dalteparin and Body Weight

dalteparin has been researched along with Body Weight in 80 studies

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)

Body Weight: The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.

Research

Studies (80)

Authors

Clinical Trials (13)

Trial Overview

Trial Outcomes

Number of Participants With Bleeding Events

Bleeding events requiring alteration in the course of care within 90 days of surgery (NCT03251963)
Timeframe: 90 days

Number of Participants With Venous Thromboembolism Events or Death

Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery (NCT03251963)
Timeframe: 90 days

Number of Patients With in Range Initial Peak Xa Level

Number of patients with in range initial peak Xa level (NCT03251963)
Timeframe: 36 hours

Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period

Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: Up to 30 days after the last intake of study medication

Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment

Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6-, or 12-month study treatment period

Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period

Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: Up to 30 days after the last intake of study medication

Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment

Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)

All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With Recurrent DVT During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: Up to 30 days after the last intake of study medication

Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. (NCT00439777)
Timeframe: 3-, 6-, or 12-month study treatment period

Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. (NCT00439777)
Timeframe: Up to 30 days after the last intake of study medication

Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: Up to 30 days after the last intake of study medication

Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6-, or 12-month study treatment period

Percentage of Participants With All Deaths

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. (NCT00439777)
Timeframe: Up to 30 days after the last intake of study medication

Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period

Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE or major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: Up to 30 days after the last intake of study medication

Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment

Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period

Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding, cardiovascular death, myocardial infarctions, stroke, or non CNS systemic embolism. Major bleeding was associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography ( PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: Up to 30 days after the last intake of study medication

Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment

Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death, cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events confirmed by independent committee blinded to treatment, based on compression ultrasound, venography, spiral CT scan, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy, results/films/images of confirmatory testing and/or case summaries (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)

All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With Recurrent DVT During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: Up to 30 days after the last intake of study medication

Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: Up to 30 days after the last intake of study medication

Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: Up to 30 days after the last intake of study medication

Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With All Deaths

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. (NCT00440193)
Timeframe: Up to 30 days after the last intake of study medication

Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

Rate of Composite of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During Intended Treatment Period

Event rate=Number of events divided by the number of patients evaluated. Each patient was categorized as having no proximal DVT, having proximal DVT, being nonevaluable for proximal DVT, having no distal DVT, having distal DVT, or being nonevaluable for distal DVT. Adjudication criteria were: Normal=All deep veins were visualized, and there was no intraluminal filling defect (ILFD). ILFD=An area of reduced, or absent filling, at least partially surrounded with contrast medium in ≥ 2 projections or a lack of filling in a vessel in which there was a cut-off that had the configuration of a thrombus. Indeterminate=A lack of filling of a region of the deep vein system, proximal or distal, without the presence of an ILFD elsewhere in the same region. Not Done=A venography was not performed. Proximal DVT was found if any of the proximal veins had an ILFD. Pulmonary embolism was radiographically (angiography, V/Q scan, computed tomography) determined. (NCT00423319)
Timeframe: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period

Event rate=Number of events divided by the number of patients evaluated. A mandatory bilateral ascending contrast venogram was to be obtained on Day 35 (± 3). Patients with confirmed symptomatic DVT at any time, or asymptomatic DVT upon venography, were to receive treatment for DVT according to the investigator's standard of care. Signs and symptoms suggestive of VTE included, but were not limited to: 1) lower extremity DVT: erythema, warmth, pain, swelling, tenderness; and 2) PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended Treatment Period started on day of randomization and, for patients who received treatment, ended at the later of 2 days after last dose of study drug or 38 days after the first dose (presurgery) of study drug. For randomized patients who did not receive study drug, the period ended 38 days after randomization. (NCT00423319)
Timeframe: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

Number of Participants With a Bleeding-related Adverse Event During the Treatment Period

All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug

Number of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued)

All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug

Number of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued)

All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug

Number of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment Period

Treatment guidelines were provided for jaundice and elevated results of liver function tests. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 30 days after the last dose of study drug

Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period

preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. MA criteria: Hemoglobin: >2 g/dL decrease from preRx or value ≤ 8 g/dL; hematocrit (%): <0.75*preRx; platelet count (*10^9 cells/L): <100,000/mm^3; erythrocytes (*10^6 cells/μL): <0.75*preRx level; leukocytes (*10^3 cells/μL): < 0.75*LLN or >1.25*ULN, or if preRx LLN use < 0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or 400/mm^3; eosinophils (*10^3 cells/μL): > 0.75*10^3 cells/μL; lymphocytes (*10^3 cells/μL): >0.75*10^3 cells/μL; monocytes (*10^3 cells/μL): >2000/mm^3; neutrophils (*10^3 cells/μL): <1.0; (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug

Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)

preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Alanine aminotransferase (ALT) (U/L): >3 *ULN: alkaline phosphatase (ALP) (U/L): >2* ULN; aspartate aminotransferase (ASP) (U/L): >3 *ULN; bilirubin, direct (mg/dL): >2*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN; calcium (mg/dL): < 0.8*LLN or >1.2 *ULN, or if preRx ULN if preRx >ULN use > 1.25*preRx or 1.1*ULN, or if preRx ULN if preRx >ULN use >1.1* preRx or 1.25*ULN, or if preRx ULN if preRx >ULN use >1.25*preRx or 1.1*ULN, or if preRx ULN if preRx >ULN use >1.1* preRx or < LLN; sodium (mEq/L): <0.95* LLN or >1.05×ULN, or if preRx ULN if preRx >ULN use >1.05 *preRx or < LLN. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug

Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)

preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Glucose, fasting (mg/dL): <.8*LLN or >1.5*ULN, or if preRx ULN if preRx >ULN use >2*preRx or 5*ULN; uric acid (mg/dL): >.5* ULN, or if preRx >ULN use >2*preRx; blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; glucose, urine : If missing preRx use ≥2, or if value ≥4, or if preRx=0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; RBC, urine (hpf): If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx dose= 1 use ≥3, or if preRx=2 or 3 use ≥4; WBC, urine (h): If missing preRx use ≥2, or if value ≥4, or if preRx =0 or .5 use ≥2, or if preRx =1 use ≥3, or if preRx=2 or 3 use ≥4. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug

Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period

Neurologic events were based on Medical Dictionary for Regulatory Activities search categories.For new or worsening events that were not related to the site of surgery, additional information was collected on a specific form. In addition, neurology consultation was to be obtained for these patients. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug

Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All suspected bleeding events were to be reported by the investigator as either an AE or SAE and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 30 days after the last dose of study drug

Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period

Event rate=Number of events divided by the number of patients evaluated. Major bleeding event defined as a bleeding event that was 1) Acute clinically overt bleeding accompanied by at least 1 of the following: decrease in hemoglobin of ≥ 2 g/dL over a 24-hour period, transfusion of ≥2 units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intra-spinal, intraocular, pericardial, an operated joint and requires reoperation or intervention, intramuscular with compartment syndrome, or retroperitoneal; 2) Fatal. CRNM was defined as acute clinically overt bleeding that did not satisfy the criteria for a major bleeding event and met at least 1 of the following: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, or hemoptysis. Minor bleeding was defined as an acute clinically overt bleeding event that did not meet the criteria for major bleeding or a CRNM. Fatal bleeding event was defined as bleeding that was the primary (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug

Rates of Adjudicated All-cause Death, VTE-related Death, Pulmonary Embolism (PE), Nonfatal PE, Deep Vein Thrombosis (DVT) (Symptomatic and Asymptomatic), Symptomatic and Asymptomatic Proximal and Distal DVT During the Intended Treatment Period

VTE=venous thromboembolic event; VTE-related death=combination of fatal or nonfatal PE and symptomatic or asymptomatic DVT. Event rate=Number of events divided by the number of patients evaluated. (NCT00423319)
Timeframe: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period

Event rate=Number of events divided by the number of patients evaluated. All suspected events were reported by investigator. Acute MI=the presence of a clinical situation (eg, abnormal history, physical examination, new electrocardiogram changes) suggestive of an MI and at least 1 of the following: elevated creatine kinase (CK)-MB or troponin T or troponin I ≥2*upper limit of normal (ULN); if CK-MB or troponin values not available, total CK ≥2*ULN; or new significant (≥0.04 sec) Q waves in ≥2 contiguous leads. Stroke=a new focal neurologic deficit of sudden onset lasting at least 24 hours that was not due to a readily identifiable nonvascular cause. Adjudication classified each reported stroke as primary hemorrhagic, nonhemorrhagic, infarction with hemorrhagic conversion, or unknown type. Thrombocytopenia=after 3 days as drop in platelet count to <100,000/mm^3 for patients with a baseline value >150,000/mm^3 or a >50% decline, if the baseline value was ≤150,000/mm^3. (NCT00423319)
Timeframe: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period

Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization; for randomized patients who did not receive study drug, the period ends 14 days after randomization. Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause. (NCT00452530)
Timeframe: Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study

Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period

Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization.Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause. (NCT00452530)
Timeframe: Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study drug

Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Bleeding AEs=all serious or nonserious bleeding-related AEs. (NCT00452530)
Timeframe: Days 1 through 12 + 2 days (nonserious AEs, bleeding AES) or 30 days (SAES, deaths) after last dose of study drug

Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM

Event rate=Number of events divided by number of patients evaluated. Adjusted difference of event rates takes into consideration type of surgery as a stratification factor. Bleeding Criteria: Major bleeding=an event consisting of clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. CRNM bleeding= clinically overt bleeding; that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event; that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding; or a change in antithrombic treatment. (NCT00452530)
Timeframe: Days 1 to 12

Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements)

preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRxULN if preRx >ULN use >1.25*preRx or 1.1*ULN, or if preRxULN if preRx>ULN use >1.1*preRx or 1.25*ULN, or if preRx < LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or < LLN; potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRxULN if preRx>ULN use >1.1*preRx or 1.05*ULN, or if preRx ULN if preRx>ULN use >1.05*preRx or 1.1*ULN, or if preRx ULN if preRx >ULN use 1.1*preRx or 5*ULN; uric acid (mg/dL): >1.5*ULN, or if preRx >ULN use >2*preRx; glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRx ULN. (NCT00452530)
Timeframe: Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up

Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis)

preRX=pretreatment. Blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; glucose, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; protein, urine: If missing preRx use ≥ 2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; Red blood cells , urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; white blood cells, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4. (NCT00452530)
Timeframe: Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (± 5 days) of follow-up

Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements)

preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal; abs=absolute. Hemoglobin (g/dL): >2 decrease from preRx value or value <=8; hematocrit (%): <0.75*preRx; platelets: <100*10^9 cells/L; erythrocytes (*10^6 cells/μL): <0.75*preRx; leukocytes: <0.75*LLN or >1.25*ULN, or if preRx ULN if preRx >ULN use >1.2*preRx or 400/mm^3; abs eosinophils: > 0.750*10^3 cells/µL; abs lymphocytes: <0.750*10*3 cells/ µL or >7.50*10^3 c/ µL; abs monocytes > 2000/mm^3; abs neutrophils: <1.0*10^3 cells/μL; ALP (U/L): >2*ULN; ALT, AST (U/L): >3*ULN; U/L; bilirubin, direct (mg/dL): >1.5*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN. (NCT00452530)
Timeframe: Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up

Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels

Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data for day 1 to 7 has been reported. (NCT00952380)
Timeframe: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase

Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level

Prespecified therapeutic anti-factor Xa level was 0.5-1.0 international unit per milliliter (IU/mL). Cumulative data of Day 1 to 7 has been reported. (NCT00952380)
Timeframe: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase

Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels

During dose adjustment phase, doses were adjusted according to prespecified therapeutic anti-Xa levels in order to achieve target prespecified therapeutic anti-factor Xa levels (0.5 to 1.0 IU/mL). Number of dose adjustments which were done within the specified time window of up to 4 hours post dose on all days (1 to 7) to achieve the prespecified therapeutic anti-Xa levels are reported. (NCT00952380)
Timeframe: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase

Number of Participants With Laboratory Abnormalities

Criteria:hematology:hemoglobin, hematocrit, erythrocytes less than(<)0.8*lower limit of normal(LLN), platelets <0.5*LLN >1.75*upper limit of normal (ULN),leukocytes <0.6* LLN >1.5* ULN, lymphocytes, lymphocytes/Leukocytes, neutrophils, neutrophils/leukocytes <0.8* LLN >1.2* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes >1.2*ULN, activated partial thromboplastin time, prothrombin time, prothrombin international normalized ratio >1.1* ULN. Clinical chemistry: bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN, protein, albumin <0.8* LLN >1.2* ULN, blood urea nitrogen, creatinine >1.3* ULN, sodium <0.95*LLN >1.05*ULN, potassium, chloride, calcium, magnesium <0.9* LLN >1.1* ULN, phosphate <0.8* LLN >1.2* ULN, glucose <0.6*LLN >1.5*ULN, estimated(est) creatinine clearance, est GFR modified and bedside schwartz, >1.0* ULN. Urinalysis: creatinine >1.0*ULN. (NCT00952380)
Timeframe: Baseline up to 104 days

Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE)

Symptomatic VTE defined as new or progressive signs and symptoms as judged by the investigator including but not limited to: objective swelling, pain or tenderness, pitting edema, erythema or cyanosis. Progression of VTE: Progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis. (NCT00952380)
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)

Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels

Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Percentage of participants who achieved the prespecified level during the dose adjustment phase were reported in this outcome measure. (NCT00952380)
Timeframe: Day 1 to 7 in dose adjustment phase

Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels

Time to achieve the target range (prespecified therapeutic anti- factor Xa levels) was defined as the number of days from the first dose of study drug to the final dose that achieves the target anti-factor Xa level. Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data of Day 1 to 7 is reported. (NCT00952380)
Timeframe: Day 1 to 7 in dose adjustment phase

Time to First Occurrence of Major Bleeding Event

Time to first occurrence of major bleeding event was defined as the time interval (in days) between date of first study treatment and date of documentation of first major bleeding event. A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter, overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, overt bleeding deemed by the attending physician to be unrelated to the participant's underlying condition and accompanied by blood product administration, bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal or intraspinal). (NCT00952380)
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)

Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)

It was defined as the time interval (in days) between date of first study treatment and date of documentation of first VTE. VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot breaks, loose and travels in the blood, this is called VTE. VTE was confirmed by at least one radiographic test and was defined as any new or progressive VTE whose signs and symptoms (identified by the investigator) included: objective swelling or tenderness, pitting edema, erythema or cyanosis. (NCT00952380)
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)

Absolute Values of Body Length of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Absolute Values of Body Length of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Absolute Values of Body Temperature of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants

Heart rate and pulse rate of participants were measured in terms of beats per minute. (NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants

Heart rate and pulse rate of participants were measured in terms of beats per minute. (NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants

Heart rate and pulse rate of participants were measured in terms of beats per minute. (NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants

Heart rate and pulse rate of participants were measured in terms of beats per minute. (NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Absolute Values of Height of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Absolute Values of Height of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Absolute Values of Height of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Absolute Values of Respiratory Rate of Participants

Respiratory rate was defined as the number of breaths per minute. (NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Absolute Values of Weight of Participants

(NCT00952380)
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Number of Participants With Physical Examination Abnormalities of Participants

Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Abnormality in physical examination was based on investigator's discretion. Only those categories in which at least 1 participant had abnormality were reported. (NCT00952380)
Timeframe: Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)

Number of Participants With Physical Examination Abnormalities of Participants

Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Abnormality in physical examination was based on investigator's discretion. Only those categories in which at least 1 participant had abnormality were reported. (NCT00952380)
Timeframe: Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)

Number of Participants With Physical Examination Abnormalities of Participants

Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Abnormality in physical examination was based on investigator's discretion. Only those categories in which at least 1 participant had abnormality were reported. (NCT00952380)
Timeframe: Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)

Number of Participants With Physical Examination Abnormalities of Participants

Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Abnormality in physical examination was based on investigator's discretion. Only those categories in which at least 1 participant had abnormality were reported. (NCT00952380)
Timeframe: Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after the last dose of study drug (up to Day 132) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. (NCT00952380)
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)

Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase

Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. The percentage of participants who had anti factor-Xa levels within the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure. (NCT00952380)
Timeframe: Day 30, Day 60, Day 90 in follow up phase

Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase

Prespecified therapeutic anti-factor Xa range was 0.5-1.0 IU/mL. The percentage of participants who had anti-factor Xa levels outside the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure. (NCT00952380)
Timeframe: Day 30, Day 60, Day 90 in follow-up phase

Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)

VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. PE is a blood clot in the lungs. Clinical response of progression was defined as progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis. Clinical response of regression: Regressed clot burden utilizing the same imaging modality as the screening visit. Clinical response of resolution: Thrombus resolution of the qualifying event measured by repeat imaging at the end of study (EOS) visit. (NCT00952380)
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)

Percentage of Participants With Major and Minor Bleeding Event

A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter 24 hours, Overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, Overt bleeding deemed by the attending physician to be unrelated to the participant's underlying condition and accompanied by blood product administration or bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal). A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major or clinically relevant no major bleeding (bleeding resulting in any medical or surgical interventions but which did not meet the criteria for major bleeding). (NCT00952380)
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)

Reviews

3 reviews available for dalteparin and Body Weight

Trials

25 trials available for dalteparin and Body Weight

Other Studies

52 other studies available for dalteparin and Body Weight