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| ID | Type | Description | Link |
|---|---|---|---|
| A6301094 | Other Identifier | Alias Study Number | |
| 2016-000394-21 | EudraCT Number |
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Three month treatment of acute VTE with Fragmin in pediatric cancer patients
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | Single arm open-label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dalteparin | Drug | dalteparin subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level | 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. | 4 hours post-dose at each Day 1 to 7 in dose adjustment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels | 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. | Day 1 to 7 in dose adjustment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Total Body Clearance of Dalteparin | 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. | 4 hours post-dose at each Day 1 to 7 in dose adjustment phase |
Inclusion Criteria:
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States | ||
| MedStar Georgetown University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35678616 | Derived | Hartman LR, Nurmeev I, Svirin P, Wolter KD, Yan JL, Jani D, Goldenberg NA, Sherman N. A phase 2 pharmacodynamic dose-finding, safety, and efficacy study of dalteparin for pediatric venous thromboembolism treatment in children with and without cancer. Pediatr Blood Cancer. 2022 Aug;69(8):e29764. doi: 10.1002/pbc.29764. Epub 2022 Jun 9. | |
| 32827160 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 18, 2016 | Mar 19, 2019 |
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| Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE) |
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. |
| Baseline up to 28 days after the last dose of study drug (up to Day 132) |
| Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE) | 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. | Baseline up to 28 days after the last dose of study drug (up to Day 132) |
| Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE) | 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. | Baseline up to 28 days after the last dose of study drug (up to Day 132) |
| Percentage of Participants With Major and Minor 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 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). | Baseline up to 28 days after the last dose of study drug (up to Day 132) |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Baseline up to 28 days after the last dose of study drug (up to Day 132) |
| Number of Participants With Laboratory Abnormalities | 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. | Baseline up to 104 days |
| 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 | Heart rate and pulse rate of participants were measured in terms of beats per minute. | Baseline, Day 1, Day 2, Day 30, Day 60, Day 90 |
| 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 | Respiratory rate was defined as the number of breaths per minute. | Baseline, Day 1, Day 2, Day 30, Day 60, Day 90 |
| 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 | 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. | Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90) |
| Time to First Occurrence of Major Bleeding Event | 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). | Baseline up to 28 days after the last dose of study drug (up to Day 132) |
| Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 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. | Day 30, Day 60, Day 90 in follow up phase |
| Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 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. | Day 30, Day 60, Day 90 in follow-up phase |
| Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels | Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data for day 1 to 7 has been reported. | 4 hours post-dose at each Day 1 to 7 in dose adjustment phase |
| Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels | 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. | Day 1 to 7 in dose adjustment phase |
| Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels | 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. | 4 hours post-dose at each Day 1 to 7 in dose adjustment phase |
| Volume of Distribution of Dalteparin | 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. | 4 hours post-dose at each Day 1 to 7 in dose adjustment phase |
| Absorption Rate Constant (Ka) of Dalteparin | 4 hours post-dose at each Day 1 to 7 in dose adjustment phase |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Wolfson Children's Hospital | Jacksonville | Florida | 32207 | United States |
| Investigational Drug Service Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Tampa General Hospital Center of Research Excellence | Tampa | Florida | 33606 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| St. Joseph's Children's Hospital of Tampa | Tampa | Florida | 33607 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| El Paso Children's Hospital | El Paso | Texas | 79905 | United States |
| Texas Tech University Health Sciences Center El Paso | El Paso | Texas | 79905 | United States |
| Texas Children's Cancer and Hematology Centers | Houston | Texas | 77030 | United States |
| Texas Children's Hospital Investigational Pharmacy Services | Houston | Texas | 77030 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Sykehusapoteket Oslo | Oslo | 0372 | Norway |
| Oslo universitetssykehus HF | Oslo | 0424 | Norway |
| FSBEI HE Kazan SMU of Minzdrav Russia | Kazan' | Republic Tatarstan | 420012 | Russia |
| SAHI "Children's Republican Clinical Hospital of the Ministry of | Kazan' | Republic Tatarstan | 420138 | Russia |
| SBHI of Moscow city Morozovskaya Children City Clinical Hospital of Moscow city | Moscow | 119049 | Russia |
| Lekarna, Univerzitetni klinicni center Ljubljana | Ljubljana | SI-1000 | Slovenia |
| Pediatricna klinika, Univerzitetni Klinicni Center Ljubljana | Ljubljana | SI-1000 | Slovenia |
| Hospital HM Universitario Monteprincipe Servicio de Farmacia | Boadilla del Monte | Madrid | 28660 | Spain |
| Hospital HM Universitario Monteprincipe | Boadilla del Monte | Madrid | 28660 | Spain |
| Damle B, Jen F, Sherman N, Jani D, Sweeney K. Population Pharmacokinetic Analysis of Dalteparin in Pediatric Patients With Venous Thromboembolism. J Clin Pharmacol. 2021 Feb;61(2):172-180. doi: 10.1002/jcph.1716. Epub 2020 Aug 21. |
| To obtain contact information for a study center near you, click here. | View source |
| FG001 | Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) | 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). |
| FG002 | Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) | 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). |
| FG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| FG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
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| NOT COMPLETED |
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The safety analysis set included all the participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) | 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). |
