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Trial record 1 of 1 for:    NCT00942968
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Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer

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ClinicalTrials.gov Identifier: NCT00942968
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Intervention Drug: dalteparin
Enrollment 338
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Period Title: Overall Study
Started 338
Treated 334
Completed 109
Not Completed 229
Reason Not Completed
Adverse Event             60
Death             76
Protocol Violation             9
Lost to Follow-up             4
Withdrawal by Subject             44
Sponsor request             5
Physician Decision             11
Progression of disease             12
Inferior vena cava filter placement             4
Pulmonary embolism (PE)             1
Participant required pancreatic biopsy             1
Deep vein thrombosis (DVT)             2
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Baseline Participants 334
Hide Baseline Analysis Population Description
Safety population included all participants who received at least 1 treatment with dalteparin sodium.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 334 participants
63.8  (10.63)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 334 participants
Female
171
  51.2%
Male
163
  48.8%
1.Primary Outcome
Title Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee
Hide Description A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of greater than or equal to (>=) 2 gram per deciliter (g/dL), 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported.
Time Frame Month 2 up to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 treatment with dalteparin sodium.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Measure Type: Number
Unit of Measure: participants
14
2.Primary Outcome
Title Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee
Hide Description A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported.
Time Frame Month 7 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one 1 treatment with dalteparin sodium.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Measure Type: Number
Unit of Measure: participants
8
3.Primary Outcome
Title Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee
Hide Description VTEs included both deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes pulmonary embolism (PE). When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (adjudicated by Central Adjudication Committee) were reported.
Time Frame Month 7 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 194
Measure Type: Number
Unit of Measure: participants
8
4.Secondary Outcome
Title Number of Participants With Investigator Identified Major Bleeding Events
Hide Description A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (identified by investigator) were reported.
Time Frame Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 treatment with dalteparin sodium.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Measure Type: Number
Unit of Measure: participants
Month 1 up to Month 6 28
Month 7 up to Month 12 7
Month 1 up to Month 12 35
Month 2 up to Month 6 15
Month 2 up to Month 12 22
5.Secondary Outcome
Title Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee
Hide Description A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major bleeding. In this outcome measure, number of participants with any (major or minor) bleeding events (adjudicated by Central Adjudication Committee) were reported.
Time Frame Month 1 up to Month 6, Month 7 up to Month 12, Month 1 up to Month 12, Month 2 up to Month 6, and Month 2 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 treatment with dalteparin sodium.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Measure Type: Number
Unit of Measure: participants
Month 1 up to Month 6 91
Month 7 up to Month 12 21
Month 1 up to Month 12 112
Month 2 up to Month 6 47
Month 2 up to Month 12 68
6.Secondary Outcome
Title Number of Participants With Fatal Bleeding Events
Hide Description Fatal bleeding events refers to those bleeding events which leads to death of participant. In this outcome measure, number of participants with fatal bleeding events were reported.
Time Frame Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 treatment with dalteparin sodium.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Measure Type: Number
Unit of Measure: participants
Month 1 up to Month 6 1
Month 7 up to Month 12 1
Month 1 up to Month 12 2
Month 2 up to Month 6 1
Month 2 up to Month 12 2
7.Secondary Outcome
Title Time to First Occurrence of Major Bleeding Event Adjudicated by Central Adjudication Committee
Hide Description Time to first occurrence of major bleeding event was defined as the time interval (in days) between the date of first study treatment and the 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: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death.
Time Frame Month 1 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 treatment with dalteparin sodium.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Mean (Standard Error)
Unit of Measure: days
332.9  (5.25)
8.Secondary Outcome
Title Time to First Occurrence of Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee
Hide Description Time to first occurrence of any bleeding event was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first bleeding event (major or minor). A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major bleeding.
Time Frame Month 1 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 treatment with dalteparin sodium.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Mean (Standard Error)
Unit of Measure: days
262.5  (8.52)
9.Secondary Outcome
Title Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)
Hide Description VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) 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 (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (identified by investigator) were reported.
Time Frame Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, 'n' signifies those participants who were evaluable at specified time intervals.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Measure Type: Number
Unit of Measure: participants
Month 1 up to Month 6 (n=334) 29
Month 7 up to Month 12 (n=195) 8
Month 1 up to Month 12 (n=334) 37
Month 2 up to Month 6 (n=295) 9
Month 2 up to Month 12 (n=295) 17
10.Secondary Outcome
Title Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee
Hide Description VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) 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 (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography. In this outcome measure, number of participants with new or recurrent VTE or CVT (adjudicated by Central Adjudication Committee) were reported.
