrombosis
Dabigatran Etexilate (DE)0.00.01.01.03.00.02.0
Warfarin1.70.00.00.00.00.00.0

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Total Dabigatran: Maximum Measured Concentration (Cmax)

Maximum measured concentration of total dabigatran in plasma, per period. (NCT01595854)
Timeframe: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours

Interventionng/mL (Geometric Mean)
Dabi 75 mg31.47
Dabi + Ticagrelor LD61.30
Dabi + Ticagrelor MD49.11

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Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)

Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran. (NCT01595854)
Timeframe: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours

Interventionng*h/mL (Geometric Mean)
Dabi 75 mg281.05
Dabi + Ticagrelor LD485.48
Dabi + Ticagrelor MD410.46

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AUCt1-t2,ss (Area Under the Concentration-time Curve for the Unbound Sum Dabigatran in Plasma From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4

AUC(2-12),ss ((area under the concentration-time curve for the idarucizumab in plasma from time point 2 to 12 h )) on Day 3 and Day 4 (NCT01688830)
Timeframe: 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h

Interventionng*h/mL (Geometric Mean)
DE (Dose Groups 14-16: Day 3)805
DE+ Placebo 5min754
DE+ 1 g Idarucizumab 5min161
DE+ 2 g Idarucizumab 5min20.9
DE+ 4 g Idarucizumab 5min11.9
DE (Dose Groups 17: Day 3)786
DE+ Placebo+ Placebo542
DE+ 5 g + 2.5 g Idarucizumab10.0

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AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 3 of the Study

"AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).~Ratio of above baseline AUEC(2-12) on Day 4 to above baseline AUEC(2-12) on Day 3 is presented.~This endpoint was determined for Activated Partial Thromboplastin time (aPTT) and Dithiothreitol (dTT)" (NCT01688830)
Timeframe: 2hours-12 hours

,
Interventionratio (Mean)
aPTTdTT
DE+ 5 g + 2.5 g Idarucizumab0.030.01
DE+ Placebo+ Placebo1.681.02

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AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab

AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity) for idarucizumab (NCT01688830)
Timeframe: -2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

Interventionnmol*h/L (Geometric Mean)
20 mg Idarucizumab 1h146
60 mg Idarucizumab 1h426
200 mg Idarucizumab 1h1950
600 mg Idarucizumab 1h6970
1.2 g Idarucizumab 1h8780
2 g Idarucizumab 1h14500
3 g Idarucizumab 1h22600
4 g Idarucizumab 1h31000
6 g Idarucizumab 1h41200
8 g Idarucizumab 1h63800
1 g Idarucizumab 5min7790
2 g Idarucizumab 5min16400
4 g Idarucizumab 5min25800
DE+ 1 g Idarucizumab 5min6480
DE+ 2 g Idarucizumab 5min16600
DE+ 4 g Idarucizumab 5min30900
DE+ 5 g + 2.5 g Idarucizumab62300

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Aet1-t2,ss (Amount of Dabigatran Etexilate Eliminated in Urine From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4 for Sum Dabigatran

"Aet1-t2,ss (amount of dabigatran etexilate eliminated in urine from time point t1 to time point t2, at steady state) on Day 3 and Day 4~Ae(0-12h,ss) of sum dabigatran" (NCT01688830)
Timeframe: Intervals 0-2, 2-6, 6-10, 10-12 hours on Day 3 post dabigatran treatment and -2 to -0:05, -0:05 to 4, 4-8, 8-10, 10-12, 12-24, 24-48, 48-72 on Day 4 post Idarucizumab treatment

Interventionμg (Geometric Mean)
DE (Dose Groups 14-16: Day 3)6600
DE+ Placebo 5min6870
DE+ 1 g Idarucizumab 5min5160
DE+ 2 g Idarucizumab 5min3820
DE+ 4 g Idarucizumab 5min3860
DE (Dose Groups 17: Day 3)6420
DE+ Placebo+ Placebo5060
DE+ 5 g + 2.5 g Idarucizumab4290

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Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab

tmax (time from dosing to maximum measured concentration) for idarucizumab (NCT01688830)
Timeframe: -2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

Interventionhours (Median)
20 mg Idarucizumab 1h1.00
60 mg Idarucizumab 1h1.03
200 mg Idarucizumab 1h1.03
600 mg Idarucizumab 1h1.10
1.2 g Idarucizumab 1h0.967
2 g Idarucizumab 1h0.984
3 g Idarucizumab 1h1.00
4 g Idarucizumab 1h1.06
6 g Idarucizumab 1h1.03
8 g Idarucizumab 1h1.08
1 g Idarucizumab 5min0.117
2 g Idarucizumab 5min0.142
4 g Idarucizumab 5min0.167
DE+ 1 g Idarucizumab 5min0.117
DE+ 2 g Idarucizumab 5min0.200
DE+ 4 g Idarucizumab 5min0.117
DE+ 5 g + 2.5 g Idarucizumab0.117

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Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2)

"Aet1-t2 (amount of idarucizumab eliminated in urine from time point t1 to time point t2)~Ae(0-7h) is presented for dose groups with 1 h infusion and Ae(0-4h) is presented for dose groups with 5 min infusion." (NCT01688830)
Timeframe: Up to 7 hours

Interventionμmol (Geometric Mean)
20 mg Idarucizumab 1hNA
60 mg Idarucizumab 1hNA
200 mg Idarucizumab 1hNA
600 mg Idarucizumab 1hNA
1.2 g Idarucizumab 1hNA
2 g Idarucizumab 1hNA
3 g Idarucizumab 1hNA
4 g Idarucizumab 1hNA
6 g Idarucizumab 1h36.1
8 g Idarucizumab 1h39.5
1 g Idarucizumab 5min2.23
2 g Idarucizumab 5min8.00
4 g Idarucizumab 5min32.6
DE+ 1 g Idarucizumab 5min1.71
DE+ 2 g Idarucizumab 5min11.0
DE+ 4 g Idarucizumab 5min33.6
DE+ 5 g + 2.5 g Idarucizumab73.5

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AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study

"AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).~Ratio of above baseline AUEC(2-12) on Day 4 to above baseline AUEC(2-12) on Day 3 is presented.~This endpoint was determined for Activated Partial Thromboplastin time (aPTT), Dithiothreitol (dTT), Thrombin time (TT) and Ecarin clotting time (ECT)" (NCT01688830)
Timeframe: 2hours-12 hours

,,,
Interventionratio (Mean)
aPTTdTTTTECT
DE+ 1 g Idarucizumab 5min0.460.260.320.28
DE+ 2 g Idarucizumab 5min0.140.060.060.07
DE+ 4 g Idarucizumab 5min0.070.020.000.03
DE+ Placebo 5min1.281.011.081.04

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C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)

"Concentrations of unbound sum dabigatran in plasma after 1.92 to 12 h, at steady state of dabigatran, on Day 4 are presented.~The endpoint refers to unbound sum dabigatran at several time points. The intended pharmacodynamic effect of idarucizumab is to reduce the concentration of this measure to levels below the lower limit of quantification (BLQ). BLQ values are not considered in the calculation of descriptive statistics; and therefore bias the result. This is the reason for applying the 2/3 rule to obtain reliable results. 2/3 rule states that, Statistics of PK parameters are only estimated when at least 2/3 of the data are evaluable." (NCT01688830)
Timeframe: 1.92 hours (h), 2 h, 2.5 h, 6 h and 12 h on Day 4

,,,,,
Interventionng/mL (Geometric Mean)
C1.92,ss (N= 9, 9, 9, 8, 2, 8)C2,ss (N= 9, 6, NA, NA, 2, NA)C2.5,ss (N= 9, NA, NA, NA, 2, NA )C6,ss (N= 9, 9, NA, NA, 2, NA)C12,ss (N= 9, 9, NA, NA, 2, NA)
DE+ 1 g Idarucizumab 5min1361.59NA15.318.2
DE+ 2 g Idarucizumab 5min96.2NANANANA
DE+ 4 g Idarucizumab 5min135NANANANA
DE+ 5 g + 2.5 g Idarucizumab112NANANANA
DE+ Placebo 5min11912313079.238.5
DE+ Placebo+ Placebo10195.692.954.828.9

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Cmax (Maximum Measured Concentration) for Idarucizumab

Cmax (maximum measured concentration) for idarucizumab (NCT01688830)
Timeframe: -2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

Interventionnmol/L (Geometric Mean)
20 mg Idarucizumab 1h79.9
60 mg Idarucizumab 1h257
200 mg Idarucizumab 1h809
600 mg Idarucizumab 1h2440
1.2 g Idarucizumab 1h4520
2 g Idarucizumab 1h7420
3 g Idarucizumab 1h11700
4 g Idarucizumab 1h15700
6 g Idarucizumab 1h22100
8 g Idarucizumab 1h33900
1 g Idarucizumab 5min6360
2 g Idarucizumab 5min13600
4 g Idarucizumab 5min21400
DE+ 1 g Idarucizumab 5min5410
DE+ 2 g Idarucizumab 5min12500
DE+ 4 g Idarucizumab 5min25800
DE+ 5 g + 2.5 g Idarucizumab35300

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Number of Days on Anticoagulation

Assess subject anticoagulant utilization and number of days on anticoagulation (NCT01706146)
Timeframe: up to 12 months

Interventiondays (Mean)
Non-Coumadin Oral Anticoagulant24.9

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Bleeding Incidence

To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation. (NCT01706146)
Timeframe: up to 12 months

Interventionparticipants (Number)
Non-Coumadin Oral Anticoagulant3

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Cmax,ss

"Maximum concentration of Dabigatran etexilate in plasma at steady state was measured.~The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration." (NCT01711853)
Timeframe: -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h

Interventionng/mL (Geometric Mean)
Dabigatran 75 mg207

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AUCtau,ss

"Area under the plasma concentration-time curve of the total dabigatran at steady state over a uniform dosing interval tau was measured.~The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration." (NCT01711853)
Timeframe: -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h

Interventionng*h/mL (Geometric Mean)
Dabigatran 75 mg2140

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Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)

Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss). (NCT01734772)
Timeframe: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours

Interventionng/mL (Geometric Mean)
Dabigratan Etexilate 110mg Bid Alone - Part 183.6
Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1136
Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1106
Dabigratan Etexilate 110mg Bid Alone - Part 297.6
Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2121

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Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)

Area under the concentration-time curve of dabigatran etexilate in plasma at steady state over the uniform dosing interval τ (AUCτ,ss). (NCT01734772)
Timeframe: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours

Interventionng*h/mL (Geometric Mean)
Dabigratan Etexilate 110mg Bid Alone - Part 1551
Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1817
Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1689
Dabigratan Etexilate 110mg Bid Alone - Part 2660
Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2844

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Percentage of Participants With Stroke

Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction. (NCT01774370)
Timeframe: up to 26 weeks

Interventionpercentage of participants (Number)
YesNo
Pradaxa Group0.3099.70

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Percentage of Participants With Systemic Embolism

Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy. (NCT01774370)
Timeframe: up to 26 weeks

Interventionpercentage of participants (Number)
No
Pradaxa Group100.0

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TRAP-induced Platelet Aggregation

TRAP-induced platelet aggregation measured by light transmittance aggregometry (LTA) was similar between groups (NCT01852162)
Timeframe: 1 week

Interventionpercentage of aggregation (Mean)
Dabigatran74
Placebo77

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Clot Kinetic: Clot Stength

Clot strength (maximal amplitude:MA) was assessed by thromboelastography. (NCT01852162)
Timeframe: 1-week

Interventionmm (Mean)
Dabigatran63.7
Placebo62.9

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Clot Kinetic: Thrombin Activity

Parameters related to thrombin activity and velocity of thrombus generation (reaction time: R; time to maximum rate of thrombus generation: TMRTG) were evaluated by thromboelastography. (NCT01852162)
Timeframe: 1-week

,
Interventionminutes (Mean)
RTMRTG
Dabigatran12.2514.32
Placebo6.768.4

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Platelet Reactivity Measured by Multiple Electrode Aggregometry.

Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by multiple electrode aggregometry. (NCT01852162)
Timeframe: 1-week

,
Interventionarbitrary aggregation units (Mean)
TRAP-induced platelet aggregationADP-induced platelet aggregationArachidonic acid-induced platelet aggregationCollagen-induced platelet aggregation
Dabigatran1176.4482.2238.9559.4
Placebo1210.6454.0230.1532.5

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Platelet Reactivity Measured by LTA

Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by light transmittance aggregometry (LTA). (NCT01852162)
Timeframe: 1-week

,
Interventionpercentage of aggregation (Mean)
ADP-induced platelet aggregationArachidonic acid-induced platelet aggregationCollagen-induced platelet aggregation
Dabigatran49.56.942.6
Placebo44.66.034.9

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Spontaneous Echo Contrast

Spontaneous Echo Contrast showed in Transesophageal echocardiography (NCT01868243)
Timeframe: 90 days

Interventionparticipants (Number)
Dabigatran2
Warfarin1

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Intracardiac Thrombus

The primary endpoint was the detection of intracardiac thrombus in TEE at the end of follow-up (90 days). (NCT01868243)
Timeframe: 90 days

Interventionparticipants (Number)
Dabigatran0
Warfarin1

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Frequency of Dose Adjustment During the Treatment Phase

Frequency of dose adjustments (i.e. number of patients with dose adjustment), temporary and permanent discontinuation from therapy, and number of patients with laboratory monitoring requirements for dose (NCT01895777)
Timeframe: From first administration of trial medication until last administration of trial medication +6 days (residual effect period).

,
InterventionParticipants (Count of Participants)
With dose adjustmentWith temporary interruptionLaboratory monitoring required
Dabigatran Etexilate6325175
Standard of Care56682

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Composite Primary Endpoint

"The primary endpoint was the combined endpoint of the proportions of patients with:~Complete thrombus resolution~Freedom from recurrent VTE~Freedom from mortality related to VTE. The events outlined in the above combined primary endpoint were assessed by radiologists or other such qualified clinicians using an appropriate method such as ultrasound, echocardiography, venography, or CT scan, based on the location of the thrombus and the test used to perform the baseline assessment.~The primary efficacy endpoint contained 3 components. Each component was evaluated separately, and only if the criteria for all 3 components were satisfied, the primary endpoint was considered achieved." (NCT01895777)
Timeframe: From the time of randomisation until Week 12, 84 days after randomisation including a visit window of 7 days.

,
InterventionParticipants (Count of Participants)
Complete thrombus resolutionFreedom from recurrent VTEFreedom from mortality related to VTEComposite endpoint met
Dabigatran Etexilate8117017781
Standard of Care38838938

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Assessment of the Acceptability of an Age-appropriate Formulation at End of Therapy (Pellets)

"Acceptability was defined as the overall ability and willingness of the patient to use the medicinal product. Questions regarding acceptability were to be answered by the patient and/or parent/caregiver (as applicable) and by the investigator/site staff.~Investigator questionnaire pellets: What is your impression about the patient's acceptability of DE intake? The score is 1 (good), 2 (satisfactory), 3 (not satisfactory) and 4 (bad).~Parents questionnaire pellets: Do you think that spitting occurs? The score is 1 (Never), 2 (sometimes) and 3 (often).~Scores refers to the end of treatment." (NCT01895777)
Timeframe: Assessment at the last study visit at day 84 (+- 7 days), or at day of early termination.

InterventionScore (Mean)
Investigator questionnaire pelletsParents questionnaire pellets
Dabigatran Etexilate1.21.2

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Assessment of the Acceptability of an Age-appropriate Formulation at End of Therapy (Oral Liquid Formulation - OLF)

"Acceptability was defined as the overall ability and willingness of the patient to use the medicinal product. Questions regarding acceptability were to be answered by the patient and/or parent/caregiver (as applicable) and by the investigator/site staff.~Investigator questionnaire flavoured OLF: What is your impression about the patient's acceptability of DE intake? The score is 1 (good), 2 (satisfactory), 3 (not satisfactory) and 4 (bad).~Investigator questionnaire unflavoured OLF: What is your impression about the patient's acceptability of DE intake? The score is 1 (good), 2 (satisfactory), 3 (not satisfactory) and 4 (bad).~Parents questionnaire flavoured OLF.: Do you think spitting occurs? The score ranges form 1 (never), 2 ( sometimes) to 3 (often).~Parents questionnaire unflavoured OLF:Do you think spitting occurs? The score ranges form 1 (never), 2 ( sometimes) to 3 (often).~Scores refers to the end of treatment." (NCT01895777)
Timeframe: Assessment at the last study visit at day 84 (+- 7 days), or at day of early termination.

InterventionScore (Mean)
Investigator questionnaire flavoured OLFInvestigator questionnaire unflavoured OLFParents questionnaire flavoured OLFParents questionnaire unflavoured OLF
Dabigatran Etexilate1.61.21.41.8

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Assessment of the Acceptability of an Age-appropriate Formulation at End of Therapy (Capsules)

"Acceptability was defined as the overall ability and willingness of the patient to use the medicinal product. Questions regarding acceptability were to be answered by the patient and/or parent/caregiver (as applicable) and by the investigator/site staff.~Investigator questionnaire capsules: What is your impression about the patient's acceptability of DE intake? The score is 1 (good), 2 (satisfactory), 3 (not satisfactory) and 4 (bad).~Parents questionnaire capsules: How acceptable was the DE treatment for the child? The score is 1 (good), 2 (satisfactory), 3 (not satisfactory) and 4 (bad).~Patients questionnaire capsules: Was taking the study capsules easy or difficult? The score is 1 (Very easy), 2 (easy), 3 (neither easy nor difficult), 4 (difficult) and 5 (very difficult).~Scores refers to the end of treatment." (NCT01895777)
Timeframe: Assessment at the last study visit at day 84 (+- 7 days), or at day of early termination.

InterventionScore (Mean)
Investigator questionnaire capsulesParents questionnaire capsulesPatient questionnaire capsules
Dabigatran Etexilate1.01.01.6

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All Components of the Primary Efficacy Endpoint

Patients with VTE-related death occurring between randomisation to Day 84 + 7 days were considered as not meeting the endpoint. The presence of recurrent VTE(s) was examined throughout the trial, and only the date of first occurrence was used for analysis. Assessment of index VTE status (best overall response) was scheduled on Day 84 ± 7 days (Visit 8) for patients who were alive without an early consent withdraw. In the case a Patient discontinued trial medication prematurely due to any reason the index VTE assessment took place at the early end of treatment visit. (NCT01895777)
Timeframe: From the time of randomisation until Week 12, 84 days after randomisation including a visit window of 7 days.

,
InterventionParticipants (Count of Participants)
Complete thrombus resolution by Day 84Recurrent VTE by Day 84VTE-related death by Day 84
Dabigatran Etexilate8170
Standard of Care3871

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All Bleeding Events

The number of participants with bleeding events includes major bleeding events (MBEs), clinically relevant non-major (CRNM) bleeding, minor bleeding events, any bleeding events, and the numbers of the combined endpoint of major and CRNM bleeding events was presented, based on adjudication-confirmed data. (NCT01895777)
Timeframe: From first administration of trial medication until last adminstration of trial medication +6 days (residual effect period). Up to 97 days.

,
InterventionParticipants (Count of Participants)
Any bleedingMajor bleedingCRNM bleedingMinor bleedingMajor and CRNM bleeding
Dabigatran Etexilate3842336
Standard of Care2221213

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Steady State Plasma Concentrations of Total Dabigatran at Visit 3

Descriptive statistics for steady state plasma concentrations of total dabigatran etexilate at visit 3 (NCT01895777)
Timeframe: From the time of randomisation until visit 3

Interventionnanogram per milliliter (Geometric Mean)
Dabigatran Etexilate79.8

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Frequency of Patients Switching the Type of Anti-coagulation Therapy Including Dabigatran Etexilate to Standard of Care Treatment and Switching From One Standard of Care Treatment to Another

"Frequency of patients switching the type of anti-coagulation therapy including Dabigatran etexilate (DE) to standard of care (SoC) treatment and switching from one standard of care treatment to another.~For DE arm, only the switch from DE to SoC was counted, while for the SoC arm, all switches among SoC treatments were counted." (NCT01895777)
Timeframe: From first administration of trial medication until last administration of trial medication +6 days (residual effect period).

InterventionParticipants (Count of Participants)
Dabigatran Etexilate22
Standard of Care2

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Freedom From Thrombus Progression at End of Therapy Compared With Baseline

Freedom from thrombus progression at end of therapy compared with baseline, based on adjudication-confirmed data. (NCT01895777)
Timeframe: From the time of randomisation until Week 12, 84 days after randomisation including a visit window of 7 days.

InterventionParticipants (Count of Participants)
Dabigatran Etexilate148
Standard of Care73

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Freedom From Major Bleeding Events (MBEs)

Freedom from major bleeding events (MBEs), defined as either fatal bleeding, clinically overt bleeding associated with a decrease in haemoglobin of at least 20 g/L in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial or otherwise involves the central nervous system, or bleeding that requires intervention in an operating suite. (NCT01895777)
Timeframe: From first administration of trial medication until last administration of trial medication +6 days (residual effect period). Up to 97 days.

InterventionProportion of participants (Number)
Dabigatran Etexilate0.977
Standard of Care0.977

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All-cause Mortality

Patients being alive at the end of observational period will be censored for all-cause mortality at the date of patients' last date known to be alive, or the date of data cut-off whichever comes first. (NCT01895777)
Timeframe: From first administration of trial medication until last administration of trial medication +6 days (residual effect period). Up to 97 days.

InterventionParticipants (Number)
Dabigatran Etexilate0
Standard of Care1

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Steady State Plasma Concentrations After at Least 3 Days Following Any Dabigatran Etexilate Dose Adjustment

Descriptive statistics for steady state plasma concentrations of total dabigatran etexilate after at least 3 days following any dabigatran etexilate dose adjustment (NCT01895777)
Timeframe: From the time of randomisation until Week 12, 84 days after randomisation including a visit window of 7 days.

Interventionnanogram per milliliter (Geometric Mean)
Dabigatran Etexilate81.7

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Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose

Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss) (NCT01896297)
Timeframe: 2 hours after the last drug administration, on day 8

Interventionng/mL (Geometric Mean)
Dabigatran Etexilate202

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Number of Participants With Minor Bleeding Events

(NCT01976507)
Timeframe: Within 4 months following procedure (+/- 4 days)

InterventionParticipants (Count of Participants)
Dabigatran Etexilate Mesylate3

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Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation.

(NCT01976507)
Timeframe: Within 4 months following procedure (+/- 4 days)

Interventionnumber of events (Number)
Dabigatran Etexilate Mesylate0

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Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation.

(NCT01976507)
Timeframe: Within 4 months following procedure (+/- 4 days)

Interventionnumber of events (Number)
Dabigatran Etexilate Mesylate1

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PTS Assessment Completion

Percentage of participants who completed post-thrombotic syndrome assessments (NCT01999179)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant17

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Biomarker Sample Collection

Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis (NCT01999179)
Timeframe: 1 year

Interventionparticipants (Number)
Low-molecular-weight Heparin or Direct Oral Anticoagulant7

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Number of Participants With Major Bleeding

Number of participants with major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant1

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Number of Participants With Recurrent Thrombosis

Number of participants with recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant0

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Number of Participants With Post-thrombotic Syndrome

The number of participants with post-thrombotic syndrome 6 months after catheter removal in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant0

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AUEC2-12

"Area under the effect curve over the time interval from 2 to 12h, AUEC2-12 on Days 4 and 11 for diluted thrombin time (dTT).~For dose groups 5 to 7(day4-Part-II): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h on day 4. For dose groups 5 to 7(day11-Part-II): 242h, 242.083h, 242.167h, 242.5h, 243h, 244h, 246h, 248h, 250h, 252h. For dose groups 8(day4-Part-II): 74.5 h, 78 h, 84 h on day 4. For dose groups 8(day11-Part-II): 242h, 242.083h,242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h on day 11.~AUEC is calculated by multiplying the ratio (Value at each time point/Ebase, unit of Vaue is [s] and Ebase is value [s] at baseline) by time. Therefore, Unit for AUEC2-12 is [h]." (NCT02028780)
Timeframe: Day 4 and Day 11 (Part II); Time frame are provided in detail in the Description section

,,,,
Interventionh (Mean)
Day 4Day 11
DE+1000mg_5m (Dose group5 - Part II)18.012.5
DE+2000mg_5m (Dose group6 - Part II)17.411.2
DE+2500mg+2500mg (Dose group8 - Part II)17.310.0
DE+4000mg_5m (Dose group7 - Part II)15.59.95
DE+Placebo_5m (Part II)16.315.8

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AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II).

"Area under the concentration-time curve of the dabigatran in plasma at steady state over the time interval 2 hours-12 hours.~Time Frame: For dose group 5 to 7 (Day 1 to 3-Part-I):74hours (h), 74.5h, 75h, 76h, 78h, 80h, 82h, 84h, For dose group 8 (Day 1 to 3-Part-I): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h and For dose group 5-7 (Day11 to Day13-Part II):242h, 242.167h, 242.5h, 243h, 244h,246h, 248h, 250h, 252h. For dose group 8 (Day11 to Day13-Part II):242h, 242.083h, 242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h." (NCT02028780)
Timeframe: Day 4 (Part I) and Day 11 (Part II). Time frame are provided in detail in the Description section

,,,,
Interventionng*h/mL (Geometric Mean)
Day 4Day 11
DE+1000mg_5m (Dose group5 - Part II)1260330
DE+2000mg_5m (Dose group6 - Part II)101082.2
DE+2500mg+2500mg (Dose group8 - Part II)110010.0
DE+4000mg_5m (Dose group7 - Part II)80210.1
DE+Placebo_5m (Part II)909909

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Ae0-74,ss on Days 4 and 11 for Sum Dabigatran (Part II)

Amount of analyte eliminated in urine at steady state from the time point 0 hours to time point 74 hours. (NCT02028780)
Timeframe: 0-2 h, 2-6 h, 6-10 h, 10-12 h,12-14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4 and Day 11.

,,,,
Interventionμg (Geometric Mean)
Day 4Day 11
DE+1000mg_5m (Dose group5 - Part II)1280012500
DE+2000mg_5m (Dose group6 - Part II)1170013100
DE+2500mg+2500mg (Dose group8 - Part II)1100010600
DE+4000mg_5m (Dose group7 - Part II)88109310
DE+Placebo_5m (Part II)92509690

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Ae0-73 for the Dose Group 4 in the Part I

Amount of the analyte excreted in urine over the time interval 0-73 (NCT02028780)
Timeframe: For dose group 4 (day1 to day4-Part-1): 0-7h, 7-13h, 13-25h, 25-49h, 49-73h

Interventionμmol (Geometric Mean)
BI8000mg_1h (Dose group4 - Part I)69.1

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Ae0-72 for Idarucizumab in the Part I & Part II.

Amount of idarucizumab eliminated in urine over the time interval 0-72. Time frame: For dose groups 1 to 3 (day1 to day4-Part-1):0-4 h, 4-8 h, 8-12 h, 12-24 h, 24-48 h, 48-72 h. For dose groups 5 to 7 (day 11 to day14-Part-II): 0-4 h, 4-8 h, 8-10 h, 10-12 h,12-24 h, 24-48 h, and 48-72 h. For dose groups 8 (day11 to day14-Part-II): 0-4h, 4-8 h, 8-10 h, 10-24 h, 24-48 h, 48-72 h. (NCT02028780)
Timeframe: Day 1 to 4 (Part I) and Day 11 to 14 (Part II); Time frame are provided in detail in the Description section

Interventionμmol (Geometric Mean)
BI1000mg_5m (Dose group1 - Part I)1.54
BI2000mg_5m (Dose group2 - Part I)6.10
BI4000mg_5m (Dose group3 - Part I)20.5
DE+1000mg_5m (Dose group5 - Part II)4.21
DE+2000mg_5m (Dose group6 - Part II)13.8
DE+4000mg_5m (Dose group7 - Part II)42.6
DE+2500mg+2500mg (Dose group8 - Part II)51.5

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Cmax for Idarucizumab in the Part I & Part II.

Maximum measured concentration of the analyte in plasma for idarucizumab Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, -0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h. (NCT02028780)
Timeframe: Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section

Interventionnmol/L (Geometric Mean)
BI1000mg_5m (Dose group1 - Part I)6810
BI2000mg_5m (Dose group2 - Part I)15700
BI4000mg_5m (Dose group3 - Part I)28100
BI8000mg_1h (Dose group4 - Part I)37600
DE+1000mg_5m (Dose group5 - Part II)9510
DE+2000mg_5m (Dose group6 - Part II)17600
DE+4000mg_5m (Dose group7 - Part II)30200
DE+2500mg+2500mg (Dose group8 - Part II)30100

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AUC0-inf for Idarucizumab in the Part I & Part II.

"Area under the concentration-time curve of the analyte in plasma for idarucizumab over the time interval from 0 extrapolated to infinity.~Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, -0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h." (NCT02028780)
Timeframe: Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section

Interventionnmol*h/L (Geometric Mean)
BI1000mg_5m (Dose group1 - Part I)9150
BI2000mg_5m (Dose group2 - Part I)19500
BI4000mg_5m (Dose group3 - Part I)37600
BI8000mg_1h (Dose group4 - Part I)76800
DE+1000mg_5m (Dose group5 - Part II)8590
DE+2000mg_5m (Dose group6 - Part II)19200
DE+4000mg_5m (Dose group7 - Part II)34500
DE+2500mg+2500mg (Dose group8 - Part II)43300

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Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.

Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran. (NCT02044367)
Timeframe: 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration

Interventionng*h/mL (Geometric Mean)
T1 (Treatment A)1000
T2 (Treatment B)958
R (Reference)727

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Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.

"Palatability question: How do you rank the taste? with 5 possible answers: Very good - Good - Fair - Acceptable - Not acceptable." (NCT02044367)
Timeframe: once on day 3 (48 hours after first dose)

,
Interventionparticipants (Number)
Very goodGoodFairAcceptableNot acceptable
T1 (Treatment A)22018112
T2 (Treatment B)01517147

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Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.

Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran. (NCT02044367)
Timeframe: 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration

Interventionng∙h/mL (Geometric Mean)
T1 (Treatment A)1220
T2 (Treatment B)1160
R (Reference)893

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Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.

Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran. (NCT02044367)
Timeframe: 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration

Interventionng/mL (Geometric Mean)
T1 (Treatment A)157
T2 (Treatment B)154
R (Reference)106

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Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.

Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran. (NCT02044367)
Timeframe: 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration

Interventionng/mL (Geometric Mean)
T1 (Treatment A)191
T2 (Treatment B)184
R (Reference)131

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Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.

"Acceptability question: Would you accept to take this medication for chronic use? with 3 possible answers: Yes - No - I am not sure." (NCT02044367)
Timeframe: once on day 3 (48 hours after first dose)

,
Interventionparticipants (Number)
YesNoI am not sure
T1 (Treatment A)3797
T2 (Treatment B)29177

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Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release.

Proportion of subjects with index event safety outcomes (resolved / recovery ongoing / deceased) at the time of their hospital discharge / release. (NCT02149303)
Timeframe: From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days

InterventionPercentage of participants (Number)
Resolved at dischargeUnresolved at discharge (Recovery ongoing)Died before discharge (Deceased)
Dabigatran Etexilate (Pradaxa®)86.47.36.3

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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release

Proportion of subjects receiving different types of interventions (i.e., medication / procedure and surgery) to manage the index events until their hospital discharge / release. (NCT02149303)
Timeframe: From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days

InterventionPercentage of participants (Number)
Fluid transfusionBlood transfusionFresh frozen plasma (FFP)Plasma cryoprecipitatePlateletsBlood coagulation factor concentratesComputed tomography (CT) scanningX-rayUpper endoscopyColonoscopyEndoscopy (unspecified whether lower or upper)Nuclear imagingUltrasoundMagnetic resonance imaging (MRI)EnteroscopySigmoidoscopySurgery or procedureDrugs for the alimentary tractBlood/anticoagulant medicationVitamin K
Dabigatran Etexilate (Pradaxa®)72.857.124.61.65.85.839.324.120.919.96.35.85.83.71.61.626.732.57.93.7

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Index Event Characteristics (i.e. Type of Bleeding and Anatomic Locations of the Index Event) at the Time of the ED / ER Presentation or Hospitalization

"Proportion of Index events by anatomic location and type are presented. The categories of Unknown and Other presented below correspond to, Unknown: Unknown location of bleeding met the criteria for major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH).~Other: Other types of bleeding represent a combined category of all other locations of bleeding whose incidence was <1.7%." (NCT02149303)
Timeframe: From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days

InterventionPercentage of events (Number)
GastrointestinalUpper tractLower tractBrain / IntracranialNon-traumaTraumaFallMotor vehicle accidentUnknownOther
Dabigatran Etexilate (Pradaxa®)61.822.534.018.84.214.714.10.50.518.8

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Time to Adjudicated Non-CV

"Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported.~Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV" (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg14
Dabigatran Etexilate 150mg4
Warfarin13
Warfarin (Excluding Elder Patients Outside USA)8

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Time to Adjudicated All Cause Death

Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death. (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg55
Dabigatran Etexilate 150mg30
Warfarin48
Warfarin (Excluding Elder Patients Outside USA)35

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Time to Composite Endpoint of Death or First Thrombotic Event

Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE). (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg108
Dabigatran Etexilate 150mg60
Warfarin83
Warfarin (Excluding Elder Patients Outside USA60
All Dabigatran Etexilate168

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Time to Adjudicated Undetermined Cause of Death

"Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported.~This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was patient died) or when there was insufficient supporting information or detail to assign the cause of death." (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg4
Dabigatran Etexilate 150mg5
Warfarin4
Warfarin (Excluding Elder Patients Outside USA)3

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Time to Composite Endpoint of Death + MI + Stroke

Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported. (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg107
Dabigatran Etexilate 150mg60
Warfarin80
Warfarin (Excluding Elder Patients Outside USA)57

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Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG

Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported. (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg149
Dabigatran Etexilate 150mg90
Warfarin131
Warfarin (Excluding Elder Patients Outside USA)98
All Dabigatran Etexilate239

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Time to First Adjudicated ISTH MBE or CRNMBE

"Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported.~Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial.~Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status.~Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'." (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg151
Dabigatran Etexilate 150mg154
Warfarin264
Warfarin (Excluding Elder Patients Outside USA)196

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Time to First Adjudicated MI

Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg44
Dabigatran Etexilate 150mg26
Warfarin29
Warfarin (Excluding Elder Patients Outside USA)22

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Time to First Adjudicated SE

"Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported.~SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy." (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg3
Dabigatran Etexilate 150mg1
Warfarin3
Warfarin (Excluding Elder Patients Outside USA)3

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Time to First Adjudicated ST

Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported. (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg15
Dabigatran Etexilate 150mg7
Warfarin8
Warfarin (Excluding Elder Patients Outside USA)7

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Time to First Adjudicated Stroke

"Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported.~Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction" (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg17
Dabigatran Etexilate 150mg9
Warfarin13
Warfarin (Excluding Elder Patients Outside USA)8

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Time to First Adjudicated Unplanned Revascularisation by PCI/CABG

Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported. (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg76
Dabigatran Etexilate 150mg51
Warfarin69
Warfarin (Excluding Elder Patients Outside USA)52

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Time to Adjudicated CV

"Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported.~CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes." (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg37
Dabigatran Etexilate 150mg21
Warfarin31
Warfarin (Excluding Elder Patients Outside USA)24

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MRTpo for Free Dabigatran

Mean residence time of the analyte in the body after po administration (MRTpo) for free dabigatran. (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionhour (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)9.9
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)9.58
Dabigatran Etexilate 150 mg Powder: Test 2 (C)9.15

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Cmax for Total Dabigatran

Maximum measured concentration of the analyte in plasma (Cmax) for total dabigatran. (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionng/mL (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)74.6
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)139
Dabigatran Etexilate 150 mg Powder: Test 2 (C)124

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Cmax for Free Dabigatran

Maximum measured concentration of the analyte in plasma (Cmax) for free dabigatran (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionng/mL (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)61.5
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)112
Dabigatran Etexilate 150 mg Powder: Test 2 (C)103

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CL/F for Free Dabigatran

Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for free dabigatran. (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

InterventionmL (milliliter)/min (minute) (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)4040
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)2310
Dabigatran Etexilate 150 mg Powder: Test 2 (C)2560

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AUC0-tz for Total Dabigatran

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for total dabigatran. (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionng*h/mL (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)565
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)1030
Dabigatran Etexilate 150 mg Powder: Test 2 (C)908

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AUC0-tz for Free Dabigatran

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for free dabigatran. (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionng*h/mL (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)436
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)794
Dabigatran Etexilate 150 mg Powder: Test 2 (C)715

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AUC0-inf for Total Dabigatran

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for total dabigatran. (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionng(nanogram)*h(hour)/mL(milliliter) (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)599
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)1050
Dabigatran Etexilate 150 mg Powder: Test 2 (C)928

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λz for Total Dabigatran

Terminal rate constant in plasma (λz) for total dabigatran. (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Intervention1/hour (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)0.079
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)0.074
Dabigatran Etexilate 150 mg Powder: Test 2 (C)0.0756

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Tmax for Total Dabigatran

Time from dosing to the maximum concentration of the analyte in plasma (tmax) for total dabigatran (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionhour (Median)
Dabigatran Etexilate 150 mg Capsule: Reference (A)2.0
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)1.5
Dabigatran Etexilate 150 mg Powder: Test 2 (C)1.5

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Assessment of Tolerability by Investigator.

Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad. (NCT02171611)
Timeframe: From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.

,,
InterventionPercentage of Participants (Number)
GoodSatisfactoryNot satisfactoryBadNot assessable
Dabigatran Etexilate 150 mg Capsule: Reference (A)100.00.00.00.00.0
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)100.00.00.00.00.0
Dabigatran Etexilate 150 mg Powder: Test 2 (C)100.00.00.00.00.0

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λz for Free Dabigatran

(NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Intervention1/hour (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)0.091
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)0.0811
Dabigatran Etexilate 150 mg Powder: Test 2 (C)0.0893

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Vz/F for Total Dabigatran

Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for total dabigatran. (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

InterventionLiter (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)2380
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)1450
Dabigatran Etexilate 150 mg Powder: Test 2 (C)1610

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Vz/F for Free Dabigatran

Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for free dabigatran. (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

InterventionLiter (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)2670
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)1700
Dabigatran Etexilate 150 mg Powder: Test 2 (C)1720

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Tmax for Free Dabigatran

Time from dosing to the maximum concentration of the analyte in plasma (tmax) for free dabigatran (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionhour (Median)
Dabigatran Etexilate 150 mg Capsule: Reference (A)2.0
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)1.51
Dabigatran Etexilate 150 mg Powder: Test 2 (C)1.5

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t1/2 for Total Dabigatran

Terminal half-life of the analyte in plasma (t1/2) for total dabigatran (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionhour (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)8.77
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)9.37
Dabigatran Etexilate 150 mg Powder: Test 2 (C)9.16

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t1/2 for Free Dabigatran

Terminal half-life of the analyte in plasma (t1/2) for free dabigatran. (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionhour (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)7.62
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)8.54
Dabigatran Etexilate 150 mg Powder: Test 2 (C)7.76

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Percentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests.

"Percentage of participants with findings in Physical examination, Vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), Clinical laboratory tests (haematology, clinical chemistry and urinalysis). Relevant findings or worsening of baseline conditions were reported as Adverse events.~There were no clinically relevant finding reported for Physical examination, Vital signs (blood pressure, pulse rate), 12-lead ECG and Clinical laboratory tests." (NCT02171611)
Timeframe: From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.

InterventionPercentage of participants (Number)
Dabigatran Etexilate 150 mg Capsule: Reference (A)0.0
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)0.0
Dabigatran Etexilate 150 mg Powder: Test 2 (C)0.0

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CL/F for Total Dabigatran

Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for total dabigatran. (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

InterventionmL (milliliter)/min (minute) (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)3130
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)1790
Dabigatran Etexilate 150 mg Powder: Test 2 (C)2020

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AUC0-inf for Free Dabigatran

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for free dabigatran. (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionng*h/mL (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)464
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)815
Dabigatran Etexilate 150 mg Powder: Test 2 (C)734

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MRTpo for Total Dabigatran

Mean residence time of the analyte in the body after po administration (MRTpo) for total dabigatran. (NCT02171611)
Timeframe: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionhour (Geometric Mean)
Dabigatran Etexilate 150 mg Capsule: Reference (A)10.8
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)10.1
Dabigatran Etexilate 150 mg Powder: Test 2 (C)10

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Central Measurement of Diluted Thrombin Time (dTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)

(NCT02197416)
Timeframe: At Visit 3 (day 4 after first dose of trial medication)

InterventionSecond (s) (Mean)
Dabigatran Etexilate (0 to < 2 Years)37.9
Dabigatran Etexilate (2 to <12 Years)40.5
Dabigatran Etexilate (12 to <18 Years)45.3

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Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)

(NCT02197416)
Timeframe: At Visit 3 (day 4 after first dose of trial medication)

InterventionSecond (s) (Mean)
Dabigatran Etexilate (0 to < 2 Years)46.6
Dabigatran Etexilate (2 to <12 Years)57.1
Dabigatran Etexilate (12 to <18 Years)56.8

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Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months

"The event-free probability of major or minor (including CRNM) bleeding event were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.~Patients who did not experience major or minor (including CRNM) bleeding event at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-bleeding related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration." (NCT02197416)
Timeframe: At month 6 (Week 26) and month 12 (Week 52) of on treatment period

,,
InterventionProbability (Number)
6 months12 months
Dabigatran Etexilate (0 to < 2 Years)0.8890.889
Dabigatran Etexilate (12 to <18 Years)0.7530.691
Dabigatran Etexilate (2 to <12 Years)0.8940.831

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Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)

(NCT02197416)
Timeframe: Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.

InterventionSecond (s) (Mean)
Dabigatran Etexilate (0 to < 2 Years)49.1
Dabigatran Etexilate (2 to <12 Years)57.3
Dabigatran Etexilate (12 to <18 Years)59.0

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Central Measurement of Ecarin Clotting Time (ECT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)

(NCT02197416)
Timeframe: Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.

InterventionSecond (s) (Mean)
Dabigatran Etexilate (0 to < 2 Years)53.3
Dabigatran Etexilate (2 to <12 Years)66.6
Dabigatran Etexilate (12 to <18 Years)69.2

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Central Measurement of Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)

(NCT02197416)
Timeframe: At Visit 3 (day 4 after first dose of trial medication)

InterventionSecond (s) (Mean)
Dabigatran Etexilate (0 to < 2 Years)52.7
Dabigatran Etexilate (2 to <12 Years)64.3
Dabigatran Etexilate (12 to <18 Years)69.5

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Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment Period

Percentage of participants with dabigatran etexilate dose adjustments during on treatment period. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration. (NCT02197416)
Timeframe: From first DE administration to 3 days of residual effect period after last DE administration, up to 52 weeks+ 3 days

InterventionPercentage of participants (Number)
Dabigatran Etexilate (0 to < 2 Years)66.7
Dabigatran Etexilate (2 to <12 Years)39.5
Dabigatran Etexilate (12 to <18 Years)21.1

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Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months

The event-free probability of PTS were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience PTS at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-PTS related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration. (NCT02197416)
Timeframe: At month 6 (Week 26) and 12 (Week 52) of on treatment period

,,
InterventionProbability (Number)
6 months12 months
Dabigatran Etexilate (0 to < 2 Years)1.0001.000
Dabigatran Etexilate (12 to <18 Years)0.9790.979
Dabigatran Etexilate (2 to <12 Years)1.0001.000

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Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months

"The event-free probability of first recurrence of VTE were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.~Patients who did not experience recurrent VTE at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-VTE related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration." (NCT02197416)
Timeframe: At month 6 (Week 26) and 12 (Week 52) of on treatment period

,,
InterventionProbability (Number)
6 months12 months
Dabigatran Etexilate (0 to < 2 Years)1.0001.000
Dabigatran Etexilate (12 to <18 Years)0.9790.979
Dabigatran Etexilate (2 to <12 Years)1.0001.000

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Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)

(NCT02197416)
Timeframe: dTT values were collected at day 4, 22, 43, 85, 127, 183, 239, and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.

