beta-alanine and Bleeding

beta-alanine has been researched along with Bleeding in 299 studies

Research

Studies (299)

Authors

Clinical Trials (34)

Trial Overview

Trial Outcomes

Chest Tube Output

The amount of chest tube drainage output from after surgery through midnight of the next day. As measured in mL. (NCT02557672)
Timeframe: 24 hours

Cryoprecipitate (Cryo) Blood Product Transfusion

The number of subject's who received 0,1,2,3 or more units of Cryo's transfused from completion of study drug administration though midnight of the next day. (NCT02557672)
Timeframe: 24 hours

Fresh Frozen Plasma (FFP) Blood Product Transfusion

The number of subject's who received 0,1,2,3 or more units of FFP's transfused from completion of study drug administration though midnight of the next day. (NCT02557672)
Timeframe: 24 hours

Platelets Blood Product Transfusion

The number of subject's who received 0,1,2,3 or more units of Platelets transfused from completion of study drug administration though midnight of the next day. (NCT02557672)
Timeframe: 24 hours

Red Blood Cell (RBC) Blood Product Transfusion

The number of subject's who received 0,1,2,3 or more units of RBC's transfused from completion of study drug administration though midnight of the next day. (NCT02557672)
Timeframe: 24 hours

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

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

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

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

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

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

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

Laboratory Measures, Especially Liver Function Tests (LFTs)

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

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

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

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

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

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

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

Deaths Related to VTE at 18 Months

Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way. (NCT00329238)
Timeframe: 18 months

Deaths Related to VTE at 36 Months

Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way. (NCT00329238)
Timeframe: 36 months

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

DVT at 18 Months

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

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)

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)

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)

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

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

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

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

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

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

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

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

Incidence of Anticoagulant-related Nephropathy in the Cohort

Primary endpoint - Incidence of ARN is the primary outcome of this study and this is based on a documentation of AKI (defined as an increase in baseline serum creatinine ≥ 0.3 mg/dL), in the absence of any other obvious etiology for the AKI identified after a standard clinical evaluation and work up by the patient's primary care physician, cardiologist or nephrologist. This incidence will be expressed as a percentage. (NCT02900170)
Timeframe: 6 months

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

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.

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)

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

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

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.

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.

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.

Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE

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 end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)

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.

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)

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.

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.

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

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)

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.

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.

Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE

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 end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)

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.

Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban

The investigators will calculate the # of gap days between refills for dabigatran/rivaroxaban/apixaban for each3 and 6 months of the pilot intervention. This will be based on pharmacy refill data and calculated using the date dabigatran/rivaroxaban/apixaban was dispensed and the # of days supplied for that prescription. We will add the # of gap days for each 3 and 6 months of the pilot for each patient, and compare the total # of gaps days between intervention and usual care patients. The gap days between refills is a validated measure of adherence and identifies patients with sub-optimal adherence.A negative gap day value indicates that participants received the refill prior to completion of the previous prescription. (NCT01578044)
Timeframe: 3 and 6 months

Apixaban Plasma Concentration, Cmax

Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1. (NCT02942407)
Timeframe: 0-12 hours post-dose

Apixaban Plasma Concentration, Cmin

Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1. (NCT02942407)
Timeframe: 0-12 hours post-dose

Area Under the Plasma Apixaban Concentration Curve From 0 to 12 Hours After Dose (AUCO-12)

Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0 to 12 hours after dose was given on Day 1. (NCT02942407)
Timeframe: 0-12 hours post-dose

Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding

"Assess the safety of apixaban versus warfarin regarding ISTH major bleeding or clinically relevant non-major bleeding events in patients with NVAF (nonvalvular atrial fibrillation) and ESRD (end-stage renal disease) on hemodialysis.~Major bleeding event is defined as:Acute clinically overt bleeding (including access site related bleeding) accompanied by 1 or more of the following: Decrease in Hgb of 2g/dL or more with overt bleeding; Transfusion of 2 or more units of packed RBCs in the setting of an overt bleeding event; Bleeding within a critical site. Hemorrhagic stroke (primary or infarction with hemorrhagic conversion) were classified as major bleeds.~Non-major bleeding event is defined as: Acute or sub-acute clinically overt bleeding (including access site related bleeding) that does not meet criteria for major bleeding & results in Hospital admission for bleeding, physician guided medical or surgical treatment for bleeding, or change in antithrombotic therapy" (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Number of Participants Experiencing Mortality