Time Frame Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, 'n' signifies those participants who were evaluable at specified time intervals.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Measure Type: Number
Unit of Measure: participants
Month 1 up to Month 6 (n=334) 29
Month 7 up to Month 12 (n=194) 8
Month 1 up to Month 12 (n=334) 37
Month 2 up to Month 6 (n=296) 10
Month 2 up to Month 12 (n=296) 18
11.Secondary Outcome
Title Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)
Hide Description VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) 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 (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography. In this outcome measure, number of participants with new or recurrent VTE or CVT (identified by investigator) were reported.
Time Frame Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, 'n' signifies those participants who were evaluable at specified time intervals.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Measure Type: Number
Unit of Measure: participants
Month 1 up to Month 6 (n=334) 29
Month 7 up to Month 12 (n=195) 8
Month 1 up to Month 12 (n=334) 37
Month 2 up to Month 6 (n=295) 9
Month 2 up to Month 12 (n=295) 17
12.Secondary Outcome
Title Time to First Occurrence of New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee
Hide Description Time to first occurrence of new or recurrent VTE was defined as the time interval (in days) between the date of first study treatment and the 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 (embolizes) 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 (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram.
Time Frame Month 1 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Mean (Standard Error)
Unit of Measure: days
294.1  (4.87)
13.Secondary Outcome
Title Time to First Occurrence of New or Recurrent VTE or CVT Adjudicated by Central Adjudication Committee
Hide Description Time to first occurrence of new or recurrent VTE or CVT was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first VTE or CVT. VTEs included both deep vein thrombosis (DVT) and pulmonary embolism (PE) .DVT is a blood clot in the deep veins of the leg. If a DVT clot that breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes pulmonary embolism (PE). When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan, contrast venography or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography.
Time Frame Month 1 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Mean (Standard Error)
Unit of Measure: days
294.1  (4.87)
14.Other Pre-specified Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Time Frame Baseline (Day 1) up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 treatment with dalteparin sodium.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Measure Type: Number
Unit of Measure: participants
AE 328
SAE 213
15.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Laboratory Abnormalities
Hide Description Criteria for abnormality: Hemoglobin greater than or equal to(>=)130*lower limit of normal(LLN); less than or equal to(<=)170*upper limit of normal(ULN), hematocrit >=0.39*LLN;<=0.51*ULN, red blood cell >=4.5*LLN;<=5.9*ULN, platelet>=150*LLN;<= 450*ULN, white blood cells >=4*LLN;<=11*ULN; lymphocytes>=0.09;<=0.44, neutrophils=>0.16*LLN;<=0.7*ULN, eosinophils<=0.04*ULN, basophils<=0.02*ULN, monocytes>0.08*ULN; bilirubin >=5.1*LLN;<=22.2*ULN, aspartate aminotransferase >=13*LLN;<=36*ULN, alanine aminotransferase>=11*LLN;<=54*ULN, alkaline phosphatase>=31*LLN ;<=104 *ULN, total protein>=60*LLN; <=76*ULN, albumin=>35*LLN;<=50*ULN, glucose>=3.77 ;<=6.05;blood urea nitrogen>=1.785*LLN;<=7.5*ULN, creatinine>=70.7*LLN;<=114.9*ULN, creatinine kinase>=30*LLN ;<=280*ULN, lactate dehydrogenase>=85*LLN;<=180*ULN, sodium>=137*LLN ;<=144*ULN, potassium >=3.5*LLN;<=5*ULN, chloride>=102*LLN;<=111*ULN, calcium>=2.22*LLN ;<=2.57*ULN, phosphorus=>0.81 ;<=1.45); nitrogen cholesterol>=1.78*LLN ;<=7.49*ULN.
