Trial Outcomes & Findings for Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer (NCT NCT00942968)
NCT ID: NCT00942968
Last Updated: 2024-04-18
Results Overview
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.
COMPLETED
PHASE4
338 participants
Month 2 up to Month 6
2024-04-18
Participant Flow
Participant milestones
| Measure |
Dalteparin Sodium
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 Study
STARTED
|
338
|
|
Overall Study
Treated
|
334
|
|
Overall Study
COMPLETED
|
109
|
|
Overall Study
NOT COMPLETED
|
229
|
Reasons for withdrawal
| Measure |
Dalteparin Sodium
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.
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|---|---|
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Overall Study
Adverse Event
|
60
|
|
Overall Study
Death
|
76
|
|
Overall Study
Protocol Violation
|
9
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
44
|
|
Overall Study
Sponsor request
|
5
|
|
Overall Study
Physician Decision
|
11
|
|
Overall Study
Progression of disease
|
12
|
|
Overall Study
Inferior vena cava filter placement
|
4
|
|
Overall Study
Pulmonary embolism (PE)
|
1
|
|
Overall Study
Participant required pancreatic biopsy
|
1
|
|
Overall Study
Deep vein thrombosis (DVT)
|
2
|
Baseline Characteristics
Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer
Baseline characteristics by cohort
| Measure |
Dalteparin Sodium
n=334 Participants
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.
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|---|---|
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Age, Continuous
|
63.8 years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
163 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 2 up to Month 6Population: Safety population included all participants who received at least 1 treatment with dalteparin sodium.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
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|---|---|
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Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee
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14 participants
|
PRIMARY outcome
Timeframe: Month 7 up to Month 12Population: Safety population included all participants who received at least one 1 treatment with dalteparin sodium.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
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|---|---|
|
Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee
|
8 participants
|
PRIMARY outcome
Timeframe: Month 7 up to Month 12Population: 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.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=194 Participants
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.
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|---|---|
|
Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee
|
8 participants
|
SECONDARY outcome
Timeframe: 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 12Population: Safety population included all participants who received at least 1 treatment with dalteparin sodium.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
|
|---|---|
|
Number of Participants With Investigator Identified Major Bleeding Events
Month 7 up to Month 12
|
7 participants
|
|
Number of Participants With Investigator Identified Major Bleeding Events
Month 1 up to Month 12
|
35 participants
|
|
Number of Participants With Investigator Identified Major Bleeding Events
Month 2 up to Month 6
|
15 participants
|
|
Number of Participants With Investigator Identified Major Bleeding Events
Month 2 up to Month 12
|
22 participants
|
|
Number of Participants With Investigator Identified Major Bleeding Events
Month 1 up to Month 6
|
28 participants
|
SECONDARY outcome
Timeframe: 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 12Population: Safety population included all participants who received at least 1 treatment with dalteparin sodium.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
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|---|---|
|
Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee
Month 1 up to Month 6
|
91 participants
|
|
Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee
Month 7 up to Month 12
|
21 participants
|
|
Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee
Month 1 up to Month 12
|
112 participants
|
|
Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee
Month 2 up to Month 6
|
47 participants
|
|
Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee
Month 2 up to Month 12
|
68 participants
|
SECONDARY outcome
Timeframe: 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 12Population: Safety population included all participants who received at least 1 treatment with dalteparin sodium.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
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|---|---|
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Number of Participants With Fatal Bleeding Events
Month 1 up to Month 12
|
2 participants
|
|
Number of Participants With Fatal Bleeding Events
Month 2 up to Month 6
|
1 participants
|
|
Number of Participants With Fatal Bleeding Events
Month 2 up to Month 12
|
2 participants
|
|
Number of Participants With Fatal Bleeding Events
Month 1 up to Month 6
|
1 participants
|
|
Number of Participants With Fatal Bleeding Events
Month 7 up to Month 12
|
1 participants
|
SECONDARY outcome
Timeframe: Month 1 up to Month 12Population: Safety population included all participants who received at least 1 treatment with dalteparin sodium.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
|
|---|---|
|
Time to First Occurrence of Major Bleeding Event Adjudicated by Central Adjudication Committee
|
332.9 days
Standard Error 5.25
|
SECONDARY outcome
Timeframe: Month 1 up to Month 12Population: Safety population included all participants who received at least 1 treatment with dalteparin sodium.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
|
|---|---|
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Time to First Occurrence of Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee
|
262.5 days
Standard Error 8.52
|
SECONDARY outcome
Timeframe: 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 12Population: 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.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
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|---|---|
|
Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)
Month 1 up to Month 6 (n=334)
|
29 participants
|
|
Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)
Month 7 up to Month 12 (n=195)
|
8 participants
|
|
Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)
Month 1 up to Month 12 (n=334)
|
37 participants
|
|
Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)
