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Trial record 1 of 1 for:    NCT00952380
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Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

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ClinicalTrials.gov Identifier: NCT00952380
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Venous Thromboembolism
Intervention Drug: dalteparin
Enrollment 38
Recruitment Details  
Pre-assignment Details The study was conducted in the 5 countries from 20 August 2009 to 20 March 2018. A total of 38 participants were enrolled. This study had dose adjustment (DA) phase (Day 1-7), pharmacodynamic (PD) phase (Day 8-14) and follow up (FU) phase (Day 15-104).
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description Participants aged greater than or equal to (>=) 0 to less than (<) 8 weeks were administered 125 international unit per kilogram (IU/kg) of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying venous thromboembolism (VTE). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days). Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days). Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days). Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days). Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Period Title: Overall Study
Started 1 2 8 7 20
Completed 1 1 6 4 14
Not Completed 0 1 2 3 6
Reason Not Completed
Other             0             0             0             0             1
Withdrawal by Subject             0             0             1             0             2
Adverse Event             0             1             0             0             3
Physician Decision             0             0             1             2             0
Non-compliant to protocol             0             0             0             1             0
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) Total
Hide Arm/Group Description Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days). Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days). Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days). Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days). Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days). Total of all reporting groups
Overall Number of Baseline Participants 1 2 8 7 20 38
Hide Baseline Analysis Population Description
The safety analysis set included all the participants who received at least 1 dose of study drug.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants 2 participants 8 participants 7 participants 20 participants 38 participants
0.0684
(0.0684 to 0.0684)
1.0569
(0.1999 to 1.9138)
5.3676
(2.3409 to 7.3949)
10.0287
(8.3833 to 11.8741)
15.7208
(12.4682 to 18.7187)
11.1577
(0.0684 to 18.7187)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 8 participants 7 participants 20 participants 38 participants
Female
0
   0.0%
1
  50.0%
2
  25.0%
5
  71.4%
6
  30.0%
14
  36.8%
Male
1
 100.0%
1
  50.0%
6
  75.0%
2
  28.6%
14
  70.0%
24
  63.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 8 participants 7 participants 20 participants 38 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
2
  25.0%
2
  28.6%
4
  20.0%
8
  21.1%
Not Hispanic or Latino
1
 100.0%
2
 100.0%
6
  75.0%
5
  71.4%
16
  80.0%
30
  78.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 8 participants 7 participants 20 participants 38 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
1
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
3
  42.9%
4
  20.0%
7
  18.4%
White
1
 100.0%
2
 100.0%
7
  87.5%
4
  57.1%
15
  75.0%
29
  76.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
   2.6%
1.Primary Outcome
Title Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level
Hide Description Prespecified therapeutic anti-factor Xa level was 0.5-1.0 international unit per milliliter (IU/mL). Cumulative data of Day 1 to 7 has been reported.
Time Frame 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase.
Arm/Group Title Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
Hide Arm/Group Description:
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 34
Median (Full Range)
Unit of Measure: IU/mL
125
(99.1 to 213.5)
2.Secondary Outcome
Title Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels
Hide Description Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Percentage of participants who achieved the prespecified level during the dose adjustment phase were reported in this outcome measure.
Time Frame Day 1 to 7 in dose adjustment phase
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all the participants who received at least 1 dose of study drug.
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 1 2 8 7 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.00 to 97.50)
100.0
(15.81 to 100.0)
100.0
(63.06 to 100.0)
100.0
(59.04 to 100.0)
85.0
(62.11 to 96.79)
3.Secondary Outcome
Title Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE)
Hide Description Symptomatic VTE defined as new or progressive signs and symptoms as judged by the investigator including but not limited to: objective swelling, pain or tenderness, pitting edema, erythema or cyanosis. Progression of VTE: Progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis.
Time Frame Baseline up to 28 days after the last dose of study drug (up to Day 132)
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this outcome measure (OM) was not planned to be collected and analyzed for age group of >=0 to <8 weeks.
Arm/Group Title Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 2 8 7 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
4.Secondary Outcome
Title Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)
Hide Description It was defined as the time interval (in days) between date of first study treatment and date of documentation of first VTE. VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot breaks, loose and travels in the blood, this is called VTE. VTE was confirmed by at least one radiographic test and was defined as any new or progressive VTE whose signs and symptoms (identified by the investigator) included: objective swelling or tenderness, pitting edema, erythema or cyanosis.
Time Frame Baseline up to 28 days after the last dose of study drug (up to Day 132)
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase.
Arm/Group Title Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
Hide Arm/Group Description:
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
[1]
Median and 95% CI was not estimable due to the low number of participants who had VTE.
5.Secondary Outcome
Title Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)
Hide Description VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. PE is a blood clot in the lungs. Clinical response of progression was defined as progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis. Clinical response of regression: Regressed clot burden utilizing the same imaging modality as the screening visit. Clinical response of resolution: Thrombus resolution of the qualifying event measured by repeat imaging at the end of study (EOS) visit.
Time Frame Baseline up to 28 days after the last dose of study drug (up to Day 132)
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this OM was not planned to be collected and analyzed for age group of >=0 to <8 weeks.
Arm/Group Title Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 2 8 7 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Progression
0
(0.00 to 84.19)
0
(0.00 to 36.94)
0
(0.00 to 40.96)
0
(0.00 to 19.51)
Regression
0
(0.00 to 84.19)
12.5
(0.32 to 52.65)
14.3
(0.36 to 57.87)
29.4
(10.31 to 55.96)
Resolution
100.0
(15.81 to 100.0)
62.5
(24.49 to 91.48)
57.1
(18.41 to 90.10)
58.8
(32.92 to 81.56)
No Change
0
(0.00 to 84.19)
0
(0.00 to 36.94)
14.3
(0.36 to 57.87)
5.9
(0.15 to 28.69)
6.Secondary Outcome
Title Percentage of Participants With Major and Minor Bleeding Event
Hide Description A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter 24 hours, Overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, Overt bleeding deemed by the attending physician to be unrelated to the participant's underlying condition and accompanied by blood product administration or bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal). A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major or clinically relevant no major bleeding (bleeding resulting in any medical or surgical interventions but which did not meet the criteria for major bleeding).
Time Frame Baseline up to 28 days after the last dose of study drug (up to Day 132)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received at least 1 dose of study drug.
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 1 2 8 7 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Major Bleeding
0
(0.00 to 97.50)
50.0
(1.26 to 98.74)
0
(0.00 to 36.94)
0
(0.00 to 40.96)
0
(0.00 to 16.84)
Minor Bleeding
0
(0.00 to 97.50)
0
(0.00 to 84.19)
50.0
(15.70 to 84.30)
57.1
(18.41 to 90.10)
40.0
(19.12 to 63.95)
7.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs) 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. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after the last dose of study drug (up to Day 132) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Time Frame Baseline up to 28 days after the last dose of study drug (up to Day 132)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received at least 1 dose of study drug.
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 1 2 8 7 20
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
1
 100.0%
2
 100.0%
7
  87.5%
7
 100.0%
19
  95.0%
SAEs
0
   0.0%
2
 100.0%
3
  37.5%
3
  42.9%
13
  65.0%
8.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities
Hide Description Criteria:hematology:hemoglobin, hematocrit, erythrocytes less than(<)0.8*lower limit of normal(LLN), platelets <0.5*LLN >1.75*upper limit of normal (ULN),leukocytes <0.6* LLN >1.5* ULN, lymphocytes, lymphocytes/Leukocytes, neutrophils, neutrophils/leukocytes <0.8* LLN >1.2* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes >1.2*ULN, activated partial thromboplastin time, prothrombin time, prothrombin international normalized ratio >1.1* ULN. Clinical chemistry: bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN, protein, albumin <0.8* LLN >1.2* ULN, blood urea nitrogen, creatinine >1.3* ULN, sodium <0.95*LLN >1.05*ULN, potassium, chloride, calcium, magnesium <0.9* LLN >1.1* ULN, phosphate <0.8* LLN >1.2* ULN, glucose <0.6*LLN >1.5*ULN, estimated(est) creatinine clearance, est GFR modified and bedside schwartz, >1.0* ULN. Urinalysis: creatinine >1.0*ULN.
Time Frame Baseline up to 104 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 1 2 8 7 19
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
2
 100.0%
8
 100.0%
5
  71.4%
19
 100.0%
9.Secondary Outcome
Title Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
Hide Description [Not Specified]
Time Frame Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 1 2 8 7 20
Median (Full Range)
Unit of Measure: millimeters of mercury (mmHg)
SBP: Baseline Number Analyzed 1 participants 1 participants 6 participants 3 participants 12 participants
101.00
(101.00 to 101.00)
50.00
(50.00 to 50.00)
110.50
(95.00 to 119.00)
96.00
(94.00 to 119.00)
117.50
(97.00 to 140.00)
SBP: Day 1 Number Analyzed 1 participants 2 participants 4 participants 6 participants 15 participants
97.00
(97.00 to 97.00)
105.50
(63.00 to 148.00)
112.0
(100.00 to 137.00)
111.00
(100.00 to 126.00)
113.00
(92.00 to 130.00)
SBP: Day 2 Number Analyzed 1 participants 1 participants 8 participants 7 participants 18 participants
94.00
(94.00 to 94.00)
75.00
(75.00 to 75.00)
107.00
(90.0 to 128.0)
112.00
(101.0 to 126.0)
119.50
(98.0 to 158.0)
SBP: Day 30 Number Analyzed 1 participants 1 participants 7 participants 5 participants 17 participants
77.0
(77.00 to 77.00)
77.00
(77.00 to 77.00)
112.00
(100.00 to 123.00)
109.00
(100.00 to 113.00)
118.00
(95.00 to 133.00)
SBP: Day 60 Number Analyzed 1 participants 1 participants 7 participants 5 participants 14 participants
74.00
(74.0 to 74.0)
102.00
(102.0 to 102.0)
101.00
(91.0 to 124.0)
118.00
(102.0 to 130.0)
117.50
(102.0 to 134.0)
SBP: Day 90 Number Analyzed 1 participants 2 participants 8 participants 7 participants 19 participants
76.00
(76.0 to 76.0)
105.00
(93.0 to 117.0)
97.50
(90.0 to 105.0)
116.00
(99.0 to 123.0)
116.00
(89.0 to 151.0)
DSBP: Baseline Number Analyzed 1 participants 1 participants 6 participants 3 participants 12 participants
60.00
(60.00 to 60.00)
41.00
(41.00 to 41.00)
66.00
(50.00 to 77.00)
67.00
(60.00 to 75.00)
65.00
(46.00 to 80.00)
DSBP: Day 1 Number Analyzed 1 participants 2 participants 4 participants 6 participants 15 participants
61.00
(61.00 to 61.00)
57.00
(41.00 to 73.00)
65.50
(50.00 to 87.00)
66.50
(54.00 to 81.00)
64.00
(48.00 to 80.00)
DSBP: Day 2 Number Analyzed 1 participants 1 participants 8 participants 7 participants 18 participants
48.00
(48.00 to 48.00)
53.00
(53.00 to 53.00)
60.50
(53.00 to 70.00)
70.00
(65.00 to 79.00)
65.00
(53.00 to 95.00)
DSBP: Day 30 Number Analyzed 1 participants 1 participants 7 participants 5 participants 17 participants
53.00
(53.00 to 53.00)
61.00
(61.00 to 61.00)
64.00
(54.00 to 68.00)
68.00
(53.00 to 71.00)
69.00
(55.00 to 87.00)
DSBP: Day 60 Number Analyzed 1 participants 1 participants 7 participants 5 participants 14 participants
51.00
(51.00 to 51.00)
57.00
(57.00 to 57.00)
60.00
(46.00 to 73.00)
67.00
(59.00 to 70.00)
67.00
(57.00 to 80.00)
DSBP: Day 90 Number Analyzed 1 participants 2 participants 8 participants 7 participants 19 participants
53.00
(53.00 to 53.00)
55.50
(51.00 to 60.00)
60.50
(52.00 to 70.00)
67.00
(56.00 to 80.00)
69.00
(59.00 to 95.00)
10.Secondary Outcome
Title Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
Hide Description Heart rate and pulse rate of participants were measured in terms of beats per minute.
Time Frame Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 1 2 8 7 20
Median (Full Range)
Unit of Measure: beats per minute (bpm)
HR: Baseline Number Analyzed 1 participants 1 participants 4 participants 0 participants 5 participants
148.00
(148.00 to 148.00)
146.00
(146.00 to 146.00)
115.00
(66.00 to 126.00)
70.00
(52.00 to 84.00)
HR: Day 1 Number Analyzed 1 participants 1 participants 1 participants 0 participants 7 participants
146.00
(146.00 to 146.00)
142.00
(142.00 to 142.00)
112.00
(112.00 to 112.00)
85.00
(46.00 to 139.00)
HR: Day 2 Number Analyzed 1 participants 1 participants 5 participants 0 participants 8 participants
136.00
(136.00 to 136.00)
130.00
(130.00 to 130.00)
114.00
(100.00 to 136.00)
75.00
(56.00 to 124.00)
HR: Day 30 Number Analyzed 1 participants 1 participants 4 participants 0 participants 8 participants
138.00
(138.00 to 138.00)
130.00
(130.00 to 130.00)
120.50
(100.00 to 124.00)
87.50
(56.00 to 126.00)
HR: Day 60 Number Analyzed 1 participants 1 participants 4 participants 0 participants 8 participants
132.00
(132.00 to 132.00)
184.00
(184.00 to 184.00)
120.00
(114.00 to 139.00)
94.50
(56.00 to 134.00)
HR: Day 90 Number Analyzed 1 participants 1 participants 4 participants 0 participants 8 participants
122.00
(122.00 to 122.00)
134.00
(134.00 to 134.00)
107.00
(96.00 to 116.00)
80.00
(66.00 to 118.00)
PR: Baseline Number Analyzed 0 participants 0 participants 2 participants 3 participants 7 participants
96.50
(68.00 to 125.00)
114.00
(80.00 to 119.00)
73.00
(67.00 to 150.00)
PR: Day 1 Number Analyzed 0 participants 1 participants 3 participants 6 participants 8 participants
108.00
(108.00 to 108.00)
121.00
(86.00 to 122.00)
87.00
(76.00 to 120.00)
94.50
(72.00 to 123.00)
PR: Day 2 Number Analyzed 0 participants 0 participants 3 participants 7 participants 10 participants
117.00
(113.00 to 138.00)
98.00
(84.00 to 127.00)
93.00
(57.00 to 161.00)
PR: Day 30 Number Analyzed 0 participants 0 participants 3 participants 5 participants 9 participants
88.00
(88.00 to 147.00)
101.00
(90.00 to 150.00)
102.00
(72.00 to 123.00)
PR: Day 60 Number Analyzed 0 participants 0 participants 3 participants 5 participants 6 participants
88.00
(88.00 to 99.00)
93.00
(75.00 to 108.00)
95.00
(62.00 to 117.00)
PR: Day 90 Number Analyzed 0 participants 1 participants 3 participants 7 participants 11 participants
140.00
(140.00 to 140.00)
114.00
(113.00 to 120.00)
96.00
(67.00 to 109.00)
92.00
(74.00 to 124.00)
11.Secondary Outcome
Title Absolute Values of Height of Participants
Hide Description [Not Specified]
Time Frame Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 1 2 8 7 20
Median (Full Range)
Unit of Measure: centimeters (cm)
Baseline Number Analyzed 1 participants 1 participants 4 participants 2 participants 9 participants
54.00
(54.00 to 54.00)
55.00
(55.00 to 55.00)
110.00
(98.00 to 125.50)
133.00
(126.00 to 140.00)
166.00
(142.00 to 178.00)
Day 1 Number Analyzed 1 participants 0 participants 3 participants 2 participants 11 participants
54.00
(54.00 to 54.00)
115.80
(98.00 to 118.00)
134.00
(126.00 to 142.00)
166.00
(113.50 to 184.00)
Day 2 Number Analyzed 0 participants 0 participants 6 participants 5 participants 15 participants
107.90
(89.50 to 120.00)
142.00
(126.00 to 159.90)
166.90
(113.60 to 189.00)
Day 30 Number Analyzed 1 participants 1 participants 5 participants 6 participants 14 participants
60.00
(60.00 to 60.00)
56.60
(56.60 to 56.60)
115.10
(89.50 to 124.50)
140.30
(128.00 to 159.90)
167.75
(113.90 to 184.00)
Day 60 Number Analyzed 1 participants 1 participants 5 participants 5 participants 13 participants
63.00
(63.00 to 63.00)
60.00
(60.00 to 60.00)
115.00
(90.00 to 124.50)
139.70
(128.00 to 161.60)
168.50
(114.20 to 183.60)
Day 90 Number Analyzed 1 participants 1 participants 6 participants 5 participants 18 participants
64.00
(64.00 to 64.00)
61.00
(61.00 to 61.00)
109.50
(91.50 to 127.00)
140.70
(129.00 to 161.60)
166.65
(115.00 to 184.00)
12.Secondary Outcome
Title Absolute Values of Weight of Participants
Hide Description [Not Specified]
Time Frame Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 1 2 8 7 20
Median (Full Range)
Unit of Measure: kilograms
Baseline Number Analyzed 1 participants 1 participants 6 participants 3 participants 9 participants
4.05
(4.05 to 4.05)
3.93
(3.93 to 3.93)
18.78
(12.80 to 34.70)
36.60
(25.40 to 45.80)
60.00
(48.00 to 86.90)
Day 1 Number Analyzed 1 participants 1 participants 4 participants 3 participants 13 participants
4.17
(4.17 to 4.17)
4.04
(4.04 to 4.04)
17.23
(13.40 to 21.20)
37.00
(25.40 to 40.60)
63.40
(19.60 to 95.20)
Day 2 Number Analyzed 1 participants 1 participants 7 participants 6 participants 16 participants
4.50
(4.50 to 4.50)
4.15
(4.15 to 4.15)
14.95
(11.90 to 34.70)
39.35
(25.40 to 64.50)
58.00
(19.70 to 89.80)
Day 30 Number Analyzed 1 participants 1 participants 7 participants 6 participants 17 participants
6.30
(6.30 to 6.30)
4.56
(4.56 to 4.56)
15.50
(13.00 to 37.20)
39.20
(23.00 to 64.50)
63.80
(21.80 to 91.70)
Day 60 Number Analyzed 1 participants 1 participants 7 participants 5 participants 14 participants
7.15
(7.15 to 7.15)
4.60
(4.60 to 4.60)
16.60
(12.70 to 37.20)
38.30
(24.10 to 68.60)
65.80
(22.70 to 90.80)
Day 90 Number Analyzed 1 participants 1 participants 7 participants 6 participants 19 participants
7.70
(7.70 to 7.70)
4.70
(4.70 to 4.70)
21.50
(14.00 to 38.50)
39.30
(24.40 to 68.60)
59.60
(22.60 to 89.80)
13.Secondary Outcome
Title Absolute Values of Respiratory Rate of Participants
Hide Description Respiratory rate was defined as the number of breaths per minute.
Time Frame Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 1 2 8 7 20
Median (Full Range)
Unit of Measure: breaths per minute
Baseline Number Analyzed 1 participants 1 participants 6 participants 3 participants 12 participants
35.00
(35.00 to 35.00)
25.00
(25.00 to 25.00)
24.00
(18.00 to 24.00)
20.00
(18.00 to 30.00)
20.00
(17.00 to 36.00)
Day 1 Number Analyzed 1 participants 2 participants 4 participants 6 participants 15 participants
34.00
(34.00 to 34.00)
36.00
(36.00 to 36.00)
21.00
(20.00 to 24.00)
18.00
(16.00 to 20.00)
18.00
(16.00 to 30.00)
Day 2 Number Analyzed 1 participants 1 participants 7 participants 7 participants 17 participants
34.00
(34.00 to 34.00)
34.00
(34.00 to 34.00)
20.00
(18.00 to 24.00)
20.00
(18.00 to 24.00)
18.00
(16.00 to 24.00)
Day 30 Number Analyzed 1 participants 1 participants 7 participants 4 participants 16 participants
34.00
(34.00 to 34.00)
36.00
(36.00 to 36.00)
22.00
(16.00 to 28.00)
22.00
(20.00 to 24.00)
18.00
(16.00 to 32.00)
Day 60 Number Analyzed 1 participants 1 participants 7 participants 4 participants 14 participants
30.00
(30.00 to 30.00)
36.00
(36.00 to 36.00)
20.00
(16.00 to 24.00)
20.00
(18.00 to 20.00)
20.00
(16.00 to 30.00)
Day 90 Number Analyzed 1 participants 2 participants 7 participants 6 participants 19 participants
24.00
(24.00 to 24.00)
34.00
(32.00 to 36.00)
22.00
(20.00 to 24.00)
20.00
(18.00 to 22.00)
18.00
(12.00 to 28.00)
14.Secondary Outcome
Title Absolute Values of Body Temperature of Participants
Hide Description [Not Specified]
Time Frame Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 1 2 8 7 20
Median (Full Range)
Unit of Measure: degree celsius
Baseline Number Analyzed 1 participants 1 participants 6 participants 3 participants 12 participants
36.60
(36.60 to 36.60)
36.70
(36.70 to 36.70)
36.50
(36.10 to 37.30)
37.00
(36.20 to 37.20)
36.80
(35.60 to 39.30)
Day 1 Number Analyzed 1 participants 2 participants 4 participants 6 participants 15 participants
36.70
(36.70 to 36.70)
36.85
(36.70 to 37.00)
36.80
(36.70 to 36.90)
36.70
(36.00 to 37.00)
36.80
(36.10 to 37.10)
Day 2 Number Analyzed 1 participants 1 participants 8 participants 7 participants 18 participants
36.90
(36.90 to 36.90)
36.40
(36.40 to 36.40)
36.70
(35.30 to 37.30)
36.70
(36.60 to 36.80)
36.70
(36.40 to 37.70)
Day 30 Number Analyzed 1 participants 1 participants 7 participants 5 participants 17 participants
36.50
(36.50 to 36.50)
36.50
(36.50 to 36.50)
36.60
(35.50 to 37.30)
36.50
(36.40 to 38.60)
36.70
(35.10 to 37.10)
Day 60 Number Analyzed 1 participants 1 participants 7 participants 5 participants 13 participants
36.60
(36.60 to 36.60)
36.70
(36.70 to 36.70)
36.80
(36.40 to 38.60)
36.60
(35.60 to 36.90)
36.60
(35.70 to 37.00)
Day 90 Number Analyzed 1 participants 2 participants 8 participants 7 participants 19 participants
36.70
(36.70 to 36.70)
37.15
(36.70 to 37.60)
36.75
(35.90 to 37.50)
36.90
(36.70 to 38.40)
36.80
(36.10 to 38.40)
15.Secondary Outcome
Title Absolute Values of Body Length of Participants
Hide Description [Not Specified]
Time Frame Baseline, Day 1, Day 2, Day 30, Day 60, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 1 2 8 7 20
Median (Full Range)
Unit of Measure: centimeter
Baseline Number Analyzed 1 participants 1 participants 1 participants 0 participants 1 participants
54
(54 to 54)
55
(55 to 55)
100
(100 to 100)
172
(172 to 172)
Day 1 Number Analyzed 1 participants 1 participants 0 participants 0 participants 1 participants
54
(54 to 54)
55
(55 to 55)
135
(135 to 135)
Day 2 Number Analyzed 1 participants 1 participants 2 participants 0 participants 1 participants
56
(56 to 56)
55.30
(55.30 to 55.30)
104.75
(89.50 to 120)
135
(135 to 135)
Day 30 Number Analyzed 1 participants 1 participants 3 participants 0 participants 1 participants
60
(60 to 60)
56.60
(56.60 to 56.60)
100
(89.50 to 124.5)
135
(135 to 135)
Day 60 Number Analyzed 1 participants 1 participants 3 participants 0 participants 1 participants
63
(63 to 63)
60
(60 to 60)
103
(90 to 124.5)
135
(135 to 135)
Day 90 Number Analyzed 1 participants 1 participants 2 participants 0 participants 2 participants
64
(64 to 64)
61
(61 to 61)
97.75
(91.50 to 104)
151.75
(135 to 168.5)
16.Secondary Outcome
Title Number of Participants With Physical Examination Abnormalities of Participants
Hide Description Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Abnormality in physical examination was based on investigator's discretion. Only those categories in which at least 1 participant had abnormality were reported.
Time Frame Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 1 2 8 7 20
Measure Type: Count of Participants
Unit of Measure: Participants
Abdomen: Screening Number Analyzed 1 participants 2 participants 7 participants 7 participants 19 participants
0
   0.0%
1
  50.0%
2
  28.6%
0
   0.0%
2
  10.5%
Abdomen: Visit 2 Number Analyzed 1 participants 1 participants 4 participants 0 participants 7 participants
0
   0.0%
0
   0.0%
2
  50.0%
0
   0.0%
Abdomen: Visit 3 Number Analyzed 1 participants 2 participants 4 participants 6 participants 12 participants
0
   0.0%
1
  50.0%
1
  25.0%
0
   0.0%
2
  16.7%
Abdomen: Visit 4 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
0
   0.0%
1
  14.3%
1
  14.3%
3
  16.7%
Abdomen: Visit 5 Number Analyzed 1 participants 1 participants 7 participants 6 participants 17 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
4
  23.5%
Abdomen: Visit 6 Number Analyzed 1 participants 1 participants 7 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
1
   7.1%
Abdomen: Visit 7 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
1
  50.0%
0
   0.0%
1
  14.3%
3
  16.7%
Chest: Screening Number Analyzed 1 participants 2 participants 7 participants 7 participants 19 participants
0
   0.0%
0
   0.0%
1
  14.3%
2
  28.6%
2
  10.5%
Chest: Visit 2 Number Analyzed 1 participants 1 participants 4 participants 0 participants 7 participants
0
   0.0%
0
   0.0%
2
  50.0%
0
   0.0%
Chest: Visit 3 Number Analyzed 1 participants 2 participants 4 participants 5 participants 12 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
  40.0%
0
   0.0%
Chest: Visit 4 Number Analyzed 1 participants 2 participants 7 participants 6 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
3
  50.0%
1
   5.6%
Chest: Visit 5 Number Analyzed 1 participants 1 participants 7 participants 5 participants 17 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
Chest: Visit 6 Number Analyzed 1 participants 1 participants 7 participants 3 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
Chest: Visit 7 Number Analyzed 1 participants 2 participants 7 participants 6 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
  33.3%
3
  16.7%
Extremities: Screening Number Analyzed 1 participants 2 participants 7 participants 7 participants 19 participants
0
   0.0%
0
   0.0%
0
   0.0%
4
  57.1%
10
  52.6%
Extremities: Visit 2 Number Analyzed 1 participants 1 participants 4 participants 0 participants 7 participants
0
   0.0%
0
   0.0%
1
  25.0%
1
  14.3%
Extremities: Visit 3 Number Analyzed 1 participants 2 participants 4 participants 6 participants 12 participants
0
   0.0%
0
   0.0%
1
  25.0%
3
  50.0%
3
  25.0%
Extremities: Visit 4 Number Analyzed 1 participants 2 participants 7 participants 7 participants 17 participants
0
   0.0%
0
   0.0%
0
   0.0%
4
  57.1%
8
  47.1%
Extremities: Visit 5 Number Analyzed 1 participants 1 participants 7 participants 6 participants 16 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
3
  18.8%
Extremities: Visit 6 Number Analyzed 1 participants 1 participants 7 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
2
  14.3%
Extremities: Visit 7 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
  28.6%
2
  11.1%
Eyes: Screening Number Analyzed 1 participants 1 participants 5 participants 0 participants 8 participants
0
   0.0%
0
   0.0%
1
  20.0%
1
  12.5%
Eyes: Visit 2 Number Analyzed 1 participants 1 participants 3 participants 0 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
Eyes: Visit 3 Number Analyzed 1 participants 1 participants 1 participants 0 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
Eyes: Visit 4 Number Analyzed 1 participants 1 participants 4 participants 0 participants 8 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
  25.0%
Eyes: Visit 5 Number Analyzed 1 participants 1 participants 4 participants 0 participants 8 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Eyes: Visit 6 Number Analyzed 1 participants 1 participants 4 participants 0 participants 8 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Eyes: Visit 7 Number Analyzed 1 participants 1 participants 4 participants 0 participants 8 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Eyes, ears, nose, throat:Screening Number Analyzed 0 participants 1 participants 2 participants 7 participants 11 participants
0
1
 100.0%
1
  50.0%
0
   0.0%
2
  18.2%
Eyes, ears, nose, throat: Visit 3 Number Analyzed 0 participants 1 participants 3 participants 6 participants 5 participants
0
   0.0%
1
  33.3%
0
   0.0%
1
  20.0%
Eyes, ears, nose, throat: Visit 4 Number Analyzed 0 participants 1 participants 3 participants 7 participants 10 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
  20.0%
Eyes, ears, nose, throat: Visit 5 Number Analyzed 0 participants 0 participants 3 participants 6 participants 9 participants
0
   0.0%
0
   0.0%
3
  33.3%
Eyes, ears, nose, throat: Visit 6 Number Analyzed 0 participants 0 participants 3 participants 4 participants 6 participants
2
  66.7%
0
   0.0%
1
  16.7%
Eyes, ears, nose, throat: Visit 7 Number Analyzed 0 participants 1 participants 3 participants 7 participants 10 participants
0
   0.0%
1
  33.3%
0
   0.0%
2
  20.0%
General appearance: Screening Number Analyzed 1 participants 2 participants 7 participants 7 participants 19 participants
0
   0.0%
0
   0.0%
2
  28.6%
1
  14.3%
3
  15.8%
General appearance: Visit 2 Number Analyzed 1 participants 1 participants 4 participants 0 participants 7 participants
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
General appearance: Visit 3 Number Analyzed 1 participants 2 participants 4 participants 6 participants 12 participants
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
   8.3%
General appearance: Visit 4 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
2
  11.1%
General appearance: Visit 5 Number Analyzed 1 participants 1 participants 7 participants 6 participants 17 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  11.8%
General appearance: Visit 6 Number Analyzed 1 participants 1 participants 7 participants 4 participants 14 participants
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
1
   7.1%
General appearance: Visit 7 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
0
   0.0%
1
  14.3%
2
  28.6%
2
  11.1%
Head: Screening Number Analyzed 1 participants 2 participants 7 participants 7 participants 19 participants
0
   0.0%
0
   0.0%
1
  14.3%
1
  14.3%
4
  21.1%
Head: Visit 3 Number Analyzed 1 participants 2 participants 4 participants 6 participants 12 participants
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
2
  16.7%
Head: Visit 4 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
5
  27.8%
Head: Visit 5 Number Analyzed 1 participants 1 participants 7 participants 6 participants 17 participants
0
   0.0%
0
   0.0%
1
  14.3%
1
  16.7%
4
  23.5%
Head: Visit 6 Number Analyzed 1 participants 1 participants 7 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
1
  14.3%
1
  25.0%
3
  21.4%
Head: Visit 7 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
0
   0.0%
1
  14.3%
1
  14.3%
5
  27.8%
Heart: Screening Number Analyzed 1 participants 2 participants 7 participants 7 participants 19 participants
0
   0.0%
0
   0.0%
1
  14.3%
1
  14.3%
0
   0.0%
Heart: Visit 3 Number Analyzed 1 participants 2 participants 4 participants 6 participants 12 participants
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
Heart: Visit 4 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
1
  50.0%
1
  14.3%
0
   0.0%
1
   5.6%
Heart: Visit 7 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
2
  11.1%
Lungs: Screening Number Analyzed 1 participants 2 participants 7 participants 7 participants 19 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
Lungs: Visit 4 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
Lungs: Visit 6 Number Analyzed 1 participants 1 participants 7 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
Lungs: Visit 7 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
Neck: Screening Number Analyzed 1 participants 2 participants 7 participants 7 participants 19 participants
0
   0.0%
1
  50.0%
1
  14.3%
1
  14.3%
2
  10.5%
Neck: Visit 4 Number Analyzed 1 participants 2 participants 7 participants 5 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
Neurological: Screening Number Analyzed 1 participants 2 participants 7 participants 7 participants 19 participants
0
   0.0%
0
   0.0%
2
  28.6%
0
   0.0%
0
   0.0%
Neurological: Visit 2 Number Analyzed 1 participants 1 participants 4 participants 0 participants 7 participants
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
Neurological: Visit 3 Number Analyzed 1 participants 2 participants 4 participants 6 participants 12 participants
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
Neurological: Visit 4 Number Analyzed 1 participants 2 participants 7 participants 6 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
Neurological: Visit 5 Number Analyzed 1 participants 1 participants 7 participants 6 participants 17 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
Neurological: Visit 7 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nose: Screening Number Analyzed 1 participants 1 participants 5 participants 0 participants 8 participants
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
Nose: Visit 2 Number Analyzed 1 participants 1 participants 3 participants 0 participants 5 participants
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
Skin: Screening Number Analyzed 1 participants 2 participants 7 participants 7 participants 19 participants
1
 100.0%
1
  50.0%
1
  14.3%
3
  42.9%
5
  26.3%
Skin: Visit 2 Number Analyzed 1 participants 1 participants 4 participants 0 participants 7 participants
1
 100.0%
0
   0.0%
0
   0.0%
1
  14.3%
Skin: Visit 3 Number Analyzed 1 participants 2 participants 4 participants 6 participants 12 participants
1
 100.0%
1
  50.0%
1
  25.0%
1
  16.7%
3
  25.0%
Skin: Visit 4 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
1
  50.0%
2
  28.6%
2
  28.6%
6
  33.3%
Skin: Visit 5 Number Analyzed 1 participants 1 participants 7 participants 6 participants 17 participants
0
   0.0%
0
   0.0%
2
  28.6%
2
  33.3%
7
  41.2%
Skin: Visit 6 Number Analyzed 1 participants 1 participants 7 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
  50.0%
5
  35.7%
Skin: Visit 7 Number Analyzed 1 participants 2 participants 7 participants 7 participants 18 participants
0
   0.0%
1
  50.0%
1
  14.3%
3
  42.9%
4
  22.2%
17.Secondary Outcome
Title Time to First Occurrence of Major Bleeding Event
Hide Description Time to first occurrence of major bleeding event was defined as the time interval (in days) between date of first study treatment and date of documentation of first major bleeding event. A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter, overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, overt bleeding deemed by the attending physician to be unrelated to the participant’s underlying condition and accompanied by blood product administration, bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal or intraspinal).
Time Frame Baseline up to 28 days after the last dose of study drug (up to Day 132)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received at least 1 dose of study drug.
Arm/Group Title Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
Hide Arm/Group Description:
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 38
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
[1]
Median and 95% CI was not estimable due to the low number of participants who had bleeding episodes.
18.Secondary Outcome
Title Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase
Hide Description Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. The percentage of participants who had anti factor-Xa levels within the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure.
Time Frame Day 30, Day 60, Day 90 in follow up phase
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Here, “number analyzed” signifies number of participants analyzed at specific time points. Data for this OM was not planned to be collected and analyzed for age group of >=0 to <8 weeks.
Arm/Group Title Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 2 8 7 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 30 Number Analyzed 1 participants 5 participants 6 participants 15 participants
100.0
(2.50 to 100.0)
100.0
(47.82 to 100.0)
33.3
(4.33 to 77.72)
93.3
(68.05 to 99.83)
Day 60 Number Analyzed 1 participants 5 participants 4 participants 11 participants
100.0
(2.50 to 100.0)
100.0
(47.82 to 100.0)
75.0
(19.41 to 99.37)
81.8
(48.22 to 97.72)
Day 90 Number Analyzed 1 participants 4 participants 2 participants 11 participants
100.0
(2.50 to 100.0)
100.0
(39.76 to 100.0)
50.0
(1.26 to 98.74)
72.7
(39.03 to 93.98)
19.Secondary Outcome
Title Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase
Hide Description Prespecified therapeutic anti-factor Xa range was 0.5-1.0 IU/mL. The percentage of participants who had anti-factor Xa levels outside the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure.
Time Frame Day 30, Day 60, Day 90 in follow-up phase
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Here, “number analyzed” signifies number of participants analyzed at specific time points. Data for this OM was not planned to be collected and analyzed for age group of >=0 to <8 weeks.
Arm/Group Title Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 2 8 7 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 30 Number Analyzed 1 participants 5 participants 6 participants 15 participants
0
(0.00 to 97.50)
0
(0.00 to 52.18)
66.7
(22.28 to 95.67)
6.7
(0.17 to 31.95)
Day 60 Number Analyzed 1 participants 5 participants 4 participants 11 participants
0
(0.00 to 97.50)
0
(0.00 to 52.18)
25.0
(0.63 to 80.59)
18.2
(2.28 to 51.78)
Day 90 Number Analyzed 1 participants 4 participants 2 participants 11 participants
0
(0.00 to 97.50)
0
(0.00 to 60.24)
50.0
(1.26 to 98.74)
27.3
(6.02 to 60.97)
20.Secondary Outcome
Title Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels
Hide Description Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data for day 1 to 7 has been reported.
Time Frame 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set. Here, “number analyzed” signifies the number of participants analyzed at specific time points. Data for this OM was not planned to be collected and analyzed for age group of >=0 to <8 weeks.
Arm/Group Title Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 2 8 7 17
Mean (Standard Deviation)
Unit of Measure: IU/kg
207.50  (8.485) 141.85  (23.550) 132.40  (12.934) 115.06  (17.164)
21.Secondary Outcome
Title Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels
Hide Description Time to achieve the target range (prespecified therapeutic anti- factor Xa levels) was defined as the number of days from the first dose of study drug to the final dose that achieves the target anti-factor Xa level. Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data of Day 1 to 7 is reported.
Time Frame Day 1 to 7 in dose adjustment phase
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this OM was not planned to be collected and analyzed for age group of >=0 to <8 weeks.
Arm/Group Title Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 2 8 7 17
Median (Full Range)
Unit of Measure: days
4.5
(4 to 5)
3.0
(1 to 7)
2.0
(1 to 3)
2.0
(1 to 4)
22.Secondary Outcome
Title Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels
Hide Description During dose adjustment phase, doses were adjusted according to prespecified therapeutic anti-Xa levels in order to achieve target prespecified therapeutic anti-factor Xa levels (0.5 to 1.0 IU/mL). Number of dose adjustments which were done within the specified time window of up to 4 hours post dose on all days (1 to 7) to achieve the prespecified therapeutic anti-Xa levels are reported.
Time Frame 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this OM was not planned to be collected and analyzed for age group of >=0 to <8 weeks.
Arm/Group Title Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description:
Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 2 8 7 17
Median (Full Range)
Unit of Measure: dose adjustment
3.5
(3 to 4)
0.5
(0 to 2)
0.0
(0 to 1)
0.0
(0 to 2)
23.Other Pre-specified Outcome
Title Total Body Clearance of Dalteparin
Hide Description Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
Time Frame 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Hide Outcome Measure Data
Hide Analysis Population Description
Data not reported for the endpoint, since the PK data was collected and analyzed in a pooled analysis, together with data from two external studies; the results of this pooled analysis will be reported separately.
Arm/Group Title Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
Hide Arm/Group Description:
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
24.Other Pre-specified Outcome
Title Volume of Distribution of Dalteparin
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Time Frame 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Hide Outcome Measure Data
Hide Analysis Population Description
Data not reported for the endpoint, since the PK data was collected and analyzed in a pooled analysis, together with data from two external studies; the results of this pooled analysis will be reported separately.
Arm/Group Title Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
Hide Arm/Group Description:
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
25.Other Pre-specified Outcome
Title Absorption Rate Constant (Ka) of Dalteparin
Hide Description [Not Specified]
Time Frame 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Hide Outcome Measure Data
Hide Analysis Population Description
Data not reported for the endpoint, since the PK data was collected and analyzed in a pooled analysis, together with data from two external studies; the results of this pooled analysis will be reported separately.
Arm/Group Title Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
Hide Arm/Group Description:
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline up to 28 days after the last dose of study drug (up to Day 132)
Adverse Event Reporting Description Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
 
Arm/Group Title Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Hide Arm/Group Description Participants aged >= 0 to < 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days). Participants aged >=8 weeks to <2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days). Participants aged >=2 years to <8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days). Participants aged >=8 years to <12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days). Participants aged >=12 years to <19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
All-Cause Mortality
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%)   0/8 (0.00%)   0/7 (0.00%)   1/20 (5.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   2/2 (100.00%)   3/8 (37.50%)   3/7 (42.86%)   13/20 (65.00%) 
Blood and lymphatic system disorders           
Anaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Febrile neutropenia * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  1/7 (14.29%)  3/20 (15.00%) 
Leukocytosis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Neutropenia * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Pancytopenia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Thrombocytopenia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  2/20 (10.00%) 
Cardiac disorders           
Tachycardia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders           
Intestinal haematoma * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Nausea * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Small intestinal obstruction * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Vomiting * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
General disorders           
Mucosal inflammation * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  2/20 (10.00%) 
Pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Pyrexia * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  1/7 (14.29%)  3/20 (15.00%) 
Immune system disorders           
Anaphylactic reaction * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Drug hypersensitivity * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Infections and infestations           
Bacterial infection * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Cellulitis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Influenza * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Oral herpes * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Pneumonia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  3/20 (15.00%) 
Respiratory syncytial virus infection * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Sepsis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  2/20 (10.00%) 
Viral infection * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Vulvovaginal candidiasis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Metabolism and nutrition disorders           
Dehydration * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  5/20 (25.00%) 
Electrolyte imbalance * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Malnutrition * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Nervous system disorders           
Dizziness * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Seizure like phenomena * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Renal and urinary disorders           
Acute kidney injury * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Haematuria * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders           
Hypoxia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  2/20 (10.00%) 
Productive cough * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Respiratory distress * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Vascular disorders           
Hypertension * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Hypotension * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Thrombophlebitis superficial * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
1
Term from vocabulary, MeDRA v21.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   2/2 (100.00%)   7/8 (87.50%)   7/7 (100.00%)   16/20 (80.00%) 
Blood and lymphatic system disorders           
Anaemia * 1  0/1 (0.00%)  1/2 (50.00%)  3/8 (37.50%)  1/7 (14.29%)  2/20 (10.00%) 
Coagulopathy * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Febrile neutropenia * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Leukopenia * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Neutropenia * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  3/20 (15.00%) 
Pancytopenia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Thrombocytopenia * 1  0/1 (0.00%)  0/2 (0.00%)  2/8 (25.00%)  0/7 (0.00%)  1/20 (5.00%) 
Cardiac disorders           
Tachycardia * 1  0/1 (0.00%)  1/2 (50.00%)  2/8 (25.00%)  2/7 (28.57%)  0/20 (0.00%) 
Ear and labyrinth disorders           
Cerumen impaction * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Ear pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Eye disorders           
Dry eye * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/20 (5.00%) 
Eye swelling * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Ocular hyperaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Photophobia * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Vision blurred * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders           
Abdominal distension * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Abdominal pain upper * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Abdominal tenderness * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Anal fissure * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/20 (5.00%) 
Ascites * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Chapped lips * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Cheilitis * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Colitis * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Constipation * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  1/20 (5.00%) 
Diarrhoea * 1  0/1 (0.00%)  0/2 (0.00%)  3/8 (37.50%)  1/7 (14.29%)  1/20 (5.00%) 
Dry mouth * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Dyspepsia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Erosive oesophagitis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Gastrointestinal pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Gingival bleeding * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/20 (5.00%) 
Haematemesis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/20 (5.00%) 
Haematochezia * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  1/20 (5.00%) 
Intestinal dilatation * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Intra-abdominal haematoma * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Lip dry * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Lip haemorrhage * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Mouth ulceration * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Nausea * 1  0/1 (0.00%)  1/2 (50.00%)  2/8 (25.00%)  1/7 (14.29%)  0/20 (0.00%) 
Oesophageal pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Perianal erythema * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Proctalgia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Stomatitis * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  1/7 (14.29%)  2/20 (10.00%) 
Vomiting * 1  0/1 (0.00%)  2/2 (100.00%)  1/8 (12.50%)  2/7 (28.57%)  1/20 (5.00%) 
General disorders           
Asthenia * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Catheter site bruise * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Catheter site haematoma * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Catheter site pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Fatigue * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  2/20 (10.00%) 
Gait disturbance * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Infusion site bruising * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Infusion site haemorrhage * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Injection site bruising * 1  0/1 (0.00%)  1/2 (50.00%)  2/8 (25.00%)  4/7 (57.14%)  8/20 (40.00%) 
Injection site haematoma * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  1/20 (5.00%) 
Injection site haemorrhage * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/20 (5.00%) 
Injection site mass * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Injection site nodule * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/20 (5.00%) 
Injection site pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  4/20 (20.00%) 
Localised oedema * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Mucosal haemorrhage * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Mucosal inflammation * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  1/7 (14.29%)  2/20 (10.00%) 
Nodule * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Oedema peripheral * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  2/7 (28.57%)  1/20 (5.00%) 
Pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  2/7 (28.57%)  1/20 (5.00%) 
Pyrexia * 1  0/1 (0.00%)  1/2 (50.00%)  2/8 (25.00%)  2/7 (28.57%)  2/20 (10.00%) 
Swelling * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Catheter site inflammation * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Hepatobiliary disorders           
Cholelithiasis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Hyperbilirubinaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Immune system disorders           
Drug hypersensitivity * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Hypocomplementaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Infections and infestations           
Aspergillus infection * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Bacterial infection * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Bacteriuria * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Clostridium difficile colitis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Clostridium difficile infection * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Conjunctivitis * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Genitourinary tract infection * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Influenza * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Infusion site cellulitis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Paronychia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Pharyngitis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Rhinitis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Rhinovirus infection * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Sinusitis bacteria * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Skin infection * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Stoma site cellulitis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Vaginal infection * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Viral diarrhoea * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Viral infection * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Injury, poisoning and procedural complications           
Bone contusion * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Contusion * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  2/7 (28.57%)  3/20 (15.00%) 
Fall * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Laceration * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Ligament sprain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Refractoriness to platelet transfusion * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Skin abrasion * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Investigations           
Activated partial thromboplastin time prolonged * 1  0/1 (0.00%)  1/2 (50.00%)  2/8 (25.00%)  0/7 (0.00%)  2/20 (10.00%) 
Alanine aminotransferase increased * 1  1/1 (100.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  2/20 (10.00%) 
Aspartate aminotransferase increased * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  2/20 (10.00%) 
Aspergillus test positive * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Blood calcium increased * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Blood fibrinogen decreased * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Blood fibrinogen increased * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Blood lactate dehydrogenase increased * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Blood urea increased * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Body temperature increased * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
C-reactive protein increased * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Haematocrit decreased * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Haemoglobin decreased * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  2/7 (28.57%)  1/20 (5.00%) 
Hepatitis A virus test positive * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
International normalised ratio increased * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Lymphocyte count decreased * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Neutrophil count decreased * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/20 (5.00%) 
Platelet count decreased * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  2/7 (28.57%)  1/20 (5.00%) 
Platelet count increased * 1  1/1 (100.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Prothrombin time prolonged * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  2/20 (10.00%) 
Transaminases increased * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  2/7 (28.57%)  0/20 (0.00%) 
Weight decreased * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
White blood cell count decreased * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/20 (5.00%) 
Metabolism and nutrition disorders           
Decreased appetite * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Fluid overload * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Hyperglycaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Hyperkalaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Hyperuricaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Hypoalbuminaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Hypocalcaemia * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  1/7 (14.29%)  2/20 (10.00%) 
Hypokalaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  2/20 (10.00%) 
Hypomagnesaemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Hyponatraemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/20 (5.00%) 
Hypophosphataemia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/20 (5.00%) 
Magnesium deficiency * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  2/20 (10.00%) 
Back pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Haemarthrosis * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Muscular weakness * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Musculoskeletal chest pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Musculoskeletal pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Myalgia * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Neck pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Pain in extremity * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  2/20 (10.00%) 
Pain in jaw * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Spinal pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Nervous system disorders           
Altered state of consciousness * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Ataxia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Dizziness * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  2/20 (10.00%) 
Headache * 1  0/1 (0.00%)  0/2 (0.00%)  2/8 (25.00%)  2/7 (28.57%)  2/20 (10.00%) 
Hypoaesthesia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Neuralgia * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  1/20 (5.00%) 
Neuropathy peripheral * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/20 (5.00%) 
Peripheral sensory neuropathy * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Psychiatric disorders           
Anxiety * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Insomnia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Mental disorder * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Renal and urinary disorders           
Haematuria * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Leukocyturia * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Reproductive system and breast disorders           
Vulvovaginal pain * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders           
Atelectasis * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Cough * 1  0/1 (0.00%)  0/2 (0.00%)  2/8 (25.00%)  0/7 (0.00%)  1/20 (5.00%) 
Epistaxis * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  3/20 (15.00%) 
Haemoptysis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Oropharyngeal pain * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  1/7 (14.29%)  4/20 (20.00%) 
Pharyngeal erythema * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Pulmonary mass * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/20 (0.00%) 
Pulmonary oedema * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Rhinitis allergic * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Rhinorrhoea * 1  0/1 (0.00%)  0/2 (0.00%)  2/8 (25.00%)  0/7 (0.00%)  0/20 (0.00%) 
Sinus disorder * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Tachypnoea * 1  0/1 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/7 (0.00%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders           
Acanthosis nigricans * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/20 (5.00%) 
Alopecia * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  1/7 (14.29%)  2/20 (10.00%) 
Dermatitis contact * 1  0/1 (0.00%)  0/2 (0.00%)  2/8 (25.00%)  0/7 (0.00%)  0/20 (0.00%) 
Dry skin * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Ecchymosis * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/20 (5.00%) 
Eczema * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/20 (0.00%) 
Erythema * 1  0/1 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  1/20 (5.00%) 
Pain of skin * 1  0/1 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/20 (5.00%) 
Petechiae * 1