Time Frame Baseline (Day 1) up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 treatment with dalteparin sodium.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Measure Type: Number
Unit of Measure: participants
0
16.Other Pre-specified Outcome
Title Number of Participants With Abnormal Physical Examinations Findings
Hide Description Physical examinations included head, ears, nose, throat (ENT), neck, heart, chest, lungs, abdomen, extremities, neurological systems, skin, general appearance and others (thigh, abdomen unobtrusive scar, breast, cardio-vascular, constitutional, face, genitalia, genitourinary, gastrointestinal, hematologic, left ankle unobtrusive scar, lymph nodes, lymphatic, malaise/fatigue, mouth, musculoskeletal, musculoskeletal, peripherally inserted central catheters line site left arm, psychiatric, skeletal, urinary, weight, activity level, bladder irritation, dyspnea and eastern cooperative oncology group performance status [used to assess how the disease affects the daily living abilities of the participant. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for less than (<) 50 percent (%) of the time; 3= in bed for greater than (>) 50% of the time; 4= 100% bedridden; 5= dead]). Abnormality in physical examinations was based on investigator's discretion.
Time Frame Baseline (Day 1), Week 1, 4, 8, 12, 24, 36, 48, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 treatment with dalteparin sodium. Here 'n' signifies those participants who were evaluable at specified categories.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Measure Type: Number
Unit of Measure: participants
Baseline : Head (n=327) 14
Baseline : Ears, nose, throat (ENT)(n=327) 20
Baseline : Neck (n=327) 10
Baseline : Heart (n=327) 26
Baseline : Chest (n=326) 40
Baseline : Lungs (n=327) 65
Baseline : Abdomen (n=327) 73
Baseline : Extremities (n=328) 203
Baseline : Neurological systems (n=327) 18
Baseline : Skin (n=327) 51
Baseline : General appearance (n=327) 47
Baseline : Others (n=47) 25
Week 1 : Head (n=213) 16
Week 1 : ENT (n=214) 20
Week 1 : Neck (n=214) 7
Week 1 : Heart (n=214) 10
Week 1 : Chest (n=213) 22
Week 1 : Lungs (n=214) 28
Week 1 :Abdomen (n=214) 62
Week 1 : Extremities (n=213) 103
Week 1 : Neurological systems (n=213) 16
Week 1 : Skin (n=213) 52
Week 1 : General appearance (n=212) 25
Week 1:Others (n=41) 23
Week 4 : Head (n=211) 12
Week 4 : ENT (n=211) 16
Week 4 : Neck (n=211) 6
Week 4 : Heart (n=210) 8
Week 4 : Chest (n=211) 23
Week 4 : Lungs (n=211) 24
Week 4 : Abdomen (n=210) 59
Week 4 : Extremities (n=211) 83
Week 4 : Neurological systems (n=211) 9
Week 4 : Skin (n=210) 49
Week 4 : General appearance (n=208) 25
Week 4 : Others (n=23) 20
Week 8 : Head (n=186) 11
Week 8 : ENT (n=186) 16
Week 8 : Neck (n=185) 4
Week 8 : Heart (n=186) 8
Week 8 : Chest (n=186) 21
Week 8 : Lungs (n=186) 31
Week 8 : Abdomen (n=186) 49
Week 8 : Extremities (n=186) 80
Week 8 : Neurological systems (n=185) 13
Week 8 : Skin (n=186) 38
Week 8 : General appearance (n=186) 16
Week 8 : Others (n=16) 12
Week 12 : Head (n=183) 10
Week 12 : ENT (n=183) 12
Week 12 : Neck (n=183) 1
Week 12 : Heart (n=183) 9
Week 12 : Chest (n=183) 22
Week 12 : Lungs (n=183) 15