Month 2 up to Month 6 (n=295)
|
9 participants
|
|
Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)
Month 2 up to Month 12 (n=295)
|
17 participants
|
SECONDARY outcome
Timeframe: 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 12Population: 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.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
|
|---|---|
|
Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee
Month 1 up to Month 6 (n=334)
|
29 participants
|
|
Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee
Month 7 up to Month 12 (n=194)
|
8 participants
|
|
Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee
Month 1 up to Month 12 (n=334)
|
37 participants
|
|
Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee
Month 2 up to Month 6 (n=296)
|
10 participants
|
|
Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee
Month 2 up to Month 12 (n=296)
|
18 participants
|
SECONDARY outcome
Timeframe: 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 12Population: 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.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
|
|---|---|
|
Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)
Month 1 up to Month 6 (n=334)
|
29 participants
|
|
Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)
Month 7 up to Month 12 (n=195)
|
8 participants
|
|
Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)
Month 1 up to Month 12 (n=334)
|
37 participants
|
|
Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)
Month 2 up to Month 6 (n=295)
|
9 participants
|
|
Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)
Month 2 up to Month 12 (n=295)
|
17 participants
|
SECONDARY outcome
Timeframe: Month 1 up to Month 12Population: Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
|
|---|---|
|
Time to First Occurrence of New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee
|
294.1 days
Standard Error 4.87
|
SECONDARY outcome
Timeframe: Month 1 up to Month 12Population: Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
|
|---|---|
|
Time to First Occurrence of New or Recurrent VTE or CVT Adjudicated by Central Adjudication Committee
|
294.1 days
Standard Error 4.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) up to Week 52Population: Safety population included all participants who received at least 1 treatment with dalteparin sodium.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
AE
|
328 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAE
|
213 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) up to Week 52Population: Safety population included all participants who received at least 1 treatment with dalteparin sodium.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
|
|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1), Week 1, 4, 8, 12, 24, 36, 48, 52Population: 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.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
|
|---|---|
|
Number of Participants With Abnormal Physical Examinations Findings
Baseline : Head (n=327)
|
14 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Baseline : Ears, nose, throat (ENT)(n=327)
|
20 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Baseline : Neck (n=327)
|
10 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Baseline : Heart (n=327)
|
26 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Baseline : Chest (n=326)
|
40 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Baseline : Lungs (n=327)
|
65 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Baseline : Abdomen (n=327)
|
73 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Baseline : Extremities (n=328)
|
203 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Baseline : Neurological systems (n=327)
|
18 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Baseline : Skin (n=327)
|
51 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Baseline : General appearance (n=327)
|
47 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Baseline : Others (n=47)
|
25 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 1 : Head (n=213)
|
16 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 1 : ENT (n=214)
|
20 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 1 : Neck (n=214)
|
7 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 1 : Heart (n=214)
|
10 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 1 : Chest (n=213)
|
22 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 1 : Lungs (n=214)
|
28 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 1 :Abdomen (n=214)
|
62 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 1 : Extremities (n=213)
|
103 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 1 : Neurological systems (n=213)
|
16 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 1 : Skin (n=213)
|
52 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 1 : General appearance (n=212)
|
25 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 1:Others (n=41)
|
23 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 4 : Head (n=211)
|
12 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 4 : ENT (n=211)
|
16 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 4 : Neck (n=211)
|
6 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 4 : Heart (n=210)
|
8 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 4 : Chest (n=211)
|
23 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 4 : Lungs (n=211)
|
24 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 4 : Abdomen (n=210)
|
59 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 4 : Extremities (n=211)
|
83 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 4 : Neurological systems (n=211)
|
9 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 4 : Skin (n=210)
|
49 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 4 : General appearance (n=208)
|
25 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 4 : Others (n=23)
|
20 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 8 : Head (n=186)
|
11 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 8 : ENT (n=186)
|
16 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 8 : Neck (n=185)
|
4 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 8 : Heart (n=186)
|
8 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 8 : Chest (n=186)
|
21 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 8 : Lungs (n=186)
|
31 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 8 : Abdomen (n=186)
|
49 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 8 : Extremities (n=186)
|
80 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 8 : Neurological systems (n=185)
|
13 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 8 : Skin (n=186)
|
38 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 8 : General appearance (n=186)
|