InterventionSecond (s) (Mean)
Dabigatran Etexilate (0 to < 2 Years)40.0
Dabigatran Etexilate (2 to <12 Years)46.0
Dabigatran Etexilate (12 to <18 Years)43.4

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Central Measurement: The Mean of dTT Ratio at 2h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.

"Central measurement: The mean of dTT (AntiFactor IIa activity) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.~dTT ratio= dTT(post dose)/dTT(baseline). The mean of dTT ratio is presented." (NCT02223260)
Timeframe: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1

Interventionratio (Mean)
ER2ER12
Dabigatran Etexilate1.591.26

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Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.

Central measurement: The mean of Ecarin Clotting Time (ECT) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation. (NCT02223260)
Timeframe: 2 h, and 12 h after dosing on day 1

Interventionsecond (Mean)
E2E12
Dabigatran Etexilate10166.9

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Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.

Central measurement: The mean of dTT (AntiFactor IIa activity) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation. (NCT02223260)
Timeframe: 2 h, and 12 h after dosing on day 1

Interventionsecond (Mean)
E2E12
Dabigatran Etexilate48.738.6

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Central Measurement: The Mean ECT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.

"Central measurement: The mean Ecarin Clotting Time (ECT) ratio at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.~ECT ratio= ECT(Post dose)/ECT(baseline), The mean of ECT ratio is presented." (NCT02223260)
Timeframe: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1

InterventionRatio (Mean)
ER2ER12
Dabigatran Etexilate2.421.63

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Incidence of All AEs During the Treatment Period

Percentage of patients with all adverse events (AEs) during the treatment period (including REP). (NCT02223260)
Timeframe: Within two days after the administration of trial medication, up to 3 days

Interventionpercentage of participants (Number)
Dabigatran Etexilate0.0

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Incidence of All Bleeding Events (Major, CRNM and Minor) During the Treatment Period.

"Percentage of patients with Incidence of all bleeding events(major, clinically relevant non-major (CRNM) & minor) during the treatment period (including the residual effect period).Bleeding events were classified as follow:~Major bleeding: 1) Fatal bleeding 2) Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL (20 g/L) in 24-h-period 3) Bleeding that was retroperitoneal, pulmonary, intracranial, or otherwise involved the central nervous system 4) Bleeding that required surgical intervention in an operating suite. CRNM bleeding: 1) Overt bleeding for which a blood product was administered & which was not directly attributable to the patient's underlying medical condition 2) Bleeding that required medical or surgical intervention to restore haemostasis, other than in an operating suite. Minor bleeding defined as any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding." (NCT02223260)
Timeframe: Within two days after the administration of trial medication, up to 3 days

InterventionPercentage of participants (Number)
Dabigatran Etexilate0.0

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PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters APTT Values.

Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters APTT values. For our simple regression model, R-squared is equal to the square of Pearson's coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit. (NCT02223260)
Timeframe: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1

InterventionR-Square (Number)
Dabigatran Etexilate0.752

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PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters dTT Values.

Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters dTT (AntiFactor IIa activity) values. For our simple regression model, R-squared is equal to the square of Pearson's coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit. (NCT02223260)
Timeframe: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1

InterventionR-Square (Number)
Dabigatran Etexilate0.920

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PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters ECT Values.

Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters ECT values. For our simple regression model, R-squared is equal to the square of Pearson's coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit. (NCT02223260)
Timeframe: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1

InterventionR-Square (Number)
Dabigatran Etexilate0.858

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Global Assessment of Acceptability and Tolerability of Study Medication

The investigator was to provide a global clinical assessment of tolerability and acceptability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable). (NCT02223260)
Timeframe: Day 1 (immediately after dosing)

Interventionpercentage of participants (Number)
GoodSatisfactoryNot satisfactoryBadNot assessable
Dabigatran Etexilate75.012.50.012.50.0

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Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.

Central measurement: The mean activated partial thromboplastin time (aPTT) coagulation time at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation. (NCT02223260)
Timeframe: 2 h, and 12 h after dosing on day 1

Interventionsecond (Mean)
E2E12
Dabigatran Etexilate78.962.8

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Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate

Plasma concentrations of total dabigatran, 2h and 12 h (+/-2h) post administration of dabigatran etexilate. (NCT02223260)
Timeframe: 2 hours (h) and 12h after drug administration on day 1

Interventionng/mL (Geometric Mean)
2h12h
Dabigatran Etexilate120.060.4

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Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.

"Central measurement: The mean aPTT (activated partial thromboplastin time) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.~aPTT ratio= aPTT (post dose)/aPTT (baseline). The mean of aPTT ratio is presented." (NCT02223260)
Timeframe: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1

Interventionratio (Mean)
ER2ER12
Dabigatran Etexilate1.861.47

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Adjudicated Ischaemic Stroke

Adjudicated ischaemic stroke is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period. (NCT02239120)
Timeframe: From randomisation until full follow up period, up to 43 months

InterventionAnnualised event rate (%/ year) (Number)
Dabigatran Etexilate 110 or 150 Milligram (mg)3.97
Acetylsalicylic Acid, Aspirin (ASA) 100 mg4.71

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Adjudicated Recurrent Stroke

Adjudicated recurrent stroke (ischemic, hemorrhagic, or unspecified) is presented. The annualised event rate represents the average number of events per patient during a 1-year period. (NCT02239120)
Timeframe: From randomisation until full follow up period, approximately 43 months.

InterventionAnnualised event rate (%/ year) (Number)
Dabigatran Etexilate 110 or 150 Milligram (mg)4.09
Acetylsalicylic Acid, Aspirin (ASA) 100 mg4.80

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All-cause Death

All-cause death is presented. The annualised event rate represents the average number of events per patient during a 1-year period. (NCT02239120)
Timeframe: From randomisation until full follow up period, up to 43 months

InterventionAnnualised event rate (%/ year) (Number)
Dabigatran Etexilate 110 or 150 Milligram (mg)1.24
Acetylsalicylic Acid, Aspirin (ASA) 100 mg1.28

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Disabling Stroke

Disabling stroke (modified Rankin Scale greater than or equal to 4, as determined 3 months after recurrent stroke) is presented. The annualised event rate represents the average number of events per patient during a 1-year period. (NCT02239120)
Timeframe: From randomisation until full follow up period, up to 43 months

InterventionAnnualised event rate (%/ year) (Number)
Dabigatran Etexilate 110 or 150 Milligram (mg)0.55
Acetylsalicylic Acid, Aspirin (ASA) 100 mg0.93

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First Major Bleed (Adjudicated)

"First major bleed is primary safety endpoint. Major bleeds were defined according to the International Society of Thrombosis and Haemostasis (ISTH) definition as follows:~Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or,~Bleeding (which should be overt) associated with a reduction in haemoglobin of at least 2 grams/ decilitre (g/dL) (1.24 millimoles Per Litre (mmol/L)), or leading to transfusion of ≥2 units of blood or packed cells (equivalent to ≥4.5 units in Japan); the haemoglobin drop should be considered to be due to and temporally related to the bleeding event and/or,~Fatal bleed. The annualised event rate represents the average number of events per patient during a 1-year period." (NCT02239120)
Timeframe: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

InterventionAnnualised event rate (%/ year) (Number)
Dabigatran Etexilate 110 or 150 Milligram (mg)1.84
Acetylsalicylic Acid, Aspirin (ASA) 100 mg1.33

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Adjudicated Life-threatening Bleed

"Major bleeds were to be classified as life-threatening if they met one or more of the following criteria: fatal bleed, symptomatic intracranial bleed, reduction in haemoglobin of at least 5 grams/ deciliter (g/dL), transfusion of at least 4 units of packed red blood cells (equivalent to 9 units in Japan), associated with hypotension requiring the use of intravenous inotropic agents, or necessitated surgical intervention.~The annualised event rate represents the average number of events per patient during a 1-year period." (NCT02239120)
Timeframe: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

InterventionAnnualised event rate (%/ year) (Number)
Dabigatran Etexilate 110 or 150 Milligram (mg)0.76
Acetylsalicylic Acid, Aspirin (ASA) 100 mg0.91

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Any Bleed (Investigator-reported)

"This was the sum of all major and minor bleeds (Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds), regardless of severity.~The annualised event rate represents the average number of events per patient during a 1-year period." (NCT02239120)
Timeframe: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

InterventionAnnualised event rate (%/ year) (Number)
Dabigatran Etexilate 110 or 150 Milligram (mg)15.21
Acetylsalicylic Acid, Aspirin (ASA) 100 mg11.64

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Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death

Adjudicated composite of non-fatal stroke, non-fatal myocardial infarction (MI), or cardiovascular death is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period. (NCT02239120)
Timeframe: From randomisation until full follow up period, up to 43 months

InterventionAnnualised event rate (%/ year) (Number)
Dabigatran Etexilate 110 or 150 Milligram (mg)4.80
Acetylsalicylic Acid, Aspirin (ASA) 100 mg5.40

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Adjudicated Fatal Bleed

Adjudicated fatal bleeding was defined as a bleeding event which the Independent Event Adjudication Committee (IAC) determined as the primary cause of death or contributed directly to death. The annualised event rate represents the average number of events per patient during a 1-year period. Because there were 0 events in one treatment group, the hazard ratio is unable to be calculated. (NCT02239120)
Timeframe: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

InterventionAnnualised event rate (%/ year) (Number)
Dabigatran Etexilate 110 or 150 Milligram (mg)0.00
Acetylsalicylic Acid, Aspirin (ASA) 100 mg0.05

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Adjudicated Intracranial Hemorrhage

"Adjudicated intracranial haemorrhage comprised the subtypes of intracerebral bleeds, intraventricular bleeds, subdural bleeds, epidural bleeds, and subarachnoid bleeds. Microbleeds did not qualify as intracranial haemorrhage, except when they were symptomatic.~The annualised event rate represents the average number of events per patient during a 1-year period." (NCT02239120)
Timeframe: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

InterventionAnnualised event rate (%/ year) (Number)
Dabigatran Etexilate 110 or 150 Milligram (mg)0.67
Acetylsalicylic Acid, Aspirin (ASA) 100 mg0.63

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Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.

Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and > 2, respectively). (NCT02240667)
Timeframe: 6 month (visit 3)

,
InterventionPercentage of participants (Number)
LowMediumHighMissing
Dabigatran (Dabigatran vs VKA)19.1245.85.8829.2
VKA (Dabigatran vs VKA)23.7446.853.9925.42

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Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month

Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy. (NCT02240667)
Timeframe: 12 month (Visit 5)

Interventionpercentage of participants (Number)
Dabigatran (Dabigatran vs VKA)89.5
VKA (Dabigatran vs VKA)89.5

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Number of Patients With the Reason for Definitive Treatment Discontinuation

Number of patients with the reason for definitive treatment discontinuation (NCT02240667)
Timeframe: Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment)

InterventionParticipants (Count of Participants)
Visit 2 (Month 3)72081633Visit 2 (Month 3)72081634Visit 3 (Month 6)72081633Visit 3 (Month 6)72081634Visit 4 (Month 9)72081633Visit 4 (Month 9)72081634Visit 5 (Month 12)72081633Visit 5 (Month 12)72081634
Patient's wishDecision of physicianOtherSerious adverse event
Dabigatran (Dabigatran vs VKA)1
VKA (Dabigatran vs VKA)1
Dabigatran (Dabigatran vs VKA)0
VKA (Dabigatran vs VKA)2
Dabigatran (Dabigatran vs VKA)2
VKA (Dabigatran vs VKA)0

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Incidence of ISTH MBE, Stroke, Systemic Embolism, or TIA (Composite Endpoint Combining Safety and Efficacy

"Percentage of patients with ISTH MBE, stroke, systemic embolism, or TIA (composite endpoint combining safety and efficacy) are presented.~These are based on adjudicated data (blinded evaluation)" (NCT02348723)
Timeframe: during and up to 2 months post-ablation

Interventionpercentage of participants (Number)
Dabigatran Etexilate 150 mg1.6
Warfarin7.2

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Incidence of Minor Bleeding Events

"Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds. Percentage of patients with Minor bleeding events are presented.~These are based on adjudicated data (blinded evaluation)" (NCT02348723)
Timeframe: during and up to 2 months post-ablation

Interventionpercentage of participants (Number)
Dabigatran Etexilate 150 mg18.6
Warfarin17.0

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Incidence of the Composite of Stroke, Systemic Embolism, or Transient Ischemic Attack (TIA)

"Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction.~Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy.~Transient ischemic attack was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.~These are based on adjudicated data (blinded evaluation).~Percentage of patients with composite of stroke, systemic embolism, or transient ischemic attack (TIA) is presented" (NCT02348723)
Timeframe: during and up to 2 months post-ablation

Interventionpercentage of participants (Number)
Dabigatran Etexilate 150 mg0.0
Warfarin0.3

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Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH)

"Major bleeds were defined according to the ISTH definition of a major bleed, as follows~Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or~Bleeding associated with a reduction in haemoglobin of at least 2 g/dL (1.24 mmol/L), or leading to transfusion of 2 or more units of blood or packed cells. and/or~Fatal bleed~These are based on adjudicated data (blinded evaluation)~Point estimates for the incidence of ISTH MBEs and their 2-sided 95% confidence intervals (CI), based on the normal approximation of independent binomial distribution without stratification, are presented." (NCT02348723)
Timeframe: during and up to 2 months post-ablation

Interventionpercentage of participants (Number)
Dabigatran Etexilate 150 mg1.6
Warfarin6.9

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Any Parenchymal Haemorrhage (PH1 or PH2)

Any parenchymal haemorrhage (PH1 or PH2) on follow-up CT scan at 7±2 days post-enrolment. (NCT02415855)
Timeframe: 7 days post-enrollment

InterventionParticipants (Count of Participants)
Dabigatran 110 mg BID3
Dabigatran 150mg BID3

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Recurrent TIA/Ischemic Stroke

Monitoring and documentation of recurrent TIAs or Ischemic Stroke occuring in participants of both arms (NCT02415855)
Timeframe: 30 days post enrolment

InterventionParticipants (Count of Participants)
Dabigatran 110 mg BID2
Dabigatran 150mg BID2

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Symptomatic Hemorrhagic Transformation Rate

Symptomatic hemorrhagic transformation rate (defined as above) in patients treated with warfarin prior to the index stroke/TIA. (NCT02415855)
Timeframe: 30 days post enrolment

InterventionParticipants (Count of Participants)
Dabigatran 110 mg BID0
Dabigatran 150mg BID0

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Symptomatic Hemorrhagic Transformation Rate (PH2)

Symptomatic Hemorrhagic Transformation Rate (PH2) associated with clinical deterioration, defined as worsening of NIHSS score of 4 or more points within 30 days of initiating dabigatran therapy. (NCT02415855)
Timeframe: 30 days post-treatment

InterventionParticipants (Count of Participants)
Dabigatran 110 mg BID0
Dabigatran 150mg BID0

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Systemic Hemorrhagic Complication Rate

Monitoring and documentation of the number of the rate of hemorrhagic complications for participants in either arm of the study. (NCT02415855)
Timeframe: 30 days post enrolment

InterventionParticipants (Count of Participants)
Dabigatran 110 mg BID0
Dabigatran 150mg BID0

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Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time

(NCT02568397)
Timeframe: Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

Interventionseconds*hour (s*h) (Mean)
Dabigatran Extexilate Day 12080
LY3314814 and Dabigatran Etexilate Day 162170
LY3314814 and Dabigatran Etexilate Day 202030

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Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran

(NCT02568397)
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

Interventionnanogram per milliliter (ng/mL) (Geometric Mean)
Dabigatran Etexilate128
LY3314814 and Dabigatran Etexilate Day 16148
LY3314814 and Dabigatran Etexilate Day 20138

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Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity)

(NCT02568397)
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

Interventionnanogram*hour per milliliter (ng*h/mL) (Geometric Mean)
Dabigatran Etexilate1090
LY3314814 and Dabigatran Etexilate Day 161240
LY3314814 and Dabigatran Etexilate Day 201110

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Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau)

(NCT02568397)
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose

Interventionng*h/mL (Geometric Mean)
LY3314814 (AZD3293)3360
LY3314814 and Dabigatran Etexilate Day 163300
LY3314814 and Dabigatran Etexilate Day 203490

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Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat

(NCT02568397)
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose

Interventionng/mL (Geometric Mean)
LY3314814 (AZD3293)342
LY3314814 and Dabigatran Etexilate Day 16315
LY3314814 and Dabigatran Etexilate Day 20331

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Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time

Ratio of maximum effect to baseline effect following administration of 150 mg dabigatran etexilate alone on Day 1, 50 mg LY3314814 and 150 mg dabigatran dosed concurrently on Day 16, and 50 mg LY3314814 and 150 mg dabigatran (dosed 4 hours later) on Day 20 (NCT02568397)
Timeframe: Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

Interventionratio of maximum effect (Median)
Dabigatran Extexilate Day 17.10
LY3314814 and Dabigatran Etexilate Day 167.09
LY3314814 and Dabigatran Etexilate Day 207.00

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Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline

The outcome measure presents LoS from initiation of treatment with oral anticoagulants to hospital discharge without consideration of baseline of patients hospitalized for any reason, who were subsequently treated with Dabigatran or Warfarin for a NVAF. (NCT02631057)
Timeframe: From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.

InterventionMonths (Mean)
Dabigatran Etexilate [Prazaxa®]9.8
Warfarin14.9

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Number of Participants With Transient Ischemic Attack

Transient ischemic attack(TIA) - defined as a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. (NCT02666742)
Timeframe: First 30 days of post ablation

Interventionparticipants (Number)
DOAC6
Aspirin22

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Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours

MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours. (NCT02666742)
Timeframe: 24 Hours post ablation

InterventionParticipants (Count of Participants)
DOAC15
Aspirin28

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Number of Participants With Stroke

Stroke - incidence of ischemic stroke - defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction. (NCT02666742)
Timeframe: First 30 days of post ablation

InterventionParticipants (Count of Participants)
DOAC0
Aspirin8

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Number of Participants With Retroperitoneal Bleed

Retroperitoneal bleeding occurs when blood enters into space immediately behind the posterior reflection of the abdominal peritoneum. The organs of this space include the esophagus, aorta, inferior vena cava, kidneys, ureters, adrenals, rectum, parts of the duodenum, parts of the pancreas, and parts of the colon. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC2
Aspirin2

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Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD)

Heart failure means that the heart isn't pumping as well as it should be. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC4
Aspirin4

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Number of Participants With In-hospital Mortality

Death occurring during the hospital stay. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC5
Aspirin3

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Number of Participants With Heart Block

Heart block is a type of heart rhythm disorder (arrhythmia). It is the slowing down or interruption of the electrical signal from the upper chambers of the heart (the atria) to the lower chambers (the ventricles). The electrical signal causes the heart muscle to contract and the heart to beat. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC2
Aspirin3

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Number of Participants With Groin Hematoma

A hematoma is a collection of blood outside of a blood vessel. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC3
Aspirin4

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Number of Participants With Fatal Pulmonary Embolism

A pulmonary embolism is a blood clot in the lung that occurs when a clot in another part of the body (often the leg or arm) moves through the bloodstream and becomes lodged in the blood vessels of the lung. This restricts blood flow to the lungs, lowers oxygen levels in the lungs and increases blood pressure in the pulmonary arteries. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC0
Aspirin1

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Number of Participants With Cardiac Tamponade

Cardiac tamponade is a medical emergency that takes place when abnormal amounts of fluid accumulate in the pericardial sac compressing the heart and leading to a decrease in cardiac output and shock. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC4
Aspirin3

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Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days

MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up. (NCT02666742)
Timeframe: 24 Hours to 30 days of post ablation

InterventionParticipants (Count of Participants)
DOAC8
Aspirin22

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Number of Perioperative Complications Associated With AtriClip Placement

Defined as: stroke, major bleeding that requires re-operation and/or transfusion of > 2 U packed red blood cells (PRBC), myocardial infarction (MI), or death. (NCT02701062)
Timeframe: Within any 24 hour period during the first 2 days post-index procedure

Interventionperioperative complications reported (Number)
AtriClip®0

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Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days

Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. (NCT02701062)
Timeframe: 365 Days Post-Procedure

Interventionpercent of participants (Number)
AtriClip With OAC15.8
AtriClip Without OAC6.7
Combined AtriClip8.5
Standard of Care With OAC14.8
Standard of Care Without OAC7.5
Combined Standard of Care8.6

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Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)

Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. (NCT02701062)
Timeframe: 30 days Post-Procedure

Interventionpercent of participants (Number)
AtriClip With OAC5.0
AtriClip Without OAC5.1
Standard of Care With OAC0.0
Standard of Care Without OAC8.0
Combined Standard of Care7.8

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Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)

Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. (NCT02701062)
Timeframe: 365 days post index procedure

Interventionpercent of participants (Number)
AtriClip With OAC19.6
AtriClip Without OAC8.2
Standard of Care With OAC16.0
Standard of Care Without OAC6.5
Combined Standard of Care9.9

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Number of Subjects With Intraoperative Successful Exclusion of LAA.

Successful exclusion of LAA is defined as no (0 mm) flow between LAA and LA and < 5 mm LAA remnant by intraoperative TEE with Doppler. (NCT02701062)
Timeframe: Intraoperative period

Interventionpercentage of participants (Number)
Total Patients, No Flow and No StumpTotal Patients, No Flow with Stump <= 5mmTotal Patients, No Flow with Stump <= 10mm
AtriClip®82.295.498.9

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Cmax (Maximum Plasma Concentration of Total Dabigatran)

This outcome measure presents maximum concentration of analyte in plasma (Cmax). (NCT02710630)
Timeframe: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

Interventionng/mL (Geometric Mean)
Dabigatran Etexilate Capsule: Ref88.6
Dabigatran Etexilate Tablet: A1102
Dabigatran Etexilate Tablet: B147.9
Dabigatran Etexilate Tablet: C152.2
Dabigatran Etexilate Tablet: D194.2
Dabigatran Etexilate Tablet: E191.9

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Cmax (Maximum Concentration of Free Dabigatran)

This outcome measure presents maximum concentration of analyte in plasma (Cmax). (NCT02710630)
Timeframe: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

Interventionng/mL (Geometric Mean)
Dabigatran Etexilate Capsule: Ref73.5
Dabigatran Etexilate Tablet: A186.8
Dabigatran Etexilate Tablet: B142.3
Dabigatran Etexilate Tablet: C145.5
Dabigatran Etexilate Tablet: D179.6
Dabigatran Etexilate Tablet: E179.2

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AUC0-tz (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)

This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point. (NCT02710630)
Timeframe: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

Interventionng*h/mL (Geometric Mean)
Dabigatran Etexilate Capsule: Ref726
Dabigatran Etexilate Tablet: A1838
Dabigatran Etexilate Tablet: B1366
Dabigatran Etexilate Tablet: C1412
Dabigatran Etexilate Tablet: D1777
Dabigatran Etexilate Tablet: E1778

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AUC0-tz (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)

This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point. (NCT02710630)
Timeframe: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

Interventionng*h/mL (Geometric Mean)
Dabigatran Etexilate Capsule: Ref600
Dabigatran Etexilate Tablet: A1714
Dabigatran Etexilate Tablet: B1318
Dabigatran Etexilate Tablet: C1354
Dabigatran Etexilate Tablet: D1649
Dabigatran Etexilate Tablet: E1661

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AUC0-infinity (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)

This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable). (NCT02710630)
Timeframe: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

Interventionng*h/mL (Geometric Mean)
Dabigatran Etexilate Capsule: Ref750
Dabigatran Etexilate Tablet: A1863
Dabigatran Etexilate Tablet: B1628
Dabigatran Etexilate Tablet: C1515
Dabigatran Etexilate Tablet: D1804
Dabigatran Etexilate Tablet: E1800

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AUC0-infinity (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)

This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable). (NCT02710630)
Timeframe: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

Interventionng*h/mL (Geometric Mean)
Dabigatran Etexilate Capsule: Ref623
Dabigatran Etexilate Tablet: A1735
Dabigatran Etexilate Tablet: B1544
Dabigatran Etexilate Tablet: C1444
Dabigatran Etexilate Tablet: D1725
Dabigatran Etexilate Tablet: E1684

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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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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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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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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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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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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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Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B

"For Cohort B, scores of PACT-Q1 at baseline were summarised descriptively.~The PACT-Q1 is composed of a single dimension (7 items) covering the expectations of patients regarding their anticoagulant treatment and is to be administered before treatment initiation.~The PACT-Q1 scores ranged from 1 (Not at all) to 5 (Extremely/Completely/ Very much)." (NCT02849509)
Timeframe: Baseline (Visit1)

,
InterventionUnit on scale (Mean)
A1 - Confidence in prevention of blood clotsA2 - Expectations of symptom reliefA3 - Expectations of side effectsA4 - Importance of ease of useA5 - Worries about making mistakesA6 - Importance of independencyA7 - Worries about cost
Cohort B (New Patients - Pradaxa)3.43.42.53.72.53.72.7
Cohort B (New Patients - VKA)3.33.32.63.52.53.72.6

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Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups

"Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups.~Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome.~Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement." (NCT02849509)
Timeframe: Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)

,
InterventionUnit on scale (Mean)
Convenience dimension scoreSatisfaction dimension score
Cohort B (New Patients - Pradaxa)80.463.9
Cohort B (New Patients - VKA)76.060.9

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Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups

"Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome.~Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.~PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis." (NCT02849509)
Timeframe: Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)

,
InterventionUnit on scale (Mean)
Convenience dimension scoreSatisfaction dimension score
Cohort B (New Patients - Pradaxa)78.461.5
Cohort B (New Patients - VKA)75.159.9

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Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment

"Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease & treatment (2 items), & anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience & satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience & for burden of disease and treatment were reversed (reversed score = 6 - item score), added together & rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed & rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable.~PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis." (NCT02849509)
Timeframe: Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)

InterventionUnit on scale (Mean)
Convenience dimension score: BaselineConvenience dimension score: Second assessmentSatisfaction dimension score: BaselineSatisfaction dimension score: Second assessment
Cohort A (Switch Patients - Pradaxa)71.479.661.063.2

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Patient Characterization at Baseline - Categorical Parameters

Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP). (NCT02849509)
Timeframe: Baseline (Visit1)

InterventionPercentage of participant (Number)
< 65 Years>= 65 and < 75 Years>= 75 YearsFemaleMaleMH: ThromboembolismMH: Cardiovascular ConditionsMH: BleedingsMH: Other ConditionsCoMo: ThromboembolismCoMo: Cardiovascular ConditionsCoMo: BleedingsCoMo: Other ConditionsCM:AntihypertensivesCM:Lipid modifying agentsCM:Antithrombotic agentsCM:Proton pump inhibitorsCM:AmiodaroneCM:H2-receptor antagonistsCM:NSAIDSCM:Verapamil
Cohort B (New Patients - VKA)53.629.416.930.969.11.54.40.93.87.640.52.317.847.828.019.87.95.82.01.71.7

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Patient Characterization at Baseline - Categorical Parameters

Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP). (NCT02849509)
Timeframe: Baseline (Visit1)

,
InterventionPercentage of participant (Number)
< 65 Years>= 65 and < 75 Years>= 75 YearsFemaleMaleMH: ThromboembolismMH: Cardiovascular ConditionsMH: BleedingsMH: Other ConditionsCoMo: ThromboembolismCoMo: Cardiovascular ConditionsCoMo: BleedingsCoMo: Other ConditionsCM:AntihypertensivesCM:Lipid modifying agentsCM:Antithrombotic agentsCM:Proton pump inhibitorsCM:AmiodaroneCM:H2-receptor antagonistsCM:NSAIDSCM:VerapamilDoP:110 mg twice dailyDoP:150 mg twice daily
Cohort A (Switch Patients - Pradaxa)25.140.634.334.365.76.37.72.65.89.864.12.426.967.546.715.316.47.48.71.81.168.131.9
Cohort B (New Patients - Pradaxa)33.243.323.538.661.43.45.11.03.74.750.92.520.856.033.59.513.97.17.12.91.558.042.0

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Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score

"CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category.~CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome." (NCT02849509)
Timeframe: Baseline (Visit1)

Interventionunit on scale (Mean)
Cohort A (Switch Patients - Pradaxa)3.1
Cohort B (New Patients - Pradaxa)2.6
Cohort B (New Patients - VKA)2.0

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Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment

"Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment.~The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items).~The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3)were compared with the second assessment (Visit 2). Within the PACT-Q2, items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction score." (NCT02849509)
Timeframe: Second assessment - Visit 2 (7-124 days after initiation on Pradaxa or VKA) and last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)

InterventionUnit on scale (Mean)
Convenience dimension score (Visit 2)Convenience dimension score (Visit 3)Satisfaction dimension score (Visit 2)Satisfaction dimension score (Visit 3)
Cohort A (Switch Patients - Pradaxa)79.682.063.264.4

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Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment

"Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction score. High scores are more favorable.~PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis." (NCT02849509)
Timeframe: Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA)

InterventionUnit on scale (Mean)
Convenience dimension score: BaselineConvenience dimension score: Last assessmentSatisfaction dimension score: BaselineSatisfaction dimension score: Last assessment
Cohort A (Switch Patients - Pradaxa)71.482.061.064.4

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Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score

"HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol.~HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome." (NCT02849509)
Timeframe: Baseline (Visit1)

Interventionunit on scale (Mean)
Cohort A (Switch Patients - Pradaxa)1.8
Cohort B (New Patients - Pradaxa)1.3
Cohort B (New Patients - VKA)1.1

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Patient Characteristics at Baseline - Creatinine Clearance

Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics. (NCT02849509)
Timeframe: Baseline (Visit1)

InterventionmL/min (Mean)
Cohort A (Switch Patients - Pradaxa)68.114
Cohort B (New Patients - Pradaxa)75.367
Cohort B (New Patients - VKA)73.017

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Cerebral Venous Recanalisation as Measured by the Change in Number of Occluded Cerebral Veins and Sinuses at Week 24

"Cerebral venous recanalisation was assessed by imaging and was adjudicated. Occlusion of cerebral veins and sinuses was scored as: 1 = full occlusion; 0 = no occlusion/partial occlusion. This score was applied using the below conventions: Superior sagittal, straight, cavernous sinuses, left and right jugular veins each scored individually as either 0 or 1; Right lateral transverse and sigmoid sinus were scored together, Left lateral transverse and sigmoid sinus were scored together, Superior petrous sinus and inferior petrous sinus were scored together; Deep venous system, Superficial cortical veins, Cerebellar veins were scored as systems.~For each patient a total score was calculated at baseline and at EOT and the recanalisation score was calculated as EOT - baseline total scores with conventions as 0 = no cerebral veins or sinuses fully occluded and 11 = all cerebral veins and sinuses fully occluded; the lower the score, the better." (NCT02913326)
Timeframe: Baseline and week 24

InterventionUnits on scale (Mean)
Dabigatran Etexilate-0.8
Warfarin-1.0

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Percentage of Participants With Clinically Relevant Non-major Bleeding Events in Full Observation Period.

A clinically relevant non-major bleeding event (CRNMBE) was a clinically overt bleed that did not meet the criteria for a major bleed but prompted a clinical response, in that it led to at least 1 of the following: A hospital admission (i.e. overnight stay in the hospital) for bleeding / A physician guided medical or surgical treatment for bleeding / A physician guided change, interruption or discontinuation of trial medication. (NCT02913326)
Timeframe: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.

InterventionPercentage of participants (Number)
Dabigatran Etexilate0.0
Warfarin1.7

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Percentage of Participants With Composite of Venous Thrombotic Event (VTE) or Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period.

"Composite of the percentage of participants with MBE according to ISTH criteria and VTE (recurring cerebral venous thrombosis (CVT); deep venous thrombosis (DVT) of any limb, pulmonary embolism (PE), splanchnic vein thrombosis) in full observation period. All components were adjudicated in a blinded manner.~Major bleeds were defined according to the ISTH definition of a major bleed, as follows:~Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or~Bleeding associated with a reduction in haemoglobin of at least 2 grams/deciLitre (1.24 millimole/Litre) within 24 h, or leading to transfusion of 2 or more units of blood or packed cells and/or~Fatal bleed" (NCT02913326)
Timeframe: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.

InterventionPercentage of participants (Number)
Dabigatran Etexilate1.7
Warfarin3.3

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Percentage of Participants With Major Bleeding According to ISTH Criteria in Full Observation Period

"Major bleeds were defined according to the ISTH definition of a major bleed, as follows:~Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or~Bleeding associated with a reduction in haemoglobin of at least 2 grams/deciLitre (1.24 millimole/Litre) within 24 h, or leading to transfusion of 2 or more units of blood or packed cells and/or~Fatal bleed" (NCT02913326)
Timeframe: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.

InterventionPercentage of participants (Number)
Dabigatran Etexilate1.7
Warfarin3.3

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Percentage of Participants With Major Bleeding According to ISTH Criteria or CRNMBEs After up to 24 Weeks

Percentage of participants with major bleeding according to ISTH criteria or CRNMBEs after up to 24 weeks. (NCT02913326)
Timeframe: From first administration of trial medication until end of treatment visit, up to 24 weeks.

InterventionPercentage of participants (Number)
Dabigatran Etexilate1.7
Warfarin5.0

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Percentage of Participants With Recurring Cerebral Venous and Dural Sinus Thrombosis; DVT of Any Limb, PE or Splanchnic Vein Thrombosis in Full Observation Period

"VTE criterions:~New neurological signs/symptoms or worsening of previous signs/symptoms with new CVT on neuroimaging.~DVT of any limb was documented by: Abnormal compression ultrasonography; An intraluminal filling defect on venography; At autopsy~Splanchnic vein thrombosis: The presence of endoluminal material/absence of flow in the extrahepatic portal veins/mesenteric veins as shown by duplex-Doppler ultrasound/contrast-enhanced CT scan/MRI.~PE was documented by: An intraluminal filling defect in segmental/more proximal branches on spiral CT scan; An intraluminal filling defect/an extension of an existing defect/a sudden cut-off of vessels>2.5 mm in diameter on the pulmonary angiogram; Perfusion defect of at least 75% of a segment with a local normal ventilation result on ventilation/perfusion lung scan; Inconclusive spiral CT, pulmonary angiography/lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasonography/venography; At autopsy." (NCT02913326)
Timeframe: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.

,
InterventionPercentage of participants (Number)
Recurring CVTDVT of any limbPESplanchnic vein thrombosis
Dabigatran Etexilate0.00.00.00.0
Warfarin0.00.00.00.0

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Percentage of Participants With Any Bleeding Event After up to 24 Weeks

Percentage of participants with any bleeding event after up to 24 weeks where any bleeding event is the sum of all major and non-major bleeding events. (NCT02913326)
Timeframe: From first administration of trial medication until end of treatment visit, up to 24 weeks.

InterventionPercentage of participants (Number)
Dabigatran Etexilate20.0
Warfarin20.0

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Percentage of Patients With Obesity

"Percentage of patients with obesity; where obesity is defined as obese, not-obese based on note of obesity or recorded body mass index (BMI) > 30 in the electronic medical records (EMR). The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available." (NCT03006341)
Timeframe: Up to 12 months

,
InterventionPercentage of patients (Number)
Before PS matchingAfter PS matching
Dabigatran Etexilate58.257.4
Warfarin51.754.2

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Percentage of Patients With Uncontrolled Hypertension

"Percentage of patients with uncontrolled hypertension; defined as SBP >160 mmHg using the most recent information prior to index date in the electronic medical records (EMR). The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available." (NCT03006341)
Timeframe: Up to 12 months

,
InterventionPercentage of patients (Number)
Before PS matchingAfter PS matching
Dabigatran Etexilate0.00.0
Warfarin0.00.0

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Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs

Percentage of patients with use of antiplatelets or non-steroidal anti-inflammatory drugs (NSAIDs). Includes use of aspirin, clopidogrel, prasugrel, ticagrelor or NSAIDs (within 1 month or on the index date) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. (NCT03006341)
Timeframe: Up to 1 month

,
InterventionPercentage of patients (Number)
Before PS matchingAfter PS matching
Dabigatran Etexilate18.017.1
Warfarin18.418.7

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Percentage of Patients With Prior Transient Ischemic Attack

Percentage of patients with any note of prior transient ischemic attack in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. (NCT03006341)
Timeframe: Up to 12 months

,
InterventionPercentage of patients (Number)
Before PS matchingAfter PS matching
Dabigatran Etexilate1.61.4
Warfarin2.12.4

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EMR Characteristic: Duration of Atrial Fibrillation

EMR characteristic: Duration of atrial fibrillation (Years / months prior to initiation of Dabigatran / Warfarin). Duration is defined as number of months prior to index date for the earliest note. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. (NCT03006341)
Timeframe: Up to 12 months

,
InterventionMonths (Mean)
Before PS matchingAfter PS matching
Dabigatran Etexilate22.522.7
Warfarin26.425.4

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EMR Characteristic: History/Duration of Congestive Heart Failure (CHF)

EMR characteristic: History/duration of Congestive Heart Failure (CHF). Duration is defined as number of months prior to index date for the earliest note. Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. (NCT03006341)
Timeframe: Up to 12 months

,
InterventionMonths (Mean)
Before PS matchingAfter PS matching
Dabigatran Etexilate28.226.0
Warfarin38.333.9

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EMR Characteristic: History/Duration of Hypertension

EMR characteristic: History/duration of hypertension. Any note of: Hypertension systolic blood pressure (SBP) >120 millimeters of mercury (mmHg) Hypertension drugs. Duration is defined as number of months prior to index date for the earliest note. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. (NCT03006341)
Timeframe: Up to 12 months

,
InterventionMonths (Mean)
Before PS matchingAfter PS matching
Dabigatran Etexilate42.443.6
Warfarin43.840.9

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EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score

EMR characteristic: HAS-BLED Score. HAS-BLED score is calculated by adding the specified points for each of the conditions listed below. Hypertension (uncontrolled), Abnormal renal and liver function, Stroke, Bleeding history or predisposition (anemia), Labile International Normalized Ratio (INR), Elderly, Drugs or alcohol (1 point each). Labile INR is defined as as the most recent INR <2 or >3 prior to cohort entry. Conditions are considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. (NCT03006341)
Timeframe: Up to 12 months

,
InterventionUnit on Scale (Mean)
Before PS matchingAfter PS matching
Dabigatran Etexilate1.41.5
Warfarin1.61.5

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EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR)

EMR characteristic: Renal function - Glomerular Filtration Rate (GFR). Estimated GFR closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. (NCT03006341)
Timeframe: Up to 12 months

,
InterventionMilliliter/minute/1.73 square meter (Mean)
Before PS matchingAfter PS matching
Dabigatran Etexilate86.585.4
Warfarin78.383.4

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EMR Characteristic: Serum Creatinine

EMR characteristic: Serum Creatinine closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. (NCT03006341)
Timeframe: Up to 12 months

,
InterventionMilligrams per deciliter (Mean)
Before PS matchingAfter PS matching
Dabigatran Etexilate1.01.0
Warfarin1.11.0

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Percentage of Patients Smoking

Percentage of patients with current/past smoking in the electronic medical records (EMR) are presented. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. (NCT03006341)
Timeframe: Up to 12 months

,
InterventionPercentage of patients (Number)
Before PS matchingAfter PS matching
Dabigatran Etexilate50.050.0
Warfarin51.850.5

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Percentage of Patients With Abnormal Liver Function

"Percentage of patients with abnormal liver function; defined as Any note of: Liver disease, cirrhosis, Active hepatitis C, Active hepatitis B, Active hepatitis A, aspartate transaminase/alanine transaminase (AST/ALT) >3 times upper limit of normal in the electronic medical records (EMR). Absence of any note would be considered as absence of the disease. Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available." (NCT03006341)
Timeframe: Up to 12 months

,
InterventionPercentage of patients (Number)
Before PS matchingAfter PS matching
Dabigatran Etexilate0.50.5
Warfarin0.70.0

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Percentage of Patients With Abnormal Renal Function

"Percentage of patients with abnormal renal function; defined as Any note of: Dialysis, renal transplant Serum Creatinine >1.3 Milligrams per Deciliter (mg/dL) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available." (NCT03006341)
Timeframe: Up to 12 months

,
InterventionPercentage of patients (Number)
Before PS matchingAfter PS matching
Dabigatran Etexilate5.56.5
Warfarin11.78.0

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Percentage of Patients With Alcohol Consumption

Percentage of patients with alcohol consumption in the electronic medical records (EMR) are presented. The patients with light to moderate, heavy and unknown quantity of alcohol consumption are considered. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. (NCT03006341)
Timeframe: Up to 12 months

,
InterventionPercentage of patients (Number)
Before PS matchingAfter PS matching
Dabigatran Etexilate47.150.0
Warfarin50.938.9

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Percentage of Patients With Bleeding History or Predisposition

Percentage of patients with bleeding history or predisposition is presented, defined as any note of major bleeding requiring hospitalization or blood transfusion or causing a decrease in hemoglobin level of > 2 gram per liter (g/L) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. (NCT03006341)
Timeframe: Up to 12 months

,
InterventionPercentage of patients (Number)
Before PS matchingAfter PS matching
Dabigatran Etexilate3.43.7
Warfarin4.74.6

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Percentage of Patients With Diabetes

Percentage of patients with any note of diabetes type I or II in the electronic medical records (EMR) is presented. Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. (NCT03006341)
Timeframe: Up to 12 months

,
InterventionPercentage of patients (Number)
Before PS matchingAfter PS matching
Dabigatran Etexilate13.414.7
Warfarin18.214.5

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Percentage of Patients With Hyperlipidemia

Percentage of patients with hyperlipidemia is presented, defined as any note of hyperlipidemia, dyslipidemia or Low Density Lipoprotein (LDL) >130 mg/dl in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available. (NCT03006341)
Timeframe: Up to 12 months

,
InterventionPercentage of patients (Number)
Before PS matchingAfter PS matching
Dabigatran Etexilate34.835.6
Warfarin36.834.0

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Hemorrhagic Stroke

"The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.03
Rivaroxaban (Dabigatran vs Rivaroxaban)0.16
Dabigatran (Dabigatran vs Apixaban)0.07
Apixaban (Dabigatran vs Apixaban)NA

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Major Urogenital Bleeding

"The event rate of major urogenital bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)NA
Rivaroxaban (Dabigatran vs Rivaroxaban)0.01
Dabigatran (Dabigatran vs Apixaban)NA
Apixaban (Dabigatran vs Apixaban)NA

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Major GI Bleeding

"The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.45
Rivaroxaban (Dabigatran vs Rivaroxaban)1.66
Dabigatran (Dabigatran vs Apixaban)1.36
Apixaban (Dabigatran vs Apixaban)0.92

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All-cause Mortality

"The event rate of all-cause mortality in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.54
Rivaroxaban (Dabigatran vs Rivaroxaban)1.37
Dabigatran (Dabigatran vs Apixaban)1.46
Apixaban (Dabigatran vs Apixaban)1.25

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Major Intracranial Bleeding

"The event rate of major intracranial bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.27
Rivaroxaban (Dabigatran vs Rivaroxaban)0.41
Dabigatran (Dabigatran vs Apixaban)0.24
Apixaban (Dabigatran vs Apixaban)0.21

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Ischemic Stroke

"The event rate of ischemic stroke in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.5
Rivaroxaban (Dabigatran vs Rivaroxaban)0.54
Dabigatran (Dabigatran vs Apixaban)0.39
Apixaban (Dabigatran vs Apixaban)0.36