Week 12 : Abdomen (n=183) 47
Week 12 : Extremities (n=183) 57
Week 12 : Neurological systems (n=183) 19
Week 12 : Skin (n=183) 39
Week 12 : General appearance (n=182) 18
Week 12 : Other (n=27) 16
Week 24 : Head (n=166) 2
Week 24 : ENT (n=166) 12
Week 24 : Neck (n=166) 4
Week 24 : Heart (n=166) 9
Week 24 : Chest (n=166) 17
Week 24 : Lungs (n=166) 14
Week 24 : Abdomen (n=166) 37
Week 24 : Extremities (n=166) 47
Week 24 : Neurological systems (n=166) 14
Week 24 : Skin (n=166) 35
Week 24 : General appearance (n=166) 9
Week 24 : Others (n=17) 11
Week 36 : Head (n=127) 6
Week 36 : ENT (n=127) 9
Week 36 : Neck (n=127) 4
Week 36 : Heart (n=127) 7
Week 36 : Chest (n=127) 18
Week 36 : Lungs (n=127) 12
Week 36 : Abdomen (n=126) 35
Week 36 : Extremities (n=127) 37
Week 36 : Neurological systems (n=127) 9
Week 36 : Skin (n=127) 32
Week 36 : General appearance (n=126) 11
Week 36 : Others (n=14) 9
Week 48 : Head (n=103) 2
Week 48 : ENT (n=103) 6
Week 48 : Neck (n=103) 3
Week 48 : Heart (n=103) 7
Week 48 : Chest (n=103) 11
Week 48 : Lungs (n=102) 14
Week 48 : Abdomen (n=103) 27
Week 48 : Extremities (n=103) 29
Week 48 : Neurological systems (n=103) 8
Week 48 : Skin (n=103) 29
Week 48 : General appearance (n=103) 9
Week 48 : Others (n=7) 3
Week 52 : Head (n=193) 7
Week 52 : ENT (n=193) 13
Week 52 : Neck (n=193) 5
Week 52 : Heart (n=193) 12
Week 52 : Chest (n=193) 23
Week 52 : Lungs (n=191) 23
Week 52 : Abdomen (n=193) 60
Week 52 : Extremities (n=193) 68
Week 52 : Neurological systems (n=193) 24
Week 52 : Skin (n=193) 38
Week 52 : General appearance (n=193) 27
Week 52 : Others (n=25) 15
17.Other Pre-specified Outcome
Title Other Pre-specified: Number of Participants With Clinically Significant Electrocardiogram Findings
Hide Description Clinically significant ECG findings included: corrected QT (QTc) > 450 ms, QTc >500 ms, change in QTc between 30 and 60 ms, change in QTc greater than or equal to 60 ms.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 treatment with dalteparin sodium.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 334
Measure Type: Number
Unit of Measure: participants
8
18.Other Pre-specified Outcome
Title Change From Baseline in Creatinine Clearance at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 in Severely Renal Impaired Participants
Hide Description Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age.
Time Frame Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Severely renal-impaired population included all participants who had at least 1 dose of study drug and had severe renal impairment at the baseline or developed severe renal impairment (CrCl) < 30 milliliter per minute during the study. Here, n' signifies those participants who were evaluable at specified time points.
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description:
Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: mL/min
Baseline (n=17) 46.0  (28.66)
Week 4 (n=15) -8.6  (25.39)
Week 8 (n=13) 2.5  (47.02)
Week 12 (n=13) 2.1  (58.15)
Week 16 (n=4) -9.2  (21.93)
Week 20 (n=2) 7.7  (7.90)
Week 24 (n=12) 4.5  (49.62)
Week 28 (n=1) -44.0 [1]   (NA)
Week 32 (n=1) -14.0 [1]   (NA)
Week 36 (n=8) 5.8  (56.91)
Week 40 (n=2) -21.0  (9.90)
Week 44 (n=2) -20.0  (4.24)