16 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 8 : Others (n=16)
|
12 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 12 : Head (n=183)
|
10 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 12 : ENT (n=183)
|
12 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 12 : Neck (n=183)
|
1 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 12 : Heart (n=183)
|
9 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 12 : Chest (n=183)
|
22 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 12 : Lungs (n=183)
|
15 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 12 : Abdomen (n=183)
|
47 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 12 : Extremities (n=183)
|
57 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 12 : Neurological systems (n=183)
|
19 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 12 : Skin (n=183)
|
39 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 12 : General appearance (n=182)
|
18 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 12 : Other (n=27)
|
16 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 24 : Head (n=166)
|
2 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 24 : ENT (n=166)
|
12 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 24 : Neck (n=166)
|
4 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 24 : Heart (n=166)
|
9 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 24 : Chest (n=166)
|
17 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 24 : Lungs (n=166)
|
14 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 24 : Abdomen (n=166)
|
37 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 24 : Extremities (n=166)
|
47 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 24 : Neurological systems (n=166)
|
14 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 24 : Skin (n=166)
|
35 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 24 : General appearance (n=166)
|
9 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 24 : Others (n=17)
|
11 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 36 : Head (n=127)
|
6 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 36 : ENT (n=127)
|
9 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 36 : Neck (n=127)
|
4 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 36 : Heart (n=127)
|
7 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 36 : Chest (n=127)
|
18 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 36 : Lungs (n=127)
|
12 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 36 : Abdomen (n=126)
|
35 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 36 : Extremities (n=127)
|
37 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 36 : Neurological systems (n=127)
|
9 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 36 : Skin (n=127)
|
32 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 36 : General appearance (n=126)
|
11 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 36 : Others (n=14)
|
9 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 48 : Head (n=103)
|
2 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 48 : ENT (n=103)
|
6 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 48 : Neck (n=103)
|
3 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 48 : Heart (n=103)
|
7 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 48 : Chest (n=103)
|
11 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 48 : Lungs (n=102)
|
14 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 48 : Abdomen (n=103)
|
27 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 48 : Extremities (n=103)
|
29 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 48 : Neurological systems (n=103)
|
8 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 48 : Skin (n=103)
|
29 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 48 : General appearance (n=103)
|
9 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 48 : Others (n=7)
|
3 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 52 : Head (n=193)
|
7 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 52 : ENT (n=193)
|
13 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 52 : Neck (n=193)
|
5 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 52 : Heart (n=193)
|
12 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 52 : Chest (n=193)
|
23 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 52 : Lungs (n=191)
|
23 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 52 : Abdomen (n=193)
|
60 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 52 : Extremities (n=193)
|
68 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 52 : Neurological systems (n=193)
|
24 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 52 : Skin (n=193)
|
38 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 52 : General appearance (n=193)
|
27 participants
|
|
Number of Participants With Abnormal Physical Examinations Findings
Week 52 : Others (n=25)
|
15 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 52Population: Safety population included all participants who received at least 1 treatment with dalteparin sodium.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=334 Participants
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.
|
|---|---|
|
Other Pre-specified: Number of Participants With Clinically Significant Electrocardiogram Findings
|
8 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: 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.
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.
Outcome measures
| Measure |
Dalteparin Sodium
n=19 Participants
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.
|
|---|---|
|
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
Baseline (n=17)
|
46.0 mL/min
Standard Deviation 28.66
|
|
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
Week 4 (n=15)
|
-8.6 mL/min
Standard Deviation 25.39
|
|
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
Week 8 (n=13)
|
2.5 mL/min
Standard Deviation 47.02
|
|
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
Week 12 (n=13)
|
2.1 mL/min
Standard Deviation 58.15
|
|
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
Week 16 (n=4)
|
-9.2 mL/min
Standard Deviation 21.93
|
|
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
Week 20 (n=2)
|
7.7 mL/min
Standard Deviation 7.90
|
|
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
Week 24 (n=12)
|
4.5 mL/min
Standard Deviation 49.62
|
|
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
Week 28 (n=1)
|
-44.0 mL/min
Standard Deviation NA
Standard deviation was not calculated since only 1 participant was evaluable at the given time point.
|
|
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
Week 32 (n=1)
|
-14.0 mL/min
Standard Deviation NA
Standard deviation was not calculated since only 1 participant was evaluable at the given time point.