| BG001 | Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) | 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). |
| BG002 | Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) | 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). |
| BG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| BG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
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| Primary | Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level | 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. | 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. | Posted | Median | Full Range | IU/mL | 4 hours post-dose at each Day 1 to 7 in dose adjustment phase |
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| Secondary | Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels | 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. | Analysis population included all the participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to 7 in dose adjustment phase |
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| Secondary | Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE) | 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. | 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. | Posted | Count of Participants | Participants | Baseline up to 28 days after the last dose of study drug (up to Day 132) |
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| Secondary | Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE) | 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. | 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. | Posted | Median | 95% Confidence Interval | days | Baseline up to 28 days after the last dose of study drug (up to Day 132) |
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| Secondary | Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE) | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 28 days after the last dose of study drug (up to Day 132) |
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| Secondary | Percentage of Participants With Major and Minor 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 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). | The safety analysis set included all the participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 28 days after the last dose of study drug (up to Day 132) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | The safety analysis set included all the participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 28 days after the last dose of study drug (up to Day 132) |
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| Secondary | Number of Participants With Laboratory Abnormalities | 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. | 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. | Posted | Count of Participants | Participants | Baseline up to 104 days |
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| Secondary | Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants | 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. | Posted | Median | Full Range | millimeters of mercury (mmHg) | Baseline, Day 1, Day 2, Day 30, Day 60, Day 90 |
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| Secondary | Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants | Heart rate and pulse rate of participants were measured in terms of beats per minute. | 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. | Posted | Median | Full Range | beats per minute (bpm) | Baseline, Day 1, Day 2, Day 30, Day 60, Day 90 |
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| Secondary | Absolute Values of Height of Participants | 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. | Posted | Median | Full Range | centimeters (cm) | Baseline, Day 1, Day 2, Day 30, Day 60, Day 90 |
| ||||||||||||||||||||||||||||
| Secondary | Absolute Values of Weight of Participants | 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. | Posted | Median | Full Range | kilograms | Baseline, Day 1, Day 2, Day 30, Day 60, Day 90 |
| ||||||||||||||||||||||||||||
| Secondary | Absolute Values of Respiratory Rate of Participants | Respiratory rate was defined as the number of breaths per minute. | 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. | Posted | Median | Full Range | breaths per minute | Baseline, Day 1, Day 2, Day 30, Day 60, Day 90 |
| |||||||||||||||||||||||||||
| Secondary | Absolute Values of Body Temperature of Participants | 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. | Posted | Median | Full Range | degree celsius | Baseline, Day 1, Day 2, Day 30, Day 60, Day 90 |
| ||||||||||||||||||||||||||||
| Secondary | Absolute Values of Body Length of Participants | 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. | Posted | Median | Full Range | centimeter | Baseline, Day 1, Day 2, Day 30, Day 60, Day 90 |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Physical Examination Abnormalities of Participants | 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. | 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. | Posted | Count of Participants | 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) |
| ||||||||||||||||||||||||||||
| Secondary | Time to First Occurrence of Major Bleeding Event | 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). | The safety analysis set included all the participants who received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | days | Baseline up to 28 days after the last dose of study drug (up to Day 132) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30, Day 60, Day 90 in follow up phase |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30, Day 60, Day 90 in follow-up phase |
| |||||||||||||||||||||||||||
| Secondary | Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels | Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data for day 1 to 7 has been reported. | 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. | Posted | Mean | Standard Deviation | IU/kg | 4 hours post-dose at each Day 1 to 7 in dose adjustment phase |
| |||||||||||||||||||||||||||
| Secondary | Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels | 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. | 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. | Posted | Median | Full Range | days | Day 1 to 7 in dose adjustment phase |
| |||||||||||||||||||||||||||
| Secondary | Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels | 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. | 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. | Posted | Median | Full Range | dose adjustment | 4 hours post-dose at each Day 1 to 7 in dose adjustment phase |
| |||||||||||||||||||||||||||
| Other Pre-specified | Total Body Clearance of Dalteparin | 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. | 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. | Posted | 4 hours post-dose at each Day 1 to 7 in dose adjustment phase |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Volume of Distribution of Dalteparin | 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. | 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. | Posted | 4 hours post-dose at each Day 1 to 7 in dose adjustment phase |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Absorption Rate Constant (Ka) of Dalteparin | 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. | Posted | 4 hours post-dose at each Day 1 to 7 in dose adjustment phase |