Week 48 (n=6) -26.0  (18.12)
Week 52 (n=11) 4.8  (50.19)
[1]
Standard deviation was not calculated since only 1 participant was evaluable at the given time point.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dalteparin Sodium
Hide Arm/Group Description Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
All-Cause Mortality
Dalteparin Sodium
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Dalteparin Sodium
Affected / at Risk (%)
Total   213/334 (63.77%) 
Blood and lymphatic system disorders   
Anaemia  1  6/334 (1.80%) 
Bone marrow failure * 1  1/334 (0.30%) 
Febrile neutropenia  1  12/334 (3.59%) 
Heparin-induced thrombocytopenia  1  2/334 (0.60%) 
Leukocytosis  1  1/334 (0.30%) 
Neutropenia  1  4/334 (1.20%) 
Pancytopenia  1  3/334 (0.90%) 
Thrombocytopenia  1  4/334 (1.20%) 
Cardiac disorders   
Acute myocardial infarction  1  1/334 (0.30%) 
Angina pectoris  1  1/334 (0.30%) 
Atrial fibrillation  1  1/334 (0.30%) 
Atrial flutter  1  2/334 (0.60%) 
Cardiac failure congestive  1  2/334 (0.60%) 
Cardio-respiratory arrest * 1  1/334 (0.30%) 
Coronary artery occlusion  1  1/334 (0.30%) 
Endocarditis noninfective * 1  1/334 (0.30%) 
Myocardial infarction * 1  1/334 (0.30%) 
Ear and labyrinth disorders   
Vertigo  1  1/334 (0.30%) 
Endocrine disorders   
Adrenal haemorrhage  1  1/334 (0.30%) 
Gastrointestinal disorders   
Abdominal pain  1  2/334 (0.60%) 
Ascites  1  5/334 (1.50%) 
Colitis  1  1/334 (0.30%) 
Colonic obstruction * 1  1/334 (0.30%) 
Diarrhoea * 1  7/334 (2.10%) 
Diarrhoea haemorrhagic  1  1/334 (0.30%) 
Duodenal obstruction  1  1/334 (0.30%) 
Gastric ulcer haemorrhage * 1  2/334 (0.60%) 
Gastritis  1  1/334 (0.30%) 
Gastrointestinal haemorrhage  1  4/334 (1.20%) 
Gastrointestinal necrosis  1  1/334 (0.30%) 
Gastrooesophageal reflux disease  1  1/334 (0.30%) 
Haematemesis  1  1/334 (0.30%) 
Intestinal obstruction  1  3/334 (0.90%) 
Intestinal perforation * 1  2/334 (0.60%) 
Intra-abdominal haemorrhage  1  1/334 (0.30%) 
Lower gastrointestinal haemorrhage * 1  1/334 (0.30%) 
Narcotic bowel syndrome * 1  1/334 (0.30%) 
Nausea * 1  5/334 (1.50%) 
Oesophageal obstruction  1  1/334 (0.30%) 
Pancreatic mass * 1  1/334 (0.30%) 
Pancreatitis  1  1/334 (0.30%) 
Peritoneal haemorrhage * 1  2/334 (0.60%) 
Rectal haemorrhage * 1  3/334 (0.90%) 
Rectal ulcer haemorrhage * 1  1/334 (0.30%) 
Small intestinal obstruction * 1  5/334 (1.50%) 
Subileus * 1  1/334 (0.30%) 
Upper gastrointestinal haemorrhage * 1  3/334 (0.90%) 
Varicose veins of abdominal wall * 1  1/334 (0.30%) 
Vomiting * 1  8/334 (2.40%) 
Small intestinal perforation * 1  1/334 (0.30%) 
General disorders   
Asthenia  1  1/334 (0.30%) 
Chills  1  1/334 (0.30%) 
Device malfunction * 1  1/334 (0.30%) 
Device occlusion * 1  2/334 (0.60%) 
Disease progression  1  29/334 (8.68%) 
Fatigue * 1  1/334 (0.30%) 
General physical health deterioration * 1  1/334 (0.30%) 
Mucosal inflammation  1  2/334 (0.60%) 
Multi-organ failure * 1  2/334 (0.60%) 
Oedema peripheral * 1  4/334 (1.20%) 
Pain * 1  2/334 (0.60%) 
Pyrexia * 1  5/334 (1.50%) 
Hepatobiliary disorders   
Bile duct obstruction  1  2/334 (0.60%) 
Cholecystitis * 1  1/334 (0.30%) 
Cholelithiasis * 1  2/334 (0.60%) 
Cholestasis * 1  1/334 (0.30%) 