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Lower GI Bleeding

"The event rate of Lower GI Bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.08
Rivaroxaban (Dabigatran vs Rivaroxaban)1.17
Dabigatran (Dabigatran vs Apixaban)0.98
Apixaban (Dabigatran vs Apixaban)0.58

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Major Extracranial Bleeding

"The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.55
Rivaroxaban (Dabigatran vs Rivaroxaban)1.83
Dabigatran (Dabigatran vs Apixaban)1.44
Apixaban (Dabigatran vs Apixaban)1.03

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Major Other Bleeding

"The event rate of major other bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.13
Rivaroxaban (Dabigatran vs Rivaroxaban)0.18
Dabigatran (Dabigatran vs Apixaban)0.11
Apixaban (Dabigatran vs Apixaban)0.13

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TIA

"The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.26
Rivaroxaban (Dabigatran vs Rivaroxaban)0.20
Dabigatran (Dabigatran vs Apixaban)0.28
Apixaban (Dabigatran vs Apixaban)0.17

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Overall Major Bleeding

"The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.82
Rivaroxaban (Dabigatran vs Rivaroxaban)2.24
Dabigatran (Dabigatran vs Apixaban)1.69
Apixaban (Dabigatran vs Apixaban)1.24

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Stroke Overall (Hemorrhagic, Ischemic, Uncertain)

"The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:~The day of discontinuation of the index NOAC exposure;~The day before a switch to an anticoagulant different from the index exposure;~The day before a change in dose for the index NOAC;~The end of continuous eligibility of a patient in the health plan (disenrollment);~The end of the study observation period; or~The date of death of the patient." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.52
Rivaroxaban (Dabigatran vs Rivaroxaban)0.69
Dabigatran (Dabigatran vs Apixaban)0.46
Apixaban (Dabigatran vs Apixaban)0.36

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Upper GI Bleeding

"The event rate of Upper GI Bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.41
Rivaroxaban (Dabigatran vs Rivaroxaban)0.55
Dabigatran (Dabigatran vs Apixaban)0.37
Apixaban (Dabigatran vs Apixaban)0.34

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Cmax of Total Dabigatran

Maximum plasma concentration of total dabigatran (Cmax). Geometric Mean is actually Adjusted geometric mean and Geometric Coefficient of Variation (gCV) is actually Intra individual gCV. (NCT03070171)
Timeframe: 1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionng/mL (Geometric Mean)
Dabigatran Etexilate Tablet (T)99.81133
Dabigatran Etexilate Capsule (R)93.54769

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AUC0-∞ of Free Dabigatran

"Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).~Geometric Mean is actually Adjusted geometric mean and Geometric Coefficient of Variation (gCV) is actually Intra individual gCV." (NCT03070171)
Timeframe: 1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionng•h/mL (Geometric Mean)
Dabigatran Etexilate Tablet (T)753.13668
Dabigatran Etexilate Capsule (R)694.57320

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AUC0-∞ of Total Dabigatran

"Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).~Geometric Mean is actually Adjusted geometric mean and Geometric Coefficient of Variation (gCV) is actually Intra individual gCV." (NCT03070171)
Timeframe: 1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionng•h/mL (Geometric Mean)
Dabigatran Etexilate Tablet (T)877.70198
Dabigatran Etexilate Capsule (R)813.94379

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AUC0-tz of Free Dabigatran

"Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz). Geometric Mean (gMean) is actually Adjusted gMean & Geometric Coefficient of Variation (gCV) is actually Intra individual gCV (%gCV).~PK exclusion criteria: 1) The subject experienced emesis at or before 2 times median Time from (last) dosing to the maximum measured concentration of the analyte in plasma (tmax). Median tmax was to be taken either from the median tmax for reference product or test product, depending on whether the subject had experienced emesis after taken the test or reference product. Median tmax was to be determined excluding the subjects experiencing emesis. 2) Time deviations 3) Use of restricted medications 4) A pre-dose concentration was >5% of the Cmax value of that subject." (NCT03070171)
Timeframe: 1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

InterventionNanogram*hour/milliliter (ng･h/mL) (Geometric Mean)
Dabigatran Etexilate Tablet (T)725.03686
Dabigatran Etexilate Capsule (R)668.42714

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AUC0-tz of Total Dabigatran

"Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz ).~Geometric Mean is actually Adjusted geometric mean and Geometric Coefficient of Variation (gCV) is actually Intra individual gCV." (NCT03070171)
Timeframe: 1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Interventionng•h/mL (Geometric Mean)
Dabigatran Etexilate Tablet (T)847.26720
Dabigatran Etexilate Capsule (R)787.31279

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Cmax of Free Dabigatran

Maximum plasma concentration of free dabigatran (Cmax). Geometric Mean is actually Adjusted geometric mean and Geometric Coefficient of Variation (gCV) is actually Intra individual gCV. (NCT03070171)
Timeframe: 1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

InterventionNanogram/milliliter (ng/mL) (Geometric Mean)
Dabigatran Etexilate Tablet (T)86.26026
Dabigatran Etexilate Capsule (R)79.16785

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Amount of Idarucizumab Eliminated in Urine Over the Time Interval From 0 to 72 Hours (h) (Ae0-72)

"Ae0-72, amount of idarucizumab eliminated in urine over the time interval from 0 to 72 h.~As per the protocol, day is counted as Day 1 = 0:00" (NCT03086356)
Timeframe: 0-2 h, 2-6 h, 6-10 h, 10-12 h,12-14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4

Interventionmicromole (μmol) (Geometric Mean)
Dabigatran Etexilate+Idarucizumab35.3

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Area Under the Concentration-time Curve of Idarucizumab in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

AUC0-∞, area under the concentration-time curve of idarucizumab in plasma over the time interval from 0 extrapolated to infinity (NCT03086356)
Timeframe: -0.017, 0.083, 0.167, 0.317, 0.417, 0.45, 0.583, 0.917, 1.417, 2.083, 3.083, 4.083, 6.083, 10.083, 12.083, 24.083, 48.083, 72.083 hours (h)

Interventionnanomoles (nmol)*hours (h) per litre (L) (Geometric Mean)
Dabigatran Etexilate+Idarucizumab44200

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Maximum Measured Concentration of Idarucizumab in Plasma (Cmax)

Cmax, maximum measured concentration of idarucizumab in plasma (NCT03086356)
Timeframe: -0.017, 0.083, 0.167, 0.317, 0.417, 0.45, 0.583, 0.917, 1.417, 2.083, 3.083, 4.083, 6.083, 10.083, 12.083, 24.083, 48.083, 72.083 hours (h)

Interventionnanomoles (nmol) per litre (L) (Geometric Mean)
Dabigatran Etexilate+Idarucizumab30900

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For Diluted Thrombin Time: Area After Subtraction of Baseline Area From Area Under the Effect Curve Over the Time Interval From 2 - 12 Hours (AUEC Above,2-12) on Day 4 and Day 11

"For diluted thrombin time: AUEC above,2-12 (area after subtraction of baseline area from area under the effect curve over the time interval from 2 - 12) on day 4 and day 11.~The standard deviation (SD) presented is actually the percentage coefficient of variation (CV %)" (NCT03086356)
Timeframe: Day 4 and day 11

Interventionhours (Mean)
Day 4Day 11
Dabigatran Etexilate+Idarucizumab8.230.118

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For Sum Dabigatran: Amount of the Analyte Excreted in Urine at Steady State Over the Time Interval 0-74 Hours (Ae0-74,ss ) on Day 4 and Day 11

"For sum dabigatran: Ae0-74,ss (amount of the analyte excreted in urine at steady state over the time interval 0-74) on day 4 and day 11 if feasible.~As per the protocol, day is counted as Day 1 = 0:00" (NCT03086356)
Timeframe: 0-2 h, 2-6 h, 6-10 h, 10-12 h,12-14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4 and Day 11.

Interventionμg (microgram) (Geometric Mean)
Day 4Day 11
Dabigatran Etexilate+Idarucizumab1170011000

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For Unbound Sum Dabigatran: Area Under the Concentration-time Curve of the Dabigatran in Plasma at Steady State Over the Time Interval 2 Hours-12 Hours

"For unbound sum dabigatran: AUC 2-12,ss (Area under the concentration-time curve of the dabigatran in plasma at steady state over the time interval 2 hours-12 hours).~As per the protocol, day is counted as Day 1 = 0:00." (NCT03086356)
Timeframe: Day 4: 74h, 74.5h, 75h, 76h, 78h, 80h, 84h; Day 11: 242h, 242.083h, 242.25h, 242.333h 243.333h, 244h, 246h, 248h, 252h

Interventionnanograms*hours/ milliliter (Geometric Mean)
Day 4Day 11
Dabigatran Etexilate+Idarucizumab127011.6

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Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).

This endpoint calculates area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity. (NCT03143166)
Timeframe: Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.

InterventionNanogram*Hour/ millilitre (ng*h/mL) (Geometric Mean)
Dabigatran Etexilate 110 mg (Reference)618
Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)188

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Maximum Concentration of Total Dabigatran in Plasma (Cmax).

This outcome is maximum measured concentration of the total dabigatran in plasma (NCT03143166)
Timeframe: Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.

InterventionNano gram per milliliter (ng/mL) (Geometric Mean)
Dabigatran Etexilate 110 mg (Reference)83.1
Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)21.8

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Maximum Concentration of Free Dabigatran in Plasma (Cmax).

This outcome is maximum measured concentration of the free dabigatran in plasma (NCT03143166)
Timeframe: Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.

InterventionNanogram per milliliter (ng/mL) (Geometric Mean)
Dabigatran Etexilate 110 mg (Reference)72.9
Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)20.0

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Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Total Dabigatran (AUC0-tz).

This endpoint calculates area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 to the time of last quantifiable time point. (NCT03143166)
Timeframe: Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.

InterventionNanogram*Hour/ millilitre (ng*h/mL) (Geometric Mean)
Dabigatran Etexilate 110 mg (Reference)667
Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)192

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Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Free Dabigatran (AUC0-tz).

This endpoint calculates area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 to the time of last quantifiable time point. (NCT03143166)
Timeframe: Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.

InterventionNanogram*Hour/ millilitre (ng*h/mL) (Geometric Mean)
Dabigatran Etexilate 110 mg (Reference)588
Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)164

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Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).

This endpoint calculates area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity (NCT03143166)
Timeframe: Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.

InterventionNanogram*Hour/ millilitre (ng*h/mL) (Geometric Mean)
Dabigatran Etexilate 110 mg (Reference)702
Dabigatran Etexilate 110 mg + Rabeprazole 20 mg Tablet (Test)214

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Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)

"Percentage of patients with suspected adverse drug reactions (ADRs). An adverse drug reaction is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility.~Percentages were pre-specified to be rounded to two decimal places." (NCT03175198)
Timeframe: From baseline till the last administration + 6 days. Up to 364 days.

InterventionPercentage of participants (Number)
Patients With Nonvalvular Atrial Fibrillation (NVAF)10.69

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Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment

The PACT-Q was a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed(reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores were more favorable. The two dimension scores were presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). (NCT03187197)
Timeframe: Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®).

InterventionUnits on Scale (Mean)
Convenience - BaselineConvenience - Visit 2Convenience - Visit 3Satisfaction - BaselineSatisfaction - Visit 2Satisfaction - Visit 3
Cohort A86.991.795.264.368.172.5

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Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups

The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching (PSM) method was used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group was summarized and used for comparison. (NCT03187197)
Timeframe: Visit 2 (30-45 days after initiation on Pradaxa® or VKA) and Visit 3 (150-210 days after initiation on Pradaxa® or VKA).

,
InterventionUnits on Scale (Mean)
Pre-PSM Convenience - Visit 2Pre-PSM Convenience - Visit 3Pre-PSM Satisfaction - Visit 2Pre-PSM Satisfaction - Visit 3PSM Convenience - Visit 2PSM Satisfaction - Visit 2
Cohort B - Pradaxa®92.493.970.173.998.571.4
Cohort B - VKA94.394.367.375.180.864.3

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Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment

The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). (NCT03187197)
Timeframe: Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®).

InterventionUnits on scale (Mean)
Convenience - Visit 2Convenience - Visit 3Satisfaction - Visit 2Satisfaction - Visit 3
Cohort A91.795.268.172.5

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Description of PACT-Q1 Items for Patients in Cohort B at Baseline

The PACT-Q1 was composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items were: Q1: How confident are you that your anticoagulant treatment will prevent blood clots? Q2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? Q3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? Q4: How important is it for you to have an anticoagulant treatment that is easy to take? Q5: How concerned are you about making mistakes when taking your anticoagulant treatment? Q6: How important is it for you to take care of your anticoagulant treatment by yourself? Q7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/Completely/Very much). (NCT03187197)
Timeframe: Baseline

,
InterventionUnits on scale (Mean)
Q1Q2Q3Q4Q5Q6Q7
Cohort B - Pradaxa®3.23.22.33.62.83.72.4
Cohort B - VKA3.03.12.13.72.73.71.9

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Incidence Rate of Major Bleeding

Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims. (NCT03254134)
Timeframe: From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years.

Interventionper patient-year (Number)
Dabigatran0.639
Warfarin1.128

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Incidence Rate of Stroke and Systemic Embolism (SE)

Incidence rate of stroke and systemic embolism (SE). (NCT03254134)
Timeframe: From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years.

Interventionper patient-year (Number)
Dabigatran2.898
Warfarin3.563

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The Number of Patients With Cardiac Tamponade and Pericardiocentesis.

The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI. (NCT03254147)
Timeframe: One year

InterventionNumber of Patients (Number)
Patients Prescribed With Non-warfarin Oral Anti Coagulants1

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The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.

The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma. (NCT03254147)
Timeframe: One year

InterventionNumber of Patients (Number)
Age <=64Age 65-74Age >=75
Patients Prescribed With Non-warfarin Oral Anti Coagulants143584

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Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event)

To evaluate the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation (NVAF) after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke. (NCT03258645)
Timeframe: Up to 3 months of follow-up after index event

InterventionPercentage of participants (Number)
0 - 24 hours (h)> 24 - 72 h> 3 - 7 days (d)> 7 - 14 d> 14 - 28 d> 28 d - 3 months
Total5.915.327.733.114.04.0

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Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.

Number of time the corresponding reason to delay oral anticoagulation (OAC) entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients. (NCT03258645)
Timeframe: Up to 3 months of follow-up after index event.

InterventionTimes (Number)
Haemorrhagic transformationIntracranial Haemorrhage (ICH) SpontaneousSeverity InfarctSize of InfarctLocation InfarctIntervention used to treat ischemic strokeAltered coagulation parametersPatients bleeding risk factorsPatients stroke risk factorsPatient preferenceRecommendation from specialistPractical considerationsReason is not specifiedOther reasons
Total408615214851864614275

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Age of Patients According to Dabigatran Initiation Time Period

Age of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. CHA2DS2-VASc and HAS-BLED were used in the statistical analysis. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/transient ischemic attack(TIA), Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalised ratio (INR), Elderly (>65 years), Drugs and Alcohol Score. (NCT03258645)
Timeframe: At first ever ischaemic stroke (index event), up to 1 day.

InterventionYears (Mean)
0 - 24 Hours72
> 24 - 72 Hours74
> 3 - 7 Days75
> 7 - 14 Days75
> 14 - 28 Days76
> 28 Days - 3 Months77

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CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period

The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score of patients according to their start dabigatran time period. CHA2DS2-VASc is used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score ranges from 0 to 9 with 0 being the best outcome. Results were reported according to their dabigatran initiation timing categories. (NCT03258645)
Timeframe: At first ever ischaemic stroke (index event), up to 1 day.

InterventionScore on a scale (Median)
0 - 24 Hours5
> 24 - 72 Hours5
> 3 - 7 Days5
> 7 - 14 Days5
> 14 - 28 Days5
> 28 Days - 3 Months5

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Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period

Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. (NCT03258645)
Timeframe: At first ever ischaemic stroke (index event), up to 1 day.

Interventionmillimetre of mercury (mm Hg) (Mean)
0 - 24 Hours87
> 24 - 72 Hours83
> 3 - 7 Days84
> 7 - 14 Days85
> 14 - 28 Days85
> 28 Days - 3 Months91

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HAS-BLED of Patients According to Dabigatran Initiation Time Period

The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED) Score of patients according to their start dabigatran time period. HAS-BLED score ranges from 0 to 9 with higher scores indicating greater risk of bleeding. Results were reported according to their dabigatran initiation timing categories. (NCT03258645)
Timeframe: At first ever ischaemic stroke (index event), up to 1 day.

InterventionScore on a scale (Median)
0 - 24 Hours3
> 24 - 72 Hours3
> 3 - 7 Days3
> 7 - 14 Days3
> 14 - 28 Days3
> 28 Days - 3 Months3

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National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period

The National Institute of Health Stroke Scale (NIHSS) score on patients with non-valvular atrial fibrillation and dabigatran initiation timing information. The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke. Results were reported according to their dabigatran initiation timing categories. (NCT03258645)
Timeframe: At first ever ischaemic stroke (index event) date, up to 1 day.

InterventionScore on a scale (Median)
0 - 24 Hours8
> 24 - 72 Hours8
> 3 - 7 Days8
> 7 - 14 Days12
> 14 - 28 Days14
> 28 Days - 3 Months15

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Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period

Percentage of patients with History of or predisposition to bleeding according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. (NCT03258645)
Timeframe: At first ever ischaemic stroke (index event), up to 1 day.

InterventionPercentage of participants (Number)
0 - 24 Hours2.1
> 24 - 72 Hours1.1
> 3 - 7 Days3.0
> 7 - 14 Days3.0
> 14 - 28 Days1.8
> 28 Days - 3 Months4.4

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Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians

Number of times of corresponding reason of choosing daily dosage of 220 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients. (NCT03258645)
Timeframe: Up to 3 months of follow-up after index event.

InterventionTimes (Number)
Haemorrhagic transformationIntracranial Haemorrhage (ICH) spontaneousSeverity of strokeSize of infarctLocation of infarctIntervention used to treat strokeAltered coagulation parametersPatients bleeding riskPatients stroke riskRecommendation from specialistReason is not specifiedOther reasonsPatients ageCo-medicationCo-morbiditiesRenal function
Total6318138476.327329510209111648

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Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians

Number of times the corresponding reason for choosing daily dosage of 300 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients. (NCT03258645)
Timeframe: Up to 3 months of follow-up after index event.

InterventionTimes (Number)
Intracranial Haemorrhage (ICH) spontaneousSeverity of strokeSize of infarctLocation of infarctIntervention used to treat strokeAltered coagulation parametersPatients bleeding riskPatients stroke riskRecommendation from specialistReason is not specifiedOther reasonsPatients ageCo-medicationCo-morbiditiesRenal function
Total1381618310348950216113951947

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Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period

Physicians' reason to delay dabigatran initiation according to their start dabigatran time period. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients. (NCT03258645)
Timeframe: At first ever ischaemic stroke (index event), up to 1 day.

,,,,,
InterventionTimes (Number)
Haemorrhagic transformationIntracranial Haemorrhage (ICH) pontaneousSeverity InfarctSize of InfarctLocation InfarctIntervention used to treat ischemic strokeAltered coagulation parametersPatients bleeding risk factorsPatients stroke risk factorsRecommendation from specialistPractical considerationsReason is not specifiedOther reasons
> 14 - 28 Days831212231622341
> 24 - 72 Hours0000000100100
> 28 Days - 3 Months1023000011310
> 3 - 7 Days2012000000010
> 7 - 14 Days2179322420050
0 - 24 Hours0000000000100

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Apparent Volume of Distribution During the Terminal Phase (Vz/F) Post-dose Period 1

Vz/F is the distribution of study drug between the plasma and the rest of the body after the dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. Vz/F was to be calculated for the parent plasma analytes only, midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvastatin. (NCT03311841)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose

,,,,
Interventionliters (Geometric Mean)
MidazolamDabigatranPitavastatinAtorvastatinRosuvastatin
End-Stage Renal Disease579314025235204870
Healthy Control422173049573804010
Mild Impairment555212040573004270
Moderate Impairment409106031752403120
Severe Impairment433123045453103720

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Apparent Plasma Terminal Half-life (t1/2) Post-dose Period 1

T1/2 is the elimination half-life of study drug. T1/2 is the time it takes for half of the study drug in the blood plasma to dissipate. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. (NCT03311841)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose

,,,,
Interventionhours (Geometric Mean)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
End-Stage Renal Disease4.4141.411.811.08.0312.414.0
Healthy Control7.996.7517.818.514.921.216.2
Mild Impairment6.768.4019.320.516.722.815.5
Moderate Impairment10.311.922.422.018.624.624.9
Severe Impairment7.7924.020.418.117.521.918.8

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Apparent Clearance After Extravascular Administration (CL/F) Post-dose Period 1

CL/F is the rate at which study drug was removed from the body. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. CL/F was to be calculated for the parent plasma analytes only, midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvastatin. (NCT03311841)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose

,,,,
Interventionliters/hour (Geometric Mean)
MidazolamDabigatranPitavastatinAtorvastatinRosuvastatin
End-Stage Renal Disease90.852.514.8304240
Healthy Control36.617819.2343171
Mild Impairment56.917514.5304191
Moderate Impairment27.561.89.8419687.0
Severe Impairment38.535.715.4210137

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Time to Maximum Plasma Concentration (Tmax) Post-dose Period 1

Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. (NCT03311841)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose

,,,,
Interventionhours (Geometric Mean)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
End-Stage Renal Disease0.502.000.502.500.255.003.00
Healthy Control1.001.500.752.000.506.003.50
Mild Impairment0.501.500.522.000.256.002.00
Moderate Impairment0.502.501.002.500.256.004.00
Severe Impairment0.503.000.504.000.256.004.00

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Plasma Concentration at 24 Hours (C24) Post-dose Period 1

C24hr is a measure of the plasma study drug concentration 24 hours post-dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. (NCT03311841)
Timeframe: 24 hours post-dose

,,,,
Interventionpg/mL (Geometric Mean)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
End-Stage Renal Disease0.28370.26.0712.94.283.672.64
Healthy Control1.577.704.1021.73.853.081.94
Mild Impairment0.73418.75.3222.45.045.023.59
Moderate Impairment2.6459.38.1332.86.034.436.01
Severe Impairment1.831074.0423.25.733.253.40

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Maximum Plasma Concentration (Cmax) Post-dose Period 1

Cmax is the peak plasma concentration of study drug after administration. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. (NCT03311841)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose

,,,,
Interventionpg/mL (Geometric Mean)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
End-Stage Renal Disease39.913224278.563.78.5822.5
Healthy Control73.218316488.121.67.6721.5
Mild Impairment70.715324410531.98.5023.6
Moderate Impairment77.231230310655.09.5040.4
Severe Impairment68.431921895.446.77.2224.4

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Effect of Rifampin on Vz/F Post-dose Period 2

To evaluate the effect of a single oral dose of rifampin on the Vz/F of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. Vz/F is the distribution of study drug between the plasma and the rest of the body after the dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose

,,,
Interventionliters (Geometric Least Squares Mean)
MidazolamDabigatranPitavastatinAtorvastatinRosuvastatin
Healthy Control (Period 2)30080049.2225565
Mild Impairment (Period 2)315101047.8272654
Moderate Impairment (Period 2)22063247.3177313
Severe Impairment (Period 2)24273336.0200272

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Effect of Rifampin on Tmax Post-dose Period 2

To evaluate the effect of a single oral dose of rifampin on the Tmax of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose

,,,
Interventionhours (Median)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
Healthy Control (Period 2)1.002.501.002.001.503.002.00
Mild Impairment (Period 2)0.502.501.003.001.001.751.00
Moderate Impairment (Period 2)0.753.001.004.001.502.502.00
Severe Impairment (Period 2)0.503.501.003.000.501.751.00

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Effect of Rifampin on t1/2 Post-dose Period 2

To evaluate the effect of a single oral dose of rifampin on the t1/2 of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. T1/2 is the elimination half-life of study drug. T1/2 is the time it takes for half of the study drug in the blood plasma to dissipate. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose

,,,
Interventionhours (Geometric Least Squares Mean)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
Healthy Control (Period 2)4.976.486.5016.52.763.496.76
Mild Impairment (Period 2)4.127.578.4021.03.223.839.64
Moderate Impairment (Period 2)5.4911.311.517.72.994.257.48
Severe Impairment (Period 2)4.1419.46.9917.23.144.564.89

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Effect of Rifampin on Cmax Post-dose Period 2

To evaluate the effect of a single oral dose of rifampin on the Cmax of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. Cmax is the peak plasma concentration of study drug after administration. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose

,,,
Interventionpg/mL (Geometric Least Squares Mean)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
Healthy Control (Period 2)81.4351599102405198236
Mild Impairment (Period 2)73.0243819131505215254
Moderate Impairment (Period 2)92.5443860119508174396
Severe Impairment (Period 2)75.442298188.4531150208

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Effect of Rifampin on CL/F Post-dose Period 2

To evaluate the effect of a single oral dose of rifampin on the CL/F of midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvatatin. CL/F is the rate at which study drug was removed from the body. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose

,,,
Interventionliters/hour (Geometric Least Squares Mean)
MidazolamDabigatranPitavastatinAtorvastatinRosuvastatin
Healthy Control (Period 2)41.885.65.2456.457.9
Mild Impairment (Period 2)53.092.83.9558.647.1
Moderate Impairment (Period 2)27.838.92.8641.128.9
Severe Impairment (Period 2)40.526.33.5744.238.6

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Effect of Rifampin on C24 Post-dose Period 2

To evaluate the effect of a single oral dose of rifampin on the C24 of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. C24 is a measure of the plasma study drug concentration 24 hours post-dose. C24 is reported as median (minimum and maximum) in severe renal impairment arm due to zero values. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: 24 hours post-dose

,,,
Interventionpg/mL (Geometric Least Squares Mean)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
Healthy Control (Period 2)0.60127.54.7217.11.355.572.42
Mild Impairment (Period 2)0.0031.14.7020.71.766.284.18
Moderate Impairment (Period 2)1.4210010.534.02.989.966.97
Severe Impairment (Period 2)0.3941747.0121.32.987.234.47

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Effect of Rifampin on AUC0-last Post-dose Period 2

To evaluate the effect of a single oral dose of rifampin on the AUC0-last of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. It is a measure of the amount of study drug in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose

,,,
Interventionpg*hr/mL (Geometric Least Squares Mean)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
Healthy Control (Period 2)23131401890127017601630854
Mild Impairment (Period 2)182283025101850169017501040
Moderate Impairment (Period 2)353683034802380242018501740
Severe Impairment (Period 2)2361040028501470222016101150

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Effect of Rifampin on AUC0-inf Post-dose Period 2

To evaluate the effect of a single oral dose of rifampin on the AUC0-inf of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. AUC0-inf is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include data from the end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose

,,,
Interventionpg*hr/mL (Geometric Least Squares Mean)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
Healthy Control (Period 2)23932901910134017701650830
Mild Impairment (Period 2)189304025301930171017601060
Moderate Impairment (Period 2)359724035002500243018701800
Severe Impairment (Period 2)2441070028501560224016201240

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Effect of Rifampin on AUC0-24 Post-dose Period 2

To evaluate the effect of a single oral dose of rifampin on the AUC0-24 of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post-dose. This is a measure of the average amount of study drug in the blood plasma over a period of 24 hours after the dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose; rifampin: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose

,,,
Interventionpg*hr/mL (Geometric Least Squares Mean)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
Healthy Control (Period 2)23430301860100017601620842
Mild Impairment (Period 2)186266024601490170017201010
Moderate Impairment (Period 2)346548033601780242018001670
Severe Impairment (Period 2)238654027601070223015801100

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Area Under the Plasma Concentration-time Curve From Time 0 to Last (AUC0-last) Post-dose Period 1

AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. This is a measure of the amount of study drug in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. (NCT03311841)
Timeframe: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose

,,,,
Interventionpg*hr/mL (Geometric Mean)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
End-Stage Renal Disease10537406491060298126171
Healthy Control26414104831450255152181
Mild Impairment16714406431490295221231
Moderate Impairment34442309502020459256479
Severe Impairment24874506021570419176269

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Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) Post-dose Period 1

AUC0-inf is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease (ESRD) requiring hemodialysis. (NCT03311841)
Timeframe: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose

,,,,
Interventionpg*hr/mL (Geometric Least Squares Mean)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
End-Stage Renal Disease11053706761100329163208
Healthy Control27315805201540292208292
Mild Impairment17616106881610329286262
Moderate Impairment364455010202240511273575
Severe Impairment26079006481680476226365

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Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) Post-dose Period 1

AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post-dose. This is a measure of the average amount of study drug in the blood plasma over a period of 24 hours after the dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. (NCT03311841)
Timeframe: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose

,,,,
Interventionpg*hr/mL (Geometric Mean)
MidazolamDabigatranPitavastatinPitavastatin lactone (metabolite)AtorvastatinOrtho-hydroxyatorvastatin (metabolite)Rosuvastatin
End-Stage Renal Disease1062100593858287115162
Healthy Control25214404151010198108153
Mild Impairment16813805431040219139191
Moderate Impairment31734407641280329143343
Severe Impairment23544705251100300112223

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International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA

INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (23). (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

Interventionratio (Mean)
Acenocoumarol: Naive2.5
Acenocoumarol: Non-Naive2.5
Warfarin: Naive2.5
Warfarin: Non-Naive2.6

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Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)

NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug. (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

Interventionmilligrams per day (Median)
Apixaban: Naive15.0
Apixaban: Non Naive30.0
Acenocoumarol: Naive16.0
Acenocoumarol: Non-Naive16.0
Warfarin: Naive53.0
Warfarin: Non-Naive16.0
Dabigatran: Naive22.0
Dabigatran: Non-Naive22.0
Rivaroxaban: Naive21.0
Rivaroxaban: Non-Naive28.0

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Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA

TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (23). (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

Interventiondays (Median)
Acenocoumarol: Naive60.2
Acenocoumarol: Non-Naive59.6
Warfarin: Naive66.2
Warfarin: Non-Naive58.9

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Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)

Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2). (NCT03441633)
Timeframe: Day 1

,,,,,,,,,
InterventionParticipants (Count of Participants)
Missing18.5 - 25 kg per m^2 (Normal)Less than (<) 18.5 kg per m^2 (Underweight)25 - 30 kg per m^2 (Overweight)Greater than (>) 30 kg per m^2 (Obese)
Acenocoumarol: Naive689844711411007410628
Acenocoumarol: Non-Naive343006860
Apixaban: Naive14244231212291624
Apixaban: Non Naive2612536493410
Dabigatran: Naive96027210735878
Dabigatran: Non-Naive1781448306317
Rivaroxaban: Naive17464641612891617
Rivaroxaban: Non-Naive3112710482498
Warfarin: Naive5092956712764
Warfarin: Non-Naive8778211977

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Risk of Thromboembolic Events: CHADS2 Score

Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age >=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke. (NCT03441633)
Timeframe: Up to 12 months prior to enrollment

Interventionstroke risk per year (Mean)
Apixaban: Naive1.7
Apixaban: Non Naive2.8
Acenocoumarol: Naive1.9
Acenocoumarol: Non-Naive2.3
Warfarin: Naive1.8
Warfarin: Non-Naive2.5
Dabigatran: Naive1.5
Dabigatran: Non-Naive2.6
Rivaroxaban: Naive1.5
Rivaroxaban: Non-Naive2.6

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Risk of Thromboembolic Events: CHA2DS2Vasc Score

Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, >=65 and <75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age >=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke. (NCT03441633)
Timeframe: Up to 12 months prior to enrollment

Interventionstroke risk per year (Mean)
Apixaban: Naive3.0
Apixaban: Non Naive4.4
Acenocoumarol: Naive3.2
Acenocoumarol: Non-Naive3.7
Warfarin: Naive2.9
Warfarin: Non-Naive3.9
Dabigatran: Naive2.7
Dabigatran: Non-Naive4.0
Rivaroxaban: Naive2.7
Rivaroxaban: Non-Naive4.1

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Risk of Bleeding Events: HAS-BLED Score

Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and >3 = high risk of bleed per 100 participants-year. (NCT03441633)
Timeframe: Up to 12 months prior to enrollment

Interventionbleed per 100 participants-year (Mean)
Apixaban: Naive1.7
Apixaban: Non Naive2.7
Acenocoumarol: Naive2.2
Acenocoumarol: Non-Naive2.5
Warfarin: Naive1.9
Warfarin: Non-Naive2.4
Dabigatran: Naive1.5
Dabigatran: Non-Naive2.6
Rivaroxaban: Naive1.6
Rivaroxaban: Non-Naive2.6

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Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year

Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate. (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

InterventionParticipants (Count of Participants)
Apixaban: Naive881
Apixaban: Non Naive236
Acenocoumarol: Naive11326
Acenocoumarol: Non-Naive85
Warfarin: Naive1009
Warfarin: Non-Naive127
Dabigatran: Naive1002
Dabigatran: Non-Naive248
Rivaroxaban: Naive1191
Rivaroxaban: Non-Naive322

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Number of Participants by Comorbidity

Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder. (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

InterventionParticipants (Count of Participants)
Apixaban: Naive3695
Apixaban: Non Naive1316
Acenocoumarol: Naive26450
Acenocoumarol: Non-Naive173
Warfarin: Naive1819
Warfarin: Non-Naive318
Dabigatran: Naive2030
Dabigatran: Non-Naive870
Rivaroxaban: Naive3731
Rivaroxaban: Non-Naive1417

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Number of Participants by Comedications

Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine. (NCT03441633)
Timeframe: Up to 30 days after date of first prescription

InterventionParticipants (Count of Participants)
Apixaban: Naive4712
Apixaban: Non Naive1406
Acenocoumarol: Naive32212
Acenocoumarol: Non-Naive188
Warfarin: Naive2286
Warfarin: Non-Naive352
Dabigatran: Naive2855
Dabigatran: Non-Naive947
Rivaroxaban: Naive5132
Rivaroxaban: Non-Naive1532

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Apparent Volume of Distribution During Terminal Phase (Vz/f) of Total Dabigatran

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/f after oral dose was influenced by the fraction absorbed. (NCT03492437)
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8

InterventionLiter (Geometric Mean)
Dabigatran Etexilate1627
Tepotinib + Dabigatran1157

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Area Under Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Total Dabigatran

AUC0-t was calculated according to the mixed log linear trapezoidal rule. (NCT03492437)
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8

Interventionnanogram*hour per milliliter (ng*h/mL) (Geometric Mean)
Dabigatran Etexilate461
Tepotinib + Dabigatran709

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Number of Participants With Clinically Significant Changes in Laboratory Values

Number of participants with clinically significant change in laboratory values were reported. Clinical significance was decided by the investigator. Laboratory investigation included hematology, biochemistry, virology, drugs of abuse, hormones, urinalysis, and coagulation. (NCT03492437)
Timeframe: Screening up to Day 4 in Period 1; Day 1 up to Day 15 in Period 2

InterventionParticipants (Count of Participants)
Dabigatran Etexilate0
Tepotinib + Dabigatran0

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Maximum Observed Plasma Concentration (Cmax) of Total Dabigatran

Cmax was obtained directly from the concentration versus time curve. (NCT03492437)
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8

InterventionNanogram per milliliter (ng/mL) (Geometric Mean)
Dabigatran Etexilate54.5
Tepotinib + Dabigatran76.9

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Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total Dabigatran

AUC0-inf was calculated as AUC0-t plus (+) AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clastpred/Lambda z, where Clastpred is the predicted plasma concentration at the last sampling time point, calculated from the log-linear regression line for Lambda z determination at which the measured plasma concentration is at or above Lower limit of quantification (LLOQ). (NCT03492437)
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8

Interventionng*hr/mL (Geometric Mean)
Dabigatran Etexilate544
Tepotinib + Dabigatran730

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Elimination Half Life (t1/2) of Total Dabigatran

Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. (NCT03492437)
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8

InterventionHour (Geometric Mean)
Dabigatran Etexilate8.18
Tepotinib + Dabigatran7.81

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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

Adverse event (AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event (SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. (NCT03492437)
Timeframe: Screening up to Day 4 in Period 1; Day 1 up to Day 15 in Period 2

,
InterventionParticipants (Count of Participants)
Treatment-emergent Adverse Events (TEAEs)Serious TEAEs
Dabigatran Etexilate40
Tepotinib + Dabigatran150

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Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Findings

Number of participants with clinically significant change in 12-lead ECG were reported. Clinical significance was decided by the investigator. The 12-lead ECGs were recorded after the participant have rested for at least 5 minutes in supine position. (NCT03492437)
Timeframe: Screening up to Day 4 in Period 1; Day 1 up to Day 15 in Period 2

InterventionParticipants (Count of Participants)
Dabigatran Etexilate0
Tepotinib + Dabigatran0

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Apparent Clearance (CL/f) of Total Dabigatran

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. (NCT03492437)
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8

InterventionLiter per hour (L/h) (Geometric Mean)
Dabigatran Etexilate138
Tepotinib + Dabigatran103

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Time to Reach Maximum Plasma Concentration (Tmax) of Total Dabigatran

Tmax is time to reach maximum observed plasma concentration obtained directly from the concentration versus time curve. (NCT03492437)
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8

InterventionHour (Median)
Dabigatran Etexilate3.00
Tepotinib + Dabigatran4.00

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Percentage of Area Under the Plasma Concentration-Time Curve From Time Tlast Extrapolated to Infinity (AUC0-inf) Obtained by Extrapolation (AUCextra%) of Total Dabigatran

The AUC from time tlast extrapolated to infinity given as percentage of AUC0-inf. AUCextra% = (AUCextra /AUC0-inf)*100. (NCT03492437)
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8

Interventionpercentage of AUC0-inf (Geometric Mean)
Dabigatran Etexilate3.03216
Tepotinib + Dabigatran2.3654

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Number of Participants With Clinically Significant Changes in Vital Signs

Number of participants with clinically significant change in vital signs were reported. Clinical significance was decided by the investigator. Vital signs included body temperature, blood pressure, and pulse rate. (NCT03492437)
Timeframe: Screening up to Day 4 in Period 1; Day 1 up to Day 15 in Period 2

InterventionParticipants (Count of Participants)
Dabigatran Etexilate0
Tepotinib + Dabigatran0

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Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date= the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)0.20
Apixaban vs Dabigatran (Dabigatran)0.25
Apixaban vs Rivaroxaban (Apixaban)0.20
Apixaban vs Rivaroxaban (Rivaroxaban)0.28
Dabigatran vs Rivaroxaban (Dabigatran)0.24
Dabigatran vs Rivaroxaban (Rivaroxaban)0.26

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Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)0.18
Apixaban vs Warfarin (Warfarin)0.78
Dabigatran vs Warfarin (Dabigatran)0.24
Dabigatran vs Warfarin (Warfarin)0.75
Rivaroxaban vs Warfarin (Rivaroxaban)0.27
Rivaroxaban vs Warfarin (Warfarin)0.74

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Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)7.66
Apixaban vs Warfarin (Warfarin)13.52
Dabigatran vs Warfarin (Dabigatran)7.2
Dabigatran vs Warfarin (Warfarin)13.53
Rivaroxaban vs Warfarin (Rivaroxaban)7.18
Rivaroxaban vs Warfarin (Warfarin)12.89

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Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)7.75
Apixaban vs Dabigatran (Dabigatran)7.47
Apixaban vs Rivaroxaban (Apixaban)7.35
Apixaban vs Rivaroxaban (Rivaroxaban)7.48
Dabigatran vs Rivaroxaban (Dabigatran)7.01
Dabigatran vs Rivaroxaban (Rivaroxaban)7.31

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Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)3.23
Apixaban vs Dabigatran (Dabigatran)4.18
Apixaban vs Rivaroxaban (Apixaban)3.28
Apixaban vs Rivaroxaban (Rivaroxaban)4.59
Dabigatran vs Rivaroxaban (Dabigatran)3.97
Dabigatran vs Rivaroxaban (Rivaroxaban)4.25

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Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)3.44
Apixaban vs Warfarin (Warfarin)6.2
Dabigatran vs Warfarin (Dabigatran)4.17
Dabigatran vs Warfarin (Warfarin)5.56
Rivaroxaban vs Warfarin (Rivaroxaban)4.32
Rivaroxaban vs Warfarin (Warfarin)5.78

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Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)1.11
Apixaban vs Dabigatran (Dabigatran)0.74
Apixaban vs Rivaroxaban (Apixaban)1.05
Apixaban vs Rivaroxaban (Rivaroxaban)1.15
Dabigatran vs Rivaroxaban (Dabigatran)0.71
Dabigatran vs Rivaroxaban (Rivaroxaban)1.14

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Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)1.1
Apixaban vs Warfarin (Warfarin)1.73
Dabigatran vs Warfarin (Dabigatran)0.78
Dabigatran vs Warfarin (Warfarin)1.71
Rivaroxaban vs Warfarin (Rivaroxaban)1.18
Rivaroxaban vs Warfarin (Warfarin)1.72

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Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)1.37
Apixaban vs Warfarin (Warfarin)2.38
Dabigatran vs Warfarin (Dabigatran)1.17
Dabigatran vs Warfarin (Warfarin)2.31
Rivaroxaban vs Warfarin (Rivaroxaban)1.47
Rivaroxaban vs Warfarin (Warfarin)2.37

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Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)6.99
Apixaban vs Dabigatran (Dabigatran)6.84
Apixaban vs Rivaroxaban (Apixaban)6.60
Apixaban vs Rivaroxaban (Rivaroxaban)6.58
Dabigatran vs Rivaroxaban (Dabigatran)6.37
Dabigatran vs Rivaroxaban (Rivaroxaban)6.43

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Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)6.9
Apixaban vs Warfarin (Warfarin)11.8
Dabigatran vs Warfarin (Dabigatran)6.53
Dabigatran vs Warfarin (Warfarin)11.92
Rivaroxaban vs Warfarin (Rivaroxaban)6.29
Rivaroxaban vs Warfarin (Warfarin)11.19

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Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938-939, M250, R233, R040-042, R048-049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)7.70
Apixaban vs Dabigatran (Dabigatran)8.65
Apixaban vs Rivaroxaban (Apixaban)7.77
Apixaban vs Rivaroxaban (Rivaroxaban)9.86
Dabigatran vs Rivaroxaban (Dabigatran)8.18
Dabigatran vs Rivaroxaban (Rivaroxaban)9.36

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Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate: number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62,H448,H3572,H356,H313,H210,H113,H052,H470,H431,I312,N020-N029,N421,N831,N857,N920,N923,N930,N938-939,M250,R233,R040-042,R048-049,T792,T810,N950,R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date= first prescription date of study drugs during intake duration. Participants were identified as NOAC user/Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)7.97
Apixaban vs Warfarin (Warfarin)14.73
Dabigatran vs Warfarin (Dabigatran)8.57
Dabigatran vs Warfarin (Warfarin)13.77
Rivaroxaban vs Warfarin (Rivaroxaban)9.55
Rivaroxaban vs Warfarin (Warfarin)14.23

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Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)3.67
Apixaban vs Dabigatran (Dabigatran)4.06
Apixaban vs Rivaroxaban (Apixaban)3.73
Apixaban vs Rivaroxaban (Rivaroxaban)4.54
Dabigatran vs Rivaroxaban (Dabigatran)3.83
Dabigatran vs Rivaroxaban (Rivaroxaban)4.35

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Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)3.75
Apixaban vs Warfarin (Warfarin)6.93
Dabigatran vs Warfarin (Dabigatran)3.86
Dabigatran vs Warfarin (Warfarin)6.61
Rivaroxaban vs Warfarin (Rivaroxaban)4.42
Rivaroxaban vs Warfarin (Warfarin)6.85

