UNIVERSE: Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02846532
• Collaborator: Bayer (Industry)
• Enrollment: 112
• Locations: 42
• Arms: 2
• Actual Duration (Months): 44
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram [mg] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram [mg/kg]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.

Condition or Disease	Intervention/Treatment	Phase
Thrombosis	Drug: Rivaroxaban; Drug: Acetylsalicylic Acid	Phase 3

Detailed Description

Part A: This part includes a 12-day Initial PK, PD, and Safety Assessment Period. Participants in Part A will not participate in Part B. Randomization in Part B of this study will begin once the cumulative data from the Initial PK, PD, and Safety Assessment Period in Part A are deemed acceptable by the Independent Data Monitoring Committee. Part A of the study will consist of an up to 21-day Screening Period, a 12-day Initial PK, PD, and Safety Assessment Period, a 12-month Open-Label Treatment Period, and a 30-day Follow-Up phone contact. Part B: Participants will be randomly assigned to two treatment groups and randomization ratio will be 2:1 for rivaroxaban and ASA. ASA will be used as control. There will be an up to a 21-day Screening Period, a 12 month Open-Label Treatment Period and a 30-day Follow-Up phone contact.

Study Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age After the Fontan Procedure
• Actual Study Start Date: Nov 16, 2016
• Actual Primary Completion Date: Jul 16, 2020
• Actual Study Completion Date: Jul 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rivaroxaban	Drug: Rivaroxaban; Participants will receive oral suspension containing rivaroxaban 1 milligram per milliliter (mg/ml) twice daily in Part A and Part B. Following total daily doses of Rivaroxaban will be administered based on the weight of the participants: 7 to <8 kilogram (kg) will receive 2.2 milligram (mg); 8 to <10 kg will receive 3.2 mg; 10 to<12 kg will receive 3.4 mg; 12 to <20 will receive 4.0 mg and 20 to <30 will receive 5.0 mg.
Experimental: Acetylsalicylic Acid	Drug: Acetylsalicylic Acid; Participants will receive 5 milligram per kilogram (mg/kg) of acetylsalicylic acid once daily up to 12 months in Part B.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic) [Up to 12 months]

   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.

2. Plasma Concentration of Rivaroxaban at Day 1 (0.5-1.5 Hours Postdose) [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.

3. Plasma Concentration of Rivaroxaban at Day 1 (1.5-4 Hours Postdose) [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.

4. Plasma Concentration of Rivaroxaban at Day 4 (Up to 3 Hours Predose) [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.

5. Plasma Concentration of Rivaroxaban at Day 4 (0.5-1.5 Hours Postdose) [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.

6. Plasma Concentration of Rivaroxaban at Day 4 (1.5-4 Hours Postdose) [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.

7. Plasma Concentration of Rivaroxaban at Day 4 (6-8 Hours Postdose) [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.

8. Plasma Concentration of Rivaroxaban at Month 3 (Up to 3 Hours Predose) [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.

9. Plasma Concentration of Rivaroxaban at Month 3 (0.5-1.5 Hours Postdose) [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.

10. Plasma Concentration of Rivaroxaban at Month 3 (2.5-4 Hours Postdose) [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.

11. Percentage of Participants With Bleeding Events [Up to 12 months]

    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.

12. Absolute Prothrombin Time (PT) at Day 1 (0.5-1.5 Hours Postdose) [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.

13. Absolute PT at Day 1 (1.5-4 Hours Postdose) [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.

14. Absolute PT at Day 4 (Up to 3 Hours Predose) [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.

15. Absolute PT at Day 4 (0.5-1.5 Hours Postdose) [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.

16. Absolute PT at Day 4 (1.5-4 Hours Postdose) [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.

17. Absolute PT at Day 4 (6-8 Hours Postdose) [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.

18. Absolute PT at Month 3 (Up to 3 Hours Predose) [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.

19. Absolute PT at Month 3 (0.5-1.5 Hours Postdose) [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.

20. Absolute PT at Month 3 (2.5-4 Hours Postdose) [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.

21. Activated Partial Thromboplastin Time (aPTT) at Day 1 (0.5-1.5 Hours Postdose) [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.

22. aPTT at Day 1 (1.5-4 Hours Postdose) [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.

23. aPTT at Day 4 (Up to 3 Hours Predose) [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.

24. aPTT at Day 4 (0.5-1.5 Hours Postdose) [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.

25. aPTT at Day 4 (1.5-4 Hours Postdose) [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.

