| Primary | Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic) | Thrombotic event was defined as the appearance of a new thrombotic burden within the cardiovascular system on either routine surveillance or clinically indicated imaging, or the occurrence of a clinical event known to be strongly associated with thrombus (such as cardioembolic stroke, pulmonary embolism). The event included ischemic stroke, pulmonary embolism, venous thrombosis, arterial/intracardiac thrombosis, and other thrombosis. | Full analysis set included all participants in Part A who received at least 1 dose of study drug and all participants in Part B who were randomized and received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG002 | Aspirin (Part B) | Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months. |
| | | Title | Denominators | Categories |
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| Any thrombotic event | | | | Ischemic stroke | |
| |
| Primary | Plasma Concentration of Rivaroxaban at Day 1 (0.5-1.5 Hours Postdose) | Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | micrograms per liter (mcg/L) | | Day 1: 0.5-1.5 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Plasma Concentration of Rivaroxaban at Day 1 (1.5-4 Hours Postdose) | Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Day 1: 1.5-4 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Plasma Concentration of Rivaroxaban at Day 4 (Up to 3 Hours Predose) | Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Day 4: Up to 3 hours predose | | | | ID | Title | Description |
|---|
| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Plasma Concentration of Rivaroxaban at Day 4 (0.5-1.5 Hours Postdose) | Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Day 4: 0.5-1.5 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Plasma Concentration of Rivaroxaban at Day 4 (1.5-4 Hours Postdose) | Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Day 4: 1.5-4 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Plasma Concentration of Rivaroxaban at Day 4 (6-8 Hours Postdose) | Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Day 4: 6-8 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Plasma Concentration of Rivaroxaban at Month 3 (Up to 3 Hours Predose) | Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Month 3: Up to 3 hours predose | | | | ID | Title | Description |
|---|
| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Plasma Concentration of Rivaroxaban at Month 3 (0.5-1.5 Hours Postdose) | Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Month 3: 0.5-1.5 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Plasma Concentration of Rivaroxaban at Month 3 (2.5-4 Hours Postdose) | Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Month 3: 2.5-4 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Percentage of Participants With Bleeding Events | Bleeding events were categorized into major, clinically relevant non-major bleeding (CRNM), and trivial bleeding events. Major bleeding: overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more; or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults; or occurring in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; or contributing to death. CRNM bleeding: overt bleeding not meeting the criteria for major bleeding but associated with: Medical intervention, or Unscheduled contact with a physician, cessation of study treatment, or Discomfort for the subject such as pain, or Impairment of activities of daily life. Trivial bleeding: any other overt bleeding event that does not meet criteria for CRNM bleeding. | Safety analysis set included all participants in Part A who received at least 1 dose of study drug and all participants in Part B who were randomized and received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Absolute Prothrombin Time (PT) at Day 1 (0.5-1.5 Hours Postdose) | Absolute prothrombin time was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | Pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, activated partial thromboplastin time (aPTT), and/or anti-factor Xa (FXa) activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Day 1: 0.5-1.5 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Absolute PT at Day 1 (1.5-4 Hours Postdose) | Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Day 1: 1.5-4 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Absolute PT at Day 4 (Up to 3 Hours Predose) | Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Day 4: Up to 3 hours predose | | | | ID | Title | Description |
|---|
| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Absolute PT at Day 4 (0.5-1.5 Hours Postdose) | Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | Pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Day 4: 0.5-1.5 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Absolute PT at Day 4 (1.5-4 Hours Postdose) | Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | Pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Day 4: 1.5-4 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Absolute PT at Day 4 (6-8 Hours Postdose) | Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Day 4: 6-8 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Absolute PT at Month 3 (Up to 3 Hours Predose) | Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Month 3: Up to 3 hours predose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Absolute PT at Month 3 (0.5-1.5 Hours Postdose) | Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Month 3: 0.5-1.5 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Absolute PT at Month 3 (2.5-4 Hours Postdose) | Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Month 3: 2.5-4 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Activated Partial Thromboplastin Time (aPTT) at Day 1 (0.5-1.5 Hours Postdose) | aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Day 1: 0.5-1.5 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | aPTT at Day 1 (1.5-4 Hours Postdose) | aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Day 1: 1.5-4 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | aPTT at Day 4 (Up to 3 Hours Predose) | aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Day 4: Up to 3 hours predose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | aPTT at Day 4 (0.5-1.5 Hours Postdose) | aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Day 4: 0.5-1.5 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | aPTT at Day 4 (1.5-4 Hours Postdose) | aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average for the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Day 4: 1.5-4 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | aPTT at Day 4 (6-8 Hours Postdose) | aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Day 4: 6-8 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | aPTT at Month 3 (Up to 3 Hours Predose) | aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Month 3: Up to 3 hours predose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | aPTT at Month 3 (0.5-1.5 Hours Postdose) | aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Month 3: 0.5-1.5 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | aPTT at Month 3 (2.5-4 Hours Postdose) | aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | seconds | | Month 3: 2.5-4 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Anti-FXa at Day 1 (0.5-1.5 Hours Postdose) | Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Day 1: 0.5-1.5 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Anti-FXa at Day 1 (1.5-4 Hours Postdose) | Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Day 1: 1.5-4 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Anti-FXa at Day 4 (6-8 Hours Postdose) | Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Day 4: 6-8 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Anti-FXa at Month 3 (Up to 3 Hours Predose) | Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Month 3: Up to 3 hours predose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as those adverse events (AEs) that occurred from the first day of study drug to the last day of study drug + 2 days inclusive. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Safety analysis set included all participants in Part A who received at least 1 dose of study drug and all participants in Part B who were randomized and received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Anti-FXa at Month 3 (0.5-1.5 Hours Postdose) | Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Month 3: 0.5-1.5 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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| Primary | Anti-FXa at Month 3 (2.5-4 Hours Postdose) | Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. | PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/L | | Month 3: 2.5-4 hours postdose | | | | ID | Title | Description |
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| OG000 | Rivaroxaban (Part A) | Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than [<] 8 kilograms [kg] participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg; and 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. | | OG001 | Rivaroxaban (Part B) | Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to <8 kg participant received 2.2 mg; 8 to <10 kg received 3.2 mg; 10 to <12 kg received 3.4 mg; 12 to <20 kg received 4.0 mg and; 20 to <30 kg received 5.0 mg) (morning and evening dosing), up to 12 months. |
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