| Primary | Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events | The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC). Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology. CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room. | | Posted | | Count of Participants | | Participants | | From first dose to 2 days after last dose (Up to approximately 12 months) | | | | ID | Title | Description |
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| OG000 | Apixaban | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight. Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID). | | OG001 | Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH. |
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| Secondary | The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death | The number of participants with thromboembolic events (intra-cardiac, shunt, inside Fontan pathway, pulmonary embolism (PE), stroke, other arterial or venous thromboembolic events, etc.) and thromboembolic event-related death detected by imaging or clinical diagnosis. Death and thromboembolic events are adjudicated by a blinded, independent events adjudication committee (EAC) | All randomized participants | Posted | | Count of Participants | | Participants | | From randomization to 2 days after last dose (Up to approximately 12 months) | | | | ID | Title | Description |
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| OG000 | Apixaban | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight. Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID). | | OG001 | Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH. |
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| Secondary | The Number of Participants With Adjudicated Major Bleeding | The number of participants with adjudicated major bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC). Major bleeding is defined as bleeding that satisfies one or more of the following criteria:
- fatal bleeding
- clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period
- bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS
- bleeding that requires surgical intervention in an operating suite, including interventional radiology
| | Posted | | Count of Participants | | Participants | | From first dose to 2 days after last dose (Up to approximately 12 months) | | | | ID | Title | Description |
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| OG000 | Apixaban | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight. Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID). | | OG001 | Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | |
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| Secondary | The Number of Participants With Adjudicated CRNM Bleeding | The number of participants with adjudicated clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. CRNM bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC). CRNM bleeding is defined as bleeding that satisfies one or both of the following criteria:
- overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition
- bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room
| | Posted | | Count of Participants | | Participants | | From first dose to 2 days after last dose (Up to approximately 12 months) | | | | ID | Title | Description |
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| OG000 | Apixaban | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight. Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID). | | OG001 | Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH. |
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| Secondary | The Number of Participants With All Adjudicated Bleeding | The number of participants with all adjudicated bleeding events | | Posted | | Count of Participants | | Participants | | From first dose to 2 days after last dose (Up to approximately 12 months) | | | | ID | Title | Description |
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| OG000 | Apixaban | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight. Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID). | | OG001 | Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH. |
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| Secondary | The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding | The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding. | | Posted | | Count of Participants | | Participants | | From first dose to 2 days after last dose (Up to approximately 12 months) | | | | ID | Title | Description |
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| OG000 | Apixaban | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight. Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID). | | OG001 | Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH. |
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| Secondary | The Number of Participant Deaths in the Study | The number of participant deaths in the study. | | Posted | | Count of Participants | | Participants | | From first dose to 2 days after last dose (Up to approximately 12 months) | | | | ID | Title | Description |
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| OG000 | Apixaban | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight. Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID). | | OG001 | Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | Participants receive thromboprophylaxis with VKA or LMWH for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants who receive LMWH are allowed to switch to VKA at any time during the study; conversely, Participants having difficulty with VKA may switch to LMWH. |
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| Secondary | Maximum Observed Concentration (Cmax) | | All treated participants in the apixaban arm with available pharmacokinetic data | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | From first dose up to 6 months after first dose | | | | ID | Title | Description |
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| OG000 | Participants Weight Range 6 to < 9 kg | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between 6 to < 9 kg will be administered 1mg apixaban twice daily (BID). | | OG001 | Participants Weight Range 9 to < 12 kg | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between 9 to < 12 kg will be administered 1.5mg apixaban twice daily (BID). | | OG002 | Participants Weight Range 12 to < 18 kg | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between 12 to < 18 kg will be administered 2mg apixaban twice daily (BID). | |
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| Secondary | Trough Observed Concentration (Cmin) | | All treated participants in the apixaban arm with available pharmacokinetic data | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | From first dose up to 6 months after first dose | | | | ID | Title | Description |
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| OG000 | Participants Weight Range 6 to < 9 kg | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between 6 to < 9 kg will be administered 1mg apixaban twice daily (BID). | | OG001 | Participants Weight Range 9 to < 12 kg | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between 9 to < 12 kg will be administered 1.5mg apixaban twice daily (BID). | | OG002 | Participants Weight Range 12 to < 18 kg | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between 12 to < 18 kg will be administered 2mg apixaban twice daily (BID). | |
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| Secondary | Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU)) | | All treated participants in the apixaban arm with available pharmacokinetic data | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng • h/mL | | From first dose up to 6 months after first dose | | | | ID | Title | Description |
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| OG000 | Participants Weight Range 6 to < 9 kg | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between 6 to < 9 kg will be administered 1mg apixaban twice daily (BID). | | OG001 | Participants Weight Range 9 to < 12 kg | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between 9 to < 12 kg will be administered 1.5mg apixaban twice daily (BID). | | OG002 | Participants Weight Range 12 to < 18 kg | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between 12 to < 18 kg will be administered 2mg apixaban twice daily (BID). |
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| Secondary | Time of Maximum Observed Concentration (Tmax) | | All treated participants in the apixaban arm with available pharmacokinetic data | Posted | | Median | Full Range | hours | | From first dose up to 6 months after first dose | | | | ID | Title | Description |
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| OG000 | Participants Weight Range 6 to < 9 kg | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between 6 to < 9 kg will be administered 1mg apixaban twice daily (BID). | | OG001 | Participants Weight Range 9 to < 12 kg | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between 9 to < 12 kg will be administered 1.5mg apixaban twice daily (BID). | | OG002 | Participants Weight Range 12 to < 18 kg | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between 12 to < 18 kg will be administered 2mg apixaban twice daily (BID). | | OG003 |
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| Secondary | Anti-FXa Activity | Anti-FXa Activity was measured to assess participant plasma apixaban levels. 125 participants received at least one dose of apixaban and had anti-FXa samples collected that contributed measurements to at least one of the timepoints below. | All treated participants in the apixaban arm that have anti-FXa samples collected | Posted | | Mean | Standard Error | ng/mL | | From first dose up to 6 months after first dose | | | | ID | Title | Description |
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| OG000 | Apixaban | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight. Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID). |
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| Secondary | Chromogenic FX Assay (Apparent FX Level) | Chromogenic FX was measured to assess (apparent) FX levels in participants and inhibition of FXa by apixaban. 125 participants received at least one dose of apixaban and had chromogenic FX assay samples collected that contributed measurements to at least one of the timepoints below. | All treated participants in the apixaban arm that have have chromogenic FX assay samples collected | Posted | | Mean | Standard Error | Percent | | From first dose up to 6 months after first dose | | | | ID | Title | Description |
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| OG000 | Apixaban | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight. Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID). |
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| Secondary | The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL) | Subjects' quality of life was measured using the PedsQL instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses. PedsQL consists of 23 items scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or for the child report for younger children ages 5-7, a 3-point Likert scale: 0 (Not at all), 2 (Sometimes), and 4 (A lot). Scores are reverse scored and transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores indicate a better HRQOL and/or lower problems. | All randomized English speaking participants 2 years and older with both baseline and post baseline questionnaire scores | Posted | | Mean | Standard Deviation | Score on a scale | | from randomization up to 12 months after randomization | | | | ID | Title | Description |
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| OG000 | Apixaban | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight. Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID). | | OG001 | Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | |
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| Secondary | Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score | Subjects' quality of life was measured using the KIDCLOT instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses. KIDCLOT Parent inventory uses a 5 point Likert scale from 1 (N/A), 2 (Never), 3 (Rarely), 4 ( Now and then), 5 (Often). Child inventory uses a 4 point Likert scale 1 (N/A), 2 (Never), 3 (Now and then), 5 (Always). Values are scores as follows 1=0, 2=1, 3=2, 4=3, 5=4. Score interpretation is 0 to 100 percent IMPACT of anticoagulation on a child's life therefore, higher scores indicates a more negative effect. | All randomized English speaking participants 6 years and older taking apixaban or warfarin with both baseline and post baseline questionnaire scores. Parent inventory includes only participants age >= 34 weeks old. | Posted | | Mean | Standard Deviation | Score on a scale | | from randomization up to 12 months after randomization | | | | ID | Title | Description |
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| OG000 | Apixaban | Participants receive thromboprophylaxis with open-label apixaban for up to 12 months or until the need for anticoagulant is resolved, whichever occurs first. Participants weighing between >/= 3 and < 35 kg will be administered apixaban twice daily (BID) in doses between 0.2mg and 4 mg depending on body weight. Children randomized to the apixaban arm of the study weighing >/= 35 kg will be administered apixaban 5 mg twice daily (BID). | | OG001 | Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) |
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