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Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)1.39
Apixaban vs Dabigatran (Dabigatran)1.12
Apixaban vs Rivaroxaban (Apixaban)1.35
Apixaban vs Rivaroxaban (Rivaroxaban)1.43
Dabigatran vs Rivaroxaban (Dabigatran)1.08
Dabigatran vs Rivaroxaban (Rivaroxaban)1.41

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Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants

Time of Maximum Plasma Concentration (Tmax) is defined as time of maximum observed plasma concentration and was calculated using non-compartmental analysis. Tmax was assessed for Quizartinib and Metabolite AC886. (NCT04459585)
Timeframe: Period 2 Day 5 (Pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

Interventionhours (Median)
QuizartinibAC886
Period 2: Dabigatran Etexilate + Quizartinib3.08.0

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Time of Maximum Plasma Concentration (Tmax) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib

Time of Maximum Plasma Concentration (Tmax) is defined as time of maximum observed plasma concentration and was calculated using non-compartmental analysis. (NCT04459585)
Timeframe: Period 1 Day 1 (Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours post-dose) and Period 2 Day 5 (pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

,
Interventionhours (Median)
Total DabigatranFree Dabigatran
Period 1: Dabigatran Etexilate2.02.0
Period 2: Dabigatran Etexilate + Quizartinib2.02.0

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Maximum Plasma Concentration (Cmax) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants

Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration and was calculated using non-compartmental analysis. Cmax was assessed for Quizartinib and Metabolite AC886. (NCT04459585)
Timeframe: Period 2 Day 5 (Pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

Interventionng/mL (Median)
QuizartinibAC886
Period 2: Dabigatran Etexilate + Quizartinib25025.7

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Area Under the Plasma Concentration-Time Curve From Time 0 to 74 Hours (AUClast,74) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants

Area Under the Plasma Concentration-Time Curve From Time 0 to 74 Hours (AUClast,74) is defined as area under the plasma concentration-time curve to the last quantifiable concentration post dose at 74 hours and was calculated using non-compartmental analysis. AUClast,74 was assessed for Quizartinib and Metabolite AC886. (NCT04459585)
Timeframe: Period 2 Day 5 (Pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

Interventionng*h/mL (Mean)
QuizartinibAC886
Period 2: Dabigatran Etexilate + Quizartinib93901350

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Area Under the Plasma Concentration-Time Curve up to Infinity (AUCinf) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib

Area Under the Plasma Concentration-Time Curve up to Infinity (AUCinf) is defined as area under the plasma concentration-time curve from the time of dosing extrapolated to infinity and was calculated using non-compartmental analysis. (NCT04459585)
Timeframe: Period 1 Day 1 (Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours post-dose) and Period 2 Day 5 (pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

,
Interventionng*h/mL (Mean)
Total DabigatranFree Dabigatran
Period 1: Dabigatran Etexilate17401420
Period 2: Dabigatran Etexilate + Quizartinib21401730

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Area Under the Plasma Concentration-Time Curve up to the Last Quantifiable Concentration Post-Dose (AUClast) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib

Area Under the Plasma Concentration-Time Curve up to the Last Quantifiable Concentration Post-Dose (AUClast) is defined as AUC from time 0 to the last measurable concentration, as calculated by the linear up-log down trapezoidal method and was calculated using non-compartmental analysis. (NCT04459585)
Timeframe: Period 1 Day 1 (Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours post-dose) and Period 2 Day 5 (pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

,
Interventionng*h/mL (Mean)
Total DabigatranFree Dabigatran
Period 1: Dabigatran Etexilate17201390
Period 2: Dabigatran Etexilate + Quizartinib21001710

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Maximum Plasma Concentration (Cmax) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib

Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration and was calculated using non-compartmental analysis. (NCT04459585)
Timeframe: Period 1 Day 1 (Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours post-dose) and Period 2 Day 5 (pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

,
Interventionng/mL (Mean)
Total DabigatranFree Dabigatran
Period 1: Dabigatran Etexilate192159
Period 2: Dabigatran Etexilate + Quizartinib239201

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Number of Participants Reporting Treatment-Emergent Adverse Events (TEAE) Relatedness to Study Medication Following Single Dose of Dabigatran Without and With Quizartinib in Participants

A Treatment-Emergent Adverse Events (TEAE) is defined as any event not present prior to the initiation of the drug treatment of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. Number of any TEAE that is related and unrelated to study medication is presented. (NCT04459585)
Timeframe: Up to 2 months

,
InterventionParticipants (Count of Participants)
RelatedUnrelated
Period 1: Dabigatran Etexilate00
Period 2: Dabigatran Etexilate + Quizartinib21

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Terminal Elimination Half-Life (T1/2) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib

Terminal Elimination Half-Life (T1/2) is defined as terminal elimination half-life and was calculated using non-compartmental analysis. (NCT04459585)
Timeframe: Period 1 Day 1 (Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours post-dose) and Period 2 Day 5 (pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

,
Interventionhours (Mean)
Total DabigatranFree Dabigatran
Period 1: Dabigatran Etexilate15.414.2
Period 2: Dabigatran Etexilate + Quizartinib18.114.1

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban0010100000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban122101123001

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy12000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only120002000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy200100000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban0001000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran0000000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban0000000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban11010200000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran3011600003

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Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption

Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment interruption. Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. (NCT05022563)
Timeframe: Within 30 days before treatment interruption during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Major Bleeding: Without Active CancerComplications of VTE: Without Active CancerThromboembolism: Without Active CancerMajor Surgery: Without Active CancerCancer-related Event: Without Active CancerKidney Function Changes: Without Active CancerLiver Function Change: Without Active CancerMajor Bleeding: With Active CancerComplications of VTE: With Active CancerThromboembolism: With Active CancerMajor Surgery: With Active CancerKidney Function Changes: With Active CancerLiver Function Change: With Active Cancer
NOAC-Based Therapy53133285661268715881213389
NOAC-Based Therapy: Apixaban5050126141012303113
NOAC-Based Therapy: Dabigatran23199587001201
NOAC-Based Therapy: Edoxaban201817476000100
NOAC-Based Therapy: Rivaroxaban4210233407995512940172775
PAC Only45209171100447220955109
Warfarin-Based Therapy2761589262457911121512

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Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation

Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment discontinuation. Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. (NCT05022563)
Timeframe: Within 30 days before treatment discontinuation during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Major Bleeding: Without Active CancerComplications of VTE: Without Active CancerThromboembolism: Without Active CancerMajor Surgery: Without Active CancerCancer-related Event: Without Active CancerKidney Function Changes: Without Active CancerLiver Function Change: Without Active CancerMajor Bleeding: With Active CancerComplications of VTE: With Active CancerThromboembolism: With Active CancerMajor Surgery: With Active CancerKidney Function Changes: With Active CancerLiver Function Change: With Active Cancer
NOAC-Based Therapy118257771691307240452362122666450
NOAC-Based Therapy: Apixaban1341235084039654014773
NOAC-Based Therapy: Dabigatran724818141334209112
NOAC-Based Therapy: Edoxaban5353252011280011553
NOAC-Based Therapy: Rivaroxaban9015537113823217232129287525142
PAC Only2018734625291383441140891904834
Warfarin-Based Therapy4210258781331041587117111416

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Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months

Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: Within 6 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC-Based Therapy105571089
NOAC-Based Therapy: Apixaban1213125
NOAC-Based Therapy: Dabigatran60646
NOAC-Based Therapy: Edoxaban81791
NOAC-Based Therapy: Rivaroxaban7209773
PAC Only75221
Warfarin-Based Therapy4393217

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Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months

Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: Within 3 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC Based Therapy: Apixaban2390290
NOAC Based Therapy: Dabigatran1225120
NOAC Based Therapy: Edoxaban1395148
NOAC-Based Therapy198482405
NOAC-Based Therapy: Rivaroxaban140371770
PAC Only222673
Warfarin-Based Therapy6313388

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Number of Participants Who Switched to Another Anticoagulant Therapy

Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC-Based Therapy1273173
NOAC-Based Therapy: Apixaban31933
NOAC-Based Therapy: Dabigatran27630
NOAC-Based Therapy: Edoxaban20426
NOAC-Based Therapy: Rivaroxaban1777208
PAC Only535208
Warfarin-Based Therapy1541144

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban61191410010

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy1085897851271308

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only125163636481115

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy591599

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Number of Participants With Interruption in Index Anticoagulant Treatment

Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC-Based Therapy8169961
NOAC-Based Therapy: Apixaban965115
NOAC-Based Therapy: Dabigatran49251
NOAC-Based Therapy: Edoxaban43938
NOAC-Based Therapy: Rivaroxaban5973728
PAC Only1226401
Warfarin-Based Therapy3429172

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Time to Treatment Discontinuation

Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The time to treatment discontinuation was defined as the period from the index date to the date of treatment discontinuation. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionDays (Median)
Without Active CancerWith Active Cancer
NOAC-Based Therapy119101
NOAC-Based Therapy: Apixaban8499
NOAC-Based Therapy: Dabigatran134118
NOAC-Based Therapy: Edoxaban154112
NOAC-Based Therapy: Rivaroxaban11997
PAC Only225
Warfarin-Based Therapy12975

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Time to Treatment Interruption

Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The time to treatment interruption was defined as the period from the index date to the date of treatment interruption. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionDays (Median)
Without Active CancerWith Active Cancer
NOAC-Based Therapy129137
NOAC-Based Therapy: Apixaban86123
NOAC-Based Therapy: Dabigatran137119
NOAC-Based Therapy: Edoxaban130159
NOAC-Based Therapy: Rivaroxaban128134
PAC Only361
Warfarin-Based Therapy163129

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Time to Treatment Switch

Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The time to treatment switch was defined as the period from the index date to the date of treatment switch. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionDays (Median)
Without Active CancerWith Active Cancer
NOAC-Based Therapy17976
NOAC-Based Therapy: Apixaban6644
NOAC-Based Therapy: Dabigatran10560
NOAC-Based Therapy: Edoxaban8798
NOAC-Based Therapy: Rivaroxaban9953
PAC Only2749
Warfarin-Based Therapy5736

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only146511510362182529

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy13623

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Number of Participants Who Completely Discontinued Index Anticoagulant Treatment

Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC-Based Therapy198262570
NOAC-Based Therapy: Apixaban2828279
NOAC-Based Therapy: Dabigatran1028115
NOAC-Based Therapy: Edoxaban1164147
NOAC-Based Therapy: Rivaroxaban141701968
PAC Only45341449
Warfarin-Based Therapy4707444

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban481330152588411

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban2143901000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy26314318310012

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban0004201000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran2112100001

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Overall Index Anticoagulant Treatment Duration

Overall anticoagulant treatment duration was defined as the time period from the index date to the earliest of treatment interruption, switch, or discontinuation. Treatment interruption: when a participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after this period of 30 days. Treatment switching: a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Treatment discontinuation: when a participant who ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to the earliest of treatment interruption, switch, or discontinuation; during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionDays (Median)
Without Active CancerWith Active Cancer
NOAC Based Therapy: Apixaban96104
NOAC Based Therapy: Dabigatran137105
NOAC Based Therapy: Edoxaban164123
NOAC-Based Therapy140111
NOAC-Based Therapy: Rivaroxaban128102
PAC Only334
Warfarin-Based Therapy13980

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban1020100001

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban105115822113

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy5111

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only5111127000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy17023012000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban0003000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran0010100000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban1010000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban4192311102

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy361130

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only102954516171006

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy63736351130010

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban3002610000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran4111200000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban1012600001

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban28101342020201

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy13524

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only541012121010

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy22631117201001

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban1310200000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran0000201000