|
|
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
Week 36 (n=8)
|
5.8 mL/min
Standard Deviation 56.91
|
|
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
Week 40 (n=2)
|
-21.0 mL/min
Standard Deviation 9.90
|
|
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
Week 44 (n=2)
|
-20.0 mL/min
Standard Deviation 4.24
|
|
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
Week 48 (n=6)
|
-26.0 mL/min
Standard Deviation 18.12
|
|
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
Week 52 (n=11)
|
4.8 mL/min
Standard Deviation 50.19
|
Adverse Events
Dalteparin Sodium
Serious adverse events
| Measure |
Dalteparin Sodium
n=334 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
6/334
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.30%
1/334
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.6%
12/334
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.60%
2/334
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.30%
1/334
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
4/334
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.90%
3/334
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
4/334
|
|
Cardiac disorders
Acute myocardial infarction
|
0.30%
1/334
|
|
Cardiac disorders
Angina pectoris
|
0.30%
1/334
|
|
Cardiac disorders
Atrial fibrillation
|
0.30%
1/334
|
|
Cardiac disorders
Atrial flutter
|
0.60%
2/334
|
|
Cardiac disorders
Cardiac failure congestive
|
0.60%
2/334
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.30%
1/334
|
|
Cardiac disorders
Coronary artery occlusion
|
0.30%
1/334
|
|
Cardiac disorders
Endocarditis noninfective
|
0.30%
1/334
|
|
Cardiac disorders
Myocardial infarction
|
0.30%
1/334
|
|
Ear and labyrinth disorders
Vertigo
|
0.30%
1/334
|
|
Endocrine disorders
Adrenal haemorrhage
|
0.30%
1/334
|
|
Gastrointestinal disorders
Abdominal pain
|
0.60%
2/334
|
|
Gastrointestinal disorders
Ascites
|
1.5%
5/334
|
|
Gastrointestinal disorders
Colitis
|
0.30%
1/334
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.30%
1/334
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
7/334
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.30%
1/334
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.30%
1/334
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.60%
2/334
|
|
Gastrointestinal disorders
Gastritis
|
0.30%
1/334
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
4/334
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.30%
1/334
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.30%
1/334
|
|
Gastrointestinal disorders
Haematemesis
|
0.30%
1/334
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.90%
3/334
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.60%
2/334
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.30%
1/334
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.30%
1/334
|
|
Gastrointestinal disorders
Narcotic bowel syndrome
|
0.30%
1/334
|
|
Gastrointestinal disorders
Nausea
|
1.5%
5/334
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.30%
1/334
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.30%
1/334
|
|
Gastrointestinal disorders
Pancreatitis
|
0.30%
1/334
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.60%
2/334
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.90%
3/334
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.30%
1/334
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.5%
5/334
|
|
Gastrointestinal disorders
Subileus
|
0.30%
1/334
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.90%
3/334
|
|
Gastrointestinal disorders
Varicose veins of abdominal wall
|
0.30%
1/334
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
8/334
|
|
General disorders
Asthenia
|
0.30%
1/334
|
|
General disorders
Chills
|
0.30%
1/334
|
|
General disorders
Device malfunction
|
0.30%
1/334
|
|
General disorders
Device occlusion
|
0.60%
2/334
|
|
General disorders
Disease progression
|
8.7%
29/334
|
|
General disorders
Fatigue
|
0.30%
1/334
|
|
General disorders
General physical health deterioration
|
0.30%
1/334
|
|
General disorders
Mucosal inflammation
|
0.60%
2/334
|
|
General disorders
Multi-organ failure
|
0.60%
2/334
|
|
General disorders
Oedema peripheral
|
1.2%
4/334
|
|
General disorders
Pain
|
0.60%
2/334
|
|
General disorders
Pyrexia
|
1.5%
5/334
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.60%
2/334
|
|
Hepatobiliary disorders
Cholecystitis
|
0.30%
1/334
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.60%
2/334
|
|
Hepatobiliary disorders
Cholestasis
|
0.30%
1/334
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.30%
1/334
|
|
Hepatobiliary disorders
Hepatic failure
|
0.30%
1/334
|
|
Hepatobiliary disorders
Jaundice
|
0.30%
1/334
|
|
Infections and infestations
Appendicitis
|
0.30%
1/334
|
|
Infections and infestations
Bacteraemia
|
0.30%
1/334
|
|
Infections and infestations
Bacterial infection
|
0.30%
1/334
|
|
Infections and infestations
Bacterial sepsis
|
0.30%
1/334
|
|
Infections and infestations
Bronchitis
|
0.30%
1/334
|
|
Infections and infestations
Candiduria
|
0.60%
2/334
|
|
Infections and infestations
Cellulitis
|
3.6%
12/334
|
|
Infections and infestations
Clostridial infection
|
0.60%
2/334
|
|
Infections and infestations
Clostridium difficile colitis
|
0.30%
1/334
|
|
Infections and infestations
Device related infection
|
