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Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)

2014年4月14日 更新者：Bristol-Myers Squibb

A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The Advance-3 Study Apixaban Dosed Orally Versus Anticoagulation With Injectable Enoxaparin to Prevent Venous Thromboembolism)

The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

5407

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Beijing
      • Beijing、Beijing、中国、100853
        • Local Institution
      • Beijing、Beijing、中国、100035
        • Local Institution
    • Guangdong
      • Guangzhou、Guangdong、中国、510405
        • Local Institution
    • Shandong
      • Qingdao、Shandong、中国、266003
        • Local Institution
    • Shanghai
      • Shanghai、Shanghai、中国、200025
        • Local Institution
      • Shanghai、Shanghai、中国、200011
        • Local Institution
      • Shanghai、Shanghai、中国、200233
        • Local Institution
  • 丹麦
      • Amager、丹麦、2300
        • Local Institution
      • Frederiksberg、丹麦、2000
        • Local Institution
      • Herlev、丹麦、2730
        • Local Institution
      • Horsholm、丹麦、2970
        • Local Institution
      • Hvidovre、丹麦、2650
        • Local Institution
      • Kobenhavn Nv、丹麦、2400
        • Local Institution
      • Silkeborg、丹麦、8600
        • Local Institution
  • 乌克兰
      • Cherkassy、乌克兰、18009
        • Local Institution
      • Chernivtsy、乌克兰、58013
        • Local Institution
      • Dnipropetrovsk、乌克兰、49005
        • Local Institution
      • Ivano-Frankivsk、乌克兰、76008
        • Local Institution
      • Kyiv、乌克兰、01601
        • Local Institution
      • Kyiv、乌克兰、04107
        • Local Institution
      • Sevastopol、乌克兰、99018
        • Local Institution
  • 以色列
      • Beer Sheva、以色列、84101
        • Local Institution
      • Haifa、以色列、31096
        • Local Institution
      • Holon、以色列、58100
        • Local Institution
      • Kfar-Saba、以色列、44281
        • Local Institution
      • Zerifin、以色列、70300
        • Local Institution
  • 俄罗斯联邦
      • Chelyabinsk、俄罗斯联邦、454021
        • Local Institution
      • Kazan、俄罗斯联邦、420029
        • Local Institution
      • Moscow、俄罗斯联邦、115522
        • Local Institution
      • Moscow、俄罗斯联邦、111539
        • Local Institution
      • Moscow、俄罗斯联邦、117292
        • Local Institution
      • Moscow、俄罗斯联邦、119415
        • Local Institution
      • Saint Petersburg、俄罗斯联邦、199106
        • Local Institution
      • Saint Petersburg、俄罗斯联邦、193312
        • Local Institution
      • Saint Petersburg、俄罗斯联邦、194354
        • Local Institution
      • Saint Petersburg、俄罗斯联邦、195427
        • Local Institution
      • Saint Petersburg、俄罗斯联邦、196247
        • Local Institution
      • Samara、俄罗斯联邦、443095
        • Local Institution
      • St.Petersburg、俄罗斯联邦、192242
        • Local Institution
      • Yaroslavl、俄罗斯联邦、150003
        • Local Institution
  • 加拿大
      • Quebec、加拿大、G1L 3L5
        • Local Institution
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 2B7
        • Local Institution
    • Ontario
      • Ajax、Ontario、加拿大、L1S 2J5
        • Local Institution
      • Cambridge、Ontario、加拿大、N1R 7L7
        • Local Institution
      • Chatham、Ontario、加拿大、N7L 4T1
        • Local Institution
      • Guelph、Ontario、加拿大、N1E 6L9
        • Local Institution
      • Newmarket、Ontario、加拿大、L3Y 5G8
        • Local Institution