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SubstanceRelationship StrengthStudiesTrialsClassesRoles
adenine
[no description available]		2.93306-aminopurines;
purine nucleobase		Daphnia magna metabolite;
Escherichia coli metabolite;
human metabolite;
mouse metabolite;
Saccharomyces cerevisiae metabolite
beta-alanine
[no description available]		25.121,03567amino acid zwitterion;
beta-amino acid		agonist;
fundamental metabolite;
human metabolite;
inhibitor;
neurotransmitter
benzene
[no description available]		7.1510aromatic annulene;
benzenes;
volatile organic compound		carcinogenic agent;
environmental contaminant;
non-polar solvent
chlorine
chloride : A halide anion formed when chlorine picks up an electron to form an an anion.		2.3110halide anion;
monoatomic chlorine		cofactor;
Escherichia coli metabolite;
human metabolite
coumarin
2H-chromen-2-one: coumarin derivative		3.5920coumarinsfluorescent dye;
human metabolite;
plant metabolite
glycine
[no description available]		4.0420alpha-amino acid;
amino acid zwitterion;
proteinogenic amino acid;
serine family amino acid		EC 2.1.2.1 (glycine hydroxymethyltransferase) inhibitor;
fundamental metabolite;
hepatoprotective agent;
micronutrient;
neurotransmitter;
NMDA receptor agonist;
nutraceutical
dalteparin
Dalteparin: A low-molecular-weight fragment of heparin, prepared by nitrous acid depolymerization of porcine mucosal heparin. The mean molecular weight is 4000-6000 daltons. It is used therapeutically as an antithrombotic agent. (From Merck Index, 11th ed)		16.458916
iodine
Iodine: A nonmetallic element of the halogen group that is represented by the atomic symbol I, atomic number 53, and atomic weight of 126.90. It is a nutritionally essential element, especially important in thyroid hormone synthesis. In solution, it has anti-infective properties and is used topically.. diiodine : Molecule comprising two covalently bonded iodine atoms with overall zero charge..		2.2510diatomic iodinenutrient
methanol
Methanol: A colorless, flammable liquid used in the manufacture of FORMALDEHYDE and ACETIC ACID, in chemical synthesis, antifreeze, and as a solvent. Ingestion of methanol is toxic and may cause blindness.. primary alcohol : A primary alcohol is a compound in which a hydroxy group, -OH, is attached to a saturated carbon atom which has either three hydrogen atoms attached to it or only one other carbon atom and two hydrogen atoms attached to it.. methanol : The primary alcohol that is the simplest aliphatic alcohol, comprising a methyl and an alcohol group.		2.4110alkyl alcohol;
one-carbon compound;
primary alcohol;
volatile organic compound		amphiprotic solvent;
Escherichia coli metabolite;
fuel;
human metabolite;
mouse metabolite;
Mycoplasma genitalium metabolite
niacin
Niacin: A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has PELLAGRA-curative, vasodilating, and antilipemic properties.. vitamin B3 : Any member of a group of vitamers that belong to the chemical structural class called pyridines that exhibit biological activity against vitamin B3 deficiency. Vitamin B3 deficiency causes a condition known as pellagra whose symptoms include depression, dermatitis and diarrhea. The vitamers include nicotinic acid and nicotinamide (and their ionized and salt forms).. nicotinic acid : A pyridinemonocarboxylic acid that is pyridine in which the hydrogen at position 3 is replaced by a carboxy group.		2.0810pyridine alkaloid;
pyridinemonocarboxylic acid;
vitamin B3		antidote;
antilipemic drug;
EC 3.5.1.19 (nicotinamidase) inhibitor;
Escherichia coli metabolite;
human urinary metabolite;
metabolite;
mouse metabolite;
plant metabolite;
vasodilator agent
succinic acid
Succinic Acid: A water-soluble, colorless crystal with an acid taste that is used as a chemical intermediate, in medicine, the manufacture of lacquers, and to make perfume esters. It is also used in foods as a sequestrant, buffer, and a neutralizing agent. (Hawley's Condensed Chemical Dictionary, 12th ed, p1099; McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed, p1851). succinic acid : An alpha,omega-dicarboxylic acid resulting from the formal oxidation of each of the terminal methyl groups of butane to the corresponding carboxy group. It is an intermediate metabolite in the citric acid cycle.		2.1510alpha,omega-dicarboxylic acid;
C4-dicarboxylic acid		anti-ulcer drug;
fundamental metabolite;
micronutrient;
nutraceutical;
radiation protective agent
urea
pseudourea: clinical use; structure. isourea : A carboximidic acid that is the imidic acid tautomer of urea, H2NC(=NH)OH, and its hydrocarbyl derivatives.		2.1510isourea;
monocarboxylic acid amide;
one-carbon compound		Daphnia magna metabolite;
Escherichia coli metabolite;
fertilizer;
flour treatment agent;
human metabolite;
mouse metabolite;
Saccharomyces cerevisiae metabolite
phenytoin
[no description available]		2.8130imidazolidine-2,4-dioneanticonvulsant;
drug allergen;
sodium channel blocker;
teratogenic agent
albuterol
Albuterol: A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol.. albuterol : A member of the class of phenylethanolamines that is 4-(2-amino-1-hydroxyethyl)-2-(hydroxymethyl)phenol having a tert-butyl group attached to the nirogen atom. It acts as a beta-adrenergic agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD).		2.3110phenols;
phenylethanolamines;
secondary amino compound		beta-adrenergic agonist;
bronchodilator agent;
environmental contaminant;
xenobiotic
amantadine
amant: an antiviral compound consisting of an adamantane derivative chemically linked to a water-solube polyanioic matrix; structure in first source		2.0810adamantanes;
primary aliphatic amine		analgesic;
antiparkinson drug;
antiviral drug;
dopaminergic agent;
NMDA receptor antagonist;
non-narcotic analgesic
amiodarone
Amiodarone: An antianginal and class III antiarrhythmic drug. It increases the duration of ventricular and atrial muscle action by inhibiting POTASSIUM CHANNELS and VOLTAGE-GATED SODIUM CHANNELS. There is a resulting decrease in heart rate and in vascular resistance.. amiodarone : A member of the class of 1-benzofurans that is 1-benzofuran substituted by a butyl group at position 2 and a 4-[2-(diethylamino)ethoxy]-3,5-diiodobenzoyl group at position 3. It is a cardiovascular drug used for the treatment of cardiac dysrhythmias.		6.791601-benzofurans;
aromatic ketone;
organoiodine compound;
tertiary amino compound		cardiovascular drug
aspirin
Aspirin: The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5). acetylsalicylate : A benzoate that is the conjugate base of acetylsalicylic acid, arising from deprotonation of the carboxy group.. acetylsalicylic acid : A member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity.		18.310829benzoic acids;
phenyl acetates;
salicylates		anticoagulant;
antipyretic;
cyclooxygenase 1 inhibitor;
cyclooxygenase 2 inhibitor;
drug allergen;
EC 1.1.1.188 (prostaglandin-F synthase) inhibitor;
geroprotector;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
plant activator;
platelet aggregation inhibitor;
prostaglandin antagonist;
teratogenic agent
astemizole
Astemizole: Antihistamine drug now withdrawn from the market in many countries because of rare but potentially fatal side effects.. astemizole : A piperidine compound having a 2-(4-methoxyphenyl)ethyl group at the 1-position and an N-[(4-fluorobenzyl)benzimidazol-2-yl]amino group at the 4-position.		2.0810benzimidazoles;
piperidines		anti-allergic agent;
anticoronaviral agent;
H1-receptor antagonist
bithionol
Bithionol: Halogenated anti-infective agent that is used against trematode and cestode infestations.. bithionol : An aryl sulfide that is diphenyl sulfide in which each phenyl group is substituted at position 2 by hydroxy and at positions 3 and 5 by chlorine. A fungicide and anthelmintic, it was used in various topical drug products for the treatment of liver flukes, but withdrawn after being shown to be a potent photosensitizer with the potential to cause serious skin disorders.		2.0810aryl sulfide;
bridged diphenyl antifungal drug;
bridged diphenyl fungicide;
dichlorobenzene;
organochlorine pesticide;
polyphenol		antifungal agrochemical;
antiplatyhelmintic drug
buspirone
Buspirone: An anxiolytic agent and serotonin receptor agonist belonging to the azaspirodecanedione class of compounds. Its structure is unrelated to those of the BENZODIAZAPINES, but it has an efficacy comparable to DIAZEPAM.. buspirone : An azaspiro compound that is 8-azaspiro[4.5]decane-7,9-dione substituted at the nitrogen atom by a 4-(piperazin-1-yl)butyl group which in turn is substituted by a pyrimidin-2-yl group at the N(4) position.		2.0810azaspiro compound;
N-alkylpiperazine;
N-arylpiperazine;
organic heteropolycyclic compound;
piperidones;
pyrimidines		anxiolytic drug;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
sedative;
serotonergic agonist
verapamil
Verapamil: A calcium channel blocker that is a class IV anti-arrhythmia agent.. verapamil : A racemate comprising equimolar amounts of dexverapamil and (S)-verapamil. An L-type calcium channel blocker of the phenylalkylamine class, it is used (particularly as the hydrochloride salt) in the treatment of hypertension, angina pectoris and cardiac arrhythmia, and as a preventive medication for migraine.. 2-(3,4-dimethoxyphenyl)-5-{[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino}-2-(propan-2-yl)pentanenitrile : A tertiary amino compound that is 3,4-dimethoxyphenylethylamine in which the hydrogens attached to the nitrogen are replaced by a methyl group and a 4-cyano-4-(3,4-dimethoxyphenyl)-5-methylhexyl group.		10.7461aromatic ether;
nitrile;
polyether;
tertiary amino compound
camostat
camostat : A benzoate ester resulting from the formal condensation of the carboxy group of 4-guanidinobenzoic acid with the hydroxy group of 2-(dimethylamino)-2-oxoethyl (4-hydroxyphenyl)acetate. It is a potent inhibitor of the human transmembrane protease serine 2 (TMPRSS2) and its mesylate salt is currently under investigation for its effectiveness in COVID-19 patients.		2.520benzoate ester;
carboxylic ester;
diester;
guanidines;
tertiary carboxamide		anti-inflammatory agent;
anticoronaviral agent;
antifibrinolytic drug;
antihypertensive agent;
antineoplastic agent;
antiviral agent;
serine protease inhibitor
carbamazepine
Carbamazepine: A dibenzazepine that acts as a sodium channel blocker. It is used as an anticonvulsant for the treatment of grand mal and psychomotor or focal SEIZURES. It may also be used in the management of BIPOLAR DISORDER, and has analgesic properties.. carbamazepine : A dibenzoazepine that is 5H-dibenzo[b,f]azepine carrying a carbamoyl substituent at the azepine nitrogen, used as an anticonvulsant.		2.1310dibenzoazepine;
ureas		analgesic;
anticonvulsant;
antimanic drug;
drug allergen;
EC 3.5.1.98 (histone deacetylase) inhibitor;
environmental contaminant;
glutamate transporter activator;
mitogen;
non-narcotic analgesic;
sodium channel blocker;
xenobiotic
carvedilol
[no description available]		2.0810carbazoles;
secondary alcohol;
secondary amino compound		alpha-adrenergic antagonist;
antihypertensive agent;
beta-adrenergic antagonist;
cardiovascular drug;
vasodilator agent
cetirizine
Cetirizine: A potent second-generation histamine H1 antagonist that is effective in the treatment of allergic rhinitis, chronic urticaria, and pollen-induced asthma. Unlike many traditional antihistamines, it does not cause drowsiness or anticholinergic side effects.. cetirizine : A member of the class of piperazines that is piperazine in which the hydrogens attached to nitrogen are replaced by a (4-chlorophenyl)(phenyl)methyl and a 2-(carboxymethoxy)ethyl group respectively.		2.0810ether;
monocarboxylic acid;
monochlorobenzenes;
piperazines		anti-allergic agent;
environmental contaminant;
H1-receptor antagonist;
xenobiotic
cifenline
[no description available]		2.0710diarylmethane
ciclopirox
[no description available]		2.0810cyclic hydroxamic acid;
hydroxypyridone antifungal drug;
pyridone		antibacterial agent;
antiseborrheic
cilostazol
[no description available]		2.2110lactam;
tetrazoles		anticoagulant;
bronchodilator agent;
EC 3.1.4.17 (3',5'-cyclic-nucleotide phosphodiesterase) inhibitor;
fibrin modulating drug;
neuroprotective agent;
platelet aggregation inhibitor;
vasodilator agent
cimetidine
Cimetidine: A histamine congener, it competitively inhibits HISTAMINE binding to HISTAMINE H2 RECEPTORS. Cimetidine has a range of pharmacological actions. It inhibits GASTRIC ACID secretion, as well as PEPSIN and GASTRIN output.. cimetidine : A member of the class of guanidines that consists of guanidine carrying a methyl substituent at position 1, a cyano group at position 2 and a 2-{[(5-methyl-1H-imidazol-4-yl)methyl]sulfanyl}ethyl group at position 3. It is a H2-receptor antagonist that inhibits the production of acid in stomach.		2.0810aliphatic sulfide;
guanidines;
imidazoles;
nitrile		adjuvant;
analgesic;
anti-ulcer drug;
H2-receptor antagonist;
P450 inhibitor
citalopram
Citalopram: A furancarbonitrile that is one of the serotonin uptake inhibitors used as an antidepressant. The drug is also effective in reducing ethanol uptake in alcoholics and is used in depressed patients who also suffer from TARDIVE DYSKINESIA in preference to tricyclic antidepressants, which aggravate dyskinesia.. citalopram : A racemate comprising equimolar amounts of (R)-citalopram and its enantiomer, escitalopram. It is used as an antidepressant, although only escitalopram is active.. 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile : A nitrile that is 1,3-dihydro-2-benzofuran-5-carbonitrile in which one of the hydrogens at position 1 is replaced by a p-fluorophenyl group, while the other is replaced by a 3-(dimethylamino)propyl group.		2.11102-benzofurans;
cyclic ether;
nitrile;
organofluorine compound;
tertiary amino compound
clonidine
Clonidine: An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION.. clonidine (amino form) : A clonidine that is 4,5-dihydro-1H-imidazol-2-amine in which one of the amino hydrogens is replaced by a 2,6-dichlorophenyl group.		2.0810clonidine;
imidazoline
diclofenac
Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.. diclofenac : A monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position.		2.0810amino acid;
aromatic amine;
dichlorobenzene;
monocarboxylic acid;
secondary amino compound		antipyretic;
drug allergen;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
environmental contaminant;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
xenobiotic
dipyridamole
Dipyridamole: A phosphodiesterase inhibitor that blocks uptake and metabolism of adenosine by erythrocytes and vascular endothelial cells. Dipyridamole also potentiates the antiaggregating action of prostacyclin. (From AMA Drug Evaluations Annual, 1994, p752). dipyridamole : A pyrimidopyrimidine that is 2,2',2'',2'''-(pyrimido[5,4-d]pyrimidine-2,6-diyldinitrilo)tetraethanol substituted by piperidin-1-yl groups at positions 4 and 8 respectively. A vasodilator agent, it inhibits the formation of blood clots.		3.6320piperidines;
pyrimidopyrimidine;
tertiary amino compound;
tetrol		adenosine phosphodiesterase inhibitor;
EC 3.5.4.4 (adenosine deaminase) inhibitor;
platelet aggregation inhibitor;
vasodilator agent
domperidone
Domperidone: A specific blocker of dopamine receptors. It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms.. domperidone : 1-[3-(Piperidin-1-yl)propyl]-1,3-dihydro-2H-benzimidazol-2-one in which the 4-position of the piperidine ring is substituted by a 5-chloro-1,3-dihydro-2H-benzimidazol-2-on-1-yl group. A dopamine antagonist, it is used as an antiemetic for the short-term treatment of nausea and vomiting, and to control gastrointestinal effects of dopaminergic drugs given in the management of parkinsonism. The free base is used in oral suspensions, while the maleate salt is used in tablet preparations.		2.0810benzimidazoles;
heteroarylpiperidine		antiemetic;
dopaminergic antagonist
epinastine
epinastine: RN given refers parent cpd. epinastine : A benzazepine that is 6,11-dihydro-5H-dibenzo[b,e]azepine in which the azepine ring is fused to the e side of 4,5-dihydro-1H-imidazol-2-amine.		2.0810benzazepine;
guanidines		anti-allergic agent;
H1-receptor antagonist;
histamine antagonist;
ophthalmology drug
ethacrynic acid
Ethacrynic Acid: A compound that inhibits symport of sodium, potassium, and chloride primarily in the ascending limb of Henle, but also in the proximal and distal tubules. This pharmacological action results in excretion of these ions, increased urinary output, and reduction in extracellular fluid. This compound has been classified as a loop or high ceiling diuretic.. etacrynic acid : An aromatic ether that is phenoxyacetic acid in which the phenyl ring is substituted by chlorines at positions 2 and 3, and by a 2-methylidenebutanoyl group at position 4. It is a loop diuretic used to treat high blood pressure resulting from diseases such as congestive heart failure, liver failure, and kidney failure. It is also a glutathione S-transferase (EC 2.5.1.18) inhibitor.		3.711aromatic ether;
aromatic ketone;
dichlorobenzene;
monocarboxylic acid		EC 2.5.1.18 (glutathione transferase) inhibitor;
ion transport inhibitor;
loop diuretic
fexofenadine
fexofenadine: a second generation antihistamine; metabolite of the antihistaminic drug terfenadine; structure in first source; RN refers to HCl. fexofenadine : A piperidine-based anti-histamine compound.		3.3110piperidines;
tertiary amine		anti-allergic agent;
H1-receptor antagonist
flecainide
Flecainide: A potent anti-arrhythmia agent, effective in a wide range of ventricular and atrial ARRHYTHMIAS and TACHYCARDIAS.. flecainide : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 2,5-bis(2,2,2-trifluoroethoxy)benzoic acid with the primary amino group of piperidin-2-ylmethylamine. An antiarrhythmic agent used (in the form of its acetate salt) to prevent and treat tachyarrhythmia (abnormal fast rhythm of the heart).		2.610aromatic ether;
monocarboxylic acid amide;
organofluorine compound;
piperidines		anti-arrhythmia drug
fluconazole
Fluconazole: Triazole antifungal agent that is used to treat oropharyngeal CANDIDIASIS and cryptococcal MENINGITIS in AIDS.. fluconazole : A member of the class of triazoles that is propan-2-ol substituted at position 1 and 3 by 1H-1,2,4-triazol-1-yl groups and at position 2 by a 2,4-difluorophenyl group. It is an antifungal drug used for the treatment of mucosal candidiasis and for systemic infections including systemic candidiasis, coccidioidomycosis, and cryptococcosis.		7.4110conazole antifungal drug;
difluorobenzene;
tertiary alcohol;
triazole antifungal drug		environmental contaminant;
P450 inhibitor;
xenobiotic
fluorouracil
Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.. 5-fluorouracil : A nucleobase analogue that is uracil in which the hydrogen at position 5 is replaced by fluorine. It is an antineoplastic agent which acts as an antimetabolite - following conversion to the active deoxynucleotide, it inhibits DNA synthesis (by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate synthetase) and so slows tumour growth.		2.5220nucleobase analogue;
organofluorine compound		antimetabolite;
antineoplastic agent;
environmental contaminant;
immunosuppressive agent;
radiosensitizing agent;
xenobiotic
furosemide
Furosemide: A benzoic-sulfonamide-furan. It is a diuretic with fast onset and short duration that is used for EDEMA and chronic RENAL INSUFFICIENCY.. furosemide : A chlorobenzoic acid that is 4-chlorobenzoic acid substituted by a (furan-2-ylmethyl)amino and a sulfamoyl group at position 2 and 5 respectively. It is a diuretic used in the treatment of congestive heart failure.		3.9421chlorobenzoic acid;
furans;
sulfonamide		environmental contaminant;
loop diuretic;
xenobiotic
gabexate
Gabexate: A serine proteinase inhibitor used therapeutically in the treatment of pancreatitis, disseminated intravascular coagulation (DIC), and as a regional anticoagulant for hemodialysis. The drug inhibits the hydrolytic effects of thrombin, plasmin, and kallikrein, but not of chymotrypsin and aprotinin.		2.0810benzoate ester
gentamicin
Gentamicins: A complex of closely related aminoglycosides obtained from MICROMONOSPORA purpurea and related species. They are broad-spectrum antibiotics, but may cause ear and kidney damage. They act to inhibit PROTEIN BIOSYNTHESIS.		2.2110
granisetron
[no description available]		2.0810aromatic amide;
indazoles
ethidium
Ethidium: A trypanocidal agent and possible antiviral agent that is widely used in experimental cell biology and biochemistry. Ethidium has several experimentally useful properties including binding to nucleic acids, noncompetitive inhibition of nicotinic acetylcholine receptors, and fluorescence among others. It is most commonly used as the bromide.. ethidium : The fluorescent compound widely used in experimental cell biology and biochemistry to reveal double-stranded DNA and RNA.		2.0710phenanthridinesfluorochrome;
intercalator
ibuprofen
Midol: combination of cinnamedrine, phenacetin, aspirin & caffeine		2.0710monocarboxylic acidantipyretic;
cyclooxygenase 1 inhibitor;
cyclooxygenase 2 inhibitor;
drug allergen;
environmental contaminant;
geroprotector;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
radical scavenger;
xenobiotic
lidocaine
Lidocaine: A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.. lidocaine : The monocarboxylic acid amide resulting from the formal condensation of N,N-diethylglycine with 2,6-dimethylaniline.		7.4920benzenes;
monocarboxylic acid amide;
tertiary amino compound		anti-arrhythmia drug;
drug allergen;
environmental contaminant;
local anaesthetic;
xenobiotic
indomethacin
Indomethacin: A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES.. indometacin : A member of the class of indole-3-acetic acids that is indole-3-acetic acid in which the indole ring is substituted at positions 1, 2 and 5 by p-chlorobenzoyl, methyl, and methoxy groups, respectively. A non-steroidal anti-inflammatory drug, it is used in the treatment of musculoskeletal and joint disorders including osteoarthritis, rheumatoid arthritis, gout, bursitis and tendinitis.		7.5420aromatic ether;
indole-3-acetic acids;
monochlorobenzenes;
N-acylindole		analgesic;
drug metabolite;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
environmental contaminant;
gout suppressant;
non-steroidal anti-inflammatory drug;
xenobiotic metabolite;
xenobiotic
avapro
Irbesartan: A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.. irbesartan : A biphenylyltetrazole that is an angiotensin II receptor antagonist used mainly for the treatment of hypertension.		3.5720azaspiro compound;
biphenylyltetrazole		angiotensin receptor antagonist;
antihypertensive agent;
environmental contaminant;
xenobiotic
ketamine
Ketamine: A cyclohexanone derivative used for induction of anesthesia. Its mechanism of action is not well understood, but ketamine can block NMDA receptors (RECEPTORS, N-METHYL-D-ASPARTATE) and may interact with sigma receptors.. ketamine : A member of the class of cyclohexanones in which one of the hydrogens at position 2 is substituted by a 2-chlorophenyl group, while the other is substituted by a methylamino group.		7.110cyclohexanones;
monochlorobenzenes;
secondary amino compound		analgesic;
environmental contaminant;
intravenous anaesthetic;
neurotoxin;
NMDA receptor antagonist;
xenobiotic
ketoconazole
1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine : A dioxolane that is 1,3-dioxolane which is substituted at positions 2, 2, and 4 by imidazol-1-ylmethyl, 2,4-dichlorophenyl, and [para-(4-acetylpiperazin-1-yl)phenoxy]methyl groups, respectively.		2.2110dichlorobenzene;
dioxolane;
ether;
imidazoles;
N-acylpiperazine;
N-arylpiperazine
lansoprazole
Lansoprazole: A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers.		3.921benzimidazoles;
pyridines;
sulfoxide		anti-ulcer drug;
EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor
losartan
Losartan: An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.. losartan : A biphenylyltetrazole where a 1,1'-biphenyl group is attached at the 5-position and has an additional trisubstituted imidazol-1-ylmethyl group at the 4'-position		2.4920biphenylyltetrazole;
imidazoles		angiotensin receptor antagonist;
anti-arrhythmia drug;
antihypertensive agent;
endothelin receptor antagonist
metformin
Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289). metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1.		7.3553guanidinesenvironmental contaminant;
geroprotector;
hypoglycemic agent;
xenobiotic
methylphenidate
Methylphenidate: A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.. methylphenidate : A racemate comprising equimolar amounts of the two threo isomers of methyl phenyl(piperidin-2-yl)acetate. A central stimulant and indirect-acting sympathomimetic, is used (generally as the hydrochloride salt) in the treatment of hyperactivity disorders in children and for the treatment of narcolepsy.. methyl phenyl(piperidin-2-yl)acetate : A amino acid ester that is methyl phenylacetate in which one of the hydrogens alpha to the carbonyl group is replaced by a piperidin-2-yl group.		3.1910beta-amino acid ester;
methyl ester;
piperidines
midazolam
Midazolam: A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.. midazolam : An imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively.		4.3331imidazobenzodiazepine;
monofluorobenzenes;
organochlorine compound		anticonvulsant;
antineoplastic agent;
anxiolytic drug;
apoptosis inducer;
central nervous system depressant;
GABAA receptor agonist;
general anaesthetic;
muscle relaxant;
sedative
minoxidil
Minoxidil: A potent direct-acting peripheral vasodilator (VASODILATOR AGENTS) that reduces peripheral resistance and produces a fall in BLOOD PRESSURE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p371). minoxidil : A pyrimidine N-oxide that is pyrimidine-2,4-diamine 3-oxide substituted by a piperidin-1-yl group at position 6.		2.2510dialkylarylamine;
tertiary amino compound
mitoxantrone
Mitoxantrone: An anthracenedione-derived antineoplastic agent.. mitoxantrone : A dihydroxyanthraquinone that is 1,4-dihydroxy-9,10-anthraquinone which is substituted by 6-hydroxy-1,4-diazahexyl groups at positions 5 and 8.		2.0810dihydroxyanthraquinoneanalgesic;
antineoplastic agent
n(alpha)-(2-naphthylsulfonylglycyl)-4-amidinophenylalanine piperidide
N(alpha)-(2-naphthylsulfonylglycyl)-4-amidinophenylalanine piperidide: thrombin inhibitor; RN given refers to parent cpd without isomeric designation		3.2710
nafamostat
nafamostat: inhibitor of trypsin, plasmin, pancreatic kallikrein, plasma kallikrein & thrombin; strongly inhibits esterolytic activities of C1r & C1 esterase complement-mediated hemolysis; antineoplastic		2.1110benzoic acids;
guanidines
nifekalant
[no description available]		2.0810amine
omeprazole
Omeprazole: A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.. omeprazole : A racemate comprising equimolar amounts of (R)- and (S)-omeprazole.. 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole : A member of the class of benzimidazoles that is 1H-benzimidazole which is substituted by a [4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl group at position 2 and a methoxy group at position 5.		9.08107aromatic ether;
benzimidazoles;
pyridines;
sulfoxide
ondansetron
Ondansetron: A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.		2.0810carbazoles
pantoprazole
Pantoprazole: 2-pyridinylmethylsulfinylbenzimidazole proton pump inhibitor that is used in the treatment of GASTROESOPHAGEAL REFLUX and PEPTIC ULCER.. pantoprazole : A member of the class of benzimidazoles that is 1H-benzimidazole substituted by a difluoromethoxy group at position 5 and a [(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl group at position 2.		8.0293aromatic ether;
benzimidazoles;
organofluorine compound;
pyridines;
sulfoxide		anti-ulcer drug;
EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor;
environmental contaminant;
xenobiotic
pentamidine
Pentamidine: Antiprotozoal agent effective in trypanosomiasis, leishmaniasis, and some fungal infections; used in treatment of PNEUMOCYSTIS pneumonia in HIV-infected patients. It may cause diabetes mellitus, central nervous system damage, and other toxic effects.. pentamidine : A diether consisting of pentane-1,5-diol in which both hydroxyl hydrogens have been replaced by 4-amidinophenyl groups. A trypanocidal drug that is used for treatment of cutaneous leishmaniasis and Chagas disease.		2.0810aromatic ether;
carboxamidine;
diether		anti-inflammatory agent;
antifungal agent;
calmodulin antagonist;
chemokine receptor 5 antagonist;
EC 2.3.1.48 (histone acetyltransferase) inhibitor;
NMDA receptor antagonist;
S100 calcium-binding protein B inhibitor;
trypanocidal drug;
xenobiotic
phenacetin
Saridon: contains phenacetin, caffeine, propyphenazone & pyrithyldione		2.0810acetamides;
aromatic ether		cyclooxygenase 3 inhibitor;
non-narcotic analgesic;
peripheral nervous system drug
phenindione
Phenindione: An indandione that has been used as an anticoagulant. Phenindione has actions similar to WARFARIN, but it is now rarely employed because of its higher incidence of severe adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p234)		2.5420aromatic ketone;
beta-diketone		anticoagulant
phenobarbital
Phenobarbital: A barbituric acid derivative that acts as a nonselective central nervous system depressant. It potentiates GAMMA-AMINOBUTYRIC ACID action on GABA-A RECEPTORS, and modulates chloride currents through receptor channels. It also inhibits glutamate induced depolarizations.. phenobarbital : A member of the class of barbiturates, the structure of which is that of barbituric acid substituted at C-5 by ethyl and phenyl groups.		2.110barbituratesanticonvulsant;
drug allergen;
excitatory amino acid antagonist;
sedative
prazosin
Prazosin: A selective adrenergic alpha-1 antagonist used in the treatment of HEART FAILURE; HYPERTENSION; PHEOCHROMOCYTOMA; RAYNAUD DISEASE; PROSTATIC HYPERTROPHY; and URINARY RETENTION.. prazosin : A member of the class of piperazines that is piperazine substituted by a furan-2-ylcarbonyl group and a 4-amino-6,7-dimethoxyquinazolin-2-yl group at positions 1 and 4 respectively.		2.0810aromatic ether;
furans;
monocarboxylic acid amide;
piperazines;
quinazolines		alpha-adrenergic antagonist;
antihypertensive agent;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor
primidone
Primidone: A barbiturate derivative that acts as a GABA modulator and anti-epileptic agent. It is partly metabolized to PHENOBARBITAL in the body and owes some of its actions to this metabolite.. primidone : A pyrimidone that is dihydropyrimidine-4,6(1H,5H)-dione substituted by an ethyl and a phenyl group at position 5. It is used as an anticonvulsant for treatment of various types of seizures.		7.4110pyrimidoneanticonvulsant;
environmental contaminant;
xenobiotic
probucol
Probucol: A drug used to lower LDL and HDL cholesterol yet has little effect on serum-triglyceride or VLDL cholesterol. (From Martindale, The Extra Pharmacopoeia, 30th ed, p993).. probucol : A dithioketal that is propane-2,2-dithiol in which the hydrogens attached to both sulfur atoms are replaced by 3,5-di-tert-butyl-4-hydroxyphenyl groups. An anticholesteremic drug with antioxidant and anti-inflammatory properties, it is used to treat high levels of cholesterol in blood.		2.2110dithioketal;
polyphenol		anti-inflammatory drug;
anticholesteremic drug;
antilipemic drug;
antioxidant;
cardiovascular drug
propofol
Propofol: An intravenous anesthetic agent which has the advantage of a very rapid onset after infusion or bolus injection plus a very short recovery period of a couple of minutes. (From Smith and Reynard, Textbook of Pharmacology, 1992, 1st ed, p206). Propofol has been used as ANTICONVULSANTS and ANTIEMETICS.. propofol : A phenol resulting from the formal substitution of the hydrogen at the 2 position of 1,3-diisopropylbenzene by a hydroxy group.		7.110phenolsanticonvulsant;
antiemetic;
intravenous anaesthetic;
radical scavenger;
sedative
rabeprazole
Rabeprazole: A 4-(3-methoxypropoxy)-3-methylpyridinyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.		3.511benzimidazoles;
pyridines;
sulfoxide		anti-ulcer drug;
EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor
ranitidine
[no description available]		2.0810aralkylamine
rimantadine
Rimantadine: An RNA synthesis inhibitor that is used as an antiviral agent in the prophylaxis and treatment of influenza.		2.0810alkylamine
risperidone
Risperidone: A selective blocker of DOPAMINE D2 RECEPTORS and SEROTONIN 5-HT2 RECEPTORS that acts as an atypical antipsychotic agent. It has been shown to improve both positive and negative symptoms in the treatment of SCHIZOPHRENIA.. risperidone : A member of the class of pyridopyrimidines that is 2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one carrying an additional 2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl group at position 2.		2.08101,2-benzoxazoles;
heteroarylpiperidine;
organofluorine compound;
pyridopyrimidine		alpha-adrenergic antagonist;
dopaminergic antagonist;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
H1-receptor antagonist;
psychotropic drug;
second generation antipsychotic;
serotonergic antagonist
sotalol
Sotalol: An adrenergic beta-antagonist that is used in the treatment of life-threatening arrhythmias.. sotalol : A sulfonamide that is N-phenylmethanesulfonamide in which the phenyl group is substituted at position 4 by a 1-hydroxy-2-(isopropylamino)ethyl group. It has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. It is used (usually as the hydrochloride salt) for the management of ventricular and supraventricular arrhythmias.		2.610ethanolamines;
secondary alcohol;
secondary amino compound;
sulfonamide		anti-arrhythmia drug;
beta-adrenergic antagonist;
environmental contaminant;
xenobiotic
imatinib
[no description available]		2.4820aromatic amine;
benzamides;
N-methylpiperazine;
pyridines;
pyrimidines		antineoplastic agent;
apoptosis inducer;
tyrosine kinase inhibitor
sulfacetamide
Sulfacetamide: An anti-bacterial agent that is used topically to treat skin infections and orally for urinary tract infections.. sulfacetamide : A sulfonamide that is sulfanilamide acylated on the sulfonamide nitrogen.		2.0810N-sulfonylcarboxamide;
substituted aniline		antibacterial drug;
antiinfective agent;
antimicrobial agent;
EC 2.5.1.15 (dihydropteroate synthase) inhibitor
sumatriptan
Sumatriptan: A serotonin agonist that acts selectively at 5HT1 receptors. It is used in the treatment of MIGRAINE DISORDERS.. sumatriptan : A sulfonamide that consists of N,N-dimethyltryptamine bearing an additional (N-methylsulfamoyl)methyl substituent at position 5. Selective agonist for a vascular 5-HT1 receptor subtype (probably a member of the 5-HT1D family). Used (in the form of its succinate salt) for the acute treatment of migraine with or without aura in adults.		2.0810sulfonamide;
tryptamines		serotonergic agonist;
vasoconstrictor agent
terfenadine
Terfenadine: A selective histamine H1-receptor antagonist devoid of central nervous system depressant activity. The drug was used for ALLERGY but withdrawn due to causing LONG QT SYNDROME.		3.3110diarylmethane
thiabendazole
Tresaderm: dermatologic soln containing dexamethasone, thiabendazole & neomycin sulfate		2.08101,3-thiazoles;
benzimidazole fungicide;
benzimidazoles		antifungal agrochemical;
antinematodal drug
ticlopidine
Ticlopidine: An effective inhibitor of platelet aggregation commonly used in the placement of STENTS in CORONARY ARTERIES.. ticlopidine : A thienopyridine that is 4,5,6,7-tetrahydrothieno[3,2-c]pyridine in which the hydrogen attached to the nitrogen is replaced by an o-chlorobenzyl group.		14.67456monochlorobenzenes;
thienopyridine		anticoagulant;
fibrin modulating drug;
hematologic agent;
P2Y12 receptor antagonist;
platelet aggregation inhibitor
tranexamic acid
Tranexamic Acid: Antifibrinolytic hemostatic used in severe hemorrhage.		4.7480amino acid
ici 204,219
zafirlukast: a leukotriene D4 receptor antagonist		2.0810carbamate ester;
indoles;
N-sulfonylcarboxamide		anti-asthmatic agent;
leukotriene antagonist
benzimidazole
1H-benzimidazole : The 1H-tautomer of benzimidazole.		2.0710benzimidazole;
polycyclic heteroarene
hydroxyproline
Hydroxyproline: A hydroxylated form of the imino acid proline. A deficiency in ASCORBIC ACID can result in impaired hydroxyproline formation.. hydroxyproline : A proline derivative that is proline substituted by at least one hydroxy group.		2.17104-hydroxyproline;
L-alpha-amino acid zwitterion		human metabolite;
mouse metabolite;
plant metabolite
spironolactone
Spironolactone: A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827). spironolactone : A steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7.		7.49203-oxo-Delta(4) steroid;
oxaspiro compound;
steroid lactone;
thioester		aldosterone antagonist;
antihypertensive agent;
diuretic;
environmental contaminant;
xenobiotic
carbon tetrachloride
Carbon Tetrachloride: A solvent for oils, fats, lacquers, varnishes, rubber waxes, and resins, and a starting material in the manufacturing of organic compounds. Poisoning by inhalation, ingestion or skin absorption is possible and may be fatal. (Merck Index, 11th ed). tetrachloromethane : A chlorocarbon that is methane in which all the hydrogens have been replaced by chloro groups.		2.2110chlorocarbon;
chloromethanes		hepatotoxic agent;
refrigerant
ethinyl estradiol
Ethinyl Estradiol: A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.. 17alpha-ethynylestradiol : A 3-hydroxy steroid that is estradiol substituted by a ethynyl group at position 17. It is a xenoestrogen synthesized from estradiol and has been shown to exhibit high estrogenic potency on oral administration.		2.081017-hydroxy steroid;
3-hydroxy steroid;
terminal acetylenic compound		xenoestrogen
tubocurarine
Tubocurarine: A neuromuscular blocker and active ingredient in CURARE; plant based alkaloid of Menispermaceae.. tubocurarine : A benzylisoquinoline alkaloid muscle relaxant which constitutes the active component of curare.. isoquinoline alkaloid : Any alkaloid that has a structure based on an isoquinoline nucleus. They are derived from the amino acids like tyrosine and phenylalanine.		2.0810bisbenzylisoquinoline alkaloiddrug allergen;
muscle relaxant;
nicotinic antagonist
adenosine diphosphate
Adenosine Diphosphate: Adenosine 5'-(trihydrogen diphosphate). An adenine nucleotide containing two phosphate groups esterified to the sugar moiety at the 5'-position.		4.7461adenosine 5'-phosphate;
purine ribonucleoside 5'-diphosphate		fundamental metabolite;
human metabolite
edetic acid
Edetic Acid: A chelating agent that sequesters a variety of polyvalent cations such as CALCIUM. It is used in pharmaceutical manufacturing and as a food additive.		2.4110ethylenediamine derivative;
polyamino carboxylic acid;
tetracarboxylic acid		anticoagulant;
antidote;
chelator;
copper chelator;
geroprotector
arginine
Arginine: An essential amino acid that is physiologically active in the L-form.. arginine : An alpha-amino acid that is glycine in which the alpha-is substituted by a 3-guanidinopropyl group.		10.64382arginine;
glutamine family amino acid;
L-alpha-amino acid;
proteinogenic amino acid		biomarker;
Escherichia coli metabolite;
micronutrient;
mouse metabolite;
nutraceutical
phencyclidine
Phencyclidine: A hallucinogen formerly used as a veterinary anesthetic, and briefly as a general anesthetic for humans. Phencyclidine is similar to KETAMINE in structure and in many of its effects. Like ketamine, it can produce a dissociative state. It exerts its pharmacological action through inhibition of NMDA receptors (RECEPTORS, N-METHYL-D-ASPARTATE). As a drug of abuse, it is known as PCP and Angel Dust.. phencyclidine : A member of the class of piperidines that is piperidine in which the nitrogen is substituted with a 1-phenylcyclohexyl group. Formerly used as an anaesthetic agent, it exhibits both hallucinogenic and neurotoxic effects.		2.1710benzenes;
piperidines		anaesthetic;
neurotoxin;
NMDA receptor antagonist;
psychotropic drug
rotenone
Derris: A plant genus of the family FABACEAE. The root is a source of rotenoids (ROTENONE) and flavonoids. Some species of Pongamia have been reclassified to this genus and some to MILLETTIA. Some species of Deguelia have been reclassified to this genus.. rotenoid : Members of the class of tetrahydrochromenochromene that consists of a cis-fused tetrahydrochromeno[3,4-b]chromene skeleton and its substituted derivatives. The term was originally restricted to natural products, but is now also used to describe semi-synthetic and fully synthetic compounds.		7.1710organic heteropentacyclic compound;
rotenones		antineoplastic agent;
metabolite;
mitochondrial NADH:ubiquinone reductase inhibitor;
phytogenic insecticide;
piscicide;
toxin
n-vinyl-2-pyrrolidinone
N-vinyl-2-pyrrolidinone: monomer of POVIDONE; structure given in first source		2.1310pyrrolidin-2-ones
pyrroles
1H-pyrrole : A tautomer of pyrrole that has the double bonds at positions 2 and 4.. pyrrole : A five-membered monocyclic heteroarene comprising one NH and four CH units which forms the parent compound of the pyrrole group of compounds. Its five-membered ring structure has three tautomers. A 'closed class'.. azole : Any monocyclic heteroarene consisting of a five-membered ring containing nitrogen. Azoles can also contain one or more other non-carbon atoms, such as nitrogen, sulfur or oxygen.		5.4951pyrrole;
secondary amine
thiophenes
Thiophenes: A monocyclic heteroarene furan in which the oxygen atom is replaced by a sulfur.. thiophenes : Compounds containing at least one thiophene ring.		21.5451812mancude organic heteromonocyclic parent;
monocyclic heteroarene;
thiophenes;
volatile organic compound		non-polar solvent
methylergonovine
Methylergonovine: A homolog of ERGONOVINE containing one more CH2 group. (Merck Index, 11th ed)		2.0810ergoline alkaloid
quinazolines
Quinazolines: A group of aromatic heterocyclic compounds that contain a bicyclic structure with two fused six-membered aromatic rings, a benzene ring and a pyrimidine ring.. quinazoline : A mancude organic heterobicyclic parent that is naphthalene in which the carbon atoms at positions 1 and 3 have been replaced by nitrogen atoms.. quinazolines : Any organic heterobicyclic compound based on a quinazoline skeleton and its substituted derivatives.		3.9540azaarene;
mancude organic heterobicyclic parent;
ortho-fused heteroarene;
quinazolines
indazoles
Indazoles: A group of heterocyclic aromatic organic compounds consisting of the fusion of BENZENE and PYRAZOLES.		2.1510indazole
benzoxazoles
1,3-benzoxazole : A benzoxazole in which the benzene ring is fused to a 1,3-oxazole ring across positions 4 and 5.. benzoxazole : Compounds based on a fused 1,2- or 1,3-oxazole and benzene bicyclic ring skeleton.		2.07101,3-benzoxazoles;
mancude organic heterobicyclic parent
thiazoles
[no description available]		17.4728621,3-thiazoles;
mancude organic heteromonocyclic parent;
monocyclic heteroarene
pyrazines
Pyrazines: A heterocyclic aromatic organic compound with the chemical formula C4H4N2.. pyrazine : A diazine that is benzene in which the carbon atoms at positions 1 and 4 have been replaced by nitrogen atoms.		2.7630diazine;
pyrazines		Daphnia magna metabolite
azacitidine
Azacitidine: A pyrimidine analogue that inhibits DNA methyltransferase, impairing DNA methylation. It is also an antimetabolite of cytidine, incorporated primarily into RNA. Azacytidine has been used as an antineoplastic agent.. 5-azacytidine : An N-glycosyl-1,3,5-triazine that is 4-amino-1,3,5-triazin-2(1H)-one substituted by a beta-D-ribofuranosyl residue via an N-glycosidic linkage. An antineoplastic agent, it is used in the treatment of myeloid leukaemia.		2.0810N-glycosyl-1,3,5-triazine;
nucleoside analogue		antineoplastic agent
betamethasone
Betamethasone: A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724)		2.251011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		anti-asthmatic agent;
anti-inflammatory drug;
immunosuppressive agent
dihydroergotamine
Dihydroergotamine: A 9,10alpha-dihydro derivative of ERGOTAMINE. It is used as a vasoconstrictor, specifically for the therapy of MIGRAINE DISORDERS.. dihydroergotamine : Ergotamine in which a single bond replaces the double bond between positions 9 and 10. A semisynthetic ergot alkaloid with weaker oxytocic and vasoconstrictor properties than ergotamine, it is used (as the methanesulfonic or tartaric acid salts) for the treatment of migraine and orthostatic hypotension.		2.0810ergot alkaloid;
semisynthetic derivative		dopamine agonist;
non-narcotic analgesic;
serotonergic agonist;
sympatholytic agent;
vasoconstrictor agent
malondialdehyde
Malondialdehyde: The dialdehyde of malonic acid.. malonaldehyde : A dialdehyde that is propane substituted by two oxo groups at the terminal carbon atoms respectively. A biomarker of oxidative damage to lipids caused by smoking, it exists in vivo mainly in the enol form.		2.1310dialdehydebiomarker
gentian violet
Gentian Violet: A dye that is a mixture of violet rosanilinis with antibacterial, antifungal, and anthelmintic properties.. crystal violet : An organic chloride salt that is the monochloride salt of crystal violet cation. It has been used in creams for the topical treatment of bacterial and fungal infections, being effective against some Gram-positive bacteria (notably Staphylococcus species) and some pathogenic fungi (including Candida species) but use declined following reports of animal carcinogenicity. It has also been used for dying wood, silk, and paper, as well as a histological stain.		2.4110organic chloride saltanthelminthic drug;
antibacterial agent;
antifungal agent;
antiseptic drug;
histological dye
acetylcysteine
N-acetyl-L-cysteine : An N-acetyl-L-amino acid that is the N-acetylated derivative of the natural amino acid L-cysteine.		3.520acetylcysteine;
L-cysteine derivative;
N-acetyl-L-amino acid		antidote to paracetamol poisoning;
antiinfective agent;
antioxidant;
antiviral drug;
ferroptosis inhibitor;
geroprotector;
human metabolite;
mucolytic;
radical scavenger;
vulnerary
erythromycin
Erythromycin: A bacteriostatic antibiotic macrolide produced by Streptomyces erythreus. Erythromycin A is considered its major active component. In sensitive organisms, it inhibits protein synthesis by binding to 50S ribosomal subunits. This binding process inhibits peptidyl transferase activity and interferes with translocation of amino acids during translation and assembly of proteins.. erythromycin : Any of several wide-spectrum macrolide antibiotics obtained from actinomycete Saccharopolyspora erythraea (formerly known as Streptomyces erythraeus).. erythromycin A : An erythromycin that consists of erythronolide A having 2,6-dideoxy-3-C-methyl-3-O-methyl-alpha-L-ribo-hexopyranosyl and 3,4,6-trideoxy-3-(dimethylamino)-beta-D-xylo-hexopyranosyl residues attahced at positions 4 and 6 respectively.		2.0810cyclic ketone;
erythromycin
d-alpha tocopherol
Vitamin E: A generic descriptor for all TOCOPHEROLS and TOCOTRIENOLS that exhibit ALPHA-TOCOPHEROL activity. By virtue of the phenolic hydrogen on the 2H-1-benzopyran-6-ol nucleus, these compounds exhibit varying degree of antioxidant activity, depending on the site and number of methyl groups and the type of ISOPRENOIDS.. tocopherol : A collective name for a group of closely related lipids that contain a chroman-6-ol nucleus substituted at position 2 by a methyl group and by a saturated hydrocarbon chain consisting of three isoprenoid units. They are designated as alpha-, beta-, gamma-, and delta-tocopherol depending on the number and position of additional methyl substituents on the aromatic ring. Tocopherols occur in vegetable oils and vegetable oil products, almost exclusively with R,R,R configuration. Tocotrienols differ from tocopherols only in having three double bonds in the hydrocarbon chain.. vitamin E : Any member of a group of fat-soluble chromanols that exhibit biological activity against vitamin E deficiency. The vitamers in this class consists of a chroman-6-ol core which is substituted at position 2 by a methyl group and (also at position 2) either a saturated or a triply-unsaturated hydrocarbon chain consisting of three isoprenoid units. The major function of vitamin E is to act as a natural antioxidant by scavenging free radicals and molecular oxygen.. (R,R,R)-alpha-tocopherol : An alpha-tocopherol that has R,R,R configuration. The naturally occurring stereoisomer of alpha-tocopherol, it is found particularly in sunflower and olive oils.		2.1510alpha-tocopherolalgal metabolite;
antiatherogenic agent;
anticoagulant;
antioxidant;
antiviral agent;
EC 2.7.11.13 (protein kinase C) inhibitor;
immunomodulator;
micronutrient;
nutraceutical;
plant metabolite
pimozide
Pimozide: A diphenylbutylpiperidine that is effective as an antipsychotic agent and as an alternative to HALOPERIDOL for the suppression of vocal and motor tics in patients with Tourette syndrome. Although the precise mechanism of action is unknown, blockade of postsynaptic dopamine receptors has been postulated. (From AMA Drug Evaluations Annual, 1994, p403). pimozide : A member of the class of benzimidazoles that is 1,3-dihydro-2H-benzimidazol-2-one in which one of the nitrogens is substituted by a piperidin-4-yl group, which in turn is substituted on the nitrogen by a 4,4-bis(p-fluorophenyl)butyl group.		2.0810benzimidazoles;
heteroarylpiperidine;
organofluorine compound		antidyskinesia agent;
dopaminergic antagonist;
first generation antipsychotic;
H1-receptor antagonist;
serotonergic antagonist
gold
Gold: A yellow metallic element with the atomic symbol Au, atomic number 79, and atomic weight 197. It is used in jewelry, goldplating of other metals, as currency, and in dental restoration. Many of its clinical applications, such as ANTIRHEUMATIC AGENTS, are in the form of its salts.		2.4110copper group element atom;
elemental gold
camptothecin
NSC 100880: carboxylate (opened lactone) form of camptothecin; RN refers to (S)-isomer; structure given in first source		3.1910delta-lactone;
pyranoindolizinoquinoline;
quinoline alkaloid;
tertiary alcohol		antineoplastic agent;
EC 5.99.1.2 (DNA topoisomerase) inhibitor;
genotoxin;
plant metabolite
ferric chloride
ferric chloride: RN given refers to cpd with MF of Fe-Cl3; used to induce experimental arterial thrombosis to evaluate antithrombotic agents		2.3110iron coordination entityastringent;
Lewis acid
fluorine
Fluorine: A nonmetallic, diatomic gas that is a trace element and member of the halogen family. It is used in dentistry as fluoride (FLUORIDES) to prevent dental caries.		7.1510diatomic fluorine;
gas molecular entity		NMR chemical shift reference compound
4-nitrophenyl 4'-guanidinobenzoate
4-nitrophenyl 4'-guanidinobenzoate: kallikrein substrate; acrosin antagonist in sperm; serine esterase inhibitor; RN given refers to parent cpd; structure		2.1110
tramadol
Tramadol: A narcotic analgesic proposed for severe pain. It may be habituating.. tramadol : A racemate consisting of equal amounts of (R,R)- and (S,S)-tramadol. A centrally acting synthetic opioid analgesic, used (as the hydrochloride salt) to treat moderately severe pain. The (R,R)-enantiomer exhibits ten-fold higher analgesic potency than the (S,S)-enantiomer. Originally developed by Gruenenthal GmbH and launched in 1977, it was subsequently isolated from the root bark of the South African tree Nauclea latifolia.. (R,R)-tramadol : A 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol in which both stereocentres have R-configuration; the (R,R)-enantiomer of the racemic opioid analgesic tramadol, it exhibits ten-fold higher analgesic potency than the (S,S)-enantiomer.		9202-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanoladrenergic uptake inhibitor;