26. aPTT at Day 4 (6-8 Hours Postdose) [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.

27. aPTT at Month 3 (Up to 3 Hours Predose) [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.

28. aPTT at Month 3 (0.5-1.5 Hours Postdose) [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.

29. aPTT at Month 3 (2.5-4 Hours Postdose) [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.

30. Anti-FXa at Day 1 (0.5-1.5 Hours Postdose) [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.

31. Anti-FXa at Day 1 (1.5-4 Hours Postdose) [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.

32. Anti-FXa at Day 4 (6-8 Hours Postdose) [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.

33. Anti-FXa at Month 3 (Up to 3 Hours Predose) [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.

34. Anti-FXa at Month 3 (0.5-1.5 Hours Postdose) [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.

35. Anti-FXa at Month 3 (2.5-4 Hours Postdose) [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.

Secondary Outcome Measures

1. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) [Up to 12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participant must be considered to be clinically stable by the investigator and able to tolerate oral or enteral administration of a suspension formulation and oral/enteral feedings

• Satisfactory initial post-Fontan transthoracic echocardiographic Screening as defined in the Post-Fontan Echocardiographic Examination Research Protocol

• Parent/legally acceptable representative must sign an informed consent form (ICF) and child assent will also be provided, if applicable, according to local requirements

Exclusion Criteria:

• Evidence of thrombosis, including those that are asymptomatic confirmed by post-Fontan procedure transthoracic echocardiogram, or other imaging techniques, during the Screening period of the study

• History of gastrointestinal disease or surgery associated with clinically relevant impaired absorption

• History of or signs/symptoms suggestive of protein-losing enteropathy

• Active bleeding or high risk for bleeding contraindicating antiplatelet or anticoagulant therapy, including a history of intracranial bleeding

• Platelet count less than (<)50*10^9/Liters (L) at Screening

• Estimated glomerular filtration rate (eGFR) <30 milliliters per minute per 1.73 meter square (mL/min/1.73m^2)

• Known clinically significant liver disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Los Angeles	California	United States
2		Gainesville	Florida	United States
3		Oak Lawn	Illinois	United States
4		Indianapolis	Indiana	United States
5		Iowa City	Iowa	United States
6		Baltimore	Maryland	United States
7		Boston	Massachusetts	United States
8		Minneapolis	Minnesota	United States
9		Omaha	Nebraska	United States
10		Durham	North Carolina	United States
11		Cincinnati	Ohio	United States
12		Hershey	Pennsylvania	United States
13		Philadelphia	Pennsylvania	United States
14		Memphis	Tennessee	United States
15		Houston	Texas	United States
16		Salt Lake City	Utah	United States
17		Milwaukee	Wisconsin	United States
18		Buenos Aires		Argentina
19		Cordoba		Argentina
20		Brussel		Belgium
21		Gent		Belgium
22		Leuven		Belgium
23		Curitiba		Brazil
24		Porto Alegre		Brazil
25		São Paulo		Brazil
26		Vancouver	British Columbia	Canada
27		Toronto	Ontario	Canada
28		Montreal	Quebec	Canada
29		Fukuoka		Japan
30		Kitakyushu-shi,		Japan
31		Setagaya-ku		Japan
32		Shizuoka-shi, Shizuoka		Japan
33		Kuala Lumpur		Malaysia
34		Mexico		Mexico
35		Leiden		Netherlands
36		Rotterdam		Netherlands
37		Utrecht		Netherlands
38		A Coruña		Spain
39		Barcelona		Spain
40		Bilbao		Spain
41		Madrid		Spain
42		Valencia		Spain

Sponsors and Collaborators

• Janssen Research & Development, LLC
• Bayer

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

• Study Protocol - Jul 27, 2017
• Statistical Analysis Plan - May 16, 2019

More Information

Additional Information:

• ERF update upload receipt

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT02846532
• Other Study ID Numbers: CR108075; 39039039CHD3001; 2015-002610-76
• First Posted: Jul 27, 2016
• Last Update Posted: Mar 28, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Janssen Research & Development, LLC: Thromboembolism; Fontan Procedure; Children
• Additional relevant MeSH terms: Thrombosis; Aspirin; Rivaroxaban

Study Results

Participant Flow

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)	Aspirin (Part B)
Arm/Group Description	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.	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.	Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Period Title: Overall Study
STARTED	12	66	34
COMPLETED	11	63	33
NOT COMPLETED	1	3	1