Gallbladder disorder * 1  1/334 (0.30%) 
Hepatic failure * 1  1/334 (0.30%) 
Jaundice * 1  1/334 (0.30%) 
Infections and infestations   
Appendicitis  1  1/334 (0.30%) 
Bacteraemia * 1  1/334 (0.30%) 
Bacterial infection * 1  1/334 (0.30%) 
Bacterial sepsis * 1  1/334 (0.30%) 
Bronchitis * 1  1/334 (0.30%) 
Candiduria * 1  2/334 (0.60%) 
Cellulitis * 1  12/334 (3.59%) 
Clostridial infection * 1  2/334 (0.60%) 
Clostridium difficile colitis * 1  1/334 (0.30%) 
Device related infection * 1  1/334 (0.30%) 
Diverticulitis  1  1/334 (0.30%) 
Escherichia sepsis  1  1/334 (0.30%) 
Gastroenteritis * 1  1/334 (0.30%) 
Gastroenteritis viral * 1  1/334 (0.30%) 
Haematoma infection * 1  1/334 (0.30%) 
Infection * 1  1/334 (0.30%) 
Lobar pneumonia * 1  2/334 (0.60%) 
Lung abscess * 1  1/334 (0.30%) 
Peritonitis  1  2/334 (0.60%) 
Postoperative wound infection * 1  1/334 (0.30%) 
Pyelonephritis * 1  1/334 (0.30%) 
Respiratory tract infection * 1  1/334 (0.30%) 
Sepsis  1  7/334 (2.10%) 
Septic shock * 1  4/334 (1.20%) 
Streptococcal sepsis * 1  1/334 (0.30%) 
Urinary tract infection * 1  5/334 (1.50%) 
Urosepsis * 1  3/334 (0.90%) 
Wound infection * 1  1/334 (0.30%) 
Pneumonia * 1  22/334 (6.59%) 
Injury, poisoning and procedural complications   
Abdominal wound dehiscence  1  1/334 (0.30%) 
Fractured sacrum * 1  1/334 (0.30%) 
Humerus fracture * 1  1/334 (0.30%) 
Inadequate analgesia * 1  1/334 (0.30%) 
Incisional hernia, obstructive * 1  1/334 (0.30%) 
Lumbar vertebral fracture * 1  1/334 (0.30%) 
Meniscus lesion * 1  1/334 (0.30%) 
Pneumothorax traumatic * 1  1/334 (0.30%) 
Post procedural haemorrhage * 1  2/334 (0.60%) 
Procedural complication * 1  1/334 (0.30%) 
Subdural haematoma * 1  1/334 (0.30%) 
Traumatic haematoma  1  1/334 (0.30%) 
Investigations   
Haemoglobin decreased  1  3/334 (0.90%) 
Staphylococcus test positive * 1  1/334 (0.30%) 
Weight decreased * 1  1/334 (0.30%) 
Metabolism and nutrition disorders   
Dehydration  1  2/334 (0.60%) 
Diabetic ketoacidosis * 1  1/334 (0.30%) 
Failure to thrive * 1  2/334 (0.60%) 
Hypercalcaemia * 1  2/334 (0.60%) 
Hyperglycaemic hyperosmolar nonketotic syndrome * 1  1/334 (0.30%) 
Hyperkalaemia * 1  3/334 (0.90%) 
Hyperphosphataemia * 1  1/334 (0.30%) 
Hypocalcaemia * 1  1/334 (0.30%) 
Hypokalaemia  1  1/334 (0.30%) 
Hypomagnesaemia * 1  1/334 (0.30%) 
Hyponatraemia * 1  3/334 (0.90%) 
Hypovolaemia * 1  1/334 (0.30%) 
Malnutrition * 1  1/334 (0.30%) 
Tumour lysis syndrome * 1  1/334 (0.30%) 
Type 2 diabetes mellitus * 1  1/334 (0.30%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  3/334 (0.90%) 
Lumbar spinal stenosis * 1  1/334 (0.30%) 
Musculoskeletal chest pain * 1  1/334 (0.30%) 
Osteolysis * 1  1/334 (0.30%) 
Pain in extremity * 1  2/334 (0.60%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma pancreas  1  1/334 (0.30%) 
Adrenocortical carcinoma * 1  1/334 (0.30%) 
Bile duct cancer * 1  2/334 (0.60%) 
Brain neoplasm * 1  1/334 (0.30%) 
Brain neoplasm malignant * 1  1/334 (0.30%) 
Bronchioloalveolar carcinoma * 1  1/334 (0.30%) 
Cancer pain * 1  2/334 (0.60%) 
Cervix cancer metastatic * 1  1/334 (0.30%) 
Cervix carcinoma * 1  2/334 (0.60%) 
Colon cancer metastatic * 1  1/334 (0.30%) 