antitussive;
capsaicin receptor antagonist;
delta-opioid receptor agonist;
kappa-opioid receptor agonist;
metabolite;
mu-opioid receptor agonist;
muscarinic antagonist;
nicotinic antagonist;
NMDA receptor antagonist;
opioid analgesic;
serotonergic antagonist;
serotonin uptake inhibitor
vecuronium bromide
Vecuronium Bromide: Monoquaternary homolog of PANCURONIUM. A non-depolarizing neuromuscular blocking agent with shorter duration of action than pancuronium. Its lack of significant cardiovascular effects and lack of dependence on good kidney function for elimination as well as its short duration of action and easy reversibility provide advantages over, or alternatives to, other established neuromuscular blocking agents.. vecuronium bromide : The organic bromide salt of a 5alpha-androstane compound having 3alpha-acetoxy-, 17beta-acetoxy-, 2beta-piperidinino- and 16beta-N-methylpiperidinium substituents.		2.0810organic bromide salt;
quaternary ammonium salt		muscle relaxant;
neuromuscular agent;
nicotinic antagonist
simvastatin
Simvastatin: A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.. simvastatin : A member of the class of hexahydronaphthalenes that is lovastatin in which the 2-methylbutyrate ester moiety has been replaced by a 2,2-dimethylbutyrate ester group. It is used as a cholesterol-lowering and anti-cardiovascular disease drug.		2.8220delta-lactone;
fatty acid ester;
hexahydronaphthalenes;
statin (semi-synthetic)		EC 1.1.1.34/EC 1.1.1.88 (hydroxymethylglutaryl-CoA reductase) inhibitor;
EC 3.4.24.83 (anthrax lethal factor endopeptidase) inhibitor;
ferroptosis inducer;
geroprotector;
prodrug
atomoxetine hydrochloride
Atomoxetine Hydrochloride: A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.. atomoxetine hydrochloride : The hydrochloride salt of atomoxetine.		3.1810hydrochlorideadrenergic uptake inhibitor;
antidepressant
itraconazole
Itraconazole: A triazole antifungal agent that inhibits cytochrome P-450-dependent enzymes required for ERGOSTEROL synthesis.. itraconazole : An N-arylpiperazine that is cis-ketoconazole in which the imidazol-1-yl group is replaced by a 1,2,4-triazol-1-yl group and in which the actyl group attached to the piperazine moiety is replaced by a p-[(+-)1-sec-butyl-5-oxo-1,5-dihydro-4H-1,2,4-triazol-4-yl]phenyl group. A potent P-glycoprotein and CYP3A4 inhibitor, it is used as an antifungal drug for the treatment of various fungal infections, including aspergillosis, blastomycosis, candidiasis, chromoblastomycosis, coccidioidomycosis, cryptococcosis, histoplasmosis, and sporotrichosis.		4.0721aromatic ether;
conazole antifungal drug;
cyclic ketal;
dichlorobenzene;
dioxolane;
N-arylpiperazine;
triazole antifungal drug;
triazoles		EC 3.6.3.44 (xenobiotic-transporting ATPase) inhibitor;
Hedgehog signaling pathway inhibitor;
P450 inhibitor
ranolazine
Ranolazine: An acetanilide and piperazine derivative that functions as a SODIUM CHANNEL BLOCKER and prevents the release of enzymes during MYOCARDIAL ISCHEMIA. It is used in the treatment of ANGINA PECTORIS.. N-(2,6-dimethylphenyl)-2-{4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl}acetamide : An aromatic amide obtained by formal condensation of the carboxy group of 2-{4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl}acetic acid with the amino group of 2,6-dimethylaniline.. ranolazine : A racemate comprising equal amounts of (R)- and (S)-ranolazine. Used for treatment of chronic angina.		7.2110aromatic amide;
monocarboxylic acid amide;
monomethoxybenzene;
N-alkylpiperazine;
secondary alcohol
clopidogrel
Clopidogrel: A ticlopidine analog and platelet purinergic P2Y receptor antagonist that inhibits adenosine diphosphate-mediated PLATELET AGGREGATION. It is used to prevent THROMBOEMBOLISM in patients with ARTERIAL OCCLUSIVE DISEASES; MYOCARDIAL INFARCTION; STROKE; or ATRIAL FIBRILLATION.. clopidogrel : A thienopyridine that is 4,5,6,7-tetrahydrothieno[3,2-c]pyridine in which the hydrogen attached to the nitrogen is replaced by an o-chlorobenzyl group, the methylene hydrogen of which is replaced by a methoxycarbonyl group (the S enantiomer). A P2Y12 receptor antagonist, it is used to inhibit blood clots and prevent heart attacks.		16.066213methyl ester;
monochlorobenzenes;
thienopyridine		anticoagulant;
P2Y12 receptor antagonist;
platelet aggregation inhibitor
topotecan
Topotecan: An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.. topotecan : A pyranoindolizinoquinoline used as an antineoplastic agent. It is a derivative of camptothecin and works by binding to the topoisomerase I-DNA complex and preventing religation of these 328 single strand breaks.		2.0810pyranoindolizinoquinolineantineoplastic agent;
EC 5.99.1.2 (DNA topoisomerase) inhibitor
aripiprazole
Aripiprazole: A piperazine and quinolone derivative that is used primarily as an antipsychotic agent. It is a partial agonist of SEROTONIN RECEPTOR, 5-HT1A and DOPAMINE D2 RECEPTORS, where it also functions as a post-synaptic antagonist, and an antagonist of SEROTONIN RECEPTOR, 5-HT2A. It is used for the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER, and as an adjunct therapy for the treatment of depression.. aripiprazole : An N-arylpiperazine that is piperazine substituted by a 4-[(2-oxo-1,2,3,4-tetrahydroquinolin-7-yl)oxy]butyl group at position 1 and by a 2,3-dichlorophenyl group at position 4. It is an antipsychotic drug used for the treatment of Schizophrenia, and other mood disorders.		2.0810aromatic ether;
delta-lactam;
dichlorobenzene;
N-alkylpiperazine;
N-arylpiperazine;
quinolone		drug metabolite;
H1-receptor antagonist;
second generation antipsychotic;
serotonergic agonist
atorvastatin
[no description available]		4.4941aromatic amide;
dihydroxy monocarboxylic acid;
monofluorobenzenes;
pyrroles;
statin (synthetic)		environmental contaminant;
xenobiotic
irinotecan
[no description available]		9.1640carbamate ester;
delta-lactone;
N-acylpiperidine;
pyranoindolizinoquinoline;
ring assembly;
tertiary alcohol;
tertiary amino compound		antineoplastic agent;
apoptosis inducer;
EC 5.99.1.2 (DNA topoisomerase) inhibitor;
prodrug
valsartan
Valsartan: A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION.. valsartan : A monocarboxylic acid amide consisting of L-valine in which the amino hydrogens have been replaced by a pentanoyl and a [2'-(1H-tetrazol-5-yl)biphenyl]-4-yl]methyl group. It exhibits antihypertensive activity.		2.3110biphenylyltetrazole;
monocarboxylic acid amide;
monocarboxylic acid		angiotensin receptor antagonist;
antihypertensive agent;
environmental contaminant;
xenobiotic
tirofiban
Tirofiban: Tyrosine analog and PLATELET GLYCOPROTEIN GPIIB-IIIA COMPLEX antagonist that inhibits PLATELET AGGREGATION and is used in the treatment of ACUTE CORONARY SYNDROME.. tirofiban : A member of the class of piperidines that is L-tyrosine in which a hydrogen attached to the amino group is replaced by a butylsulfonyl group and in which the hydrogen attached to the phenolic hydroxy group is replaced by a 4-(piperidin-4-yl)butyl group.		2.4820L-tyrosine derivative;
piperidines;
sulfonamide		anticoagulant;
fibrin modulating drug;
platelet glycoprotein-IIb/IIIa receptor antagonist
adenosine
quinquefolan B: isolated from roots of Panax quinquefolium L.; RN not in Chemline 10/87; RN from Toxlit		9.9193adenosines;
purines D-ribonucleoside		analgesic;
anti-arrhythmia drug;
fundamental metabolite;
human metabolite;
vasodilator agent
oseltamivir
Oseltamivir: An acetamido cyclohexene that is a structural homolog of SIALIC ACID and inhibits NEURAMINIDASE.. oseltamivir : A cyclohexenecarboxylate ester that is the ethyl ester of oseltamivir acid. An antiviral prodrug (it is hydrolysed to the active free carboxylic acid in the liver), it is used to slow the spread of influenza.		3.6320acetamides;
amino acid ester;
cyclohexenecarboxylate ester;
primary amino compound		antiviral drug;
EC 3.2.1.18 (exo-alpha-sialidase) inhibitor;
environmental contaminant;
prodrug;
xenobiotic
25-hydroxycholesterol
[no description available]		7.411025-hydroxy steroid;
oxysterol		human metabolite
iopamidol
Iopamidol: A non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiological procedures.. iopamidol : A benzenedicarboxamide compound having N-substituted carbamoyl groups at the 1- and 3-positions, iodo substituents at the 2-, 4- and 6-positions and a (2S)-2-hydroxypropanamido group at the 5-position.		2.0810benzenedicarboxamide;
organoiodine compound;
pentol		environmental contaminant;
radioopaque medium;
xenobiotic
telmisartan
Telmisartan: A biphenyl compound and benzimidazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION.. telmisartan : A member of the class of benzimidazoles used widely in the treatment of hypertension.		2.5320benzimidazoles;
biphenyls;
carboxybiphenyl		angiotensin receptor antagonist;
antihypertensive agent;
EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor;
environmental contaminant;
xenobiotic
talinolol
[no description available]		3.7120ureas
fluindione
fluindione: structure		2.5420cyclic ketone;
indanones
tocophersolan
tocophersolan: RN given refers to parent cpd		2.1510tocol
tosyllysine chloromethyl ketone
Tosyllysine Chloromethyl Ketone: An inhibitor of SERINE ENDOPEPTIDASES. Acts as an alkylating agent and is known to interfere with the translation process.		2.1110sulfonic acid derivative
indicine
indicine: RN given refers to (1R-(1alpha,7(2R*,3S*),7abeta))-isomer		3.5110carboxylic ester;
pyrrolizines
clarithromycin
Clarithromycin: A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit PROTEIN SYNTHESIS in BACTERIA by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation.. clarithromycin : The 6-O-methyl ether of erythromycin A, clarithromycin is a macrolide antibiotic used in the treatment of respiratory-tract, skin and soft-tissue infections. It is also used to eradicate Helicobacter pylori in the treatment of peptic ulcer disease. It prevents bacteria from growing by interfering with their protein synthesis.		5.3762macrolide antibioticantibacterial drug;
environmental contaminant;
protein synthesis inhibitor;
xenobiotic
fibrinogen
Fibrinogen: Plasma glycoprotein clotted by thrombin, composed of a dimer of three non-identical pairs of polypeptide chains (alpha, beta, gamma) held together by disulfide bonds. Fibrinogen clotting is a sol-gel change involving complex molecular arrangements: whereas fibrinogen is cleaved by thrombin to form polypeptides A and B, the proteolytic action of other enzymes yields different fibrinogen degradation products.. D-iditol : The D-enantiomer of iditol.		5.42170iditolfungal metabolite
mci 9038
[no description available]		8.21241peptide
lopinavir
[no description available]		7.5520amphetamines;
dicarboxylic acid diamide		anticoronaviral agent;
antiviral drug;
HIV protease inhibitor
indobufen
indobufen: thromboxane A2 antagonist		2.1710isoindoles
fingolimod hydrochloride
Fingolimod Hydrochloride: A sphingosine-derivative and IMMUNOSUPPRESSIVE AGENT that blocks the migration and homing of LYMPHOCYTES to the CENTRAL NERVOUS SYSTEM through its action on SPHINGOSINE 1-PHOSPHATE RECEPTORS. It is used in the treatment of MULTIPLE SCLEROSIS.. fingolimod hydrochloride : The hydrochloride salt of 2-amino-2-[2-(4-octylphenyl) ethyl]-1,3-propanediol (fingolimod).		2.4720hydrochlorideimmunosuppressive agent;
prodrug;
sphingosine-1-phosphate receptor agonist
imatinib mesylate
imatinib methanesulfonate : A methanesulfonate (mesylate) salt that is the monomesylate salt of imatinib. Used for treatment of chronic myelogenous leukemia and gastrointestinal stromal tumours.		2.6920methanesulfonate saltanticoronaviral agent;
antineoplastic agent;
apoptosis inducer;
tyrosine kinase inhibitor
h-d-phe-pip-arg-pna
S 2238: chromogenic substrate for thrombin; used in amidolytic assay; patterned after N-terminal portion of A alpha chain of fibrinogen; synonym S-2238 refers to di-HCl		2.1110
dihydroethidium
dihydroethidium: RN given is for the (+-)-isomer		2.0710
ulipristal acetate
RTI 3021-012: progesterone receptor antagonist. ulipristal acetate : A 20-oxo steroid obtained by acetylation of the 17-hydroxy group of (11beta,17alpha)-17-acetyl-11-[4-(dimethylamino)phenyl]-3-oxoestra-4,9-dien-17-ol (ulipristal). A selective progesterone receptor modulator, which is employed as an emergency contraceptive.		2.061020-oxo steroid;
3-oxo-Delta(4) steroid;
acetate ester;
steroid ester;
tertiary amino compound		contraceptive drug;
progesterone receptor modulator;
progestin
umifenovir
umifenovir: an antiviral agent		2.3110indolyl carboxylic acid
thrombin receptor peptide sfllrnp
thrombin receptor peptide SFLLRNP: a synthetic peptide that induces early events of T cell activation and synergizes with TCR cross-linking for CD69 expression & interleukin-2 production; thrombin receptor agonist; do not confuse with TRAP peptide		2.1510
levofloxacin
Levofloxacin: The L-isomer of Ofloxacin.. levofloxacin : An optically active form of ofloxacin having (S)-configuration; an inhibitor of bacterial topoisomerase IV and DNA gyrase.		2.08109-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid;
fluoroquinolone antibiotic;
quinolone antibiotic		antibacterial drug;
DNA synthesis inhibitor;
EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor;
topoisomerase IV inhibitor
biotin
vitamin B7 : Any member of a group of vitamers that belong to the chemical structural class called biotins that exhibit biological activity against vitamin B7 deficiency. Vitamin B7 deficiency is very rare in individuals who take a normal balanced diet. Foods rich in biotin are egg yolk, liver, cereals, vegetables (spinach, mushrooms) and rice. Symptoms associated with vitamin B7 deficiency include thinning hair, scaly skin rashes around eyes, nose and mouth, and brittle nails. The vitamers include biotin and its ionized and salt forms.		5.1840biotins;
vitamin B7		coenzyme;
cofactor;
Escherichia coli metabolite;
fundamental metabolite;
human metabolite;
mouse metabolite;
nutraceutical;
prosthetic group;
Saccharomyces cerevisiae metabolite
angiotensin ii
Giapreza: injectable form of angiotensin II used to increase blood pressure in adult patients with septic or other distributive shock. Ile(5)-angiotensin II : An angiotensin II that acts on the central nervous system (PDB entry: 1N9V).		2.6120amino acid zwitterion;
angiotensin II		human metabolite
atropine
tropan-3alpha-yl 3-hydroxy-2-phenylpropanoate : A tropane alkaloid that is (1R,5)-8-methyl-8-azabicyclo[3.2.1]octane substituted by a (3-hydroxy-2-phenylpropanoyl)oxy group at position 3.		2.2510
melagatran
[no description available]		4.7650azetidines;
carboxamidine;
dicarboxylic acid monoamide;
non-proteinogenic alpha-amino acid;
secondary amino compound		anticoagulant;
EC 3.4.21.5 (thrombin) inhibitor;
serine protease inhibitor
dronedarone
Dronedarone: A non-iodinated derivative of amiodarone that is used for the treatment of ARRHYTHMIA.. dronedarone : A member of the class of 1-benzofurans used for the treatment of cardiac arrhythmias.		7.711401-benzofurans;
aromatic ether;
aromatic ketone;
sulfonamide;
tertiary amino compound		anti-arrhythmia drug;
environmental contaminant;
xenobiotic
darunavir
Darunavir: An HIV PROTEASE INHIBITOR that is used in the treatment of AIDS and HIV INFECTIONS. Due to the emergence of ANTIVIRAL DRUG RESISTANCE when used alone, it is administered in combination with other ANTI-HIV AGENTS.. darunavir : An N,N-disubstituted benzenesulfonamide bearing an unsubstituted amino group at the 4-position, used for the treatment of HIV infection. A second-generation HIV protease inhibitor, darunavir was designed to form robust interactions with the protease enzyme from many strains of HIV, including those from treatment-experienced patients with multiple resistance mutations to other protease inhibitors.		2.6120carbamate ester;
furofuran;
sulfonamide		antiviral drug;
HIV protease inhibitor
cortisone
[no description available]		2.081011-oxo steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		human metabolite;
mouse metabolite
noscapine
Noscapine: A naturally occurring opium alkaloid that is a centrally acting antitussive agent.. (-)-noscapine : A benzylisoquinoline alkaloid that is 1,2,3,4-tetrahydroisoquinoline which is substituted by a 4,5-dimethoxy-3-oxo-1,3-dihydro-2-benzofuran-1-yl group at position 1, a methylenedioxy group at positions 6-7 and a methoxy group at position 8. Obtained from plants of the Papaveraceae family, it lacks significant painkilling properties and is primarily used for its antitussive (cough-suppressing) effects.		2.0810aromatic ether;
benzylisoquinoline alkaloid;
cyclic acetal;
isobenzofuranone;
organic heterobicyclic compound;
organic heterotricyclic compound;
tertiary amino compound		antineoplastic agent;
antitussive;
apoptosis inducer;
plant metabolite
ritonavir
Ritonavir: An HIV protease inhibitor that works by interfering with the reproductive cycle of HIV. It also inhibits CYTOCHROME P-450 CYP3A.. ritonavir : An L-valine derivative that is L-valinamide in which alpha-amino group has been acylated by a [(2-isopropyl-1,3-thiazol-4-yl)methyl]methylcarbamoyl group and in which a hydrogen of the carboxamide amino group has been replaced by a (2R,4S,5S)-4-hydroxy-1,6-diphenyl-5-{[(1,3-thiazol-5-ylmethoxy)carbonyl]amino}hexan-2-yl group. A CYP3A inhibitor and antiretroviral drug from the protease inhibitor class used to treat HIV infection and AIDS, it is often used as a fixed-dose combination with another protease inhibitor, lopinavir. Also used in combination with dasabuvir sodium hydrate, ombitasvir and paritaprevir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver.		7.01821,3-thiazoles;
carbamate ester;
carboxamide;
L-valine derivative;
ureas		antiviral drug;
environmental contaminant;
HIV protease inhibitor;
xenobiotic
fibrin
Fibrin: A protein derived from FIBRINOGEN in the presence of THROMBIN, which forms part of the blood clot.		7.67161peptide
quinidine
Quinidine: An optical isomer of quinine, extracted from the bark of the CHINCHONA tree and similar plant species. This alkaloid dampens the excitability of cardiac and skeletal muscles by blocking sodium and potassium currents across cellular membranes. It prolongs cellular ACTION POTENTIALS, and decreases automaticity. Quinidine also blocks muscarinic and alpha-adrenergic neurotransmission.. quinidine : A cinchona alkaloid consisting of cinchonine with the hydrogen at the 6-position of the quinoline ring substituted by methoxy.		8.4260cinchona alkaloidalpha-adrenergic antagonist;
anti-arrhythmia drug;
antimalarial;
drug allergen;
EC 1.14.13.181 (13-deoxydaunorubicin hydroxylase) inhibitor;
EC 3.6.3.44 (xenobiotic-transporting ATPase) inhibitor;
muscarinic antagonist;
P450 inhibitor;
potassium channel blocker;
sodium channel blocker
arachidonic acid
icosa-5,8,11,14-tetraenoic acid : Any icosatetraenoic acid with the double bonds at positions 5, 8, 11 and 14.. arachidonate : A long-chain fatty acid anion resulting from the removal of a proton from the carboxy group of arachidonic acid.		2.8730icosa-5,8,11,14-tetraenoic acid;
long-chain fatty acid;
omega-6 fatty acid		Daphnia galeata metabolite;
EC 3.1.1.1 (carboxylesterase) inhibitor;
human metabolite;
mouse metabolite
tacrolimus
Tacrolimus: A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.. tacrolimus (anhydrous) : A macrolide lactam containing a 23-membered lactone ring, originally isolated from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis.		2.1110macrolide lactambacterial metabolite;
immunosuppressive agent
ferulic acid
ferulate : A monocarboxylic acid anion obtained by the deprotonation of the carboxy group of ferulic acid.		3.5110ferulic acidsanti-inflammatory agent;
antioxidant;
apoptosis inhibitor;
cardioprotective agent;
MALDI matrix material;
plant metabolite
cerivastatin
cerivastatin: cerivastatin is the ((E)-(+))-isomer; structure given in first source. cerivastatin : (3R,5S)-3,5-dihydroxyhept-6-enoic acid in which the (7E)-hydrogen is substituted by a 4-(4-fluorophenyl)-2,6-diisopropyl-5-(methoxymethyl)pyridin-3-yl group. Formerly used (as its sodium salt) to lower cholesterol and prevent cardiovascular disease, it was withdrawn from the market worldwide in 2001 following reports of a severe form of muscle toxicity.		2.0410dihydroxy monocarboxylic acid;
pyridines;
statin (synthetic)
cocaine
Cocaine: An alkaloid ester extracted from the leaves of plants including coca. It is a local anesthetic and vasoconstrictor and is clinically used for that purpose, particularly in the eye, ear, nose, and throat. It also has powerful central nervous system effects similar to the amphetamines and is a drug of abuse. Cocaine, like amphetamines, acts by multiple mechanisms on brain catecholaminergic neurons; the mechanism of its reinforcing effects is thought to involve inhibition of dopamine uptake.. cocaine : A tropane alkaloid obtained from leaves of the South American shrub Erythroxylon coca.		2.5320benzoate ester;
methyl ester;
tertiary amino compound;
tropane alkaloid		adrenergic uptake inhibitor;
central nervous system stimulant;
dopamine uptake inhibitor;
environmental contaminant;
local anaesthetic;
mouse metabolite;
plant metabolite;
serotonin uptake inhibitor;
sodium channel blocker;
sympathomimetic agent;
vasoconstrictor agent;
xenobiotic
zithromax
Azithromycin: A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.. azithromycin : A macrolide antibiotic useful for the treatment of bacterial infections.		2.6920macrolide antibioticantibacterial drug;
environmental contaminant;
xenobiotic
eptifibatide
[no description available]		2.4110homodetic cyclic peptide;
macrocycle;
organic disulfide		anticoagulant;
platelet aggregation inhibitor
imidazolidines
[no description available]		3.1910azacycloalkane;
imidazolidines;
saturated organic heteromonocyclic parent
s 1033
[no description available]		2.2110(trifluoromethyl)benzenes;
imidazoles;
pyridines;
pyrimidines;
secondary amino compound;
secondary carboxamide		anticoronaviral agent;
antineoplastic agent;
tyrosine kinase inhibitor
leuprolide
Leuprolide: A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.. leuprolide : An oligopeptide comprising pyroglutamyl, histidyl, tryptophyl, seryl, tyrosyl, D-leucyl, leucyl, arginyl, and N-ethylprolinamide residues joined in sequence. It is a synthetic nonapeptide analogue of gonadotropin-releasing hormone, and is used as a subcutaneous hydrogel implant (particularly as the acetate salt) for the treatment of prostate cancer and for the suppression of gonadal sex hormone production in children with central precocious puberty.		2.0710oligopeptideanti-estrogen;
antineoplastic agent;
gonadotropin releasing hormone agonist
urb 597
cyclohexyl carbamic acid 3'-carbamoylbiphenyl-3-yl ester: a fatty acid amide hydrolase inhibitor; structure in first source		2.2510biphenyls
thioacetamide
Thioacetamide: A crystalline compound used as a laboratory reagent in place of HYDROGEN SULFIDE. It is a potent hepatocarcinogen.. thioacetamide : A thiocarboxamide consiting of acetamide having the oxygen replaced by sulfur.		7.2110thiocarboxamidehepatotoxic agent
digoxin
Digoxin: A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666). digoxin : A cardenolide glycoside that is digitoxin beta-hydroxylated at C-12. A cardiac glycoside extracted from the foxglove plant, Digitalis lanata, it is used to control ventricular rate in atrial fibrillation and in the management of congestive heart failure with atrial fibrillation, but the margin between toxic and therapeutic doses is small.		7.6991cardenolide glycoside;
steroid saponin		anti-arrhythmia drug;
cardiotonic drug;
EC 3.6.3.9 (Na(+)/K(+)-transporting ATPase) inhibitor;
epitope
nadp
[no description available]		2.610
maraviroc
[no description available]		2.0810tropane alkaloid
dasatinib
N-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-yl)amino)-1,3-thiazole-5-carboxamide: a dasatinib prodrug; structure in first source. dasatinib (anhydrous) : An aminopyrimidine that is 2-methylpyrimidine which is substituted at position 4 by the primary amino group of 2-amino-1,3-thiazole-5-carboxylic acid and at position 6 by a 4-(2-hydroxyethyl)piperazin-1-yl group, and in which the carboxylic acid group has been formally condensed with 2-chloro-6-methylaniline to afford the corresponding amide. A multi-targeted kinase inhibitor, it is used, particularly as the monohydrate, for the treatment of chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia. Note that the name 'dasatinib' is used to refer to the monohydrate (USAN) as well as to anhydrous dasatinib (INN).		2.21101,3-thiazoles;
aminopyrimidine;
monocarboxylic acid amide;
N-(2-hydroxyethyl)piperazine;
N-arylpiperazine;
organochlorine compound;
secondary amino compound;
tertiary amino compound		anticoronaviral agent;
antineoplastic agent;
tyrosine kinase inhibitor
zd 6474
CH 331: structure in first source		2.0710aromatic ether;
organobromine compound;
organofluorine compound;
piperidines;
quinazolines;
secondary amine		antineoplastic agent;
tyrosine kinase inhibitor
sanorg 34006
idraparinux: a synthetic analogue of the pentasaccharide sequence in heparins		7.49160
ovalbumin
Ovalbumin: An albumin obtained from the white of eggs. It is a member of the serpin superfamily.		2.2510
sphingosine
sphing-4-enine : A sphingenine in which the C=C double bond is located at the 4-position.. sphingenine : A 2-aminooctadecene-1,3-diol having (2S,3R)-configuration.. sphingoid : Sphinganine, its homologs and stereoisomers, and the hydroxy and unsaturated derivatives of these compounds.. 2-aminooctadec-4-ene-1,3-diol : A 2-aminooctadecene-1,3-diol having its double bond at position 4.		2.4720sphing-4-eninehuman metabolite;
mouse metabolite
vitamin k semiquinone radical
vitamin K semiquinone radical: found in active preparations of vitamin K-dependent carboxylase. vitamin K : Any member of a group of fat-soluble 2-methyl-1,4-napthoquinones that exhibit biological activity against vitamin K deficiency. Vitamin K is required for the synthesis of prothrombin and certain other blood coagulation factors.		19.342909
azaleatin
azaleatin : A monomethoxyflavone that is quercetin in which the hydroxy group at position 5 is replaced by a methoxy group.		3.51107-hydroxyflavonol;
monomethoxyflavone;
tetrahydroxyflavone		plant metabolite
rhamnetin
rhamnetin: aglycone of xanthorhamnin; from Rhamnus. rhamnetin : A monomethoxyflavone that is quercetin methylated at position 7.		3.5110monomethoxyflavone;
tetrahydroxyflavone		anti-inflammatory agent;
antioxidant;
metabolite
ozagrel
ozagrel: RN refers to (E)-isomer		3.5110cinnamic acids
fondaparinux
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.. 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.		10.74400amino sugar;
oligosaccharide sulfate;
pentasaccharide derivative		anticoagulant
20-hydroxy-5,8,11,14-eicosatetraenoic acid
20-hydroxy-5,8,11,14-eicosatetraenoic acid: stimulator of renal sodium, potassium atpase; RN given is for the (all-Z) isomer. 20-HETE : A HETE that consists of arachidonic acid bearing a hydroxy substituent at position 20.		2.3110HETE;
hydroxy monocarboxylic acid		human metabolite;
mouse metabolite
levetiracetam
Levetiracetam: A pyrrolidinone and acetamide derivative that is used primarily for the treatment of SEIZURES and some movement disorders, and as a nootropic agent.. levetiracetam : A pyrrolidinone and carboxamide that is N-methylpyrrolidin-2-one in which one of the methyl hydrogens is replaced by an aminocarbonyl group, while another is replaced by an ethyl group (the S enantiomer). An anticonvulsant, it is used for the treatment of epilepsy in both human and veterinary medicine.		2.610pyrrolidin-2-onesanticonvulsant;
environmental contaminant;
xenobiotic
vitamin k 1
Vitamin K 1: A family of phylloquinones that contains a ring of 2-methyl-1,4-naphthoquinone and an isoprenoid side chain. Members of this group of vitamin K 1 have only one double bond on the proximal isoprene unit. Rich sources of vitamin K 1 include green plants, algae, and photosynthetic bacteria. Vitamin K1 has antihemorrhagic and prothrombogenic activity.. phylloquinone : A member of the class of phylloquinones that consists of 1,4-naphthoquinone having methyl and phytyl groups at positions 2 and 3 respectively. The parent of the class of phylloquinones.		2.4920phylloquinones;
vitamin K		cofactor;
human metabolite;
plant metabolite
deamino arginine vasopressin
Deamino Arginine Vasopressin: A synthetic analog of the pituitary hormone, ARGININE VASOPRESSIN. Its action is mediated by the VASOPRESSIN receptor V2. It has prolonged antidiuretic activity, but little pressor effects. It also modulates levels of circulating FACTOR VIII and VON WILLEBRAND FACTOR.		2.2110heterodetic cyclic peptidediagnostic agent;
renal agent;
vasopressin receptor agonist
fluticasone
Fluticasone: A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.. fluticasone : A trifluorinated corticosteroid used in the form of its propionate ester for treatment of allergic rhinitis.		2.251011beta-hydroxy steroid;
17alpha-hydroxy steroid;
3-oxo-Delta(4) steroid;
corticosteroid;
fluorinated steroid;
thioester		anti-allergic agent;
anti-asthmatic drug
methyl ferulate
methyl ferulate: inhibits LDL oxidation; isolated from Chrysanthemum coronarium; structure in first source. trans-methylferulate : A cinnamate ester that is the methyl ester of ferulic acid. It has been isolated from Pisonia aculeata.		7.0810cinnamate ester;
guaiacols;
methyl ester		plant metabolite
indinavir sulfate
Indinavir: A potent and specific HIV protease inhibitor that appears to have good oral bioavailability.		2.0810dicarboxylic acid diamide;
N-(2-hydroxyethyl)piperazine;
piperazinecarboxamide		HIV protease inhibitor
enalapril
Enalapril: An angiotensin-converting enzyme inhibitor that is used to treat HYPERTENSION and HEART FAILURE.. enalapril : A dicarboxylic acid monoester that is ethyl 4-phenylbutanoate in which a hydrogen alpha to the carboxy group is substituted by the amino group of L-alanyl-L-proline (S-configuration).		2.5520dicarboxylic acid monoester;
dipeptide		antihypertensive agent;
EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor;
geroprotector;
prodrug
fumarates
Fumarates: Compounds based on fumaric acid.. fumarate(2-) : A C4-dicarboxylate that is the E-isomer of but-2-enedioate(2-)		3.6220butenedioate;
C4-dicarboxylate		human metabolite;
metabolite;
Saccharomyces cerevisiae metabolite
imidapril
imidapril: structure given in first source. imidapril : A member of the class of imidazolidines that is (4S)-1-methyl-2-oxoimidazolidine-4-carboxylic acid in which the hydrogen of the imidazolidine nitrogen has been substituted by (1S)-1-{[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino}ethyl group. It is the prodrug for imidaprilat, an ACE inhibitor used for the treatment of chronic heart failure.		3.1910dicarboxylic acid monoester;
dipeptide;
ethyl ester;
imidazolidines;
N-acylurea;
secondary amino compound		antihypertensive agent;
EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor;
prodrug
ximelagatran
ximelagatran: prodrug (via hydroxylation) of melagatran & a direct thrombin inhibitor; liver toxicity concerns so AZD0837 being developed to replace this. ximelagatran : A member of the class of azetidines that is melagatran in which the carboxylic acid group has been converted to the corresponding ethyl ester and in which the amidine group has been converted into the corresponding amidoxime. A prodrug for melagatran, ximelagatran was the first orally available direct thrombin inhibitor to be brought to market as an anticoagulant, but was withdrawn in 2006 following reports of it causing liver damage.		8.78300amidoxime;
azetidines;
carboxamide;
ethyl ester;
hydroxylamines;
secondary amino compound;
secondary carboxamide;
tertiary carboxamide		anticoagulant;
EC 3.4.21.5 (thrombin) inhibitor;
prodrug;
serine protease inhibitor
aliskiren
aliskiren: orally active nonpeptidic renin inhibitor. aliskiren : A monomethoxybenzene compound having a 3-methoxypropoxy group at the 2-position and a multi-substituted branched alkyl substituent at the 4-position.		3.6220monocarboxylic acid amide;
monomethoxybenzene		antihypertensive agent
famotidine
[no description available]		2.08101,3-thiazoles;
guanidines;
sulfonamide		anti-ulcer drug;
H2-receptor antagonist;
P450 inhibitor
axitinib
[no description available]		2.4110aryl sulfide;
benzamides;
indazoles;
pyridines		antineoplastic agent;
tyrosine kinase inhibitor;
vascular endothelial growth factor receptor antagonist
rilpivirine
[no description available]		2.1310aminopyrimidine;
nitrile		EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor;
HIV-1 reverse transcriptase inhibitor
glucuronyl glucosamine glycan sulfate
[no description available]		3.6920
chlorhexidine
Chlorhexidine: A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.. chlorhexidine : A bisbiguanide compound with a structure consisting of two (p-chlorophenyl)guanide units linked by a hexamethylene bridge.		2.0810biguanides;
monochlorobenzenes		antibacterial agent;
antiinfective agent
bms-262084
BMS-262084: an azetidinone-based tryptase inhibitor; structure in first source		2.0510
ym 60828
YM 60828: YM-466 is the mesylate salt		3.5110
rwj-56110
RWJ-56110: a PAR-1 antagonist; structure in first source		2.1510
ticagrelor
Ticagrelor: An adenosine triphosphate analogue and reversible P2Y12 PURINORECEPTOR antagonist that inhibits ADP-mediated PLATELET AGGREGATION. It is used for the prevention of THROMBOEMBOLISM by patients with ACUTE CORONARY SYNDROME or a history of MYOCARDIAL INFARCTION.. ticagrelor : A triazolopyrimidine that is an adenosine isostere; the cyclopentane ring is similar to ribose and the nitrogen-rich [1,2,3]triazolo[4,5-d]pyrimidine moiety resembles the nucleobase adenine. A platelet aggregation inhibitor which is used for prevention of thromboembolic events in patients with acute coronary syndrome.		12.62310aryl sulfide;
hydroxyether;
organofluorine compound;
secondary amino compound;
triazolopyrimidines		P2Y12 receptor antagonist;
platelet aggregation inhibitor
rivaroxaban
Rivaroxaban: A morpholine and thiophene derivative that functions as a FACTOR XA INHIBITOR and is used in the treatment and prevention of DEEP-VEIN THROMBOSIS and PULMONARY EMBOLISM. It is also used for the prevention of STROKE and systemic embolization in patients with non-valvular ATRIAL FIBRILLATION, and for the prevention of atherothrombotic events in patients after an ACUTE CORONARY SYNDROME.. rivaroxaban : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 5-chlorothiophene-2-carboxylic acid with the amino group of 4-{4-[(5S)-5-(aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one. An anticoagulant used for prophylaxis of venous thromboembolism in patients with knee or hip replacement surgery.		25.841,60254aromatic amide;
lactam;
monocarboxylic acid amide;
morpholines;
organochlorine compound;
oxazolidinone;
thiophenes		anticoagulant;
EC 3.4.21.6 (coagulation factor Xa) inhibitor
l 374087
[no description available]		3.2710
darexaban
[no description available]		4.7330
cay 10499
[no description available]		2.2510carbamate ester
vernakalant
vernakalant: an antiarrhythmic agent and mixed ion channel blocker		4.730alcohol;
phenols
ly517717
LY517717: an oral anticoagulant		3.1410
azd 0837
AZD 0837: anticoagulant prodrug of AR-H067637		4.7230
vorapaxar
vorapaxar: has antiplatelet activity; structure in first source. vorapaxar : A carbamate ester that is the ethyl ester of [(1R,3aR,4aR,6R,8aR,9S,9aS)-9-{(E)-2-[5-(3-fluorophenyl)pyridin-2-yl]ethynyl}-1-methyl-3-oxododecahydronaphtho[2,3-c]furan-6-yl]carbamic acid. A protease-activated receptor-1 antagonist used (as its sulfate salt) for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease. It has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke and urgent coronary revascularisation.		3.6120carbamate ester;
lactone;
naphthofuran;
organofluorine compound;
pyridines		cardiovascular drug;
platelet aggregation inhibitor;
protease-activated receptor-1 antagonist
prasugrel hydrochloride
Prasugrel Hydrochloride: A piperazine derivative and PLATELET AGGREGATION INHIBITOR that is used to prevent THROMBOSIS in patients with ACUTE CORONARY SYNDROME; UNSTABLE ANGINA and MYOCARDIAL INFARCTION, as well as in those undergoing PERCUTANEOUS CORONARY INTERVENTIONS.. prasugrel hydrochloride : A racemate comprising equal amounts of (R)- and (S)-prasugrel hydrochloride. Used to prevent blood clots in people with acute coronary syndrome who are undergoing a procedure after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels.		7.3390
apixaban
[no description available]		23.861,01326aromatic ether;
lactam;
piperidones;
pyrazolopyridine		anticoagulant;
EC 3.4.21.6 (coagulation factor Xa) inhibitor
betrixaban
betrixaban: a highly potent, selective, and orally efficacious factor Xa inhibitor; structure in first source. betrixaban : A secondary carboxamide obtained by formal condensation of the carboxy group of 4-(N,N-dimethylcarbamimidoyl)benzoic acid with the amino group of 2-amino-N-(5-chloropyridin-2-yl)-5-methoxybenzamide. A synthetic anticoagulant compound that targets activated factor Xa in the coagulation cascade.		6.84110benzamides;
guanidines;
monochloropyridine;
monomethoxybenzene;
secondary carboxamide		anticoagulant;
EC 3.4.21.6 (coagulation factor Xa) inhibitor
edoxaban
edoxaban : A monocarboxylic acid amide that is used (as its tosylate monohydrate) for the treatment of deep vein thrombosis and pulmonary embolism.		17.593072chloropyridine;
monocarboxylic acid amide;
tertiary amino compound;
thiazolopyridine		anticoagulant;
EC 3.4.21.6 (coagulation factor Xa) inhibitor;
platelet aggregation inhibitor
alpha-synuclein
alpha-Synuclein: A synuclein that is a major component of LEWY BODIES and plays a role in SYNUCLEINOPATHIES, neurodegeneration and neuroprotection.		2.1710
e 5555
E 5555: a 2-iminopyridine derivative and platelet aggregation inhibitor		3.1910aromatic ketone
sitagliptin phosphate
Sitagliptin Phosphate: A pyrazine-derived DIPEPTIDYL-PEPTIDASE IV INHIBITOR and HYPOGLYCEMIC AGENT that increases the levels of the INCRETIN hormones GLUCAGON-LIKE PEPTIDE-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It is used in the treatment of TYPE 2 DIABETES.		2.1710
crizotinib
Crizotinib: A piperidine and aminopyridine derivative that acts as an inhibitor of RECEPTOR PROTEIN-TYROSINE KINASES, including ANAPLASTIC LYMPHOMA KINASE (ALK) and HEPATOCYTE GROWTH FACTOR RECEPTOR (HGFR; c-Met). It is used in the treatment of NON-SMALL CELL LUNG CANCER.. crizotinib : A 3-[1-(2,6-dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)pyrazol-4-yl]pyridin-2-amine that has R configuration at the chiral centre. The active enantiomer, it acts as a kinase inhibitor and is used for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)		2.41103-[1-(2,6-dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)pyrazol-4-yl]pyridin-2-amineantineoplastic agent;
biomarker;
EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor
mdv 3100
[no description available]		3.2510(trifluoromethyl)benzenes;
benzamides;
imidazolidinone;
monofluorobenzenes;
nitrile;
thiocarbonyl compound		androgen antagonist;
antineoplastic agent
cgp 39393
desirudin: recombinant hirudin; has identical amino acid sequence as the natural hirudin variant 1 but lacks the sulphate group on Tyr(63). desirudin : A heterodetic cyclic peptide composed of 65 amino acids joined in sequence and cyclised by three disulfide bridges between cysteine residues 6-14, 16-28 and 22-39. It is a highly specific inhibitor of thrombin and used as an anticoagulant in patients to prevent venous thromboembolism. Its amino acid sequence differs from natural hirudin by lack of sulfate group on Tyr-63.		3.1410
bivalirudin
bivalirudin: designed to bind to the alpha-thrombin catalytic site and anion-binding exosite for fibrin(ogen) recognition. bivalirudin : A synthetic peptide of 20 amino acids, comprising D-Phe, Pro, Arg, Pro, Gly, Gly, Gly, Gly, Asn, Gly, Asp, Phe, Glu, Glu, Ile, Pro, Glu, Glu, Tyr, and Leu in sequence. A congener of hirudin (a naturally occurring drug found in the saliva of the medicinal leech), it a specific and reversible inhibitor of thrombin, and is used as an anticoagulant.		6.26110polypeptideanticoagulant;
EC 3.4.21.5 (thrombin) inhibitor
idrabiotaparinux
idrabiotaparinux: a biotinylated form of idraparinux with anticoagulant properties		5.1840
ristocetin
Ristocetin: An antibiotic mixture of two components, A and B, obtained from Nocardia lurida (or the same substance produced by any other means). It is no longer used clinically because of its toxicity. It causes platelet agglutination and blood coagulation and is used to assay those functions in vitro.. ristocetin : A heterodetic cyclic peptide that is produced by species of Amycolatopsis and Nocardia.		2.2110glycopeptide;
heterodetic cyclic peptide;
macrocycle;
tetrasaccharide derivative		antibacterial drug;
antimicrobial agent;
bacterial metabolite;
platelet-activating factor receptor agonist
pci 32765
ibrutinib: a Btk protein inhibitor. ibrutinib : A member of the class of acrylamides that is (3R)-3-[4-amino-3-(4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidine in which the piperidine nitrogen is replaced by an acryloyl group. A selective and covalent inhibitor of the enzyme Bruton's tyrosine kinase, it is used for treatment of B-cell malignancies.		2.9330acrylamides;
aromatic amine;
aromatic ether;
N-acylpiperidine;
pyrazolopyrimidine;
tertiary carboxamide		antineoplastic agent;
EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor
cardiovascular agents
Cardiovascular Agents: Agents that affect the rate or intensity of cardiac contraction, blood vessel diameter, or blood volume.		2.0810
fibrinopeptide a
Fibrinopeptide A: Two small peptide chains removed from the N-terminal segment of the alpha chains of fibrinogen by the action of thrombin during the blood coagulation process. Each peptide chain contains 18 amino acid residues. In vivo, fibrinopeptide A is used as a marker to determine the rate of conversion of fibrinogen to fibrin by thrombin.		2.1510
cobicistat
[no description available]		6.96531,3-thiazoles;
carbamate ester;
monocarboxylic acid amide;
morpholines;
ureas		P450 inhibitor
emd1214063
tepotinib: MET inhibitor		2.610
plx4032
[no description available]		2.610aromatic ketone;
difluorobenzene;
monochlorobenzenes;
pyrrolopyridine;
sulfonamide		antineoplastic agent;
B-Raf inhibitor
piperidines
Piperidines: A family of hexahydropyridines.		3.0840
natriuretic peptide, brain
Natriuretic Peptide, Brain: A PEPTIDE that is secreted by the BRAIN and the HEART ATRIA, stored mainly in cardiac ventricular MYOCARDIUM. It can cause NATRIURESIS; DIURESIS; VASODILATION; and inhibits secretion of RENIN and ALDOSTERONE. It improves heart function. It contains 32 AMINO ACIDS.		5.1631polypeptide
dicumarol
Dicumarol: An oral anticoagulant that interferes with the metabolism of vitamin K. It is also used in biochemical experiments as an inhibitor of reductases.		2.1710hydroxycoumarinanticoagulant;
EC 1.6.5.2 [NAD(P)H dehydrogenase (quinone)] inhibitor;
Hsp90 inhibitor;
vitamin K antagonist
acenocoumarol
Acenocoumarol: A coumarin that is used as an anticoagulant. Its actions and uses are similar to those of WARFARIN. (From Martindale, The Extra Pharmacopoeia, 30th ed, p233). acenocoumarol : A hydroxycoumarin that is warfarin in which the hydrogen at position 4 of the phenyl substituent is replaced by a nitro group.		7.42191C-nitro compound;
hydroxycoumarin;
methyl ketone		anticoagulant;
EC 1.6.5.2 [NAD(P)H dehydrogenase (quinone)] inhibitor
warfarin
Warfarin: An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.. warfarin : A racemate comprising equal amounts of (R)- and (S)-warfarin. Extensively used as both an anticoagulant drug and as a pesticide against rats and mice.. 4-hydroxy-3-(3-oxo-1-phenylbutyl)-1-benzopyran-2-one : A member of the class of coumarins that is 4-hydroxycoumarin which is substituted at position 3 by a 1-phenyl-3-oxo-1-butyl group.		26.441,174156benzenes;
hydroxycoumarin;
methyl ketone
phenprocoumon
Phenprocoumon: Coumarin derivative that acts as a long acting oral anticoagulant.. phenprocoumon : A hydroxycoumarin that is 4-hydroxycoumarin which is substituted at position 3 by a 1-phenylpropyl group.		11.26235hydroxycoumarinanticoagulant;
EC 1.6.5.2 [NAD(P)H dehydrogenase (quinone)] inhibitor
ati 5923
tecarfarin: a vitamin K epoxide reductase inhibitor; structure in first source		3.1710
kaolinite
Kaolin: The most common mineral of a group of hydrated aluminum silicates, approximately H2Al2Si2O8-H2O. It is prepared for pharmaceutical and medicinal purposes by levigating with water to remove sand, etc. (From Merck Index, 11th ed) The name is derived from Kao-ling (Chinese: high ridge), the original site. (From Grant & Hackh's Chemical Dictionary, 5th ed). kaolin : An aluminosilicate soft white mineral named after the hill in China (Kao-ling) from which it was mined for centuries. In its natural state kaolin is a white, soft powder consisting principally of the mineral kaolinite, and varying amounts of other minerals such as muscovite, quartz, feldspar, and anatase. It is used in the manufacture of china and porcelain and also widely used in the production of paper, rubber, paint, drying agents, and many other products.		2.8930aluminosilicate mineral;
mixture		antidiarrhoeal drug;
excipient
transforming growth factor beta
Transforming Growth Factor beta: A factor synthesized in a wide variety of tissues. It acts synergistically with TGF-alpha in inducing phenotypic transformation and can also act as a negative autocrine growth factor. TGF-beta has a potential role in embryonal development, cellular differentiation, hormone secretion, and immune function. TGF-beta is found mostly as homodimer forms of separate gene products TGF-beta1, TGF-beta2 or TGF-beta3. Heterodimers composed of TGF-beta1 and 2 (TGF-beta1.2) or of TGF-beta2 and 3 (TGF-beta2.3) have been isolated. The TGF-beta proteins are synthesized as precursor proteins.		2.9630
per977
PER977: a factor Xa inhibitor; structure in first source		9.22181
hirudin
Hirudin: A 65-residue polypeptide from LEECHES.		6.66140
cyclin d1
Cyclin D1: Protein encoded by the bcl-1 gene which plays a critical role in regulating the cell cycle. Overexpression of cyclin D1 is the result of bcl-1 rearrangement, a t(11;14) translocation, and is implicated in various neoplasms.		2.1310
contraceptives, postcoital
Contraceptives, Postcoital: Contraceptive substances to be used after COITUS. These agents include high doses of estrogenic drugs; progesterone-receptor blockers; ANTIMETABOLITES; ALKALOIDS, and PROSTAGLANDINS.		2.0610
daptomycin
[no description available]		2.1110
refludan
lepirudin : A heterodetic cyclic peptide composed of 65 amino acids joined in sequence and cyclised by three disulfide bridges between cysteine residues 6-14, 16-28 and 22-39. It is a highly specific inhibitor of thrombin and used as an anticoagulant in patients with heparin-induced thrombocytopenia.		3.8830
cyclosporine
Cyclosporine: A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).		3.511
factor f430
factor F430: low mol wt nickel-containing cpd from Methanobacterium. coenzyme F430 : A nickel tetrapyrrole found only in methanogenic Archaea. It is the prosthetic group of the enzyme methyl coenzyme M reductase which catalyses the release of methane in the final step of methanogenesis.		2.2110
thromboplastin
Thromboplastin: Constituent composed of protein and phospholipid that is widely distributed in many tissues. It serves as a cofactor with factor VIIa to activate factor X in the extrinsic pathway of blood coagulation.		4.97130
exudates
Malaysia: A parliamentary democracy with a constitutional monarch in southeast Asia, consisting of 11 states (West Malaysia) on the Malay Peninsula and two states (East Malaysia) on the island of BORNEO. It is also called the Federation of Malaysia. Its capital is Kuala Lumpur. Before 1963 it was the Union of Malaya. It reorganized in 1948 as the Federation of Malaya, becoming independent from British Malaya in 1957 and becoming Malaysia in 1963 as a federation of Malaya, Sabah, Sarawak, and Singapore (which seceded in 1965). The form Malay- probably derives from the Tamil malay, mountain, with reference to its geography. (From Webster's New Geographical Dictionary, 1988, p715 & Room, Brewer's Dictionary of Names, 1992, p329)		3.0740
angiogenin
angiogenin: human tumor protein which stimulates growth of blood vessels; contains 123 amino acids; member of the pancreatic ribonuclease superfamily; MW 14,400		2.2510
levoleucovorin
Levoleucovorin: A folate analog consisting of the pharmacologically active isomer of LEUCOVORIN.. (6S)-5-formyltetrahydrofolic acid : The pharmacologically active (6S)-stereoisomer of 5-formyltetrahydrofolic acid.		2.08105-formyltetrahydrofolic acidantineoplastic agent;
metabolite
rifampin
Rifampin: A semisynthetic antibiotic produced from Streptomyces mediterranei. It has a broad antibacterial spectrum, including activity against several forms of Mycobacterium. In susceptible organisms it inhibits DNA-dependent RNA polymerase activity by forming a stable complex with the enzyme. It thus suppresses the initiation of RNA synthesis. Rifampin is bactericidal, and acts on both intracellular and extracellular organisms. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p1160)		4.7832cyclic ketal;
hydrazone;
N-iminopiperazine;
N-methylpiperazine;
rifamycins;
semisynthetic derivative;
zwitterion		angiogenesis inhibitor;
antiamoebic agent;
antineoplastic agent;
antitubercular agent;
DNA synthesis inhibitor;
EC 2.7.7.6 (RNA polymerase) inhibitor;
Escherichia coli metabolite;
geroprotector;
leprostatic drug;
neuroprotective agent;
pregnane X receptor agonist;
protein synthesis inhibitor
trypsinogen
Trypsinogen: The inactive proenzyme of trypsin secreted by the pancreas, activated in the duodenum via cleavage by enteropeptidase. (Stedman, 25th ed)		2.4110
ConditionIndicatedRelationship StrengthStudiesTrials
Deep Vein Thrombosis
[description not available]		017.1613813
Venous Thrombosis
The formation or presence of a blood clot (THROMBUS) within a vein.		017.1613813
Blood Clot
[description not available]		020.322234
Thrombosis
Formation and development of a thrombus or blood clot in the blood vessel.		020.322234
Thromboembolism
Obstruction of a blood vessel (embolism) by a blood clot (THROMBUS) in the blood stream.		124.2636959
Congenital Zika Syndrome
[description not available]		02.2510
Disease Models, Animal
Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.		09.15580
Zika Virus Infection
A viral disease transmitted by the bite of AEDES mosquitoes infected with ZIKA VIRUS. Its mild DENGUE-like symptoms include fever, rash, headaches and ARTHRALGIA. The viral infection during pregnancy, in rare cases, is associated with congenital brain and ocular abnormalities, called Congenital Zika Syndrome, including MICROCEPHALY and may also lead to GUILLAIN-BARRE SYNDROME.		02.2510
Acute Ischemic Stroke
[description not available]		011.93402
Bleeding
[description not available]		029.571,657645
Ischemic Stroke
Stroke due to BRAIN ISCHEMIA resulting in interruption or reduction of blood flow to a part of the brain. When obstruction is due to a BLOOD CLOT formed within in a cerebral blood vessel it is a thrombotic stroke. When obstruction is formed elsewhere and moved to block a cerebral blood vessel (see CEREBRAL EMBOLISM) it is referred to as embolic stroke. Wake-up stroke refers to ischemic stroke occurring during sleep while cryptogenic stroke refers to ischemic stroke of unknown origin.		113.93402
Hemorrhage
Bleeding or escape of blood from a vessel.		131.571,657645
Thromboembolism, Venous
[description not available]		024.52498108
Auricular Fibrillation
[description not available]		030.412,482667
Hematochezia