Baseline Characteristics

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)	Aspirin (Part B)	Total
Arm/Group Description	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.	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.	Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.	Total of all reporting groups
Overall Participants	12	66	34	112
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	2.5 (0.67)	4.1 (1.74)	4.2 (1.8)	3.9 (1.74)
Sex: Female, Male (Count of Participants)
Female	5 41.7%	30 45.5%	11 32.4%	46 41.1%
Male	7 58.3%	36 54.5%	23 67.6%	66 58.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 8.3%	22 33.3%	11 32.4%	34 30.4%
Not Hispanic or Latino	11 91.7%	42 63.6%	19 55.9%	72 64.3%
Unknown or Not Reported	0 0%	2 3%	4 11.8%	6 5.4%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	14 21.2%	7 20.6%	21 18.8%
Black or African American	3 25%	8 12.1%	1 2.9%	12 10.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
White	8 66.7%	40 60.6%	20 58.8%	68 60.7%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	2 3%	3 8.8%	5 4.5%
Other	1 8.3%	2 3%	3 8.8%	6 5.4%
Region of Enrollment (Count of Participants)
ARGENTINA	0 0%	5 7.6%	1 2.9%	6 5.4%
BELGIUM	0 0%	5 7.6%	4 11.8%	9 8%
BRAZIL	0 0%	7 10.6%	10 29.4%	17 15.2%
CANADA	0 0%	3 4.5%	3 8.8%	6 5.4%
JAPAN	0 0%	8 12.1%	1 2.9%	9 8%
MALAYSIA	0 0%	5 7.6%	5 14.7%	10 8.9%
MEXICO	0 0%	6 9.1%	2 5.9%	8 7.1%
NETHERLANDS	0 0%	1 1.5%	0 0%	1 0.9%
SPAIN	5 41.7%	1 1.5%	0 0%	6 5.4%
UNITED STATES	7 58.3%	25 37.9%	8 23.5%	40 35.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)	Aspirin (Part B)
Arm/Group Description	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.	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.	Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Measure Participants	12	64	34
Any thrombotic event	8.3 69.2%	1.6 2.4%	8.8 25.9%
Ischemic stroke	0 0%	0 0%	2.9 8.5%
Pulmonary embolism	0 0%	1.6 2.4%	0 0%
Venous thrombosis	8.3 69.2%	0 0%	5.9 17.4%
Arterial/intracardiac thrombosis	0 0%	0 0%	0 0%
Other thrombosis	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Plasma Concentration of Rivaroxaban at Day 1 (0.5-1.5 Hours Postdose)
Description	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.
Time Frame	Day 1: 0.5-1.5 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	60
Mean (Standard Deviation) [micrograms per liter (mcg/L)]	46.69 (39.4)	92.86 (72.6)

3. Primary Outcome

Title	Plasma Concentration of Rivaroxaban at Day 1 (1.5-4 Hours Postdose)
Description	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.
Time Frame	Day 1: 1.5-4 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	61
Mean (Standard Deviation) [mcg/L]	86.62 (43.1)	103.61 (62.6)

4. Primary Outcome

Title	Plasma Concentration of Rivaroxaban at Day 4 (Up to 3 Hours Predose)
Description	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.
Time Frame	Day 4: Up to 3 hours predose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	0
Mean (Standard Deviation) [mcg/L]	36.58 (37.4)

5. Primary Outcome

Title	Plasma Concentration of Rivaroxaban at Day 4 (0.5-1.5 Hours Postdose)
Description	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.
Time Frame	Day 4: 0.5-1.5 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	0
Mean (Standard Deviation) [mcg/L]	107.58 (54.2)

6. Primary Outcome

Title	Plasma Concentration of Rivaroxaban at Day 4 (1.5-4 Hours Postdose)
Description	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.
Time Frame	Day 4: 1.5-4 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	0
Mean (Standard Deviation) [mcg/L]	147.18 (116)

7. Primary Outcome

Title	Plasma Concentration of Rivaroxaban at Day 4 (6-8 Hours Postdose)
Description	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.
Time Frame	Day 4: 6-8 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	0
Mean (Standard Deviation) [mcg/L]	66.81 (64.6)

8. Primary Outcome

Title	Plasma Concentration of Rivaroxaban at Month 3 (Up to 3 Hours Predose)
Description	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.
Time Frame	Month 3: Up to 3 hours predose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	10	52
Mean (Standard Deviation) [mcg/L]	38.23 (25.7)	29.41 (25.5)