Endometrial cancer metastatic * 1  1/334 (0.30%) 
Gastric cancer * 1  1/334 (0.30%) 
Glioblastoma * 1  4/334 (1.20%) 
Glioblastoma multiforme  1  1/334 (0.30%) 
Intracranial tumour haemorrhage * 1  1/334 (0.30%) 
Liposarcoma * 1  1/334 (0.30%) 
Lung cancer metastatic * 1  2/334 (0.60%) 
Lung neoplasm malignant * 1  6/334 (1.80%) 
Malignant neoplasm progression * 1  4/334 (1.20%) 
Malignant ovarian cyst * 1  1/334 (0.30%) 
Malignant pleural effusion * 1  1/334 (0.30%) 
Mantle cell lymphoma * 1  1/334 (0.30%) 
Metastases to central nervous system  1  4/334 (1.20%) 
Metastatic carcinoma of the bladder * 1  1/334 (0.30%) 
Metastatic pain * 1  1/334 (0.30%) 
Neoplasm * 1  1/334 (0.30%) 
Non-Hodgkin's lymphoma recurrent * 1  1/334 (0.30%) 
Non-small cell lung cancer * 1  2/334 (0.60%) 
Non-small cell lung cancer metastatic  1  1/334 (0.30%) 
Non-small cell lung cancer stage IV * 1  1/334 (0.30%) 
Oesophageal adenocarcinoma * 1  1/334 (0.30%) 
Oesophageal carcinoma * 1  3/334 (0.90%) 
Oncologic complication  1  2/334 (0.60%) 
Ovarian cancer * 1  4/334 (1.20%) 
Pancreatic carcinoma * 1  8/334 (2.40%) 
Pancreatic carcinoma metastatic * 1  3/334 (0.90%) 
Prostate cancer metastatic  1  1/334 (0.30%) 
Rectal cancer * 1  1/334 (0.30%) 
Rectal cancer metastatic * 1  2/334 (0.60%) 
Renal cell carcinoma * 1  1/334 (0.30%) 
Sarcoma * 1  1/334 (0.30%) 
Small cell lung cancer stage unspecified * 1  3/334 (0.90%) 
Small intestine carcinoma metastatic * 1  1/334 (0.30%) 
Squamous cell carcinoma of the cervix * 1  1/334 (0.30%) 
T-cell lymphoma recurrent * 1  1/334 (0.30%) 
Tumour haemorrhage * 1  1/334 (0.30%) 
Tumour invasion * 1  1/334 (0.30%) 
Tumour necrosis * 1  1/334 (0.30%) 
Uterine cancer * 1  1/334 (0.30%) 
Uterine leiomyosarcoma * 1  1/334 (0.30%) 
Vulval cancer * 1  1/334 (0.30%) 
Nervous system disorders   
Brain oedema  1  1/334 (0.30%) 
Cerebrovascular accident * 1  3/334 (0.90%) 
Embolic cerebral infarction * 1  1/334 (0.30%) 
Haemorrhage intracranial * 1  2/334 (0.60%) 
Haemorrhagic stroke * 1  1/334 (0.30%) 
Headache * 1  1/334 (0.30%) 
Hemiparesis * 1  1/334 (0.30%) 
Neuralgia * 1  1/334 (0.30%) 
Normal pressure hydrocephalus * 1  1/334 (0.30%) 
Paraplegia * 1  1/334 (0.30%) 
Stupor * 1  1/334 (0.30%) 
Syncope * 1  1/334 (0.30%) 
Thrombotic stroke  1  1/334 (0.30%) 
Transient ischaemic attack * 1  1/334 (0.30%) 
Psychiatric disorders   
Delirium  1  1/334 (0.30%) 
Depression * 1  1/334 (0.30%) 
Mental disorder  1  1/334 (0.30%) 
Mental status changes * 1  4/334 (1.20%) 
Substance-induced psychotic disorder * 1  1/334 (0.30%) 
Renal and urinary disorders   
Calculus bladder  1  1/334 (0.30%) 
Haematuria * 1  4/334 (1.20%) 
Postrenal failure * 1  1/334 (0.30%) 
Renal failure * 1  5/334 (1.50%) 
Renal failure acute * 1  4/334 (1.20%) 
Renal impairment * 1  1/334 (0.30%) 
Reproductive system and breast disorders   
Ovarian mass  1  1/334 (0.30%) 
Vaginal haemorrhage * 1  2/334 (0.60%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/334 (0.30%) 
Chronic obstructive pulmonary disease * 1  2/334 (0.60%) 
Dyspnoea * 1  3/334 (0.90%) 
Emphysema * 1  1/334 (0.30%) 
Epistaxis * 1  2/334 (0.60%) 
Hiccups * 1  1/334 (0.30%) 
Hypoxia * 1  1/334 (0.30%) 
Lung infiltration  1  1/334 (0.30%) 