The passage of bright red blood from the rectum. The blood may or may not be mixed with formed stool in the form of blood, blood clots, bloody stool or diarrhea.		016.141733
Benign Neoplasms
[description not available]		09.47440
Atrial Fibrillation
Abnormal cardiac rhythm that is characterized by rapid, uncoordinated firing of electrical impulses in the upper chambers of the heart (HEART ATRIA). In such case, blood cannot be effectively pumped into the lower chambers of the heart (HEART VENTRICLES). It is caused by abnormal impulse generation.		132.412,482667
Gastrointestinal Hemorrhage
Bleeding in any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM.		016.141733
Neoplasms
New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.		09.47440
Venous Thromboembolism
Obstruction of a vein or VEINS (embolism) by a blood clot (THROMBUS) in the blood stream.		126.52498108
Anterior Circulation Transient Ischemic Attack
[description not available]		014.365210
Ischemic Attack, Transient
Brief reversible episodes of focal, nonconvulsive ischemic dysfunction of the brain having a duration of less than 24 hours, and usually less than one hour, caused by transient thrombotic or embolic blood vessel occlusion or stenosis. Events may be classified by arterial distribution, temporal pattern, or etiology (e.g., embolic vs. thrombotic). (From Adams et al., Principles of Neurology, 6th ed, pp814-6)		014.365210
Apoplexy
[description not available]		029.681,860599
Stroke
A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)		131.681,860599
Morbid Obesity
[description not available]		04.3660
Obesity, Morbid
The condition of weighing two, three, or more times the ideal weight, so called because it is associated with many serious and life-threatening disorders. In the BODY MASS INDEX, morbid obesity is defined as having a BMI greater than 40.0 kg/m2.		04.3660
Hypercoagulability
[description not available]		019.41565
6th Nerve Palsy
[description not available]		02.3110
Pachymeningitis
[description not available]		02.3110
IgG4 Related Systemic Disease
[description not available]		02.3110
Lateral Sinus Thrombophlebitis
[description not available]		02.3110
Immunoglobulin G4-Related Disease
A spectrum of systemic autoimmune diseases in which IMMUNOGLOBULIN G4 plays a pathophysiologic role. It can affect multiple organs in highly variable presentations, characterized by inflammatory lesions composed of IgG4-positive PLASMA CELLS, further infiltrated by T helper cells (T-LYMPHOCYTES, HELPER-INDUCER) when linked to progressive FIBROSIS and eventual organ damage.		02.3110
Mastoiditis
Inflammation of the honeycomb-like MASTOID BONE in the skull just behind the ear. It is usually a complication of OTITIS MEDIA.		02.3110
Meningitis
Inflammation of the coverings of the brain and/or spinal cord, which consist of the PIA MATER; ARACHNOID; and DURA MATER. Infections (viral, bacterial, and fungal) are the most common causes of this condition, but subarachnoid hemorrhage (HEMORRHAGES, SUBARACHNOID), chemical irritation (chemical MENINGITIS), granulomatous conditions, neoplastic conditions (CARCINOMATOUS MENINGITIS), and other inflammatory conditions may produce this syndrome. (From Joynt, Clinical Neurology, 1994, Ch24, p6)		02.3110
Thrombophilia
A disorder of HEMOSTASIS in which there is a tendency for the occurrence of THROMBOSIS.		014.41565
Blood Pressure, High
[description not available]		010.43282
Hypertension
Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.		010.43282
Blood Loss, Postoperative
[description not available]		013.79556
Complication, Postoperative
[description not available]		017.3912222
Postoperative Complications
Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery.		017.3912222
Digestive System Disorders
[description not available]		02.3110
Digestive System Diseases
Diseases in any part of the GASTROINTESTINAL TRACT or the accessory organs (LIVER; BILIARY TRACT; PANCREAS).		02.3110
Ulcer
A lesion on the surface of the skin or a mucous surface, produced by the sloughing of inflammatory necrotic tissue.		03.3960
2019 Novel Coronavirus Disease
[description not available]		08.78134
Recrudescence
[description not available]		018.449450
Cardio-embolic Stroke
[description not available]		08.7585
Necrosis
The death of cells in an organ or tissue due to disease, injury or failure of the blood supply.		04.2860
Thrombopenia
[description not available]		07.26180
Thrombocytopenia
A subnormal level of BLOOD PLATELETS.		07.26180
Cardiac Failure
[description not available]		010.28401
Heart Failure
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.		010.28401
Kidney Diseases
Pathological processes of the KIDNEY or its component tissues.		012.32414
Drug Overdose
Accidental or deliberate use of a medication or street drug in excess of normal dosage.		09.46330
Acute Coronary Syndrome
An episode of MYOCARDIAL ISCHEMIA that generally lasts longer than a transient anginal episode that ultimately may lead to MYOCARDIAL INFARCTION.		013.48525
Cardiomyopathies, Primary
[description not available]		02.4110
Amyloidosis
A group of sporadic, familial and/or inherited, degenerative, and infectious disease processes, linked by the common theme of abnormal protein folding and deposition of AMYLOID. As the amyloid deposits enlarge they displace normal tissue structures, causing disruption of function. Various signs and symptoms depend on the location and size of the deposits.		02.4110
Cardiomyopathies
A group of diseases in which the dominant feature is the involvement of the CARDIAC MUSCLE itself. Cardiomyopathies are classified according to their predominant pathophysiological features (DILATED CARDIOMYOPATHY; HYPERTROPHIC CARDIOMYOPATHY; RESTRICTIVE CARDIOMYOPATHY) or their etiological/pathological factors (CARDIOMYOPATHY, ALCOHOLIC; ENDOCARDIAL FIBROELASTOSIS).		02.4110
Embolus
[description not available]		025.59599470
Cardiovascular Stroke
[description not available]		024.99559465
Diabetes Mellitus
A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.		011.1207
Embolism
Blocking of a blood vessel by an embolus which can be a blood clot or other undissolved material in the blood stream.		025.59599470
Myocardial Infarction
NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).		024.99559465
Emergencies
Situations or conditions requiring immediate intervention to avoid serious adverse results.		016.93381
Coagulation Disorders, Blood
[description not available]		09.61280
Blood Coagulation Disorders
Hemorrhagic and thrombotic disorders that occur as a consequence of abnormalities in blood coagulation due to a variety of factors such as COAGULATION PROTEIN DISORDERS; BLOOD PLATELET DISORDERS; BLOOD PROTEIN DISORDERS or nutritional conditions.		09.61280
Acute Kidney Failure
[description not available]		013.23400
Hematuria
Presence of blood in the urine.		05.0780
Interstitial Nephritis
[description not available]		02.4110
Nephritis, Interstitial
Inflammation of the interstitial tissue of the kidney. This term is generally used for primary inflammation of KIDNEY TUBULES and/or surrounding interstitium. For primary inflammation of glomerular interstitium, see GLOMERULONEPHRITIS. Infiltration of the inflammatory cells into the interstitial compartment results in EDEMA, increased spaces between the tubules, and tubular renal dysfunction.		02.4110
Acute Kidney Injury
Abrupt reduction in kidney function. Acute kidney injury encompasses the entire spectrum of the syndrome including acute kidney failure; ACUTE KIDNEY TUBULAR NECROSIS; and other less severe conditions.		08.23400
B16 Melanoma
[description not available]		02.4110
HIV Coinfection
[description not available]		03.1140
HIV Infections
Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).		03.1140
Chronic Kidney Diseases
[description not available]		013.85713
Renal Insufficiency, Chronic
Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)		013.85713
Amentia
[description not available]		07.16121
Dementia
An acquired organic mental disorder with loss of intellectual abilities of sufficient severity to interfere with social or occupational functioning. The dysfunction is multifaceted and involves memory, behavior, personality, judgment, attention, spatial relations, language, abstract thought, and other executive functions. The intellectual decline is usually progressive, and initially spares the level of consciousness.		012.16121
Shingles
[description not available]		02.5420
Herpes Zoster
An acute infectious, usually self-limited, disease believed to represent activation of latent varicella-zoster virus (HERPESVIRUS 3, HUMAN) in those who have been rendered partially immune after a previous attack of CHICKENPOX. It involves the SENSORY GANGLIA and their areas of innervation and is characterized by severe neuralgic pain along the distribution of the affected nerve and crops of clustered vesicles over the area. (From Dorland, 27th ed)		07.5420
Patent Foramen Ovale
[description not available]		05.6322
Foramen Ovale, Patent
A condition in which the FORAMEN OVALE in the ATRIAL SEPTUM fails to close shortly after birth. This results in abnormal communications between the two upper chambers of the heart. An isolated patent ovale foramen without other structural heart defects is usually of no hemodynamic significance.		05.6322
Brain Hemorrhage
[description not available]		017.2913411
Adverse Drug Event
[description not available]		010.4264
Intracranial Hemorrhages
Bleeding within the SKULL, including hemorrhages in the brain and the three membranes of MENINGES. The escape of blood often leads to the formation of HEMATOMA in the cranial epidural, subdural, and subarachnoid spaces.		017.2913411
Drug-Related Side Effects and Adverse Reactions
Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.		010.4264
Mitral Stenosis
[description not available]		05.1831
Mitral Valve Stenosis
Narrowing of the passage through the MITRAL VALVE due to FIBROSIS, and CALCINOSIS in the leaflets and chordal areas. This elevates the left atrial pressure which, in turn, raises pulmonary venous and capillary pressure leading to bouts of DYSPNEA and TACHYCARDIA during physical exertion. RHEUMATIC FEVER is its primary cause.		05.1831
Obesity
A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY).		013.52211
Abdominal Injuries
General or unspecified injuries involving organs in the abdominal cavity.		02.8830
Esophageal Diseases
Pathological processes in the ESOPHAGUS.		03.2350
Ischemia
A hypoperfusion of the BLOOD through an organ or tissue caused by a PATHOLOGIC CONSTRICTION or obstruction of its BLOOD VESSELS, or an absence of BLOOD CIRCULATION.		05.64110
Nasal Bleeding
[description not available]		05.85120
Epistaxis
Bleeding from the nose.		05.85120
Craniocerebral Injuries
[description not available]		05.7261
Craniocerebral Trauma
Traumatic injuries involving the cranium and intracranial structures (i.e., BRAIN; CRANIAL NERVES; MENINGES; and other structures). Injuries may be classified by whether or not the skull is penetrated (i.e., penetrating vs. nonpenetrating) or whether there is an associated hemorrhage.		05.7261
Aortic Diseases
Pathological processes involving any part of the AORTA.		03.0540
Brain Hemorrhage, Cerebral
[description not available]		013.8712
Cerebral Hemorrhage
Bleeding into one or both CEREBRAL HEMISPHERES including the BASAL GANGLIA and the CEREBRAL CORTEX. It is often associated with HYPERTENSION and CRANIOCEREBRAL TRAUMA.		013.8712
Chronic Liver Failure
[description not available]		03.560
Hepatocellular Carcinoma
[description not available]		02.7220
Cancer of Liver
[description not available]		02.8830
Budd-Chiari Syndrome
A condition in which the hepatic venous outflow is obstructed anywhere from the small HEPATIC VEINS to the junction of the INFERIOR VENA CAVA and the RIGHT ATRIUM. Usually the blockage is extrahepatic and caused by blood clots (THROMBUS) or fibrous webs. Parenchymal FIBROSIS is uncommon.		07.9830
Carcinoma, Hepatocellular
A primary malignant neoplasm of epithelial liver cells. It ranges from a well-differentiated tumor with EPITHELIAL CELLS indistinguishable from normal HEPATOCYTES to a poorly differentiated neoplasm. The cells may be uniform or markedly pleomorphic, or form GIANT CELLS. Several classification schemes have been suggested.		02.7220
Liver Neoplasms
Tumors or cancer of the LIVER.		02.8830
End Stage Liver Disease
Final stage of a liver disease when the liver failure is irreversible and LIVER TRANSPLANTATION is needed.		03.560
Heart Valve Diseases
Pathological conditions involving any of the various HEART VALVES and the associated structures (PAPILLARY MUSCLES and CHORDAE TENDINEAE).		08.51162
Atherogenesis
[description not available]		09.83200
Atherosclerosis
A thickening and loss of elasticity of the walls of ARTERIES that occurs with formation of ATHEROSCLEROTIC PLAQUES within the ARTERIAL INTIMA.		09.83200
Leg Ulcer
Ulceration of the skin and underlying structures of the lower extremity. About 90% of the cases are due to venous insufficiency (VARICOSE ULCER), 5% to arterial disease, and the remaining 5% to other causes.		02.5720
Muscular Weakness
[description not available]		02.4110
Rhabdomyolysis
Necrosis or disintegration of skeletal muscle often followed by myoglobinuria.		07.6920
Muscle Weakness
A vague complaint of debility, fatigue, or exhaustion attributable to weakness of various muscles. The weakness can be characterized as subacute or chronic, often progressive, and is a manifestation of many muscle and neuromuscular diseases. (From Wyngaarden et al., Cecil Textbook of Medicine, 19th ed, p2251)		02.4110
Brain Emboli
[description not available]		014.173312
Anterior Choroidal Artery Infarction
[description not available]		08.93121
Cerebral Infarction
The formation of an area of NECROSIS in the CEREBRUM caused by an insufficiency of arterial or venous blood flow. Infarcts of the cerebrum are generally classified by hemisphere (i.e., left vs. right), lobe (e.g., frontal lobe infarction), arterial distribution (e.g., INFARCTION, ANTERIOR CEREBRAL ARTERY), and etiology (e.g., embolic infarction).		08.93121
Embolism, Pulmonary
[description not available]		015.711146
Pulmonary Embolism
Blocking of the PULMONARY ARTERY or one of its branches by an EMBOLUS.		015.711146
Cardiac Tamponade
Compression of the heart by accumulated fluid (PERICARDIAL EFFUSION) or blood (HEMOPERICARDIUM) in the PERICARDIUM surrounding the heart. The affected cardiac functions and CARDIAC OUTPUT can range from minimal to total hemodynamic collapse.		05.0271
Cerebral Ischemia
[description not available]		015.910211
Brain Ischemia
Localized reduction of blood flow to brain tissue due to arterial obstruction or systemic hypoperfusion. This frequently occurs in conjunction with brain hypoxia (HYPOXIA, BRAIN). Prolonged ischemia is associated with BRAIN INFARCTION.		015.910211
Choroid Neovascularization
[description not available]		02.4110
Wet Macular Degeneration
A form of RETINAL DEGENERATION in which abnormal CHOROIDAL NEOVASCULARIZATION occurs under the RETINA and MACULA LUTEA, causing bleeding and leaking of fluid. This leads to bulging and or lifting of the macula and the distortion or destruction of central vision.		02.4110
Overweight
A status with BODY WEIGHT that is above certain standards. In the scale of BODY MASS INDEX, overweight is defined as having a BMI of 25.0-29.9 kg/m2. Overweight may or may not be due to increases in body fat (ADIPOSE TISSUE), hence overweight does not equal over fat.		08.6420
Apnea, Obstructive Sleep
[description not available]		03.6420
Anoxemia
[description not available]		02.4110
Hypoxia
Sub-optimal OXYGEN levels in the ambient air of living organisms.		02.4110
Sleep Apnea, Obstructive
A disorder characterized by recurrent apneas during sleep despite persistent respiratory efforts. It is due to upper airway obstruction. The respiratory pauses may induce HYPERCAPNIA or HYPOXIA. Cardiac arrhythmias and elevation of systemic and pulmonary arterial pressures may occur. Frequent partial arousals occur throughout sleep, resulting in relative SLEEP DEPRIVATION and daytime tiredness. Associated conditions include OBESITY; ACROMEGALY; MYXEDEMA; micrognathia; MYOTONIC DYSTROPHY; adenotonsilar dystrophy; and NEUROMUSCULAR DISEASES. (From Adams et al., Principles of Neurology, 6th ed, p395)		03.6420
Anti-Phospholipid Antibody Syndrome
[description not available]		07.59151
Antiphospholipid Syndrome
The presence of antibodies directed against phospholipids (ANTIBODIES, ANTIPHOSPHOLIPID). The condition is associated with a variety of diseases, notably systemic lupus erythematosus and other connective tissue diseases, thrombopenia, and arterial or venous thromboses. In pregnancy it can cause abortion. Of the phospholipids, the cardiolipins show markedly elevated levels of anticardiolipin antibodies (ANTIBODIES, ANTICARDIOLIPIN). Present also are high levels of lupus anticoagulant (LUPUS COAGULATION INHIBITOR).		07.59151
Angiitis
[description not available]		02.4110
Vasculitis
Inflammation of any one of the blood vessels, including the ARTERIES; VEINS; and rest of the vasculature system in the body.		02.4110
Cardiac Diseases
[description not available]		012.29304
Heart Diseases
Pathological conditions involving the HEART including its structural and functional abnormalities.		012.29304
Acute Febrile Neutrophilic Dermatosis
[description not available]		02.4110
Body Weight
The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.		012.4392
Osteoporotic Fractures
Breaks in bones resulting from low bone mass and microarchitectural deterioration characteristic of OSTEOPOROSIS.		04.2150
Acute Edematous Pancreatitis
[description not available]		02.4110
Pancreatitis
INFLAMMATION of the PANCREAS. Pancreatitis is classified as acute unless there are computed tomographic or endoscopic retrograde cholangiopancreatographic findings of CHRONIC PANCREATITIS (International Symposium on Acute Pancreatitis, Atlanta, 1992). The two most common forms of acute pancreatitis are ALCOHOLIC PANCREATITIS and gallstone pancreatitis.		07.4110
Adjuvant Arthritis
[description not available]		02.4110
Rheumatoid Arthritis
[description not available]		07.6120
Arthritis, Rheumatoid
A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.		02.6120
Deficiency, Protein C
[description not available]		07.9664
Acute Disease
Disease having a short and relatively severe course.		015.476412
Cirrhosis, Liver
[description not available]		05.15150
Liver Cirrhosis
Liver disease in which the normal microcirculation, the gross vascular anatomy, and the hepatic architecture have been variably destroyed and altered with fibrous septa surrounding regenerated or regenerating parenchymal nodules.		05.15150
Ache
[description not available]		03.0120
Pain
An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.		08.0120
Vascular Malformations
A spectrum of congenital, inherited, or acquired abnormalities in BLOOD VESSELS that can adversely affect the normal blood flow in ARTERIES or VEINS. Most are congenital defects such as abnormal communications between blood vessels (fistula), shunting of arterial blood directly into veins bypassing the CAPILLARIES (arteriovenous malformations), formation of large dilated blood blood-filled vessels (cavernous angioma), and swollen capillaries (capillary telangiectases). In rare cases, vascular malformations can result from trauma or diseases.		03.3250
Aging
The gradual irreversible changes in structure and function of an organism that occur as a result of the passage of time.		05.93140
Diffuse Parenchymal Lung Disease
[description not available]		04.01100
Lung Diseases, Interstitial
A diverse group of lung diseases that affect the lung parenchyma. They are characterized by an initial inflammation of PULMONARY ALVEOLI that extends to the interstitium and beyond leading to diffuse PULMONARY FIBROSIS. Interstitial lung diseases are classified by their etiology (known or unknown causes), and radiological-pathological features.		04.01100
Breast Cancer
[description not available]		03.8790
Breast Neoplasms
Tumors or cancer of the human BREAST.		03.8790
Berger Disease
[description not available]		03.8430
Glomerulonephritis, IGA
A chronic form of glomerulonephritis characterized by deposits of predominantly IMMUNOGLOBULIN A in the mesangial area (GLOMERULAR MESANGIUM). Deposits of COMPLEMENT C3 and IMMUNOGLOBULIN G are also often found. Clinical features may progress from asymptomatic HEMATURIA to END-STAGE KIDNEY DISEASE.		03.8430
Dizzyness
[description not available]		02.610
Drop Attack
[description not available]		02.610
Dizziness
An imprecise term which may refer to a sense of spatial disorientation, motion of the environment, or lightheadedness.		02.610
Syncope
A transient loss of consciousness and postural tone caused by diminished blood flow to the brain (i.e., BRAIN ISCHEMIA). Presyncope refers to the sensation of lightheadedness and loss of strength that precedes a syncopal event or accompanies an incomplete syncope. (From Adams et al., Principles of Neurology, 6th ed, pp367-9)		02.610
Hemorrhagic Stroke
Stroke due to rupture of a weakened blood vessel in the brain (e.g., CEREBRAL HEMISPHERES; CEREBELLUM; SUBARACHNOID SPACE).		08.5210
Liver Dysfunction
[description not available]		07.13110
Liver Diseases
Pathological processes of the LIVER.		07.13110
Glaucoma
An ocular disease, occurring in many forms, having as its primary characteristics an unstable or a sustained increase in the intraocular pressure which the eye cannot withstand without damage to its structure or impairment of its function. The consequences of the increased pressure may be manifested in a variety of symptoms, depending upon type and severity, such as excavation of the optic disk, hardness of the eyeball, corneal anesthesia, reduced visual acuity, seeing of colored halos around lights, disturbed dark adaptation, visual field defects, and headaches. (Dictionary of Visual Science, 4th ed)		07.610
Intraocular Pressure
The pressure of the fluids in the eye.		07.7620
Innate Inflammatory Response
[description not available]		09.92220
Inflammation
A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.		09.92220
Local Neoplasm Recurrence
[description not available]		03.5210
Spider Veins
[description not available]		02.610
Telangiectasis
Permanent dilation of preexisting blood vessels (CAPILLARIES; ARTERIOLES; VENULES) creating small focal red lesions, most commonly in the skin or mucous membranes. It is characterized by the prominence of skin blood vessels, such as vascular spiders.		02.610
Heavy Menstrual Bleeding
[description not available]		02.9830
Menorrhagia
Excessive uterine bleeding during MENSTRUATION.		02.9830
Chylopericardium
[description not available]		03.2350
Pericardial Effusion
Fluid accumulation within the PERICARDIUM. Serous effusions are associated with pericardial diseases. Hemopericardium is associated with trauma. Lipid-containing effusion (chylopericardium) results from leakage of THORACIC DUCT. Severe cases can lead to CARDIAC TAMPONADE.		08.2350
Carcinoma, Non-Small Cell Lung
[description not available]		02.610
Cancer of Lung
[description not available]		02.8430
Carcinoma, Non-Small-Cell Lung
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.		02.610
Lung Neoplasms
Tumors or cancer of the LUNG.		02.8430
Bouillaud Disease
[description not available]		03.7730
Rheumatic Heart Disease
Cardiac manifestation of systemic rheumatological conditions, such as RHEUMATIC FEVER. Rheumatic heart disease can involve any part the heart, most often the HEART VALVES and the ENDOCARDIUM.		03.7730
Colorectal Cancer
[description not available]		02.610
Colorectal Neoplasms
Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.		02.610
Vascular Diseases
Pathological processes involving any of the BLOOD VESSELS in the cardiac or peripheral circulation. They include diseases of ARTERIES; VEINS; and rest of the vasculature system in the body.		03.140
Leanness
[description not available]		02.610
Chronic Kidney Failure
[description not available]		09.02191
Kidney Failure, Chronic
The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.		09.02191
Anemia
A reduction in the number of circulating ERYTHROCYTES or in the quantity of HEMOGLOBIN.		03.3660
Hemorrhage, Subarachnoid
[description not available]		03.2150
Subarachnoid Hemorrhage
Bleeding into the intracranial or spinal SUBARACHNOID SPACE, most resulting from INTRACRANIAL ANEURYSM rupture. It can occur after traumatic injuries (SUBARACHNOID HEMORRHAGE, TRAUMATIC). Clinical features include HEADACHE; NAUSEA; VOMITING, nuchal rigidity, variable neurological deficits and reduced mental status.		03.2150
Heart Disease, Ischemic
[description not available]		07.4391
Myocardial Ischemia
A disorder of cardiac function caused by insufficient blood flow to the muscle tissue of the heart. The decreased blood flow may be due to narrowing of the coronary arteries (CORONARY ARTERY DISEASE), to obstruction by a thrombus (CORONARY THROMBOSIS), or less commonly, to diffuse narrowing of arterioles and other small vessels within the heart. Severe interruption of the blood supply to the myocardial tissue may result in necrosis of cardiac muscle (MYOCARDIAL INFARCTION).		07.4391
Arteriosclerosis, Coronary
[description not available]		013.233112
Coronary Artery Disease
Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.		013.233112
Fasciitis, Necrotizing
A fulminating bacterial infection of the deep layers of the skin and FASCIA. It can be caused by many different organisms, with STREPTOCOCCUS PYOGENES being the most common.		02.2110
Endotoxin Shock
[description not available]		02.2110
Group A Strep Infection
[description not available]		02.2110
Shock, Septic
Sepsis associated with HYPOTENSION or hypoperfusion despite adequate fluid resuscitation. Perfusion abnormalities may include but are not limited to LACTIC ACIDOSIS; OLIGURIA; or acute alteration in mental status.		02.2110
Streptococcal Infections
Infections with bacteria of the genus STREPTOCOCCUS.		02.2110
Cranial Sinus Thrombosis
[description not available]		06.1251
Hereditary Hemorrhagic Telangiectasia
[description not available]		03.9220
Telangiectasia, Hereditary Hemorrhagic
An autosomal dominant vascular anomaly characterized by telangiectases of the skin and mucous membranes and by recurrent gastrointestinal bleeding. This disorder is caused by mutations of a gene (on chromosome 9q3) which encodes endoglin, a membrane glycoprotein that binds TRANSFORMING GROWTH FACTOR BETA.		03.9220
Catastrophic Illness
An acute or prolonged illness usually considered to be life-threatening or with the threat of serious residual disability. Treatment may be radical and is frequently costly.		02.2110
Hematoma
A collection of blood outside the BLOOD VESSELS. Hematoma can be localized in an organ, space, or tissue.		111.59213
Brain Thrombosis
[description not available]		011.541810
Acute Confusional Senile Dementia
[description not available]		04.78100
Alzheimer Disease
A degenerative disease of the BRAIN characterized by the insidious onset of DEMENTIA. Impairment of MEMORY, judgment, attention span, and problem solving skills are followed by severe APRAXIAS and a global loss of cognitive abilities. The condition primarily occurs after age 60, and is marked pathologically by severe cortical atrophy and the triad of SENILE PLAQUES; NEUROFIBRILLARY TANGLES; and NEUROPIL THREADS. (From Adams et al., Principles of Neurology, 6th ed, pp1049-57)		04.78100
Chronic Illness
[description not available]		05.22100
Chronic Disease
Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2).		05.22100
Sterility, Male
[description not available]		02.2110
48,XXYY Syndrome
[description not available]		02.2110
Infertility, Male
The inability of the male to effect FERTILIZATION of an OVUM after a specified period of unprotected intercourse. Male sterility is permanent infertility.		02.2110
Klinefelter Syndrome
A form of male HYPOGONADISM, characterized by the presence of an extra X CHROMOSOME, small TESTES, seminiferous tubule dysgenesis, elevated levels of GONADOTROPINS, low serum TESTOSTERONE, underdeveloped secondary sex characteristics, and male infertility (INFERTILITY, MALE). Patients tend to have long legs and a slim, tall stature. GYNECOMASTIA is present in many of the patients. The classic form has the karyotype 47,XXY. Several karyotype variants include 48,XXYY; 48,XXXY; 49,XXXXY, and mosaic patterns ( 46,XY/47,XXY; 47,XXY/48,XXXY, etc.).		02.2110
Kidney Failure
A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism.		014.884713
Renal Insufficiency
Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE.		121.884713
Blood Loss, Surgical
Loss of blood during a surgical procedure.		013.84426
Cognitive Decline
[description not available]		04.2431
Cognitive Dysfunction
Diminished or impaired mental and/or intellectual function.		04.2431
Degenerative Diseases, Central Nervous System
[description not available]		02.2110
Neurodegenerative Diseases
Hereditary and sporadic conditions which are characterized by progressive nervous system dysfunction. These disorders are often associated with atrophy of the affected central or peripheral nervous system structures.		02.2110
Abnormality, Heart
[description not available]		03.5520
Heart Defects, Congenital
Developmental abnormalities involving structures of the heart. These defects are present at birth but may be discovered later in life.		03.5520
Eye Hemorrhage
Intraocular hemorrhage from the vessels of various tissues of the eye.		04.6690
Cholera Infantum
[description not available]		05.4772
Injuries
Used with anatomic headings, animals, and sports for wounds and injuries. Excludes cell damage, for which pathology is used.		06.69130
Sensitivity and Specificity
Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)		012.68343
Wounds and Injuries
Damage inflicted on the body as the direct or indirect result of an external force, with or without disruption of structural continuity.		18.69130
Alloxan Diabetes
[description not available]		02.930
Diabetic Angiopathies
VASCULAR DISEASES that are associated with DIABETES MELLITUS.		02.2510
Bone Fractures
[description not available]		04.5850
Intertrochanteric Fractures
[description not available]		04.3260
Age-Related Osteoporosis
[description not available]		03.9440
Hip Fractures
Fractures of the FEMUR HEAD; the FEMUR NECK; (FEMORAL NECK FRACTURES); the trochanters; or the inter- or subtrochanteric region. Excludes fractures of the acetabulum and fractures of the femoral shaft below the subtrochanteric region (FEMORAL FRACTURES).		04.3260
Osteoporosis
Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.		03.9440
Fractures, Bone
Breaks in bones.		04.5850
Dysarthosis
[description not available]		02.2110
Brachial Paresis
[description not available]		03.0340
Diabetes Mellitus, Adult-Onset
[description not available]		06.0491
Diabetes Mellitus, Type 2
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.		06.0491
Breathlessness
[description not available]		03.6580
Lassitude
[description not available]		02.2110
Pyrexia
[description not available]		02.2110
Cough
A sudden, audible expulsion of air from the lungs through a partially closed glottis, preceded by inhalation. It is a protective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions, or to prevent aspiration of foreign materials into the lungs.		02.2110
Dyspnea
Difficult or labored breathing.		03.6580
Fatigue
The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli.		02.2110
Fever
An abnormal elevation of body temperature, usually as a result of a pathologic process.		02.2110
Complications of Diabetes Mellitus
[description not available]		03.7630
Precordial Catch
[description not available]		03.2350
Chest Pain
Pressure, burning, or numbness in the chest.		08.2350
Hemoptysis
Expectoration or spitting of blood originating from any part of the RESPIRATORY TRACT, usually from hemorrhage in the lung parenchyma (PULMONARY ALVEOLI) and the BRONCHIAL ARTERIES.		03.0740
Disease Exacerbation
[description not available]		04.92120
Hemorrhage, Intracranial, Traumatic
[description not available]		02.5920
Mouth Ulcer
[description not available]		02.6120
Oral Ulcer
A loss of mucous substance of the mouth showing local excavation of the surface, resulting from the sloughing of inflammatory necrotic tissue. It is the result of a variety of causes, e.g., denture irritation, aphthous stomatitis (STOMATITIS, APHTHOUS); NOMA; necrotizing gingivitis (GINGIVITIS, NECROTIZING ULCERATIVE); TOOTHBRUSHING; and various irritants. (From Jablonski, Dictionary of Dentistry, 1992, p842)		02.6120
Infections, Coronavirus
[description not available]		07.8654
Pneumonia, Viral
Inflammation of the lung parenchyma that is caused by a viral infection.		07.8654
Coronavirus Infections
Virus diseases caused by the CORONAVIRUS genus. Some specifics include transmissible enteritis of turkeys (ENTERITIS, TRANSMISSIBLE, OF TURKEYS); FELINE INFECTIOUS PERITONITIS; and transmissible gastroenteritis of swine (GASTROENTERITIS, TRANSMISSIBLE, OF SWINE).		07.8654
Vascular Injuries
[description not available]		02.6120
Pulmonary Veno Occlusive Disease
[description not available]		02.2510
Pulmonary Veno-Occlusive Disease
Pathological process resulting in the fibrous obstruction of the small- and medium-sized PULMONARY VEINS and PULMONARY HYPERTENSION. Veno-occlusion can arise from fibrous proliferation of the VASCULAR INTIMA and VASCULAR MEDIA; THROMBOSIS; or a combination of both.		02.2510
Dysphagia
[description not available]		02.8730
Colicky Pain
[description not available]		02.2510
Deglutition Disorders
Difficulty in SWALLOWING which may result from neuromuscular disorder or mechanical obstruction. Dysphagia is classified into two distinct types: oropharyngeal dysphagia due to malfunction of the PHARYNX and UPPER ESOPHAGEAL SPHINCTER; and esophageal dysphagia due to malfunction of the ESOPHAGUS.		02.8730
Esophagitis
INFLAMMATION, acute or chronic, of the ESOPHAGUS caused by BACTERIA, chemicals, or TRAUMA.		04.47190
Abdominal Pain
Sensation of discomfort, distress, or agony in the abdominal region.		02.2510
Aortic Stenosis
[description not available]		02.5320
Aortic Valve Stenosis
A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.		02.5320
Hangman Fracture
[description not available]		02.8330
Spinal Fractures
Broken bones in the vertebral column.		02.8330
Idiopathic Parkinson Disease
[description not available]		02.6120
Parkinson Disease
A progressive, degenerative neurologic disease characterized by a TREMOR that is maximal at rest, retropulsion (i.e. a tendency to fall backwards), rigidity, stooped posture, slowness of voluntary movements, and a masklike facial expression. Pathologic features include loss of melanin containing neurons in the substantia nigra and other pigmented nuclei of the brainstem. LEWY BODIES are present in the substantia nigra and locus coeruleus but may also be found in a related condition (LEWY BODY DISEASE, DIFFUSE) characterized by dementia in combination with varying degrees of parkinsonism. (Adams et al., Principles of Neurology, 6th ed, p1059, pp1067-75)		02.6120
Alopecia Cicatrisata
[description not available]		02.2510
Alopecia
Absence of hair from areas where it is normally present.		02.2510
Degloving Injuries
Avulsions of the superficial tissues of SKIN and SUBCUTANEOUS TISSUE from the underlying FASCIA.		07.2510
Acute Liver Injury, Drug-Induced
[description not available]		05.1150
Chemical and Drug Induced Liver Injury
A spectrum of clinical liver diseases ranging from mild biochemical abnormalities to ACUTE LIVER FAILURE, caused by drugs, drug metabolites, herbal and dietary supplements and chemicals from the environment.		05.1150
Bacteremia
The presence of viable bacteria circulating in the blood. Fever, chills, tachycardia, and tachypnea are common acute manifestations of bacteremia. The majority of cases are seen in already hospitalized patients, most of whom have underlying diseases or procedures which render their bloodstreams susceptible to invasion.		04.2431
Hematoma, Subdural
Accumulation of blood in the SUBDURAL SPACE between the DURA MATER and the arachnoidal layer of the MENINGES. This condition primarily occurs over the surface of a CEREBRAL HEMISPHERE, but may develop in the spinal canal (HEMATOMA, SUBDURAL, SPINAL). Subdural hematoma can be classified as the acute or the chronic form, with immediate or delayed symptom onset, respectively. Symptoms may include loss of consciousness, severe HEADACHE, and deteriorating mental status.		03.3960
Cancer of Esophagus
[description not available]		02.5720
Esophageal Neoplasms
Tumors or cancer of the ESOPHAGUS.		02.5720
Airway Remodeling
The structural changes in the number, mass, size and/or composition of the airway tissues.		02.2510
Asthma, Bronchial
[description not available]		02.8830
Asthma
A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).		07.8830
Pneumothorax, Primary Spontaneous
[description not available]		03.4620
Acute Hypercapnic Respiratory Failure
[description not available]		02.5320
Pneumothorax
An accumulation of air or gas in the PLEURAL CAVITY, which may occur spontaneously or as a result of trauma or a pathological process. The gas may also be introduced deliberately during PNEUMOTHORAX, ARTIFICIAL.		03.4620
Respiratory Insufficiency
Failure to adequately provide oxygen to cells of the body and to remove excess carbon dioxide from them. (Stedman, 25th ed)		02.5320
Chronic Primary Open Angle Glaucoma
[description not available]		02.2510
Choroidal Detachment
Separation of the CHOROID from the SCLERA.		02.2510
Choroid Hemorrhage
Hemorrhage from the vessels of the choroid.		03.7730
Glaucoma, Open-Angle
Glaucoma in which the angle of the anterior chamber is open and the trabecular meshwork does not encroach on the base of the iris.		02.2510
Acute Hepatic Failure
[description not available]		02.9630
Liver Failure, Acute
A form of rapid-onset LIVER FAILURE, also known as fulminant hepatic failure, caused by severe liver injury or massive loss of HEPATOCYTES. It is characterized by sudden development of liver dysfunction and JAUNDICE. Acute liver failure may progress to exhibit cerebral dysfunction even HEPATIC COMA depending on the etiology that includes hepatic ISCHEMIA, drug toxicity, malignant infiltration, and viral hepatitis such as post-transfusion HEPATITIS B and HEPATITIS C.		02.9630
Agnogenic Myeloid Metaplasia
[description not available]		03.2310
Primary Myelofibrosis
A de novo myeloproliferation arising from an abnormal stem cell. It is characterized by the replacement of bone marrow by fibrous tissue, a process that is mediated by CYTOKINES arising from the abnormal clone.		03.2310
Alcohol Abuse
[description not available]		02.8630
Alcoholism
A primary, chronic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. The disease is often progressive and fatal. It is characterized by impaired control over drinking, preoccupation with the drug alcohol, use of alcohol despite adverse consequences, and distortions in thinking, most notably denial. Each of these symptoms may be continuous or periodic. (Morse & Flavin for the Joint Commission of the National Council on Alcoholism and Drug Dependence and the American Society of Addiction Medicine to Study the Definition and Criteria for the Diagnosis of Alcoholism: in JAMA 1992;268:1012-4)		02.8630
Cancer of Stomach
[description not available]		02.6120
Stomach Neoplasms
Tumors or cancer of the STOMACH.		02.6120
Acquired Autoimmune Hemolytic Anemia
[description not available]		02.2510
Anemia, Hemolytic, Autoimmune
Acquired hemolytic anemia due to the presence of AUTOANTIBODIES which agglutinate or lyse the patient's own RED BLOOD CELLS.		02.2510
Hyperlipemia
[description not available]		02.3110
Hyperlipidemias
Conditions with excess LIPIDS in the blood.		02.3110
Cerebral Infarction, Middle Cerebral Artery
[description not available]		03.81100
Atheroma
[description not available]		03.2550
Adenocarcinoma, Basal Cell
[description not available]		03.0240
Carotid Artery Thrombosis
Blood clot formation in any part of the CAROTID ARTERIES. This may produce CAROTID STENOSIS or occlusion of the vessel, leading to TRANSIENT ISCHEMIC ATTACK; CEREBRAL INFARCTION; or AMAUROSIS FUGAX.		02.930
Cancer of Sigmoid
[description not available]		02.2510
Adenocarcinoma
A malignant epithelial tumor with a glandular organization.		03.0240
Infarction, Middle Cerebral Artery
NECROSIS occurring in the MIDDLE CEREBRAL ARTERY distribution system which brings blood to the entire lateral aspects of each CEREBRAL HEMISPHERE. Clinical signs include impaired cognition; APHASIA; AGRAPHIA; weak and numbness in the face and arms, contralaterally or bilaterally depending on the infarction.		03.81100
Airflow Obstruction, Chronic
[description not available]		02.830
Pulmonary Disease, Chronic Obstructive
A disease of chronic diffuse irreversible airflow obstruction. Subcategories of COPD include CHRONIC BRONCHITIS and PULMONARY EMPHYSEMA.		02.830
Arterial Diseases, Carotid
[description not available]		02.5220
Carotid Artery Diseases
Pathological conditions involving the CAROTID ARTERIES, including the common, internal, and external carotid arteries. ATHEROSCLEROSIS and TRAUMA are relatively frequent causes of carotid artery pathology.		02.5220
Capillary Telangiectasia, Brain
[description not available]		03.1710
Aneurysm, Arteriovenous
[description not available]		03.1710
Colonic Polyps
Discrete tissue masses that protrude into the lumen of the COLON. These POLYPS are connected to the wall of the colon either by a stalk, pedunculus, or by a broad base.		02.7620
Genetic Predisposition
[description not available]		03.5120
Injury, Ischemia-Reperfusion
[description not available]		02.5920
Reperfusion Injury
Adverse functional, metabolic, or structural changes in tissues that result from the restoration of blood flow to the tissue (REPERFUSION) following ISCHEMIA.		07.5920
Demyelinative Myelitis
[description not available]		02.2510
ST Elevated Myocardial Infarction
[description not available]		04.1121
ST Elevation Myocardial Infarction
A clinical syndrome defined by MYOCARDIAL ISCHEMIA symptoms; persistent elevation in the ST segments of the ELECTROCARDIOGRAM; and release of BIOMARKERS of myocardial NECROSIS (e.g., elevated TROPONIN levels). ST segment elevation in the ECG is often used in determining the treatment protocol (see also NON-ST ELEVATION MYOCARDIAL INFARCTION).		04.1121
Cardiovascular Diseases
Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.		08.14370
Adverse Effects, Long Term
[description not available]		02.3110
Drug Withdrawal Symptoms
[description not available]		02.3110
Substance Withdrawal Syndrome
Physiological and psychological symptoms associated with withdrawal from the use of a drug after prolonged administration or habituation. The concept includes withdrawal from smoking or drinking, as well as withdrawal from an administered drug.		02.3110
B-Cell Chronic Lymphocytic Leukemia
[description not available]		02.3110
Leukemia, Lymphocytic, Chronic, B-Cell
A chronic leukemia characterized by abnormal B-lymphocytes and often generalized lymphadenopathy. In patients presenting predominately with blood and bone marrow involvement it is called chronic lymphocytic leukemia (CLL); in those predominately with enlarged lymph nodes it is called small lymphocytic lymphoma. These terms represent spectrums of the same disease.		02.3110
Chest Injuries
[description not available]		02.2510
Cirrhosis
[description not available]		02.8830
Ureteral Obstruction
Blockage in any part of the URETER causing obstruction of urine flow from the kidney to the URINARY BLADDER. The obstruction may be congenital, acquired, unilateral, bilateral, complete, partial, acute, or chronic. Depending on the degree and duration of the obstruction, clinical features vary greatly such as HYDRONEPHROSIS and obstructive nephropathy.		02.3110
Fibrosis
Any pathological condition where fibrous connective tissue invades any organ, usually as a consequence of inflammation or other injury.		02.8830
Neointima
The new and thickened layer of scar tissue that forms on a PROSTHESIS, or as a result of vessel injury especially following ANGIOPLASTY or stent placement.		07.6620
Pleurisy
INFLAMMATION of PLEURA, the lining of the LUNG. When PARIETAL PLEURA is involved, there is pleuritic CHEST PAIN.		02.2510
Pleurisy, Tuberculous
[description not available]		02.2510
Pleural Effusion
Presence of fluid in the pleural cavity resulting from excessive transudation or exudation from the pleural surfaces. It is a sign of disease and not a diagnosis in itself.		07.8930
Pregnancy
The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.		08.56150
Coagulation, Disseminated Intravascular
[description not available]		03.1140
Disseminated Intravascular Coagulation
A disorder characterized by procoagulant substances entering the general circulation causing a systemic thrombotic process. The activation of the clotting mechanism may arise from any of a number of disorders. A majority of the patients manifest skin lesions, sometimes leading to PURPURA FULMINANS.		08.1140
Hemorrhagic Shock
[description not available]		03.3560
Hemorrhage, Uterine
[description not available]		05.3670
Uterine Hemorrhage
Bleeding from blood vessels in the UTERUS, sometimes manifested as vaginal bleeding.		05.3670
Peripheral Arterial Diseases
[description not available]		011.591916
Peripheral Arterial Disease
Lack of perfusion in the EXTREMITIES resulting from atherosclerosis. It is characterized by INTERMITTENT CLAUDICATION, and an ANKLE BRACHIAL INDEX of 0.9 or less.		011.591916
Coronary Heart Disease
[description not available]		04.940
Cerebral Arteriosclerosis
[description not available]		02.3110
Intracranial Arteriosclerosis
Vascular diseases characterized by thickening and hardening of the walls of ARTERIES inside the SKULL. There are three subtypes: (1) atherosclerosis with fatty deposits in the ARTERIAL INTIMA; (2) Monckeberg's sclerosis with calcium deposits in the media and (3) arteriolosclerosis involving the small caliber arteries. Clinical signs include HEADACHE; CONFUSION; transient blindness (AMAUROSIS FUGAX); speech impairment; and HEMIPARESIS.		02.3110
Coronary Disease
An imbalance between myocardial functional requirements and the capacity of the CORONARY VESSELS to supply sufficient blood flow. It is a form of MYOCARDIAL ISCHEMIA (insufficient blood supply to the heart muscle) caused by a decreased capacity of the coronary vessels.		04.940
Left Ventricular Hypertrophy
[description not available]		010.8141
Hypertrophy, Left Ventricular
Enlargement of the LEFT VENTRICLE of the heart. This increase in ventricular mass is attributed to sustained abnormal pressure or volume loads and is a contributor to cardiovascular morbidity and mortality.		05.8141
Livedo Reticularis
A condition characterized by a reticular or fishnet pattern on the skin of lower extremities and other parts of the body. This red and blue pattern is due to deoxygenated blood in unstable dermal blood vessels. The condition is intensified by cold exposure and relieved by rewarming.		02.6120
Metabolic Acidosis
[description not available]		03.711
Acidosis
A pathologic condition of acid accumulation or depletion of base in the body. The two main types are RESPIRATORY ACIDOSIS and metabolic acidosis, due to metabolic acid build up.		03.711
Cancer of Gastrointestinal Tract
[description not available]		04.6451
Eye Disorders
[description not available]		03.2310
Eye Diseases
Diseases affecting the eye.		03.2310
Extravascular Hemolysis
[description not available]		02.3110
Hemolysis
The destruction of ERYTHROCYTES by many different causal agents such as antibodies, bacteria, chemicals, temperature, and changes in tonicity.		02.3110
Postthrombotic Syndrome
A condition caused by one or more episodes of DEEP VEIN THROMBOSIS, usually the blood clots are lodged in the legs. Clinical features include EDEMA; PAIN; aching; heaviness; and MUSCLE CRAMP in the leg. When severe leg swelling leads to skin breakdown, it is called venous STASIS ULCER.		09.8721
Cardiac Rupture, Traumatic
[description not available]		03.8630
Erythremia
[description not available]		02.3110
Hemorrhagic Thrombocythemia
[description not available]		02.3110
Polycythemia Vera
A myeloproliferative disorder of unknown etiology, characterized by abnormal proliferation of all hematopoietic bone marrow elements and an absolute increase in red cell mass and total blood volume, associated frequently with splenomegaly, leukocytosis, and thrombocythemia. Hematopoiesis is also reactive in extramedullary sites (liver and spleen). In time myelofibrosis occurs.		02.3110
Thrombocythemia, Essential
A clinical syndrome characterized by repeated spontaneous hemorrhages and a remarkable increase in the number of circulating platelets.		02.3110
Pulmonary Arterial Remodeling
[description not available]		02.3110
Esophageal Stricture
[description not available]		02.1510
Esophageal Stenosis
A stricture of the ESOPHAGUS. Most are acquired but can be congenital.		02.1510
Kidney Stones
[description not available]		02.1510
Adenoma, Prostatic
[description not available]		02.1510
Kidney Calculi
Stones in the KIDNEY, usually formed in the urine-collecting area of the kidney (KIDNEY PELVIS). Their sizes vary and most contains CALCIUM OXALATE.		02.1510
Prostatic Hyperplasia
Increase in constituent cells in the PROSTATE, leading to enlargement of the organ (hypertrophy) and adverse impact on the lower urinary tract function. This can be caused by increased rate of cell proliferation, reduced rate of cell death, or both.		02.1510
Blood Poisoning
[description not available]		02.5520
Sepsis
Systemic inflammatory response syndrome with a proven or suspected infectious etiology. When sepsis is associated with organ dysfunction distant from the site of infection, it is called severe sepsis. When sepsis is accompanied by HYPOTENSION despite adequate fluid infusion, it is called SEPTIC SHOCK.		02.5520
Blunt Injuries
[description not available]		03.7330
Osteoarthritis of Knee
[description not available]		02.1510
Coxarthrosis
[description not available]		02.5420
Osteoarthritis, Hip
Noninflammatory degenerative disease of the hip joint which usually appears in late middle or old age. It is characterized by growth or maturational disturbances in the femoral neck and head, as well as acetabular dysplasia. A dominant symptom is pain on weight-bearing or motion.		02.5420
Osteoarthritis, Knee
Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)		02.1510
Vascular Calcification
Deposition of calcium into the blood vessel structures. Excessive calcification of the vessels are associated with ATHEROSCLEROTIC PLAQUES formation particularly after MYOCARDIAL INFARCTION (see MONCKEBERG MEDIAL CALCIFIC SCLEROSIS) and chronic kidney diseases which in turn increase VASCULAR STIFFNESS.		02.1510
Aneurysm, Aortic
[description not available]		02.5520
Melena
The black, tarry, foul-smelling FECES that contain degraded blood.		02.5120
Aortic Aneurysm
An abnormal balloon- or sac-like dilatation in the wall of AORTA.		02.5520
MODS
[description not available]		03.7130
Linear Skull Fracture
[description not available]		02.1510
Multiple Organ Failure
A progressive condition usually characterized by combined failure of several organs such as the lungs, liver, kidney, along with some clotting mechanisms, usually postinjury or postoperative.		03.7130
Cardiac Remodeling, Ventricular
[description not available]		04.4811
Mediastinal Diseases
Disorders of the mediastinum, general or unspecified.		02.1510
Emesis
[description not available]		02.8330
Esophageal Perforation
An opening or hole in the ESOPHAGUS that is caused by TRAUMA, injury, or pathological process.		02.1510
Vomiting
The forcible expulsion of the contents of the STOMACH through the MOUTH.		07.8330
Allergy, Drug
[description not available]		07.3651
Drug Hypersensitivity