9. Primary Outcome

Title	Plasma Concentration of Rivaroxaban at Month 3 (0.5-1.5 Hours Postdose)
Description	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.
Time Frame	Month 3: 0.5-1.5 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	10	55
Mean (Standard Deviation) [mcg/L]	86.25 (32.0)	94.12 (82.2)

10. Primary Outcome

Title	Plasma Concentration of Rivaroxaban at Month 3 (2.5-4 Hours Postdose)
Description	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.
Time Frame	Month 3: 2.5-4 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	10	57
Mean (Standard Deviation) [mcg/L]	96.67 (58.4)	102.99 (56.0)

11. Primary Outcome

Title	Percentage of Participants With Bleeding Events
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)	Aspirin (Part B)
Arm/Group Description	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.	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.	Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Measure Participants	12	64	34
Any bleeding event	33.3 277.5%	35.9 54.4%	41.2 121.2%
Major Bleeding	0 0%	1.6 2.4%	0 0%
Clinically relevant non-major bleeding	8.3 69.2%	6.3 9.5%	8.8 25.9%
Trivial bleeding	25.0 208.3%	32.8 49.7%	35.3 103.8%

12. Primary Outcome

Title	Absolute Prothrombin Time (PT) at Day 1 (0.5-1.5 Hours Postdose)
Description	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.
Time Frame	Day 1: 0.5-1.5 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	56
Mean (Standard Deviation) [seconds]	15.46 (1.90)	18.02 (2.58)

13. Primary Outcome

Title	Absolute PT at Day 1 (1.5-4 Hours Postdose)
Description	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.
Time Frame	Day 1: 1.5-4 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	55
Mean (Standard Deviation) [seconds]	16.58 (1.84)	18.76 (2.25)

14. Primary Outcome

Title	Absolute PT at Day 4 (Up to 3 Hours Predose)
Description	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.
Time Frame	Day 4: Up to 3 hours predose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	0
Mean (Standard Deviation) [seconds]	15.21 (1.54)

15. Primary Outcome

Title	Absolute PT at Day 4 (0.5-1.5 Hours Postdose)
Description	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.
Time Frame	Day 4: 0.5-1.5 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	0
Mean (Standard Deviation) [seconds]	17.95 (2.10)

16. Primary Outcome

Title	Absolute PT at Day 4 (1.5-4 Hours Postdose)
Description	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.
Time Frame	Day 4: 1.5-4 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	0
Mean (Standard Deviation) [seconds]	18.73 (3.30)

17. Primary Outcome

Title	Absolute PT at Day 4 (6-8 Hours Postdose)
Description	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.
Time Frame	Day 4: 6-8 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	0
Mean (Standard Deviation) [seconds]	16.13 (2.13)

18. Primary Outcome

Title	Absolute PT at Month 3 (Up to 3 Hours Predose)
Description	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.
Time Frame	Month 3: Up to 3 hours predose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	56
Mean (Standard Deviation) [seconds]	17.59 (2.65)	16.45 (2.27)

19. Primary Outcome

Title	Absolute PT at Month 3 (0.5-1.5 Hours Postdose)
Description	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.
Time Frame	Month 3: 0.5-1.5 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	8	48
Mean (Standard Deviation) [seconds]	20.13 (3.55)	18.89 (3.69)

20. Primary Outcome

Title	Absolute PT at Month 3 (2.5-4 Hours Postdose)
Description	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.
Time Frame	Month 3: 2.5-4 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	7	51
Mean (Standard Deviation) [seconds]	19.14 (2.61)	19.69 (2.81)

21. Primary Outcome

Title	Activated Partial Thromboplastin Time (aPTT) at Day 1 (0.5-1.5 Hours Postdose)
Description	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.
Time Frame	Day 1: 0.5-1.5 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	56
Mean (Standard Deviation) [seconds]	31.4 (4.68)	30.69 (8.23)

22. Primary Outcome

Title	aPTT at Day 1 (1.5-4 Hours Postdose)
Description	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.
Time Frame	Day 1: 1.5-4 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	55
Mean (Standard Deviation) [seconds]	32.83 (3.79)	30.25 (3.80)

23. Primary Outcome

Title	aPTT at Day 4 (Up to 3 Hours Predose)
Description	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.
Time Frame	Day 4: Up to 3 hours predose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	0
Mean (Standard Deviation) [seconds]	33.08 (5.68)

24. Primary Outcome

Title	aPTT at Day 4 (0.5-1.5 Hours Postdose)
Description	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.
Time Frame	Day 4: 0.5-1.5 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	0
Mean (Standard Deviation) [seconds]	36.17 (6.99)