Evaluate mortality rates for those participants randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Number of Participants Experiencing Stroke

"Adjudcated stroke defined as a new, non-traumatic episode of focal or global neurological dysfunction of sudden onset caused by central nervous system (CNS) vascular injury as a result of hemorrhage or infarction and not due to a readily identifiable non-vascular cause (i.e. brain tumor). CNS includes brain, spinal cord and retina. The required duration of the deficit is ≥ 24 hours.~Events with neurologic deficit lasting for < 24 hours and an imaging modality showing evidence of an acute stroke will be counted as stroke as well.~A retinal ischemic event (embolism, infarction) will be considered a stroke" (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Number of Participants Experiencing Stroke or Systemic Embolism

Number of participants experiencing adjudicated stroke or systemic embolism. (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Number of Participants Experiencing Stroke, Systemic Embolism, Major Bleeding or All-cause Mortality

"Evaluate those experiencing stroke, systemic embolism, ISTH major bleeding, or all-cause mortality for those randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis~Definitions of stroke and systemic embolism are provided under the measurement description of the secondary outcomes for each individual event. Definition of major bleed is provided in outcome measurement description of the primary outcome measure." (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Number of Participants Experiencing Systemic Embolism

"Adjudicated diagnosis of systemic arterial embolism (Non-pulmonary, non-cranial events) will require a positive clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which is supported by evidence of embolism/thrombosis from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.~Clinical presentation would include:~Abrupt development of pain, absent pulses, pallor, and/or paresis in an extremity (at least an entire digit) without previous severe claudication or findings of severe peripheral vascular disease.~Renal embolism will be diagnosed when sudden flank pain or a change in renal laboratory findings occurred.~Abdominal vascular/visceral embolism was considered definite if acute abdominal symptoms or referred symptoms developed along with a change in abdominal examination or appropriate laboratory values." (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Persistence of Therapy

Evaluate days between time from initiation to discontinuation of randomized therapy. (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Cmin,1 of Unbound Sum (Free) Dabigatran

Cmin,1 (Minimum concentrations at any time point since the end of first vial of idarucizumab up to 4 hours after the completion of second vial) of unbound sum (free) dabigatran, provided that two vials given not more than 15 min apart in group A and B. (NCT02104947)
Timeframe: Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial

Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively

Occurrence of major/life-threatening/fatal bleeding (for group B only) intraoperatively and up to 24 hours post-surgery were classified according to major or life-threatening bleeding (ISTH [International Society for Thrombosis and Hemostasis] definition). 95% Confidence Interval (CI) is from Clopper-Pearson method. (NCT02104947)
Timeframe: within 24 hours of surgery

Time to Cessation of Bleeding (for Group A Only)

Time to cessation of bleeding (for Group A only) since first infusion up to 24 hours after the completion of second infusion; bleeding status was to be categorized before and at several time points after treatment. (NCT02104947)
Timeframe: from the first infusion up to 24 hours after the last infusion on Day 1

Duration of Reversal

Duration of reversal, defined as the time period a patient remained completely reversed based on dTT or ECT, up to 24 hours or re-starting the treatment of dabigatran. (NCT02104947)
Timeframe: from the first infusion up to 24 hours after the last infusion on Day 1

Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT

"Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion.~Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients).~Reversal is calculated as 100* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100." (NCT02104947)
Timeframe: from the end of the first infusion up to 4 hours after the last infusion on Day 1

Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial

"Reversal of anticoagulation as measured by diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first vial of idarucizumab and before the start of second vial.~Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100*(pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100." (NCT02104947)
Timeframe: after the first vial of idarucizumab and before the start of second vial on Day1

Reversal of aPTT and TT From Central Laboratory

"Reversal of anticoagulation as measured by Activated Partial Thromboplastin Time (aPTT) and Thrombin time (TT), at any time point since the end of first infusion up to 4 hours after the completion of the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients).~Reversal is calculated as 100* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100." (NCT02104947)
Timeframe: from the end of the first infusion up to 4 hours after the last infusion on Day 1

Number of Participants Who Died During Treatment Period

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

Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period

Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee (NCT00657150)
Timeframe: 28-35 days

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

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

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

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

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

Volume of Blood Loss

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

Blood Transfusion

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

Laboratory Analyses

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

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

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

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