      • Oshawa、Ontario、加拿大、L1J 2J2
        • Local Institution
      • Sarnia、Ontario、加拿大、N7T 6H3
        • Local Institution
      • Scarborough、Ontario、加拿大、M1S 4T7
        • Local Institution
      • St. Catharines、Ontario、加拿大、L2R 7P3
        • Local Institution
      • Stratford、Ontario、加拿大、N5A 2N4
        • Local Institution
      • Waterloo、Ontario、加拿大、N2J 1C4
        • Local Institution
      • Windsor、Ontario、加拿大、N8W 1E6
        • Local Institution
    • Quebec
      • Montreal、Quebec、加拿大、H3G 1A4
        • Local Institution
  • 匈牙利
      • Budapest、匈牙利、1081
        • Local Institution
      • Kecskemet、匈牙利、6000
        • Local Institution
      • Szeged、匈牙利、6720
        • Local Institution
      • Szolnok、匈牙利、5000
        • Local Institution
  • 印度
      • Bangalore、印度、560034
        • Local Institution
      • Mangalore、印度、575001
        • Local Institution
    • Gujarat
      • Ahmedabad、Gujarat、印度、380015
        • Local Institution
    • Punjab
      • Ludhiana、Punjab、印度、141001
        • Local Institution
    • Uttar Prsdesh
      • Lucknow、Uttar Prsdesh、印度、226003
        • Local Institution
  • 墨西哥
      • Aguascalientes、墨西哥、20010
        • Local Institution
      • Chihuahua、墨西哥、31020
        • Local Institution
    • Baja California
      • Tijuana、Baja California、墨西哥、22010
        • Local Institution
    • Distrito Federal
      • Mexico City、Distrito Federal、墨西哥、06726
        • Local Institution
      • Mexico City、Distrito Federal、墨西哥、07760
        • Local Institution
    • Jalisco
      • Guadalajara、Jalisco、墨西哥、45235
        • Local Institution
    • Nuevo Leon
      • Monterrey、Nuevo Leon、墨西哥、64460
        • Local Institution
    • Tamaulipas
      • Cd. Madero、Tamaulipas、墨西哥、89240
        • Local Institution
  • 德国
      • Frankfurt、德国、60528
        • Local Institution
      • Frankfurt / Main、德国、65929
        • Local Institution
      • Rheinfelden、德国、79618
        • Local Institution
  • 挪威
      • Gjettum、挪威、1346
        • Local Institution
      • Kongsvinger、挪威、2212
        • Local Institution
      • Lillehammer、挪威、2629
        • Local Institution
      • Tonsberg、挪威、3116
        • Local Institution
      • Tynset、挪威、2500
        • Local Institution
  • 比利时
      • Antwerp、比利时、2020
        • Local Institution
      • Brasschaat、比利时、2930
        • Local Institution
      • Genk、比利时、3600
        • Local Institution
      • Hasselt、比利时、3500
        • Local Institution
      • Leuven、比利时、3000
        • Local Institution
  • 法国
      • Nice、法国、06200
        • Local Institution
      • Paris、法国、75014
        • Local Institution
      • Paris、法国、75019
        • Local Institution
      • Paris、法国、75679
        • Local Institution
      • Saint Etienne、法国、42100
        • Local Institution
      • Saint-Saulve、法国、59880
        • Local Institution
  • 波兰
      • Gdansk、波兰、80-803
        • Local Institution
      • Lodz、波兰、91-002
        • Local Institution
      • Szczecin、波兰、71-252
        • Local Institution
      • Warszawa、波兰、03-242
        • Local Institution
      • Warszawa、波兰、02-005
        • Local Institution
      • Wroclaw、波兰、50-556
        • Local Institution
  • 澳大利亚
    • New South Wales
      • Camperdown、New South Wales、澳大利亚、2050
        • Local Institution
      • Kogarah、New South Wales、澳大利亚、2217
        • Local Institution