0.30%
1/334
|
|
Infections and infestations
Diverticulitis
|
0.30%
1/334
|
|
Infections and infestations
Escherichia sepsis
|
0.30%
1/334
|
|
Infections and infestations
Gastroenteritis
|
0.30%
1/334
|
|
Infections and infestations
Gastroenteritis viral
|
0.30%
1/334
|
|
Infections and infestations
Haematoma infection
|
0.30%
1/334
|
|
Infections and infestations
Infection
|
0.30%
1/334
|
|
Infections and infestations
Lobar pneumonia
|
0.60%
2/334
|
|
Infections and infestations
Lung abscess
|
0.30%
1/334
|
|
Infections and infestations
Peritonitis
|
0.60%
2/334
|
|
Infections and infestations
Postoperative wound infection
|
0.30%
1/334
|
|
Infections and infestations
Pyelonephritis
|
0.30%
1/334
|
|
Infections and infestations
Respiratory tract infection
|
0.30%
1/334
|
|
Infections and infestations
Sepsis
|
2.1%
7/334
|
|
Infections and infestations
Septic shock
|
1.2%
4/334
|
|
Infections and infestations
Streptococcal sepsis
|
0.30%
1/334
|
|
Infections and infestations
Urinary tract infection
|
1.5%
5/334
|
|
Infections and infestations
Urosepsis
|
0.90%
3/334
|
|
Infections and infestations
Wound infection
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Inadequate analgesia
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.60%
2/334
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.30%
1/334
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.30%
1/334
|
|
Investigations
Haemoglobin decreased
|
0.90%
3/334
|
|
Investigations
Staphylococcus test positive
|
0.30%
1/334
|
|
Investigations
Weight decreased
|
0.30%
1/334
|
|
Metabolism and nutrition disorders
Dehydration
|
0.60%
2/334
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.30%
1/334
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.60%
2/334
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.60%
2/334
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.30%
1/334
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.90%
3/334
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.30%
1/334
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.30%
1/334
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.30%
1/334
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.30%
1/334
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.90%
3/334
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.30%
1/334
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.30%
1/334
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.30%
1/334
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.30%
1/334
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.90%
3/334
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.30%
1/334
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.30%
1/334
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.30%
1/334
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.60%
2/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenocortical carcinoma
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.60%
2/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar carcinoma
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.60%
2/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix cancer metastatic
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.60%
2/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
1.2%
4/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.60%
2/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.8%
6/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.2%
4/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ovarian cyst
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.2%
4/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma recurrent
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.60%
2/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.90%
3/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.60%
2/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
1.2%
4/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
2.4%
8/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.90%
3/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.60%
2/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.90%
3/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma recurrent
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyosarcoma
|
0.30%
1/334
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.30%
1/334
|
|
Nervous system disorders
Brain oedema
|
0.30%
1/334
|
|
Nervous system disorders
Cerebrovascular accident
|
0.90%
3/334
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.30%
1/334
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.60%
2/334
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.30%
1/334
|
|
Nervous system disorders
Headache
|
0.30%
1/334
|
|
Nervous system disorders
Hemiparesis
|
0.30%
1/334
|
|
Nervous system disorders
Neuralgia
|
0.30%
1/334
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.30%
1/334
|
|
Nervous system disorders
Paraplegia
|
0.30%
1/334
|
|
Nervous system disorders
Stupor
|
0.30%
1/334
|
|
Nervous system disorders
Syncope
|
0.30%
1/334
|
|
Nervous system disorders
Thrombotic stroke
|
0.30%
1/334
|
|
Nervous system disorders
Transient ischaemic attack
|
0.30%
1/334
|
|
Psychiatric disorders
Delirium
|
0.30%
1/334
|
|
Psychiatric disorders
Depression
|
0.30%
1/334
|
|
Psychiatric disorders