Painful respiration * 1  1/334 (0.30%) 
Pleural effusion * 1  10/334 (2.99%) 
Pleuritic pain * 1  1/334 (0.30%) 
Pneumonia aspiration * 1  2/334 (0.60%) 
Pneumothorax * 1  1/334 (0.30%) 
Pulmonary embolism * 1  20/334 (5.99%) 
Respiratory failure * 1  3/334 (0.90%) 
Stridor * 1  1/334 (0.30%) 
Skin and subcutaneous tissue disorders   
Decubitus ulcer * 1  1/334 (0.30%) 
Urticaria * 1  1/334 (0.30%) 
Vascular disorders   
Deep vein thrombosis * 1  8/334 (2.40%) 
Embolism venous * 1  2/334 (0.60%) 
Hypertension * 1  1/334 (0.30%) 
Hypotension * 1  4/334 (1.20%) 
Jugular vein thrombosis * 1  1/334 (0.30%) 
Subclavian artery stenosis * 1  1/334 (0.30%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dalteparin Sodium
Affected / at Risk (%)
Total   328/334 (98.20%) 
Blood and lymphatic system disorders   
Anemia * 1  54/334 (16.17%) 
Thrombocytopenia * 1  42/334 (12.57%) 
Neutropenia * 1  27/334 (8.08%) 
Cardiac disorders   
Tachycardia * 1  18/334 (5.39%) 
Gastrointestinal disorders   
Nausea * 1  81/334 (24.25%) 
Constipation * 1  71/334 (21.26%) 
Diarrhea * 1  60/334 (17.96%) 
Vomiting * 1  42/334 (12.57%) 
Abdominal pain * 1  41/334 (12.28%) 
Ascites * 1  22/334 (6.59%) 
General disorders   
Injection site hematoma  1  91/334 (27.25%) 
Fatigue * 1  90/334 (26.95%) 
Odema peripheral * 1  80/334 (23.95%) 
Disease progression * 1  37/334 (11.08%) 
Pyrexia * 1  24/334 (7.19%) 
Asthenia  1  19/334 (5.69%) 
Injection site hemorrhage * 1  17/334 (5.09%) 
Infections and infestations   
Pneumonia * 1  34/334 (10.18%) 
Urinary tract infection * 1  32/334 (9.58%) 
Upper respiratory tract infection * 1  22/334 (6.59%) 
Cellulitis * 1  19/334 (5.69%) 
Injury, poisoning and procedural complications   
Contusion * 1  52/334 (15.57%) 
Investigations   
Weight decreased * 1  36/334 (10.78%) 
Hemoglobin decreased * 1  17/334 (5.09%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  48/334 (14.37%) 
Hypokalemia * 1  36/334 (10.78%) 
Dehydration * 1  24/334 (7.19%) 
Hyponatremia * 1  20/334 (5.99%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  45/334 (13.47%) 
Pain in extremity * 1  33/334 (9.88%) 
Arthralgia * 1  24/334 (7.19%) 
Muscle spasms * 1  17/334 (5.09%) 
Nervous system disorders   
Headache  1  33/334 (9.88%) 
Dizziness * 1  27/334 (8.08%) 
Neuropathy peripheral * 1  22/334 (6.59%) 
Psychiatric disorders   
Anxiety * 1  27/334 (8.08%) 
Insomnia * 1  27/334 (8.08%) 
Renal and urinary disorders   
Hematuria * 1  22/334 (6.59%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  52/334 (15.57%) 
Cough * 1  36/334 (10.78%) 
Epistaxis * 1  34/334 (10.18%) 
Pleural effusion * 1  31/334 (9.28%) 
Pulmonary embolism * 1  24/334 (7.19%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  22/334 (6.59%) 
Rash * 1  22/334 (6.59%) 
Dry skin * 1  18/334 (5.39%) 
Ecchymosis * 1  18/334 (5.39%) 
Vascular disorders   
Hypotension  1  23/334 (6.89%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00942968    
Other Study ID Numbers: FRAG-A001-401
A6301095 ( Other Identifier: Alias Study Number )
First Submitted: July 16, 2009
First Posted: July 21, 2009
Results First Submitted: January 4, 2017
Results First Posted: February 24, 2017
Last Update Posted: February 24, 2017