      • Lismore、New South Wales、澳大利亚、2480
        • Local Institution
    • Queensland
      • Southport、Queensland、澳大利亚、4215
        • Local Institution
    • South Australia
      • Bedford Park、South Australia、澳大利亚、5042
        • Local Institution
    • Victoria
      • Box Hill、Victoria、澳大利亚、3128
        • Local Institution
      • Malvern、Victoria、澳大利亚、3144
        • Local Institution
      • Windsor、Victoria、澳大利亚、3181
        • Local Institution
    • Western Australia
      • Perth、Western Australia、澳大利亚、6000
        • Local Institution
  • 瑞典
      • Gothenburg、瑞典、416 85
        • Local Institution
      • Stockholm、瑞典、182 88
        • Local Institution
  • 罗马尼亚
      • Bucharest、罗马尼亚、021659
        • Local Institution
      • Cluj Napoca、罗马尼亚、400132
        • Local Institution
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35209
        • West Alabama Research, Llc
      • Birmingham、Alabama、美国、35209
        • Capstone Clinical Trials, Inc
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • Martin Bowen Hefley Orthopedics
      • Little Rock、Arkansas、美国、72205
        • Orthoarkansas, P.A.
    • California
      • Sacramento、California、美国、95817
        • UC Davis Medical Center
    • Colorado
      • Aurora、Colorado、美国、80012
        • Colorado Orthopedic Consultants, PC
      • Denver、Colorado、美国、80230
        • Advanced Orthopedic And Sports Medicine Specilists
      • Denver、Colorado、美国、80230
        • Denver-Vail Orthopedics, P.C.
    • Florida
      • Brandon、Florida、美国、33511
        • PAB Clinical Research
      • Clearwater、Florida、美国、33756
        • Research Alliance, Inc.
      • Ft. Lauderdale、Florida、美国、33316
        • Shrock Orthopedic Research
      • Tamarac、Florida、美国、33321
        • Phoenix Clinical Research, LLC
    • Georgia
      • Decatur、Georgia、美国、30033
        • Atlanta Knee And Sports Medicine
    • Idaho
      • Boise、Idaho、美国、83702
        • Americana Orthopedics
      • Meridian、Idaho、美国、83642
        • Bosie Orthopedic Clinic
    • Pennsylvania
      • Altoona、Pennsylvania、美国、16602
        • University Orthopedic Center
    • Texas
      • Lubbock、Texas、美国、79410
        • Gill Orthopedic Center
      • Lubbock、Texas、美国、79410
        • Robert R. King, Md
      • San Antonio、Texas、美国、78217
        • Unlimited Research
  • 英国
    • Greater London
      • London、Greater London、英国、SE5 9RS
        • Local Institution
    • Lancashire
      • Wigan、Lancashire、英国、WN6 9EP
        • Local Institution
    • Surrey
      • Epsom、Surrey、英国、KT18 7EG
        • Local Institution
  • 西班牙
      • Badalona-Barcelone、西班牙、08916
        • Local Institution
      • Barcelona、西班牙、08035
        • Local Institution
      • Barcelona、西班牙、08036
        • Local Institution
      • Barcelona、西班牙、08006
        • Local Institution
      • Barcelona、西班牙、08024
        • Local Institution
  • 阿根廷
    • Buenos Aires
      • Capital Federal、Buenos Aires、阿根廷、C1199ACK
        • Local Institution
      • Capital Federal、Buenos Aires、阿根廷、C1280AEB
        • Local Institution
      • Capital Federal、Buenos Aires、阿根廷、C1425AGP
        • Local Institution
      • Ciudad De Buenos Aires、Buenos Aires、阿根廷、C1426BOS
        • Local Institution
      • Coronel Suarez、Buenos Aires、阿根廷、B7540GHD
        • Local Institution
      • Monte Grande、Buenos Aires、阿根廷、B1842DID
        • Local Institution