Immunologically mediated adverse reactions to medicinal substances used legally or illegally.		07.3651
Liver Steatosis
[description not available]		02.5220
Fatty Liver
Lipid infiltration of the hepatic parenchymal cells resulting in a yellow-colored liver. The abnormal lipid accumulation is usually in the form of TRIGLYCERIDES, either as a single large droplet or multiple small droplets. Fatty liver is caused by an imbalance in the metabolism of FATTY ACIDS.		07.5220
Weight Gain
Increase in BODY WEIGHT over existing weight.		02.5220
Brain Vascular Disorders
[description not available]		03.4320
Cerebrovascular Disorders
A spectrum of pathological conditions of impaired blood flow in the brain. They can involve vessels (ARTERIES or VEINS) in the CEREBRUM, the CEREBELLUM, and the BRAIN STEM. Major categories include INTRACRANIAL ARTERIOVENOUS MALFORMATIONS; BRAIN ISCHEMIA; CEREBRAL HEMORRHAGE; and others.		03.4320
Calciphylaxes
[description not available]		02.1510
Injuries, Multiple
[description not available]		04.4370
Closed Head Injuries
[description not available]		02.8330
Hematoma, Subdural, Chronic
Accumulation of blood in the SUBDURAL SPACE with delayed onset of neurological symptoms. Symptoms may include loss of consciousness, severe HEADACHE, and deteriorating mental status.		02.8330
No-Reflow Phenomenon
Markedly reduced or absent REPERFUSION in an infarct zone following the removal of an obstruction or constriction of an artery.		07.5420
Cancer of Prostate
[description not available]		03.7130
Prostatic Neoplasms
Tumors or cancer of the PROSTATE.		03.7130
HIV
Human immunodeficiency virus. A non-taxonomic and historical term referring to any of two species, specifically HIV-1 and/or HIV-2. Prior to 1986, this was called human T-lymphotropic virus type III/lymphadenopathy-associated virus (HTLV-III/LAV). From 1986-1990, it was an official species called HIV. Since 1991, HIV was no longer considered an official species name; the two species were designated HIV-1 and HIV-2.		07.1710
Arteriovenous Malformations
Abnormal formation of blood vessels that shunt arterial blood directly into veins without passing through the CAPILLARIES. They usually are crooked, dilated, and with thick vessel walls. A common type is the congenital arteriovenous fistula. The lack of blood flow and oxygen in the capillaries can lead to tissue damage in the affected areas.		02.1710
Diverticula
[description not available]		02.1710
Gastroduodenal Ulcer
[description not available]		02.5420
Hemorrhoids
Swollen veins in the lower part of the RECTUM or ANUS. Hemorrhoids can be inside the anus (internal), under the skin around the anus (external), or protruding from inside to outside of the anus. People with hemorrhoids may or may not exhibit symptoms which include bleeding, itching, and pain.		02.1710
Peptic Ulcer
Ulcer that occurs in the regions of the GASTROINTESTINAL TRACT which come into contact with GASTRIC JUICE containing PEPSIN and GASTRIC ACID. It occurs when there are defects in the MUCOSA barrier. The common forms of peptic ulcers are associated with HELICOBACTER PYLORI and the consumption of nonsteroidal anti-inflammatory drugs (NSAIDS).		02.5420
Proliferative Vitreoretinopathy
[description not available]		02.1710
Vitreoretinopathy, Proliferative
Vitreoretinal membrane shrinkage or contraction secondary to the proliferation of primarily retinal pigment epithelial cells and glial cells, particularly fibrous astrocytes, followed by membrane formation. The formation of fibrillar collagen and cellular proliferation appear to be the basis for the contractile properties of the epiretinal and vitreous membranes.		02.1710
Neoplasm Metastasis, Unknown Primary
[description not available]		02.5120
Cardiomyopathy, Chagas
[description not available]		02.1710
Chagas Cardiomyopathy
A disease of the CARDIAC MUSCLE developed subsequent to the initial protozoan infection by TRYPANOSOMA CRUZI. After infection, less than 10% develop acute illness such as MYOCARDITIS (mostly in children). The disease then enters a latent phase without clinical symptoms until about 20 years later. Myocardial symptoms of advanced CHAGAS DISEASE include conduction defects (HEART BLOCK) and CARDIOMEGALY.		02.1710
Agranulocytosis
A decrease in the number of GRANULOCYTES; (BASOPHILS; EOSINOPHILS; and NEUTROPHILS).		02.8330
Hepatitis
INFLAMMATION of the LIVER.		02.8630
Hematoma, Epidural, Spinal
A rare epidural hematoma in the spinal epidural space, usually due to a vascular malformation (CENTRAL NERVOUS SYSTEM VASCULAR MALFORMATIONS) or TRAUMA. Spontaneous spinal epidural hematoma is a neurologic emergency due to a rapidly evolving compressive MYELOPATHY.		04.5850
Auricular Flutter
[description not available]		09.42201
Atrial Flutter
Rapid, irregular atrial contractions caused by a block of electrical impulse conduction in the right atrium and a reentrant wave front traveling up the inter-atrial septum and down the right atrial free wall or vice versa. Unlike ATRIAL FIBRILLATION which is caused by abnormal impulse generation, typical atrial flutter is caused by abnormal impulse conduction. As in atrial fibrillation, patients with atrial flutter cannot effectively pump blood into the lower chambers of the heart (HEART VENTRICLES).		09.42201
Angiodysplasia
Acquired degenerative dilation or expansion (ectasia) of normal BLOOD VESSELS, often associated with aging. They are isolated, tortuous, thin-walled vessels and sources of bleeding. They occur most often in mucosal capillaries of the GASTROINTESTINAL TRACT leading to GASTROINTESTINAL HEMORRHAGE and ANEMIA.		02.1710
Infections, Staphylococcal
[description not available]		04.2231
Staphylococcal Infections
Infections with bacteria of the genus STAPHYLOCOCCUS.		04.2231
Left Ventricular Dysfunction
[description not available]		04.650
Ventricular Dysfunction, Left
A condition in which the LEFT VENTRICLE of the heart was functionally impaired. This condition usually leads to HEART FAILURE; MYOCARDIAL INFARCTION; and other cardiovascular complications. Diagnosis is made by measuring the diminished ejection fraction and a depressed level of motility of the left ventricular wall.		04.650
Diabetic Glomerulosclerosis
[description not available]		02.1710
Diabetic Nephropathies
KIDNEY injuries associated with diabetes mellitus and affecting KIDNEY GLOMERULUS; ARTERIOLES; KIDNEY TUBULES; and the interstitium. Clinical signs include persistent PROTEINURIA, from microalbuminuria progressing to ALBUMINURIA of greater than 300 mg/24 h, leading to reduced GLOMERULAR FILTRATION RATE and END-STAGE RENAL DISEASE.		02.1710
Cerebral Microangiopathies
[description not available]		02.1710
Cerebral Small Vessel Diseases
Pathological processes or diseases where cerebral MICROVESSELS show abnormalities. They are often associated with aging, hypertension and risk factors for lacunar infarcts (see LACUNAR INFARCTION); LEUKOARAIOSIS; and CEREBRAL HEMORRHAGE.		02.1710
Congenital Myotonic Dystrophy
[description not available]		02.5720
Myotonic Dystrophy
Neuromuscular disorder characterized by PROGRESSIVE MUSCULAR ATROPHY; MYOTONIA, and various multisystem atrophies. Mild INTELLECTUAL DISABILITY may also occur. Abnormal TRINUCLEOTIDE REPEAT EXPANSION in the 3' UNTRANSLATED REGIONS of DMPK PROTEIN gene is associated with Myotonic Dystrophy 1. DNA REPEAT EXPANSION of zinc finger protein-9 gene intron is associated with Myotonic Dystrophy 2.		02.5720
Ventricular Fibrillation
A potentially lethal cardiac arrhythmia that is characterized by uncoordinated extremely rapid firing of electrical impulses (400-600/min) in HEART VENTRICLES. Such asynchronous ventricular quivering or fibrillation prevents any effective cardiac output and results in unconsciousness (SYNCOPE). It is one of the major electrocardiographic patterns seen with CARDIAC ARREST.		02.1710
Pulmonary Hypertension
[description not available]		02.1710
Hypertension, Pulmonary
Increased VASCULAR RESISTANCE in the PULMONARY CIRCULATION, usually secondary to HEART DISEASES or LUNG DISEASES.		02.1710
Ambulation Difficulty
[description not available]		02.1710
Drug Abuse, Intravenous
[description not available]		03.0910
Cardiovascular Pregnancy Complications
[description not available]		03.7430
Arterial Obstructive Diseases
[description not available]		04.9880
Arterial Occlusive Diseases
Pathological processes which result in the partial or complete obstruction of ARTERIES. They are characterized by greatly reduced or absence of blood flow through these vessels. They are also known as arterial insufficiency.		04.9880
Duncan Disease
[description not available]		02.1710
Lymphoproliferative Disorders
Disorders characterized by proliferation of lymphoid tissue, general or unspecified.		02.1710
Cancer of Pancreas
[description not available]		02.2110
Pancreatic Neoplasms
Tumors or cancer of the PANCREAS. Depending on the types of ISLET CELLS present in the tumors, various hormones can be secreted: GLUCAGON from PANCREATIC ALPHA CELLS; INSULIN from PANCREATIC BETA CELLS; and SOMATOSTATIN from the SOMATOSTATIN-SECRETING CELLS. Most are malignant except the insulin-producing tumors (INSULINOMA).		02.2110
Obstructive Lung Diseases
[description not available]		02.1710
Lung Diseases, Obstructive
Any disorder marked by obstruction of conducting airways of the lung. AIRWAY OBSTRUCTION may be acute, chronic, intermittent, or persistent.		02.1710
Apical Ballooning Syndrome
[description not available]		02.1710
Edema, Pulmonary
[description not available]		02.1710
Bimalleolar Ankle Fractures
[description not available]		02.1710
Splenic Rupture
Rupture of the SPLEEN due to trauma or disease.		07.8930
Pulmonary Edema
Excessive accumulation of extravascular fluid in the lung, an indication of a serious underlying disease or disorder. Pulmonary edema prevents efficient PULMONARY GAS EXCHANGE in the PULMONARY ALVEOLI, and can be life-threatening.		02.1710
Takotsubo Cardiomyopathy
A transient left ventricular apical dysfunction or ballooning accompanied by electrocardiographic (ECG) T wave inversions. This abnormality is associated with high levels of CATECHOLAMINES, either administered or endogenously secreted from a tumor or during extreme stress.		02.1710
Ankle Fractures
Fractures of any of the bones of the ANKLE.		02.1710
Acute Onset Vascular Dementia
[description not available]		02.1710
Dementia, Vascular
An imprecise term referring to dementia associated with CEREBROVASCULAR DISORDERS, including CEREBRAL INFARCTION (single or multiple), and conditions associated with chronic BRAIN ISCHEMIA. Diffuse, cortical, and subcortical subtypes have been described. (From Gerontol Geriatr 1998 Feb;31(1):36-44)		02.1710
Cruveilhier-Baumgarten Syndrome
Liver cirrhosis with intrahepatic portal obstruction, HYPERTENSION, and patent UMBILICAL VEINS.		02.2110
Cirrhoses, Experimental Liver
[description not available]		02.2110
Angiogenesis, Pathologic
[description not available]		02.2110
Hypertension, Portal
Abnormal increase of resistance to blood flow within the hepatic PORTAL SYSTEM, frequently seen in LIVER CIRRHOSIS and conditions with obstruction of the PORTAL VEIN.		02.2110
Encephalopathy, Traumatic
[description not available]		02.6120
Brain Injuries, Traumatic
A form of acquired brain injury which occurs when a sudden trauma causes damage to the brain.		02.6120
Hepatic Insufficiency
Conditions in which the LIVER functions fall below the normal ranges. Severe hepatic insufficiency may cause LIVER FAILURE or DEATH. Treatment may include LIVER TRANSPLANTATION.		03.8721
Coronary Thrombosis
Coagulation of blood in any of the CORONARY VESSELS. The presence of a blood clot (THROMBUS) often leads to MYOCARDIAL INFARCTION.		07.2772
Prosthesis Durability
[description not available]		02.7930
Rupture, Spontaneous
Tear or break of an organ, vessel or other soft part of the body, occurring in the absence of external force.		02.6120
Mesenteric Vascular Occlusion
Obstruction of the flow in the SPLANCHNIC CIRCULATION by ATHEROSCLEROSIS; EMBOLISM; THROMBOSIS; STENOSIS; TRAUMA; and compression or intrinsic pressure from adjacent tumors. Rare causes are drugs, intestinal parasites, and vascular immunoinflammatory diseases such as PERIARTERITIS NODOSA and THROMBOANGIITIS OBLITERANS. (From Juergens et al., Peripheral Vascular Diseases, 5th ed, pp295-6)		02.2110
Anasarca
[description not available]		02.2110
Edema
Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.		07.2110
Granulocytic Leukemia, Chronic
[description not available]		02.2110
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Clonal hematopoetic disorder caused by an acquired genetic defect in PLURIPOTENT STEM CELLS. It starts in MYELOID CELLS of the bone marrow, invades the blood and then other organs. The condition progresses from a stable, more indolent, chronic phase (LEUKEMIA, MYELOID, CHRONIC PHASE) lasting up to 7 years, to an advanced phase composed of an accelerated phase (LEUKEMIA, MYELOID, ACCELERATED PHASE) and BLAST CRISIS.		02.2110
Abortion, Tubal
[description not available]		02.2110
Abortion, Spontaneous
Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.		02.2110
Elevated ICP (Intracranial Pressure)
[description not available]		02.2110
Bilateral Headache
[description not available]		03.8821
Deficiency, Protein S
[description not available]		02.5320
Headache
The symptom of PAIN in the cranial region. It may be an isolated benign occurrence or manifestation of a wide variety of HEADACHE DISORDERS.		03.8821
Intracranial Hypertension
Increased pressure within the cranial vault. This may result from several conditions, including HYDROCEPHALUS; BRAIN EDEMA; intracranial masses; severe systemic HYPERTENSION; PSEUDOTUMOR CEREBRI; and other disorders.		02.2110
Carotid Artery Narrowing
[description not available]		02.5820
Carotid Stenosis
Narrowing or stricture of any part of the CAROTID ARTERIES, most often due to atherosclerotic plaque formation. Ulcerations may form in atherosclerotic plaques and induce THROMBUS formation. Platelet or cholesterol emboli may arise from stenotic carotid lesions and induce a TRANSIENT ISCHEMIC ATTACK; CEREBROVASCULAR ACCIDENT; or temporary blindness (AMAUROSIS FUGAX). (From Adams et al., Principles of Neurology, 6th ed, pp 822-3)		02.5820
ER-Negative PR-Negative HER2-Negative Breast Cancer
[description not available]		02.2110
Metastase
[description not available]		02.5520
Neoplasm Metastasis
The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.		02.5520
Triple Negative Breast Neoplasms
Breast neoplasms that do not express ESTROGEN RECEPTORS; PROGESTERONE RECEPTORS; and do not overexpress the NEU RECEPTOR/HER-2 PROTO-ONCOGENE PROTEIN.		02.2110
Bacterial Endocarditides
[description not available]		02.5520
Endocarditis, Bacterial
Inflammation of the ENDOCARDIUM caused by BACTERIA that entered the bloodstream. The strains of bacteria vary with predisposing factors, such as CONGENITAL HEART DEFECTS; HEART VALVE DISEASES; HEART VALVE PROSTHESIS IMPLANTATION; or intravenous drug use.		02.5520
Hyperkinetic Dysphonia
[description not available]		02.2110
Hemothorax
Hemorrhage within the pleural cavity.		07.5820
Emphysema, Subcutaneous
[description not available]		02.2110
Dysphonia
Difficulty and/or pain in PHONATION or speaking.		07.2110
Degenerative Disc Disease
[description not available]		02.2110
Intervertebral Disc Degeneration
Degenerative changes in the INTERVERTEBRAL DISC due to aging or structural damage, especially to the vertebral end-plates.		02.2110
Acute Generalised Exanthematous Pustulosis
[description not available]		02.2110
Palmoplantaris Pustulosis
[description not available]		02.5720
Psoriasis
A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.		02.5720
Aneurysm, Thoracic Aortic
[description not available]		02.8130
Aortic Dissection
[description not available]		03.0440
Aortic Aneurysm, Thoracic
An abnormal balloon- or sac-like dilatation in the wall of the THORACIC AORTA. This proximal descending portion of aorta gives rise to the visceral and the parietal branches above the aortic hiatus at the diaphragm.		02.8130
Esophageal Reflux
[description not available]		02.2510
Gastroesophageal Reflux
Retrograde flow of gastric juice (GASTRIC ACID) and/or duodenal contents (BILE ACIDS; PANCREATIC JUICE) into the distal ESOPHAGUS, commonly due to incompetence of the LOWER ESOPHAGEAL SPHINCTER.		02.2510
Asymptomatic Colonization
[description not available]		02.2510
Ileus
A condition caused by the lack of intestinal PERISTALSIS or INTESTINAL MOTILITY without any mechanical obstruction. This interference of the flow of INTESTINAL CONTENTS often leads to INTESTINAL OBSTRUCTION. Ileus may be classified into postoperative, inflammatory, metabolic, neurogenic, and drug-induced.		02.0810
Critical Illness
A disease or state in which death is possible or imminent.		02.7830
Hepatic Failure
[description not available]		03.0110
Liver Failure
Severe inability of the LIVER to perform its normal metabolic functions, as evidenced by severe JAUNDICE and abnormal serum levels of AMMONIA; BILIRUBIN; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; LACTATE DEHYDROGENASES; and albumin/globulin ratio. (Blakiston's Gould Medical Dictionary, 4th ed)		03.0110
Complication, Intraoperative
[description not available]		04.1630
Abdominal Aortic Aneurysm
[description not available]		02.0810
Arrhythmia
[description not available]		04.1831
Aortic Aneurysm, Ruptured
[description not available]		02.0810
Arrhythmias, Cardiac
Any disturbances of the normal rhythmic beating of the heart or MYOCARDIAL CONTRACTION. Cardiac arrhythmias can be classified by the abnormalities in HEART RATE, disorders of electrical impulse generation, or impulse conduction.		04.1831
Aortic Aneurysm, Abdominal
An abnormal balloon- or sac-like dilatation in the wall of the ABDOMINAL AORTA which gives rise to the visceral, the parietal, and the terminal (iliac) branches below the aortic hiatus at the diaphragm.		02.0810
Dermatitis Medicamentosa
[description not available]		03.3360
Eosinophilia, Tropical
[description not available]		02.5220
Exanthem
[description not available]		02.9940
Eosinophilia
Abnormal increase of EOSINOPHILS in the blood, tissues or organs.		07.5220
Exanthema
Diseases in which skin eruptions or rashes are a prominent manifestation. Classically, six such diseases were described with similar rashes; they were numbered in the order in which they were reported. Only the fourth (Duke's disease), fifth (ERYTHEMA INFECTIOSUM), and sixth (EXANTHEMA SUBITUM) numeric designations survive as occasional synonyms in current terminology.		07.9940
Electrocardiogram QT Prolonged
[description not available]		03.4711
Long QT Syndrome
A condition that is characterized by episodes of fainting (SYNCOPE) and varying degree of ventricular arrhythmia as indicated by the prolonged QT interval. The inherited forms are caused by mutation of genes encoding cardiac ion channel proteins. The two major forms are ROMANO-WARD SYNDROME and JERVELL-LANGE NIELSEN SYNDROME.		03.4711
Catheter-Associated Infections
[description not available]		02.0810
Rib Fractures
Fractures of any of the RIBS.		0310
Indigestion
[description not available]		022.87451443
Dyspepsia
Impaired digestion, especially after eating.		022.87451443
Disease, Pulmonary
[description not available]		02.4820
Lung Diseases
Pathological processes involving any part of the LUNG.		02.4820
Acid Aspiration Syndrome
[description not available]		02.0810
Gastric Ulcer
[description not available]		07.0810
Pneumonia, Aspiration
A type of lung inflammation resulting from the aspiration of food, liquid, or gastric contents into the upper RESPIRATORY TRACT.		02.0810
Stomach Ulcer
Ulceration of the GASTRIC MUCOSA due to contact with GASTRIC JUICE. It is often associated with HELICOBACTER PYLORI infection or consumption of nonsteroidal anti-inflammatory drugs (NSAIDS).		02.0810
Brain Hemorrhage, Cerebral, Traumatic
[description not available]		02.0810
Ankle Injuries
Harm or hurt to the ankle or ankle joint usually inflicted by an external source.		02.0810
Hemorrhage, Oral
[description not available]		04.8440
Coronary Occlusion
Complete blockage of blood flow through one of the CORONARY ARTERIES, usually from CORONARY ATHEROSCLEROSIS.		02.7830
Intestinal Volvulus
A twisting in the intestine (INTESTINES) that can cause INTESTINAL OBSTRUCTION.		02.0810
Colonic Diseases
Pathological processes in the COLON region of the large intestine (INTESTINE, LARGE).		02.0810
Intestinal Perforation
Opening or penetration through the wall of the INTESTINES.		02.5120
Cicatrization
The formation of fibrous tissue in the place of normal tissue during the process of WOUND HEALING. It includes scar tissue formation occurring in healing internal organs as well as in the skin after surface injuries.		02.0810
Cicatrix
The fibrous tissue that replaces normal tissue during the process of WOUND HEALING.		02.0810
Conus Medullaris Syndrome
[description not available]		02.0810
Abscess, Epidural
[description not available]		02.0810
Anemia, Hypoplastic
[description not available]		02.0810
Anemia, Aplastic
A form of anemia in which the bone marrow fails to produce adequate numbers of peripheral blood elements.		02.0810
Cancer of Colon
[description not available]		02.0810
Colonic Neoplasms
Tumors or cancer of the COLON.		02.0810
Hemorrhagic Diathesis
[description not available]		03.420
Hemorrhagic Disorders
Spontaneous or near spontaneous bleeding caused by a defect in clotting mechanisms (BLOOD COAGULATION DISORDERS) or another abnormality causing a structural flaw in the blood vessels (HEMOSTATIC DISORDERS).		03.420
Mitral Incompetence
[description not available]		02.0810
Infections, Prosthesis-Related
[description not available]		02.0810
Mitral Valve Insufficiency
Backflow of blood from the LEFT VENTRICLE into the LEFT ATRIUM due to imperfect closure of the MITRAL VALVE. This can lead to mitral valve regurgitation.		02.0810
Blood Pressure, Low
[description not available]		02.4820
Hypotension
Abnormally low BLOOD PRESSURE that can result in inadequate blood flow to the brain and other vital organs. Common symptom is DIZZINESS but greater negative impacts on the body occur when there is prolonged depravation of oxygen and nutrients.		02.4820
Adenohypophyseal Hyposecretion
[description not available]		02.110
Hypopituitarism
Diminution or cessation of secretion of one or more hormones from the anterior pituitary gland (including LH; FOLLICLE STIMULATING HORMONE; SOMATOTROPIN; and CORTICOTROPIN). This may result from surgical or radiation ablation, non-secretory PITUITARY NEOPLASMS, metastatic tumors, infarction, PITUITARY APOPLEXY, infiltrative or granulomatous processes, and other conditions.		07.110
Urinary Tract Infections
Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.		02.0810
Emesis, Postoperative
[description not available]		0310
Postoperative Nausea and Vomiting
Emesis and queasiness occurring after anesthesia.		0310
Alcohol Drinking
Behaviors associated with the ingesting of ALCOHOLIC BEVERAGES, including social drinking.		02.0810
Autosomal Hemophilia A
[description not available]		04.5850
Hemophilia A
The classic hemophilia resulting from a deficiency of factor VIII. It is an inherited disorder of blood coagulation characterized by a permanent tendency to hemorrhage.		04.5850
Hyperpotassemia
[description not available]		02.4920
Periphlebitis
Periphlebitis is inflammation of the outer coat of a vein or of tissues surrounding the vein.		02.110
Hyperkalemia
Abnormally high potassium concentration in the blood, most often due to defective renal excretion. It is characterized clinically by electrocardiographic abnormalities (elevated T waves and depressed P waves, and eventually by atrial asystole). In severe cases, weakness and flaccid paralysis may occur. (Dorland, 27th ed)		07.4920
Phlebitis
Inflammation of a vein, often a vein in the leg. Phlebitis associated with a blood clot is called (THROMBOPHLEBITIS).		02.110
Anterior Cerebral Circulation Infarction
[description not available]		04.1830
Brain Infarction
Tissue NECROSIS in any area of the brain, including the CEREBRAL HEMISPHERES, the CEREBELLUM, and the BRAIN STEM. Brain infarction is the result of a cascade of events initiated by inadequate blood flow through the brain that is followed by HYPOXIA and HYPOGLYCEMIA in brain tissue. Damage may be temporary, permanent, selective or pan-necrosis.		04.1830
HbS Disease
[description not available]		02.110
Anemia, Sickle Cell
A disease characterized by chronic hemolytic anemia, episodic painful crises, and pathologic involvement of many organs. It is the clinical expression of homozygosity for hemoglobin S.		02.110
Hospital-Acquired Condition
[description not available]		0310
Acute Brain Injuries
[description not available]		02.4920
Brain Injuries
Acute and chronic (see also BRAIN INJURIES, CHRONIC) injuries to the brain, including the cerebral hemispheres, CEREBELLUM, and BRAIN STEM. Clinical manifestations depend on the nature of injury. Diffuse trauma to the brain is frequently associated with DIFFUSE AXONAL INJURY or COMA, POST-TRAUMATIC. Localized injuries may be associated with NEUROBEHAVIORAL MANIFESTATIONS; HEMIPARESIS, or other focal neurologic deficits.		02.4920
Bronchiectasis
Persistent abnormal dilatation of the bronchi.		07.110
Libman-Sacks Disease
[description not available]		03.0340
Lupus Erythematosus, Systemic
A chronic, relapsing, inflammatory, and often febrile multisystemic disorder of connective tissue, characterized principally by involvement of the skin, joints, kidneys, and serosal membranes. It is of unknown etiology, but is thought to represent a failure of the regulatory mechanisms of the autoimmune system. The disease is marked by a wide range of system dysfunctions, an elevated erythrocyte sedimentation rate, and the formation of LE cells in the blood or bone marrow.		03.0340
Aqueductal Stenosis
[description not available]		02.5220
Cancer of Endometrium
[description not available]		02.110
Endometrial Neoplasms
Tumors or cancer of ENDOMETRIUM, the mucous lining of the UTERUS. These neoplasms can be benign or malignant. Their classification and grading are based on the various cell types and the percent of undifferentiated cells.		02.110
Aortic Incompetence
[description not available]		02.110
Aortic Valve Insufficiency
Pathological condition characterized by the backflow of blood from the ASCENDING AORTA back into the LEFT VENTRICLE, leading to regurgitation. It is caused by diseases of the AORTIC VALVE or its surrounding tissue (aortic root).		02.110
Femur Neck Fractures
[description not available]		02.5220
Femoral Neck Fractures
Fractures of the short, constricted portion of the thigh bone between the femur head and the trochanters. It excludes intertrochanteric fractures which are HIP FRACTURES.		02.5220
Short Bowel Syndrome
A malabsorption syndrome resulting from extensive operative resection of the SMALL INTESTINE, the absorptive region of the GASTROINTESTINAL TRACT.		07.110
Diverticulitis
Inflammation of a DIVERTICULUM or diverticula.		02.110
Infective Endocarditis
[description not available]		02.110
Bacterial Infections, Gram-Positive
[description not available]		02.110
Endocarditis
Inflammation of the inner lining of the heart (ENDOCARDIUM), the continuous membrane lining the four chambers and HEART VALVES. It is often caused by microorganisms including bacteria, viruses, fungi, and rickettsiae. Left untreated, endocarditis can damage heart valves and become life-threatening.		07.110
Gram-Positive Bacterial Infections
Infections caused by bacteria that retain the crystal violet stain (positive) when treated by the gram-staining method.		02.110
Complications, Hematologic Pregnancy
[description not available]		02.4720
Injuries, Leg
[description not available]		02.110
Carcinoma, Epidermoid
[description not available]		02.110
Carcinoma, Squamous Cell
A carcinoma derived from stratified SQUAMOUS EPITHELIAL CELLS. It may also occur in sites where glandular or columnar epithelium is normally present. (From Stedman, 25th ed)		02.110
Hemostatic Disorders
Pathological processes involving the integrity of blood circulation. Hemostasis depends on the integrity of BLOOD VESSELS, blood fluidity, and BLOOD COAGULATION. Majority of the hemostatic disorders are caused by disruption of the normal interaction between the VASCULAR ENDOTHELIUM, the plasma proteins (including BLOOD COAGULATION FACTORS), and PLATELETS.		07.4920
Injury, Myocardial Reperfusion
[description not available]		02.1110
Remission, Spontaneous
A spontaneous diminution or abatement of a disease over time, without formal treatment.		02.110
Experimental Lung Inflammation
Inflammation of any part, segment or lobe, of the lung parenchyma.		02.110
Pneumonia
Infection of the lung often accompanied by inflammation.		07.110
Fatty Liver, Nonalcoholic
[description not available]		02.5220
Non-alcoholic Fatty Liver Disease
Fatty liver finding without excessive ALCOHOL CONSUMPTION.		02.5220
Activated Protein C Resistance
A hemostatic disorder characterized by a poor anticoagulant response to activated protein C (APC). The activated form of Factor V (Factor Va) is more slowly degraded by activated protein C. Factor V Leiden mutation (R506Q) is the most common cause of APC resistance.		03.3560
Allergic Cutaneous Angiitis
[description not available]		02.5220
Shock, Cardiogenic
Shock resulting from diminution of cardiac output in heart disease.		02.110
Pyrosis
[description not available]		02.1110
Heartburn
Substernal pain or burning sensation, usually associated with regurgitation of gastric juice into the esophagus.		02.1110
Long Sleeper Syndrome
[description not available]		02.1110
Depression
Depressive states usually of moderate intensity in contrast with MAJOR DEPRESSIVE DISORDER present in neurotic and psychotic disorders.		07.5320
Sleep Wake Disorders
Abnormal sleep-wake schedule or pattern associated with the CIRCADIAN RHYTHM which affect the length, timing, and/or rigidity of the sleep-wake cycle relative to the day-night cycle.		02.1110
Diarrhea
An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.		03.8521
Dermatoses
[description not available]		03.730
Skin Diseases
Diseases involving the DERMIS or EPIDERMIS.		03.730
Cardiomyopathy, Congestive
[description not available]		03.0540
Cardiomyopathy, Dilated
A form of CARDIAC MUSCLE disease that is characterized by ventricular dilation, VENTRICULAR DYSFUNCTION, and HEART FAILURE. Risk factors include SMOKING; ALCOHOL DRINKING; HYPERTENSION; INFECTION; PREGNANCY; and mutations in the LMNA gene encoding LAMIN TYPE A, a NUCLEAR LAMINA protein.		03.0540
Back Ache
[description not available]		02.1110
Back Pain
Acute or chronic pain located in the posterior regions of the THORAX; LUMBOSACRAL REGION; or the adjacent regions.		02.1110
Acute Inferior Myocardial Infarction
[description not available]		02.1110
Femoral Hernia
[description not available]		02.1110
Acute Onset Aura Migraine
[description not available]		02.1110
Fusiform Aneurysm
Elongated, spindle-shaped dilation in the wall of blood vessels, usually large ARTERIES with ATHEROSCLEROSIS.		02.1110
Aneurysm
Pathological outpouching or sac-like dilatation in the wall of any blood vessel (ARTERIES or VEINS) or the heart (HEART ANEURYSM). It indicates a thin and weakened area in the wall which may later rupture. Aneurysms are classified by location, etiology, or other characteristics.		07.1110
Migraine with Aura
A subtype of migraine disorder, characterized by recurrent attacks of reversible neurological symptoms (aura) that precede or accompany the headache. Aura may include a combination of sensory disturbances, such as blurred VISION; HALLUCINATIONS; VERTIGO; NUMBNESS; and difficulty in concentrating and speaking. Aura is usually followed by features of the COMMON MIGRAINE, such as PHOTOPHOBIA; PHONOPHOBIA; and NAUSEA. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)		02.1110
Low Bone Density
[description not available]		02.1110
Calcification, Pathologic
[description not available]		02.1110
Fracture, Pathologic
[description not available]		02.1110
Bone Diseases, Metabolic
Diseases that affect the METABOLIC PROCESSES of BONE TISSUE.		02.1110
Calcinosis
Pathologic deposition of calcium salts in tissues.		02.1110
Anxiety
Feelings or emotions of dread, apprehension, and impending disaster but not disabling as with ANXIETY DISORDERS.		07.1510
Circulatory Collapse
[description not available]		02.1310
Shock
A pathological condition manifested by failure to perfuse or oxygenate vital organs.		02.1310
Femoral Fractures
Fractures of the femur.		02.1310
Infections, Helicobacter
[description not available]		02.1110
Helicobacter Infections
Infections with organisms of the genus HELICOBACTER, particularly, in humans, HELICOBACTER PYLORI. The clinical manifestations are focused in the stomach, usually the gastric mucosa and antrum, and the upper duodenum. This infection plays a major role in the pathogenesis of type B gastritis and peptic ulcer disease.		02.1110
Conjunctival Diseases
Diseases involving the CONJUNCTIVA.		02.520
Cardio-Renal Syndrome
Condition where a primary dysfunction of either heart or kidney results in failure of the other organ (e.g., HEART FAILURE with worsening RENAL INSUFFICIENCY).		02.1310
Hemorrhage, Vitreous
[description not available]		02.5420
Choroid Diseases
Disorders of the choroid including hereditary choroidal diseases, neoplasms, and other abnormalities of the vascular layer of the uvea.		02.1310
Hyphema
Bleeding in the anterior chamber of the eye.		07.5420
Vitreous Hemorrhage
Hemorrhage into the VITREOUS BODY.		07.5420
Absence Seizure
[description not available]		02.1310
Seizures
Clinical or subclinical disturbances of cortical function due to a sudden, abnormal, excessive, and disorganized discharge of brain cells. Clinical manifestations include abnormal motor, sensory and psychic phenomena. Recurrent seizures are usually referred to as EPILEPSY or seizure disorder.		02.1310
Malabsorption Syndromes
General term for a group of MALNUTRITION syndromes caused by failure of normal INTESTINAL ABSORPTION of nutrients.		02.1310
Thyrotoxicosis
A hypermetabolic syndrome caused by excess THYROID HORMONES which may come from endogenous or exogenous sources. The endogenous source of hormone may be thyroid HYPERPLASIA; THYROID NEOPLASMS; or hormone-producing extrathyroidal tissue. Thyrotoxicosis is characterized by NERVOUSNESS; TACHYCARDIA; FATIGUE; WEIGHT LOSS; heat intolerance; and excessive SWEATING.		07.1310
Cystic Fibrosis of Pancreas
[description not available]		02.1310
Cystic Fibrosis
An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.		07.1310
Eczematous Disorders
[description not available]		02.1310
Eczema, Dyshidrotic
A recurrent eczematous reaction characterized by the development of vesicular eruptions on the palms and soles, particularly along the sides and between the digits. It is accompanied by pruritus, a burning sensation, and hyperhidrosis. The disease is self-limiting, lasting only a few weeks. (Dorland, 27th ed)		02.1310
Acute-Phase Reaction
An early local inflammatory reaction to insult or injury that consists of fever, an increase in inflammatory humoral factors, and an increased synthesis by hepatocytes of a number of proteins or glycoproteins usually found in the plasma.		03.0410
Hemorrhage, Retinal
[description not available]		02.1510
Duodenal Diseases
Pathological conditions in the DUODENUM region of the small intestine (INTESTINE, SMALL).		02.1510
Acute Mesenteric Arterial Embolus
[description not available]		02.1310
Retinal Pigment Epithelial Detachment
[description not available]		02.1310
Retinal Detachment
Separation of the inner layers of the retina (neural retina) from the pigment epithelium. Retinal detachment occurs more commonly in men than in women, in eyes with degenerative myopia, in aging and in aphakia. It may occur after an uncomplicated cataract extraction, but it is seen more often if vitreous humor has been lost during surgery. (Dorland, 27th ed; Newell, Ophthalmology: Principles and Concepts, 7th ed, p310-12).		07.1310
Chronic Idiopathic Intestinal Pseudo-Obstruction
[description not available]		02.1310
Anorectal Diseases
[description not available]		02.520
Intestinal Pseudo-Obstruction
A type of ILEUS, a functional not mechanical obstruction of the INTESTINES. This syndrome is caused by a large number of disorders involving the smooth muscles (MUSCLE, SMOOTH) or the NERVOUS SYSTEM.		02.1310
Rectal Diseases
Pathological developments in the RECTUM region of the large intestine (INTESTINE, LARGE).		02.520
Benign Neoplasms, Brain
[description not available]		02.1310
Astrocytoma, Grade IV
[description not available]		02.1310
Brain Neoplasms
Neoplasms of the intracranial components of the central nervous system, including the cerebral hemispheres, basal ganglia, hypothalamus, thalamus, brain stem, and cerebellum. Brain neoplasms are subdivided into primary (originating from brain tissue) and secondary (i.e., metastatic) forms. Primary neoplasms are subdivided into benign and malignant forms. In general, brain tumors may also be classified by age of onset, histologic type, or presenting location in the brain.		02.1310
Glioblastoma
A malignant form of astrocytoma histologically characterized by pleomorphism of cells, nuclear atypia, microhemorrhage, and necrosis. They may arise in any region of the central nervous system, with a predilection for the cerebral hemispheres, basal ganglia, and commissural pathways. Clinical presentation most frequently occurs in the fifth or sixth decade of life with focal neurologic signs or seizures.		07.1310
Infectious Diseases
[description not available]		03.0610
Dehydration
The condition that results from excessive loss of water from a living organism.		03.0610
Communicable Diseases
An illness caused by an infectious agent or its toxins that occurs through the direct or indirect transmission of the infectious agent or its products from an infected individual or via an animal, vector or the inanimate environment to a susceptible animal or human host.		03.0610
Autoimmune Thrombocytopenia
[description not available]		02.4720
Purpura, Thrombocytopenic, Idiopathic
Thrombocytopenia occurring in the absence of toxic exposure or a disease associated with decreased platelets. It is mediated by immune mechanisms, in most cases IMMUNOGLOBULIN G autoantibodies which attach to platelets and subsequently undergo destruction by macrophages. The disease is seen in acute (affecting children) and chronic (adult) forms.		02.4720
Angor Pectoris
[description not available]		02.1310
Angina Pectoris
The symptom of paroxysmal pain consequent to MYOCARDIAL ISCHEMIA usually of distinctive character, location and radiation. It is thought to be provoked by a transient stressful situation during which the oxygen requirements of the MYOCARDIUM exceed that supplied by the CORONARY CIRCULATION.		02.1310
Intestinal Obstruction
Any impairment, arrest, or reversal of the normal flow of INTESTINAL CONTENTS toward the ANAL CANAL.		02.1510
Coxsackie Virus Infections
[description not available]		02.1510
Alogia
[description not available]		02.520
Aphasia
A cognitive disorder marked by an impaired ability to comprehend or express language in its written or spoken form. This condition is caused by diseases which affect the language areas of the dominant hemisphere. Clinical features are used to classify the various subtypes of this condition. General categories include receptive, expressive, and mixed forms of aphasia.		02.520
Carcinogenesis
The origin, production or development of cancer through genotypic and phenotypic changes which upset the normal balance between cell proliferation and cell death. Carcinogenesis generally requires a constellation of steps, which may occur quickly or over a period of many years.		02.1310
Cancer of Ovary
[description not available]		02.1310
Ovarian Neoplasms
Tumors or cancer of the OVARY. These neoplasms can be benign or malignant. They are classified according to the tissue of origin, such as the surface EPITHELIUM, the stromal endocrine cells, and the totipotent GERM CELLS.		02.1310
Coma
A profound state of unconsciousness associated with depressed cerebral activity from which the individual cannot be aroused. Coma generally occurs when there is dysfunction or injury involving both cerebral hemispheres or the brain stem RETICULAR FORMATION.		02.1510
Infections, Orthomyxoviridae
[description not available]		02.1310
Orthomyxoviridae Infections
Virus diseases caused by the ORTHOMYXOVIRIDAE.		02.1310
Glaucoma, Suspect
[description not available]		02.1510
Ocular Hypertension
A condition in which the intraocular pressure is elevated above normal and which may lead to glaucoma.		02.1510
Skin Ulcer
An ULCER of the skin and underlying tissues.		02.1510
Bacterial Pneumonia
[description not available]		02.4820
Infections, Klebsiella
[description not available]		02.1510
Klebsiella Infections
Infections with bacteria of the genus KLEBSIELLA.		02.1510
Pneumonia, Bacterial
Inflammation of the lung parenchyma that is caused by bacterial infections.		02.4820
Macular Holes
[description not available]		02.1510
Retinal Perforations
Perforations through the whole thickness of the retina including the macula as the result of inflammation, trauma, degeneration, etc. The concept includes retinal breaks, tears, dialyses, and holes.		02.1510
Pus
[description not available]		02.0410
Infection, Postoperative Wound
[description not available]		02.0410
Erythema
Redness of the skin produced by congestion of the capillaries. This condition may result from a variety of disease processes.		03.4311
Diseases, Peripheral Vascular
[description not available]		02.0410
Peripheral Vascular Diseases
Pathological processes involving any one of the BLOOD VESSELS in the vasculature outside the HEART.		02.0410
Acute Respiratory Distress Syndrome
[description not available]		02.0510
Respiratory Distress Syndrome
A syndrome characterized by progressive life-threatening RESPIRATORY INSUFFICIENCY in the absence of known LUNG DISEASES, usually following a systemic insult such as surgery or major TRAUMA.		02.0510
Alveolitis, Fibrosing
[description not available]		03.6730
Sclerosis, Systemic
[description not available]		02.9610
Pulmonary Fibrosis
A process in which normal lung tissues are progressively replaced by FIBROBLASTS and COLLAGEN causing an irreversible loss of the ability to transfer oxygen into the bloodstream via PULMONARY ALVEOLI. Patients show progressive DYSPNEA finally resulting in death.		08.6730
Scleroderma, Systemic
A chronic multi-system disorder of CONNECTIVE TISSUE. It is characterized by SCLEROSIS in the SKIN, the LUNGS, the HEART, the GASTROINTESTINAL TRACT, the KIDNEYS, and the MUSCULOSKELETAL SYSTEM. Other important features include diseased small BLOOD VESSELS and AUTOANTIBODIES. The disorder is named for its most prominent feature (hard skin), and classified into subsets by the extent of skin thickening: LIMITED SCLERODERMA and DIFFUSE SCLERODERMA.		02.9610
Abnormalities, Drug-Induced
Congenital abnormalities caused by medicinal substances or drugs of abuse given to or taken by the mother, or to which she is inadvertently exposed during the manufacture of such substances. The concept excludes abnormalities resulting from exposure to non-medicinal chemicals in the environment.		02.0510
Puerperal Disorders
Disorders or diseases associated with PUERPERIUM, the six-to-eight-week period immediately after PARTURITION in humans.		02.0510
Invasiveness, Neoplasm
[description not available]		02.0510
Delirium of Mixed Origin
[description not available]		02.9710
Delirium
A disorder characterized by CONFUSION; inattentiveness; disorientation; ILLUSIONS; HALLUCINATIONS; agitation; and in some instances autonomic nervous system overactivity. It may result from toxic/metabolic conditions or structural brain lesions. (From Adams et al., Principles of Neurology, 6th ed, pp411-2)		02.9710
Symptom Cluster
[description not available]		02.0610
Syndrome
A characteristic symptom complex.		07.0610
Air Embolism
[description not available]		02.0610
Blood Coagulation Disorders, Inherited
Hemorrhagic and thrombotic disorders that occur as a consequence of inherited abnormalities in blood coagulation.		02.9810
Hemiplegia, Crossed
[description not available]		02.0610
Hemiplegia
Severe or complete loss of motor function on one side of the body. This condition is usually caused by BRAIN DISEASES that are localized to the cerebral hemisphere opposite to the side of weakness. Less frequently, BRAIN STEM lesions; cervical SPINAL CORD DISEASES; PERIPHERAL NERVOUS SYSTEM DISEASES; and other conditions may manifest as hemiplegia. The term hemiparesis (see PARESIS) refers to mild to moderate weakness involving one side of the body.		02.0610
Itching
[description not available]		02.0610
Pruritus
An intense itching sensation that produces the urge to rub or scratch the skin to obtain relief.		02.0610
Aneurysm, Anterior Cerebral Artery
[description not available]		02.0610
Intracranial Aneurysm
Abnormal outpouching in the wall of intracranial blood vessels. Most common are the saccular (berry) aneurysms located at branch points in CIRCLE OF WILLIS at the base of the brain. Vessel rupture results in SUBARACHNOID HEMORRHAGE or INTRACRANIAL HEMORRHAGES. Giant aneurysms (		02.0610
Splenic Diseases
Diseases involving the SPLEEN.		02.0710
Angina at Rest
[description not available]		05.6721
Asystole
[description not available]		04.3711
Cardiac Arrest, Sudden
[description not available]		04.3711
Angina, Unstable
Precordial pain at rest, which may precede a MYOCARDIAL INFARCTION.		05.6721
Heart Arrest
Cessation of heart beat or MYOCARDIAL CONTRACTION. If it is treated within a few minutes, heart arrest can be reversed in most cases to normal cardiac rhythm and effective circulation.		04.3711
Death, Sudden, Cardiac
Unexpected rapid natural death due to cardiovascular collapse within one hour of initial symptoms. It is usually caused by the worsening of existing heart diseases. The sudden onset of symptoms, such as CHEST PAIN and CARDIAC ARRHYTHMIAS, particularly VENTRICULAR TACHYCARDIA, can lead to the loss of consciousness and cardiac arrest followed by biological death. (from Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine, 7th ed., 2005)		04.3711
Cranial Epidural Hematoma
[description not available]		02.0710
Paroxysmal Reciprocal Tachycardia
[description not available]		02.0710
Tachycardia, Paroxysmal
Abnormally rapid heartbeats with sudden onset and cessation.		02.0710
Brain Hemorrhage, Traumatic
Bleeding within the brain as a result of penetrating and nonpenetrating CRANIOCEREBRAL TRAUMA. Traumatically induced hemorrhages may occur in any area of the brain, including the CEREBRUM; BRAIN STEM (see BRAIN STEM HEMORRHAGE, TRAUMATIC); and CEREBELLUM.		02.0710
Basilar Artery Insufficiency
[description not available]		02.0710
Gastritis
Inflammation of the GASTRIC MUCOSA, a lesion observed in a number of unrelated disorders.		09.3220
Bone Cancer
[description not available]		02.0710
Bone Neoplasms
Tumors or cancer located in bone tissue or specific BONES.		02.0710
Urinary Retention
Inability to empty the URINARY BLADDER with voiding (URINATION).		02.0710
Allergic Reaction
[description not available]		02.9910
Hypersensitivity
Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.		02.9910
Amyotrophy, Thenar, Of Carpal Origin
[description not available]		02.0710
Carpal Tunnel Syndrome
Entrapment of the MEDIAN NERVE in the carpal tunnel, which is formed by the flexor retinaculum and the CARPAL BONES. This syndrome may be associated with repetitive occupational trauma (CUMULATIVE TRAUMA DISORDERS); wrist injuries; AMYLOID NEUROPATHIES; rheumatoid arthritis (see ARTHRITIS, RHEUMATOID); ACROMEGALY; PREGNANCY; and other conditions. Symptoms include burning pain and paresthesias involving the ventral surface of the hand and fingers which may radiate proximally. Impairment of sensation in the distribution of the median nerve and thenar muscle atrophy may occur. (Joynt, Clinical Neurology, 1995, Ch51, p45)		07.0710
MS (Multiple Sclerosis)
[description not available]		02.0710
Cancer of the Thyroid
[description not available]		02.0710
Multiple Sclerosis
An autoimmune disorder mainly affecting young adults and characterized by destruction of myelin in the central nervous system. Pathologic findings include multiple sharply demarcated areas of demyelination throughout the white matter of the central nervous system. Clinical manifestations include visual loss, extra-ocular movement disorders, paresthesias, loss of sensation, weakness, dysarthria, spasticity, ataxia, and bladder dysfunction. The usual pattern is one of recurrent attacks followed by partial recovery (see MULTIPLE SCLEROSIS, RELAPSING-REMITTING), but acute fulminating and chronic progressive forms (see MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE) also occur. (Adams et al., Principles of Neurology, 6th ed, p903)		02.0710
Thyroid Neoplasms
Tumors or cancer of the THYROID GLAND.		02.0710
Carcinoma, Neuroendocrine
A group of carcinomas which share a characteristic morphology, often being composed of clusters and trabecular sheets of round blue cells, granular chromatin, and an attenuated rim of poorly demarcated cytoplasm. Neuroendocrine tumors include carcinoids, small (oat) cell carcinomas, medullary carcinoma of the thyroid, Merkel cell tumor, cutaneous neuroendocrine carcinoma, pancreatic islet cell tumors, and pheochromocytoma. Neurosecretory granules are found within the tumor cells. (Segen, Dictionary of Modern Medicine, 1992)		02.0710
Coronary Restenosis
Recurrent narrowing or constriction of a coronary artery following surgical procedures performed to alleviate a prior obstruction.		02.0710
Hematemesis
Vomiting of blood that is either fresh bright red, or older coffee-ground in character. It generally indicates bleeding of the UPPER GASTROINTESTINAL TRACT.		02.4820
Gastric Diseases
[description not available]		02.0810
Post-Traumatic Subarachnoid Hemorrhage
[description not available]		02.0710
Drug-Induced Stevens Johnson Syndrome
[description not available]		02.0810
Stevens-Johnson Syndrome
Rare cutaneous eruption characterized by extensive KERATINOCYTE apoptosis resulting in skin detachment with mucosal involvement. It is often provoked by the use of drugs (e.g., antibiotics and anticonvulsants) or associated with PNEUMONIA, MYCOPLASMA. It is considered a continuum of Toxic Epidermal Necrolysis.		02.0810
Adrenal Gland Hypofunction
[description not available]		02.0810
Adrenal Gland Diseases
Pathological processes of the ADRENAL GLANDS.		02.0810
Adrenal Insufficiency
Conditions in which the production of adrenal CORTICOSTEROIDS falls below the requirement of the body. Adrenal insufficiency can be caused by defects in the ADRENAL GLANDS, the PITUITARY GLAND, or the HYPOTHALAMUS.		02.0810
Bladder Cancer
[description not available]		02.0810
Urinary Bladder Neoplasms
Tumors or cancer of the URINARY BLADDER.		02.0810
Carcinoma, Transitional Cell
A malignant neoplasm derived from TRANSITIONAL EPITHELIAL CELLS, occurring chiefly in the URINARY BLADDER; URETERS; or RENAL PELVIS.		02.0810
Flatus
[description not available]		03.4311
Flatulence
Production or presence of gas in the gastrointestinal tract which may be expelled through the anus.		03.4311
Postphlebitic Disease
[description not available]		02.9610
Community Acquired Infection
[description not available]		02.0410
Cardiac Cancer
[description not available]		02.0410
Primary Peritonitis
[description not available]		02.0410
Peritonitis
INFLAMMATION of the PERITONEUM lining the ABDOMINAL CAVITY as the result of infectious, autoimmune, or chemical processes. Primary peritonitis is due to infection of the PERITONEAL CAVITY via hematogenous or lymphatic spread and without intra-abdominal source. Secondary peritonitis arises from the ABDOMINAL CAVITY itself through RUPTURE or ABSCESS of intra-abdominal organs.		02.0410