Mental disorder
|
0.30%
1/334
|
|
Psychiatric disorders
Mental status changes
|
1.2%
4/334
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.30%
1/334
|
|
Renal and urinary disorders
Calculus bladder
|
0.30%
1/334
|
|
Renal and urinary disorders
Haematuria
|
1.2%
4/334
|
|
Renal and urinary disorders
Postrenal failure
|
0.30%
1/334
|
|
Renal and urinary disorders
Renal failure
|
1.5%
5/334
|
|
Renal and urinary disorders
Renal failure acute
|
1.2%
4/334
|
|
Renal and urinary disorders
Renal impairment
|
0.30%
1/334
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.30%
1/334
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.60%
2/334
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.30%
1/334
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.60%
2/334
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.90%
3/334
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.30%
1/334
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.60%
2/334
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.30%
1/334
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.30%
1/334
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.30%
1/334
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.30%
1/334
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
10/334
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.30%
1/334
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.60%
2/334
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.30%
1/334
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.0%
20/334
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.90%
3/334
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.30%
1/334
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.30%
1/334
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.30%
1/334
|
|
Vascular disorders
Deep vein thrombosis
|
2.4%
8/334
|
|
Vascular disorders
Embolism venous
|
0.60%
2/334
|
|
Vascular disorders
Hypertension
|
0.30%
1/334
|
|
Vascular disorders
Hypotension
|
1.2%
4/334
|
|
Vascular disorders
Jugular vein thrombosis
|
0.30%
1/334
|
|
Vascular disorders
Subclavian artery stenosis
|
0.30%
1/334
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.30%
1/334
|
|
Infections and infestations
Pneumonia
|
6.6%
22/334
|
Other adverse events
| Measure |
Dalteparin Sodium
n=334 participants at risk
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.
|
|---|---|
|
General disorders
Injection site hematoma
|
27.2%
91/334
|
|
General disorders
Fatigue
|
26.9%
90/334
|
|
Gastrointestinal disorders
Nausea
|
24.3%
81/334
|
|
General disorders
Odema peripheral
|
24.0%
80/334
|
|
Gastrointestinal disorders
Constipation
|
21.3%
71/334
|
|
Gastrointestinal disorders
Diarrhea
|
18.0%
60/334
|
|
Blood and lymphatic system disorders
Anemia
|
16.2%
54/334
|
|
Injury, poisoning and procedural complications
Contusion
|
15.6%
52/334
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.6%
52/334
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.4%
48/334
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.5%
45/334
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.6%
42/334
|
|
Gastrointestinal disorders
Vomiting
|
12.6%
42/334
|
|
Gastrointestinal disorders
Abdominal pain
|
12.3%
41/334
|
|
General disorders
Disease progression
|
11.1%
37/334
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
36/334
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.8%
36/334
|
|
Investigations
Weight decreased
|
10.8%
36/334
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.2%
34/334
|
|
Infections and infestations
Pneumonia
|
10.2%
34/334
|
|
Nervous system disorders
Headache
|
9.9%
33/334
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.9%
33/334
|
|
Infections and infestations
Urinary tract infection
|
9.6%
32/334
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.3%
31/334
|
|
Psychiatric disorders
Anxiety
|
8.1%
27/334
|
|
Nervous system disorders
Dizziness
|
8.1%
27/334
|
|
Psychiatric disorders
Insomnia
|
8.1%
27/334
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.1%
27/334
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.2%
24/334
|
|
Metabolism and nutrition disorders
Dehydration
|
7.2%
24/334
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.2%
24/334
|
|
General disorders
Pyrexia
|
7.2%
24/334
|
|
Vascular disorders
Hypotension
|
6.9%
23/334
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.6%
22/334
|
|
Gastrointestinal disorders
Ascites
|
6.6%
22/334
|
|
Renal and urinary disorders
Hematuria
|
6.6%
22/334
|
|
Nervous system disorders
Neuropathy peripheral
|
6.6%
22/334
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.6%
22/334
|
|
Infections and infestations
Upper respiratory tract infection
|
6.6%
22/334
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.0%
20/334
|
|
General disorders
Asthenia
|
5.7%
19/334
|
|
Infections and infestations
Cellulitis
|
5.7%
19/334
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.4%
18/334
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.4%
18/334
|
|
Cardiac disorders
Tachycardia
|
5.4%
18/334
|
|
Investigations
Hemoglobin decreased
|
5.1%
17/334
|
|
General disorders
Injection site hemorrhage
|
5.1%
17/334
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.1%
17/334
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER