Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00952380

Collaborator

(none)

Enrollment

Locations

Arm

103

Actual Duration (Months)

1.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Three month treatment of acute VTE with Fragmin in pediatric cancer patients

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism	Drug: dalteparin	Phase 2

Detailed Description

Primary study objectives include are to determine the pharmacodynamic (PD) profiles for treatment doses of dalteparin in pediatric subjects of different ages with cancer and venous thromboembolism (VTE), using anti-Xa (Xa) levels and a population PD analysis methodology, and to determine the median dose required to achieve therapeutic anti- Xa levels (0.5 to 1.0 International Units [IU]/mL) based on subject age and weight.

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A THREE MONTH PROSPECTIVE OPEN LABEL STUDY OF THERAPY WITH FRAGMIN(REGISTERED) (DALTEPARIN SODIUM INJECTION) IN CHILDREN WITH VENOUS THROMBOEMBOLISM WITH OR WITHOUT MALIGNANCIES

Actual Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Single Arm Single arm open-label	Drug: dalteparin dalteparin subcutaneous injection

Arm

Intervention/Treatment

Other: Single Arm

Single arm open-label

Drug: dalteparin

dalteparin subcutaneous injection

Outcome Measures

Primary Outcome Measures

Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level [4 hours post-dose at each Day 1 to 7 in dose adjustment phase]
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.

Secondary Outcome Measures

Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels [Day 1 to 7 in dose adjustment phase]
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.
Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE) [Baseline up to 28 days after the last dose of study drug (up to Day 132)]
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 to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE) [Baseline up to 28 days after the last dose of study drug (up to Day 132)]
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.
Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE) [Baseline up to 28 days after the last dose of study drug (up to Day 132)]
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.
Percentage of Participants With Major and Minor Bleeding Event [Baseline up to 28 days after the last dose of study drug (up to Day 132)]
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).
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 28 days after the last dose of study drug (up to Day 132)]
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.
Number of Participants With Laboratory Abnormalities [Baseline up to 104 days]
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.
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants [Baseline, Day 1, Day 2, Day 30, Day 60, Day 90]
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants [Baseline, Day 1, Day 2, Day 30, Day 60, Day 90]
Heart rate and pulse rate of participants were measured in terms of beats per minute.
Absolute Values of Height of Participants [Baseline, Day 1, Day 2, Day 30, Day 60, Day 90]
Absolute Values of Weight of Participants [Baseline, Day 1, Day 2, Day 30, Day 60, Day 90]
Absolute Values of Respiratory Rate of Participants [Baseline, Day 1, Day 2, Day 30, Day 60, Day 90]
Respiratory rate was defined as the number of breaths per minute.
Absolute Values of Body Temperature of Participants [Baseline, Day 1, Day 2, Day 30, Day 60, Day 90]
Absolute Values of Body Length of Participants [Baseline, Day 1, Day 2, Day 30, Day 60, Day 90]
Number of Participants With Physical Examination Abnormalities of Participants [Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)]
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 to First Occurrence of Major Bleeding Event [Baseline up to 28 days after the last dose of study drug (up to Day 132)]
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).
Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase [Day 30, Day 60, Day 90 in follow up phase]
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. The percentage of participants who had anti factor-Xa levels within the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure.
Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase [Day 30, Day 60, Day 90 in follow-up phase]
Prespecified therapeutic anti-factor Xa range was 0.5-1.0 IU/mL. The percentage of participants who had anti-factor Xa levels outside the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure.
Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels [4 hours post-dose at each Day 1 to 7 in dose adjustment phase]
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data for day 1 to 7 has been reported.
Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels [Day 1 to 7 in dose adjustment phase]
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.
Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels [4 hours post-dose at each Day 1 to 7 in dose adjustment phase]
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.

Other Outcome Measures

Total Body Clearance of Dalteparin [4 hours post-dose at each Day 1 to 7 in dose adjustment phase]
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.
Volume of Distribution of Dalteparin [4 hours post-dose at each Day 1 to 7 in dose adjustment phase]
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.
Absorption Rate Constant (Ka) of Dalteparin [4 hours post-dose at each Day 1 to 7 in dose adjustment phase]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Colorado	Aurora	Colorado	United States	80045
2	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
3	Nemours Children's Clinic	Jacksonville	Florida	United States	32207
4	Wolfson Children's Hospital	Jacksonville	Florida	United States	32207
5	Investigational Drug Service Tampa General Hospital	Tampa	Florida	United States	33606
6	Tampa General Hospital Center of Research Excellence	Tampa	Florida	United States	33606
7	Tampa General Hospital	Tampa	Florida	United States	33606
8	University of South Florida	Tampa	Florida	United States	33606
9	St. Joseph's Children's Hospital of Tampa	Tampa	Florida	United States	33607
10	Children's Hospital of Michigan	Detroit	Michigan	United States	48201
11	Children's Mercy Hospitals and Clinics	Kansas City	Missouri	United States	64108
12	St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105
13	El Paso Children's Hospital	El Paso	Texas	United States	79905
14	Texas Tech University Health Sciences Center El Paso	El Paso	Texas	United States	79905
15	Texas Children's Cancer and Hematology Centers	Houston	Texas	United States	77030
16	Texas Children's Hospital Investigational Pharmacy Services	Houston	Texas	United States	77030
17	Texas Children's Hospital	Houston	Texas	United States	77030
18	Sykehusapoteket Oslo	Oslo		Norway	0372
19	Oslo universitetssykehus HF	Oslo		Norway	0424
20	FSBEI HE Kazan SMU of Minzdrav Russia	Kazan	Republic Tatarstan	Russian Federation	420012
21	SAHI "Children's Republican Clinical Hospital of the Ministry of	Kazan	Republic Tatarstan	Russian Federation	420138
22	SBHI of Moscow city Morozovskaya Children City Clinical Hospital of Moscow city	Moscow		Russian Federation	119049
23	Lekarna, Univerzitetni klinicni center Ljubljana	Ljubljana		Slovenia	SI-1000
24	Pediatricna klinika, Univerzitetni Klinicni Center Ljubljana	Ljubljana		Slovenia	SI-1000
25	Hospital HM Universitario Monteprincipe Servicio de Farmacia	Boadilla del Monte	Madrid	Spain	28660
26	Hospital HM Universitario Monteprincipe	Boadilla del Monte	Madrid	Spain	28660

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00952380

Other Study ID Numbers:

FRAG-A001-201
A6301094
2016-000394-21

First Posted:

Aug 6, 2009

Last Update Posted:

Apr 16, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Pfizer

VTE

Additional relevant MeSH terms:

Thromboembolism

Venous Thromboembolism

Dalteparin

Tinzaparin

Heparin, Low-Molecular-Weight

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	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)
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

Baseline Characteristics

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
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 Participants	1	2	8	7	20	38
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	0.0684	1.0569	5.3676	10.0287	15.7208	11.1577
Sex: Female, Male (Count of Participants)
Female	0 0%	1 50%	2 25%	5 71.4%	6 30%	14 36.8%
Male	1 100%	1 50%	6 75%	2 28.6%	14 70%	24 63.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	2 25%	2 28.6%	4 20%	8 21.1%
Not Hispanic or Latino	1 100%	2 100%	6 75%	5 71.4%	16 80%	30 78.9%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	1 5%	1 2.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	3 42.9%	4 20%	7 18.4%
White	1 100%	2 100%	7 87.5%	4 57.1%	15 75%	29 76.3%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	1 12.5%	0 0%	0 0%	1 2.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

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)
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).
Measure Participants	34
Median (Full Range) [IU/mL]	125

2. Secondary Outcome

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

Outcome Measure Data

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)
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).
Measure Participants	1	2	8	7	20
Number (95% Confidence Interval) [percentage of participants]	0 0%	100.0 5000%	100.0 1250%	100.0 1428.6%	85.0 425%

3. Secondary Outcome

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

Outcome Measure Data

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)
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).
Measure Participants	2	8	7	17
Count of Participants [Participants]	0 0%	0 0%	1 12.5%	0 0%

4. Secondary Outcome

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

Outcome Measure Data

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)
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).
Measure Participants	34
Median (95% Confidence Interval) [days]	NA

5. Secondary Outcome

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

Outcome Measure Data

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)
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).
Measure Participants	2	8	7	17
Progression	0 0%	0 0%	0 0%	0 0%
Regression	0 0%	12.5 625%	14.3 178.8%	29.4 420%
Resolution	100.0 10000%	62.5 3125%	57.1 713.8%	58.8 840%
No Change	0 0%	0 0%	14.3 178.8%	5.9 84.3%

6. Secondary Outcome

Title	Percentage of Participants With Major and Minor Bleeding Event
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)

Outcome Measure Data

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)
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).
Measure Participants	1	2	8	7	20
Major Bleeding	0 0%	50.0 2500%	0 0%	0 0%	0 0%
Minor Bleeding	0 0%	0 0%	50.0 625%	57.1 815.7%	40.0 200%

7. Secondary Outcome

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

Outcome Measure Data

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)
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).
Measure Participants	1	2	8	7	20
AEs	1 100%	2 100%	7 87.5%	7 100%	19 95%
SAEs	0 0%	2 100%	3 37.5%	3 42.9%	13 65%

8. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities
Description	Criteria:hematology:hemoglobin, hematocrit, erythrocytes less than(<)0.8lower limit of normal(LLN), platelets <0.5LLN >1.75upper 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 >1.2ULN, activated partial thromboplastin time, prothrombin time, prothrombin international normalized ratio >1.1 ULN. Clinical chemistry: bilirubin >1.5ULN, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase >3.0ULN, protein, albumin <0.8* LLN >1.2* ULN, blood urea nitrogen, creatinine >1.3* ULN, sodium <0.95LLN >1.05ULN, potassium, chloride, calcium, magnesium <0.9* LLN >1.1* ULN, phosphate <0.8* LLN >1.2* ULN, glucose <0.6LLN >1.5ULN, 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

Outcome Measure Data

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)
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).
Measure Participants	1	2	8	7	19
Count of Participants [Participants]	1 100%	2 100%	8 100%	5 71.4%	19 95%

9. Secondary Outcome

Title	Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
Description
Time Frame	Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Outcome Measure Data

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)
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).
Measure Participants	1	2	8	7	20
SBP: Baseline	101.00	50.00	110.50	96.00	117.50
SBP: Day 1	97.00	105.50	112.0	111.00	113.00
SBP: Day 2	94.00	75.00	107.00	112.00	119.50
SBP: Day 30	77.0	77.00	112.00	109.00	118.00
SBP: Day 60	74.00	102.00	101.00	118.00	117.50
SBP: Day 90	76.00	105.00	97.50	116.00	116.00
DSBP: Baseline	60.00	41.00	66.00	67.00	65.00
DSBP: Day 1	61.00	57.00	65.50	66.50	64.00
DSBP: Day 2	48.00	53.00	60.50	70.00	65.00
DSBP: Day 30	53.00	61.00	64.00	68.00	69.00
DSBP: Day 60	51.00	57.00	60.00	67.00	67.00
DSBP: Day 90	53.00	55.50	60.50	67.00	69.00

10. Secondary Outcome

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

Outcome Measure Data

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)
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).
Measure Participants	1	2	8	7	20
HR: Baseline	148.00	146.00	115.00	70.00
HR: Day 1	146.00	142.00	112.00	85.00
HR: Day 2	136.00	130.00	114.00	75.00
HR: Day 30	138.00	130.00	120.50	87.50
HR: Day 60	132.00	184.00	120.00	94.50
HR: Day 90	122.00	134.00	107.00	80.00
PR: Baseline	96.50	114.00	73.00
PR: Day 1	108.00	121.00	87.00	94.50
PR: Day 2	117.00	98.00	93.00
PR: Day 30	88.00	101.00	102.00
PR: Day 60	88.00	93.00	95.00
PR: Day 90	140.00	114.00	96.00	92.00

11. Secondary Outcome

Title	Absolute Values of Height of Participants
Description
Time Frame	Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Outcome Measure Data

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)
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).
Measure Participants	1	2	8	7	20
Baseline	54.00	55.00	110.00	133.00	166.00
Day 1	54.00	115.80	134.00	166.00
Day 2	107.90	142.00	166.90
Day 30	60.00	56.60	115.10	140.30	167.75
Day 60	63.00	60.00	115.00	139.70	168.50
Day 90	64.00	61.00	109.50	140.70	166.65

12. Secondary Outcome

Title	Absolute Values of Weight of Participants
Description
Time Frame	Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Outcome Measure Data

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)
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).
Measure Participants	1	2	8	7	20
Baseline	4.05	3.93	18.78	36.60	60.00
Day 1	4.17	4.04	17.23	37.00	63.40
Day 2	4.50	4.15	14.95	39.35	58.00
Day 30	6.30	4.56	15.50	39.20	63.80
Day 60	7.15	4.60	16.60	38.30	65.80
Day 90	7.70	4.70	21.50	39.30	59.60

13. Secondary Outcome

Title	Absolute Values of Respiratory Rate of Participants
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

Outcome Measure Data

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)
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).
Measure Participants	1	2	8	7	20
Baseline	35.00	25.00	24.00	20.00	20.00
Day 1	34.00	36.00	21.00	18.00	18.00
Day 2	34.00	34.00	20.00	20.00	18.00
Day 30	34.00	36.00	22.00	22.00	18.00
Day 60	30.00	36.00	20.00	20.00	20.00
Day 90	24.00	34.00	22.00	20.00	18.00

14. Secondary Outcome

Title	Absolute Values of Body Temperature of Participants
Description
Time Frame	Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Outcome Measure Data

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)
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).
Measure Participants	1	2	8	7	20
Baseline	36.60	36.70	36.50	37.00	36.80
Day 1	36.70	36.85	36.80	36.70	36.80
Day 2	36.90	36.40	36.70	36.70	36.70
Day 30	36.50	36.50	36.60	36.50	36.70
Day 60	36.60	36.70	36.80	36.60	36.60
Day 90	36.70	37.15	36.75	36.90	36.80

15. Secondary Outcome

Title	Absolute Values of Body Length of Participants
Description
Time Frame	Baseline, Day 1, Day 2, Day 30, Day 60, Day 90

Outcome Measure Data

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)
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).
Measure Participants	1	2	8	7	20
Baseline	54	55	100	172
Day 1	54	55	135
Day 2	56	55.30	104.75	135
Day 30	60	56.60	100	135
Day 60	63	60	103	135
Day 90	64	61	97.75	151.75

16. Secondary Outcome

Title	Number of Participants With Physical Examination Abnormalities of Participants
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)

Outcome Measure Data

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)
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).
Measure Participants	1	2	8	7	20
Abdomen: Screening	0 0%	1 50%	2 25%	0 0%	2 10%
Abdomen: Visit 2	0 0%	0 0%	2 25%	0 0%
Abdomen: Visit 3	0 0%	1 50%	1 12.5%	0 0%	2 10%
Abdomen: Visit 4	0 0%	0 0%	1 12.5%	1 14.3%	3 15%
Abdomen: Visit 5	0 0%	0 0%	0 0%	1 14.3%	4 20%
Abdomen: Visit 6	0 0%	0 0%	0 0%	1 14.3%	1 5%
Abdomen: Visit 7	0 0%	1 50%	0 0%	1 14.3%	3 15%
Chest: Screening	0 0%	0 0%	1 12.5%	2 28.6%	2 10%
Chest: Visit 2	0 0%	0 0%	2 25%	0 0%
Chest: Visit 3	0 0%	0 0%	0 0%	2 28.6%	0 0%
Chest: Visit 4	0 0%	0 0%	0 0%	3 42.9%	1 5%
Chest: Visit 5	0 0%	0 0%	0 0%	1 14.3%	0 0%
Chest: Visit 6	0 0%	0 0%	0 0%	1 14.3%	0 0%
Chest: Visit 7	0 0%	0 0%	0 0%	2 28.6%	3 15%
Extremities: Screening	0 0%	0 0%	0 0%	4 57.1%	10 50%
Extremities: Visit 2	0 0%	0 0%	1 12.5%	1 14.3%
Extremities: Visit 3	0 0%	0 0%	1 12.5%	3 42.9%	3 15%
Extremities: Visit 4	0 0%	0 0%	0 0%	4 57.1%	8 40%
Extremities: Visit 5	0 0%	0 0%	0 0%	1 14.3%	3 15%
Extremities: Visit 6	0 0%	0 0%	0 0%	1 14.3%	2 10%
Extremities: Visit 7	0 0%	0 0%	0 0%	2 28.6%	2 10%
Eyes: Screening	0 0%	0 0%	1 12.5%	1 14.3%
Eyes: Visit 2	0 0%	0 0%	0 0%	1 14.3%
Eyes: Visit 3	0 0%	0 0%	0 0%	1 14.3%
Eyes: Visit 4	0 0%	0 0%	0 0%	2 28.6%
Eyes: Visit 5	0 0%	0 0%	0 0%	1 14.3%
Eyes: Visit 6	0 0%	0 0%	0 0%	1 14.3%
Eyes: Visit 7	0 0%	0 0%	0 0%	1 14.3%
Eyes, ears, nose, throat:Screening	0 0%	1 50%	1 12.5%	0 0%	2 10%
Eyes, ears, nose, throat: Visit 3	0 0%	1 50%	0 0%	1 14.3%
Eyes, ears, nose, throat: Visit 4	0 0%	0 0%	0 0%	2 28.6%
Eyes, ears, nose, throat: Visit 5	0 0%	0 0%	3 37.5%
Eyes, ears, nose, throat: Visit 6	2 200%	0 0%	1 12.5%
Eyes, ears, nose, throat: Visit 7	0 0%	1 50%	0 0%	2 28.6%
General appearance: Screening	0 0%	0 0%	2 25%	1 14.3%	3 15%
General appearance: Visit 2	0 0%	0 0%	1 12.5%	0 0%
General appearance: Visit 3	0 0%	0 0%	1 12.5%	0 0%	1 5%
General appearance: Visit 4	0 0%	0 0%	0 0%	1 14.3%	2 10%
General appearance: Visit 5	0 0%	0 0%	0 0%	0 0%	2 10%
General appearance: Visit 6	0 0%	1 50%	0 0%	0 0%	1 5%
General appearance: Visit 7	0 0%	0 0%	1 12.5%	2 28.6%	2 10%
Head: Screening	0 0%	0 0%	1 12.5%	1 14.3%	4 20%
Head: Visit 3	0 0%	0 0%	1 12.5%	0 0%	2 10%
Head: Visit 4	0 0%	0 0%	1 12.5%	0 0%	5 25%
Head: Visit 5	0 0%	0 0%	1 12.5%	1 14.3%	4 20%
Head: Visit 6	0 0%	0 0%	1 12.5%	1 14.3%	3 15%
Head: Visit 7	0 0%	0 0%	1 12.5%	1 14.3%	5 25%
Heart: Screening	0 0%	0 0%	1 12.5%	1 14.3%	0 0%
Heart: Visit 3	0 0%	1 50%	0 0%	0 0%	0 0%
Heart: Visit 4	0 0%	1 50%	1 12.5%	0 0%	1 5%
Heart: Visit 7	0 0%	1 50%	0 0%	0 0%	2 10%
Lungs: Screening	0 0%	0 0%	0 0%	1 14.3%	0 0%
Lungs: Visit 4	0 0%	0 0%	0 0%	0 0%	1 5%
Lungs: Visit 6	0 0%	0 0%	0 0%	0 0%	1 5%
Lungs: Visit 7	0 0%	0 0%	0 0%	0 0%	1 5%
Neck: Screening	0 0%	1 50%	1 12.5%	1 14.3%	2 10%
Neck: Visit 4	0 0%	0 0%	0 0%	0 0%	1 5%
Neurological: Screening	0 0%	0 0%	2 25%	0 0%	0 0%
Neurological: Visit 2	0 0%	0 0%	1 12.5%	0 0%
Neurological: Visit 3	0 0%	0 0%	1 12.5%	0 0%	0 0%
Neurological: Visit 4	0 0%	0 0%	0 0%	0 0%	1 5%
Neurological: Visit 5	0 0%	0 0%	0 0%	0 0%	1 5%
Neurological: Visit 7	0 0%	1 50%	0 0%	0 0%	0 0%
Nose: Screening	0 0%	0 0%	1 12.5%	0 0%
Nose: Visit 2	0 0%	0 0%	1 12.5%	0 0%
Skin: Screening	1 100%	1 50%	1 12.5%	3 42.9%	5 25%
Skin: Visit 2	1 100%	0 0%	0 0%	1 14.3%
Skin: Visit 3	1 100%	1 50%	1 12.5%	1 14.3%	3 15%
Skin: Visit 4	0 0%	1 50%	2 25%	2 28.6%	6 30%
Skin: Visit 5	0 0%	0 0%	2 25%	2 28.6%	7 35%
Skin: Visit 6	0 0%	0 0%	0 0%	2 28.6%	5 25%
Skin: Visit 7	0 0%	1 50%	1 12.5%	3 42.9%	4 20%

17. Secondary Outcome

Title	Time to First Occurrence of Major Bleeding Event
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)

Outcome Measure Data

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)
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).
Measure Participants	38
Median (95% Confidence Interval) [days]	NA

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
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

Outcome Measure Data

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)
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).
Measure Participants	2	8	7	17
Day 30	100.0 10000%	100.0 5000%	33.3 416.3%	93.3 1332.9%
Day 60	100.0 10000%	100.0 5000%	75.0 937.5%	81.8 1168.6%
Day 90	100.0 10000%	100.0 5000%	50.0 625%	72.7 1038.6%

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
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

Outcome Measure Data

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)
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).
Measure Participants	2	8	7	17
Day 30	0 0%	0 0%	66.7 833.8%	6.7 95.7%
Day 60	0 0%	0 0%	25.0 312.5%	18.2 260%
Day 90	0 0%	0 0%	50.0 625%	27.3 390%

20. Secondary Outcome

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

Outcome Measure Data

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)
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).
Measure Participants	2	8	7	17
Mean (Standard Deviation) [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
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

Outcome Measure Data

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)
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).
Measure Participants	2	8	7	17
Median (Full Range) [days]	4.5	3.0	2.0	2.0

22. Secondary Outcome

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

Outcome Measure Data

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)
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).
Measure Participants	2	8	7	17
Median (Full Range) [dose adjustment]	3.5	0.5	0.0	0.0

23. Other Pre-specified Outcome

Title	Total Body Clearance of Dalteparin
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

Outcome Measure Data

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)

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).

Measure Participants

24. Other Pre-specified Outcome

Title	Volume of Distribution of Dalteparin
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

Outcome Measure Data

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)

Arm/Group Description

Measure Participants

25. Other Pre-specified Outcome

Title	Absorption Rate Constant (Ka) of Dalteparin
Description
Time Frame	4 hours post-dose at each Day 1 to 7 in dose adjustment phase

Outcome Measure Data

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)

Arm/Group Description

Measure Participants

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)
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)
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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		2/2 (100%)		3/8 (37.5%)		3/7 (42.9%)		13/20 (65%)
Blood and lymphatic system disorders
Anaemia	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Febrile neutropenia	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		1/7 (14.3%)		3/20 (15%)
Leukocytosis	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Neutropenia	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Pancytopenia	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Thrombocytopenia	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		2/20 (10%)
Cardiac disorders
Tachycardia	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Gastrointestinal disorders
Intestinal haematoma	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Nausea	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Small intestinal obstruction	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Vomiting	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
General disorders
Mucosal inflammation	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		2/20 (10%)
Pain	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Pyrexia	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		1/7 (14.3%)		3/20 (15%)
Immune system disorders
Anaphylactic reaction	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Drug hypersensitivity	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Infections and infestations
Bacterial infection	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Cellulitis	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Influenza	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Oral herpes	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Pneumonia	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		3/20 (15%)
Respiratory syncytial virus infection	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Sepsis	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		2/20 (10%)
Viral infection	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Vulvovaginal candidiasis	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Metabolism and nutrition disorders
Dehydration	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		5/20 (25%)
Electrolyte imbalance	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Malnutrition	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Nervous system disorders
Dizziness	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Seizure like phenomena	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Renal and urinary disorders
Acute kidney injury	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Haematuria	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Respiratory, thoracic and mediastinal disorders
Hypoxia	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		2/20 (10%)
Productive cough	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Respiratory distress	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Vascular disorders
Hypertension	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Hypotension	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Thrombophlebitis superficial	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Other (Not Including 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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/1 (100%)		2/2 (100%)		7/8 (87.5%)		7/7 (100%)		16/20 (80%)
Blood and lymphatic system disorders
Anaemia	0/1 (0%)		1/2 (50%)		3/8 (37.5%)		1/7 (14.3%)		2/20 (10%)
Coagulopathy	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Febrile neutropenia	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Leukopenia	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Neutropenia	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		3/20 (15%)
Pancytopenia	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Thrombocytopenia	0/1 (0%)		0/2 (0%)		2/8 (25%)		0/7 (0%)		1/20 (5%)
Cardiac disorders
Tachycardia	0/1 (0%)		1/2 (50%)		2/8 (25%)		2/7 (28.6%)		0/20 (0%)
Ear and labyrinth disorders
Cerumen impaction	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Ear pain	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Eye disorders
Dry eye	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		1/20 (5%)
Eye swelling	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Ocular hyperaemia	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Photophobia	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Vision blurred	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Gastrointestinal disorders
Abdominal distension	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Abdominal pain upper	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Abdominal tenderness	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Anal fissure	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		1/20 (5%)
Ascites	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Chapped lips	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Cheilitis	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Colitis	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Constipation	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		1/20 (5%)
Diarrhoea	0/1 (0%)		0/2 (0%)		3/8 (37.5%)		1/7 (14.3%)		1/20 (5%)
Dry mouth	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Dyspepsia	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Erosive oesophagitis	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Gastrointestinal pain	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Gingival bleeding	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		1/20 (5%)
Haematemesis	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		1/20 (5%)
Haematochezia	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		1/20 (5%)
Intestinal dilatation	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Intra-abdominal haematoma	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Lip dry	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Lip haemorrhage	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Mouth ulceration	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Nausea	0/1 (0%)		1/2 (50%)		2/8 (25%)		1/7 (14.3%)		0/20 (0%)
Oesophageal pain	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Perianal erythema	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Proctalgia	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Stomatitis	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		1/7 (14.3%)		2/20 (10%)
Vomiting	0/1 (0%)		2/2 (100%)		1/8 (12.5%)		2/7 (28.6%)		1/20 (5%)
General disorders
Asthenia	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Catheter site bruise	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Catheter site haematoma	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Catheter site pain	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Fatigue	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		2/20 (10%)
Gait disturbance	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Infusion site bruising	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Infusion site haemorrhage	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Injection site bruising	0/1 (0%)		1/2 (50%)		2/8 (25%)		4/7 (57.1%)		8/20 (40%)
Injection site haematoma	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		1/20 (5%)
Injection site haemorrhage	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		1/20 (5%)
Injection site mass	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Injection site nodule	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		1/20 (5%)
Injection site pain	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		4/20 (20%)
Localised oedema	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Mucosal haemorrhage	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Mucosal inflammation	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		1/7 (14.3%)		2/20 (10%)
Nodule	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Oedema peripheral	0/1 (0%)		0/2 (0%)		0/8 (0%)		2/7 (28.6%)		1/20 (5%)
Pain	0/1 (0%)		0/2 (0%)		0/8 (0%)		2/7 (28.6%)		1/20 (5%)
Pyrexia	0/1 (0%)		1/2 (50%)		2/8 (25%)		2/7 (28.6%)		2/20 (10%)
Swelling	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Catheter site inflammation	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Hepatobiliary disorders
Cholelithiasis	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Hyperbilirubinaemia	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Immune system disorders
Drug hypersensitivity	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Hypocomplementaemia	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Infections and infestations
Aspergillus infection	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Bacterial infection	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Bacteriuria	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Clostridium difficile colitis	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Clostridium difficile infection	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Conjunctivitis	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Genitourinary tract infection	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Influenza	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Infusion site cellulitis	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Paronychia	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Pharyngitis	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Rhinitis	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Rhinovirus infection	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Sinusitis bacteria	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Skin infection	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Stoma site cellulitis	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Vaginal infection	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Viral diarrhoea	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Viral infection	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Injury, poisoning and procedural complications
Bone contusion	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Contusion	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		2/7 (28.6%)		3/20 (15%)
Fall	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Laceration	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Ligament sprain	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Refractoriness to platelet transfusion	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Skin abrasion	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Investigations
Activated partial thromboplastin time prolonged	0/1 (0%)		1/2 (50%)		2/8 (25%)		0/7 (0%)		2/20 (10%)
Alanine aminotransferase increased	1/1 (100%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		2/20 (10%)
Aspartate aminotransferase increased	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		2/20 (10%)
Aspergillus test positive	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Blood calcium increased	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Blood fibrinogen decreased	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Blood fibrinogen increased	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Blood lactate dehydrogenase increased	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Blood urea increased	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Body temperature increased	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
C-reactive protein increased	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Haematocrit decreased	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Haemoglobin decreased	0/1 (0%)		0/2 (0%)		0/8 (0%)		2/7 (28.6%)		1/20 (5%)
Hepatitis A virus test positive	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
International normalised ratio increased	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Lymphocyte count decreased	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Neutrophil count decreased	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		1/20 (5%)
Platelet count decreased	0/1 (0%)		0/2 (0%)		0/8 (0%)		2/7 (28.6%)		1/20 (5%)
Platelet count increased	1/1 (100%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Prothrombin time prolonged	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		2/20 (10%)
Transaminases increased	0/1 (0%)		0/2 (0%)		0/8 (0%)		2/7 (28.6%)		0/20 (0%)
Weight decreased	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
White blood cell count decreased	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		1/20 (5%)
Metabolism and nutrition disorders
Decreased appetite	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Fluid overload	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Hyperglycaemia	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Hyperkalaemia	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Hyperuricaemia	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Hypoalbuminaemia	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Hypocalcaemia	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		1/7 (14.3%)		2/20 (10%)
Hypokalaemia	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		2/20 (10%)
Hypomagnesaemia	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Hyponatraemia	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		1/20 (5%)
Hypophosphataemia	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		1/20 (5%)
Magnesium deficiency	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		2/20 (10%)
Back pain	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Haemarthrosis	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Muscular weakness	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Musculoskeletal chest pain	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Musculoskeletal pain	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Myalgia	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Neck pain	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Pain in extremity	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		2/20 (10%)
Pain in jaw	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Spinal pain	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Nervous system disorders
Altered state of consciousness	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Ataxia	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Dizziness	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		2/20 (10%)
Headache	0/1 (0%)		0/2 (0%)		2/8 (25%)		2/7 (28.6%)		2/20 (10%)
Hypoaesthesia	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Neuralgia	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		1/20 (5%)
Neuropathy peripheral	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		1/20 (5%)
Peripheral sensory neuropathy	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Psychiatric disorders
Anxiety	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Insomnia	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Mental disorder	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Renal and urinary disorders
Haematuria	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Leukocyturia	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Reproductive system and breast disorders
Vulvovaginal pain	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Cough	0/1 (0%)		0/2 (0%)		2/8 (25%)		0/7 (0%)		1/20 (5%)
Epistaxis	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		3/20 (15%)
Haemoptysis	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Oropharyngeal pain	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		1/7 (14.3%)		4/20 (20%)
Pharyngeal erythema	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Pulmonary mass	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Pulmonary oedema	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Rhinitis allergic	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Rhinorrhoea	0/1 (0%)		0/2 (0%)		2/8 (25%)		0/7 (0%)		0/20 (0%)
Sinus disorder	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Tachypnoea	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Skin and subcutaneous tissue disorders
Acanthosis nigricans	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Alopecia	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		1/7 (14.3%)		2/20 (10%)
Dermatitis contact	0/1 (0%)		0/2 (0%)		2/8 (25%)		0/7 (0%)		0/20 (0%)
Dry skin	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Ecchymosis	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		1/20 (5%)
Eczema	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Erythema	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		1/20 (5%)
Pain of skin	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		1/20 (5%)
Petechiae	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Pruritus generalised	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Rash	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Rash erythematous	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Rash macular	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Rash maculo-papular	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Red man syndrome	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Skin discolouration	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Skin disorder	0/1 (0%)		1/2 (50%)		0/8 (0%)		0/7 (0%)		0/20 (0%)
Skin induration	0/1 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)		1/20 (5%)
Urticaria contact	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Vascular disorders
Deep vein thrombosis	0/1 (0%)		0/2 (0%)		0/8 (0%)		1/7 (14.3%)		0/20 (0%)
Haematoma	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)
Hypertension	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		2/20 (10%)
Vein disorder	0/1 (0%)		0/2 (0%)		1/8 (12.5%)		0/7 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00952380

Other Study ID Numbers:

FRAG-A001-201
A6301094
2016-000394-21

First Posted:

Aug 6, 2009

Last Update Posted:

Apr 16, 2019

Last Verified:

Mar 1, 2019

Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

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