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Key Inclusion Criteria

  • Patients undergoing elective unilateral total hip replacement or a revision of at least 1 component of a total hip replacement.
  • Patients who were willing and able to undergo bilateral ascending contrast venography
  • Either sex, any race, 18 years and older

Key Exclusion Criteria

  • Known or suspected bleeding or coagulation disorder in the patient or his or her first-degree relative
  • Known or suspected history of heparin-induced thrombocytopenia
  • Known coagulopathy
  • Active bleeding or at high risk for bleeding
  • Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
  • Active hepatobiliary disease
  • Alcohol and/or substance abuse within the past year
  • Any condition for which surgery or administration of an anticoagulant is contraindicated
  • Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure >180 mm Hg or supine diastolic blood pressure >105 mm Hg
  • Clinically significant laboratory abnormalities at the enrollment visit:
  • Hemoglobin <10 g/dL
  • Platelet count <100,000/mm^3
  • Creatinine clearance <30 mL/min, as estimated by the method of Cockcroft and Gault
  • Alanine aminotransferase or aspartate aminotransferase >2*upper limit of normal or a total bilirubin ≥ 1.5*1 (unless an alternative causative factor such as Gilbert's syndrome was identified)
  • Need for ongoing treatment with a parenteral or oral anticoagulant (eg, subjects with mechanical valves, warfarin eligible atrial fibrillation)
  • Current use of dextrans or fibrinolytics
  • Treatment with medications affecting coagulation or platelet function

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Apixaban, 2.5 mg BID plus placebo
Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
药品：Apixaban
Oral tablets, 2.5 mg, twice daily, 5weeks
其他名称：
  • BMS-562247
  • Eliquis®
药品：Enoxaparin-matching placebo
Administered as injection
实验性的：Enoxaparin, 40 mg QD plus placebo
Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
药品：Enoxaparin
Subcutaneous, 40 mg, once daily, 5 weeks
其他名称：
  • Lovenox®
药品：Apixaban-matching placebo
Administered as oral tablets

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
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.
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

次要结果测量

结果测量
措施说明
大体时间
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
大体时间：Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
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.
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
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
大体时间：Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
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.
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period
大体时间：First dose of study drug (presurgery) through 2 days after the last dose of study drug
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
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
大体时间：First dose of study drug (presurgery) through 30 days after the last dose of study drug
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.
First dose of study drug (presurgery) through 30 days after the last dose of study drug
Number of Participants With a Bleeding-related Adverse Event During the Treatment Period
大体时间：First dose of study drug (presurgery) through 2 days after the last dose of study drug
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.
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)
大体时间：First dose of study drug (presurgery) through 2 days after the last dose of study drug
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.
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)
大体时间：First dose of study drug (presurgery) through 2 days after the last dose of study drug
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.
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
大体时间：First dose of study drug (presurgery) through 2 days after the last dose of study drug
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.
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
大体时间：First dose of study drug (presurgery) through 2 days after the last dose of study drug
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 <LLN; basophils (*10^3 cells/μL): >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;
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)
大体时间：First dose of study drug (presurgery) through 2 days after the last dose of study drug
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 <LLN use <0.75* preRx or >ULN if preRx >ULN use > 1.25*preRx or <LLN; chloride (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or <LLN; bicarbonate (mEq/L): < 0.75* LLN or >1.25*ULN, or if preRx <LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; potassium (mEq/L): < 0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or < LLN; sodium (mEq/L): <0.95* LLN or >1.05×ULN, or if preRx <LLN use <0.95* predose or >ULN if preRx >ULN use >1.05 *preRx or < LLN.
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)
大体时间：First dose of study drug (presurgery) through 2 days after the last dose of study drug
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 <LLN use <.8*preRx or >ULN if preRx >ULN use >2*preRx or <LLN; protein, total (g/L): If missing preRx use ≥2, or if value ≥4 or preRx =0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; creatine kinase (U/L): >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.
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
大体时间：First dose of study drug (presurgery) through 30 days after the last dose of study drug
Treatment guidelines were provided for jaundice and elevated results of liver function tests.
First dose of study drug (presurgery) through 30 days after the last dose of study drug
Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period
大体时间：Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
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.
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

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Bristol-Myers Squibb

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研究主要日期

学习开始

2007年3月1日

初级完成 (实际的)

2009年9月1日

研究完成 (实际的)

2009年9月1日

研究注册日期

首次提交

2007年1月17日

首先提交符合 QC 标准的

2007年1月17日

首次发布 (估计)

2007年1月18日

研究记录更新

最后更新发布 (估计)

2014年5月14日

上次提交的符合 QC 标准的更新

2014年4月14日

最后验证

2014年4月1日

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  • CV185-035

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