|
|
Baseline up to 28 days after the last dose of study drug (up to Day 132)
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dalteparin Sodium: Group 1 (>=0 to <8 Weeks) | 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). | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) | 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). | 0 | 2 | 2 | 2 | 2 | 2 |
| EG002 | Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) | 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). | 0 | 8 | 3 | 8 | 7 | 8 |
| EG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). | 0 | 7 | 3 | 7 | 7 | 7 |
| EG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). | 1 | 20 | 13 | 20 | 16 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Intestinal haematoma | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Seizure like phenomena | Nervous system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MeDRA v21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Eye swelling | Eye disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Chapped lips | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Vein disorder | Vascular disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hypocomplementaemia | Immune system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Vulvovaginal pain | Reproductive system and breast disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Intestinal dilatation | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Intra-abdominal haematoma | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Lip haemorrhage | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Perianal erythema | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Catheter site bruise | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Catheter site haematoma | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Infusion site bruising | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Infusion site haemorrhage | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Injection site haematoma | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Injection site mass | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Injection site nodule | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Mucosal haemorrhage | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Nodule | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Swelling | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MeDRA v21.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MeDRA v21.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MeDRA v21.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MeDRA v21.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MeDRA v21.0 | Non-systematic Assessment |
| |
| Refractoriness to platelet transfusion | Injury, poisoning and procedural complications | MeDRA v21.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MeDRA v21.0 | Non-systematic Assessment |
| |
| Catheter site inflammation | General disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Genitourinary tract infection | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Infusion site cellulitis | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Sinusitis bacteria | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Stoma site cellulitis | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Viral diarrhoea | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Acanthosis nigricans | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Red man syndrome | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Urticaria contact | Skin and subcutaneous tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Aspergillus test positive | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Blood calcium increased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Blood fibrinogen increased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Haematocrit decreased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hepatitis A virus test positive | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Magnesium deficiency | Metabolism and nutrition disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MeDRA v21.0 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 18, 2015 | Mar 19, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017985 | Dalteparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
|
|
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).
| OG002 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 |
| Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) |
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). |
| OG002 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
|
|
| OG001 | Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) | 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). |
| OG002 | Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
|
|
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). |
| OG002 | Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
|
|
| OG001 | Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years) | 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). |
| OG002 | Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
|
|
| OG002 | Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
|
|
| OG002 | Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
|
|
| Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) |
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). |
| OG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
|
|
| Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) |
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). |
| OG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
|
|
| OG002 | Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
|
|
| Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) |
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). |
| OG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
|
|
| Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) |
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). |
| OG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
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| OG002 | Dalteparin Sodium: Group 3 (>=2 Years to <8 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG004 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
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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).
| OG002 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
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| OG002 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
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| OG002 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
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| OG002 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
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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).
| OG002 | Dalteparin Sodium: Group 4 (>=8 Years to <12 Years) | 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). |
| OG003 | Dalteparin Sodium: Group 5 (>=12 Years to <19 Years) | 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). |
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