25. Primary Outcome

Title	aPTT at Day 4 (1.5-4 Hours Postdose)
Description	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.
Time Frame	Day 4: 1.5-4 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	0
Mean (Standard Deviation) [seconds]	37.58 (8.45)

26. Primary Outcome

Title	aPTT at Day 4 (6-8 Hours Postdose)
Description	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.
Time Frame	Day 4: 6-8 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	0
Mean (Standard Deviation) [seconds]	32.83 (5.94)

27. Primary Outcome

Title	aPTT at Month 3 (Up to 3 Hours Predose)
Description	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.
Time Frame	Month 3: Up to 3 hours predose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	12	51
Mean (Standard Deviation) [seconds]	25.36 (3.76)	28.70 (3.76)

28. Primary Outcome

Title	aPTT at Month 3 (0.5-1.5 Hours Postdose)
Description	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.
Time Frame	Month 3: 0.5-1.5 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	8	48
Mean (Standard Deviation) [seconds]	26.60 (2.55)	31.15 (4.17)

29. Primary Outcome

Title	aPTT at Month 3 (2.5-4 Hours Postdose)
Description	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.
Time Frame	Month 3: 2.5-4 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	7	51
Mean (Standard Deviation) [seconds]	26.74 (1.79)	31.67 (3.58)

30. Primary Outcome

Title	Anti-FXa at Day 1 (0.5-1.5 Hours Postdose)
Description	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.
Time Frame	Day 1: 0.5-1.5 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	6	43
Mean (Standard Deviation) [mcg/L]	66.93 (23.9)	99.46 (60.6)

31. Primary Outcome

Title	Anti-FXa at Day 1 (1.5-4 Hours Postdose)
Description	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.
Time Frame	Day 1: 1.5-4 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	11	52
Mean (Standard Deviation) [mcg/L]	74.06 (32.4)	104.57 (55.5)

32. Primary Outcome

Title	Anti-FXa at Day 4 (6-8 Hours Postdose)
Description	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.
Time Frame	Day 4: 6-8 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	11	0
Mean (Standard Deviation) [mcg/L]	74.21 (60.6)

33. Primary Outcome

Title	Anti-FXa at Month 3 (Up to 3 Hours Predose)
Description	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.
Time Frame	Month 3: Up to 3 hours predose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	3	17
Mean (Standard Deviation) [mcg/L]	60.51 (29.4)	53.41 (15.0)

34. Secondary Outcome

Title	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)	Aspirin (Part B)
Arm/Group Description	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.	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.	Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Measure Participants	12	64	34
Number [percentage of participants]	91.7 764.2%	85.9 130.2%	85.3 250.9%

35. Primary Outcome

Title	Anti-FXa at Month 3 (0.5-1.5 Hours Postdose)
Description	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.
Time Frame	Month 3: 0.5-1.5 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	0	37
Mean (Standard Deviation) [mcg/L]	110.90 (75.8)

36. Primary Outcome

Title	Anti-FXa at Month 3 (2.5-4 Hours Postdose)
Description	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.
Time Frame	Month 3: 2.5-4 hours postdose

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rivaroxaban (Part A)	Rivaroxaban (Part B)
Arm/Group Description	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.	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.
Measure Participants	0	51
Mean (Standard Deviation) [mcg/L]	93.48 (50.3)

Adverse Events

Time Frame	Up to 12 months
Adverse Event Reporting Description	The safety population consisted of 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.
Arm/Group Title	Rivaroxaban (Part A)		Rivaroxaban (Part B)		Aspirin (Part B)
Arm/Group Description	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.		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.		Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
All Cause Mortality
	Rivaroxaban (Part A)		Rivaroxaban (Part B)		Aspirin (Part B)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/64 (0%)		0/34 (0%)
Serious Adverse Events
	Rivaroxaban (Part A)		Rivaroxaban (Part B)		Aspirin (Part B)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/12 (50%)		19/64 (29.7%)		8/34 (23.5%)
Cardiac disorders
Cardiac Failure Congestive	0/12 (0%)		1/64 (1.6%)		0/34 (0%)
Supraventricular Tachycardia	0/12 (0%)		1/64 (1.6%)		0/34 (0%)
Eye disorders
Periorbital Oedema	0/12 (0%)		1/64 (1.6%)		0/34 (0%)
General disorders
Pyrexia	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Swelling Face	0/12 (0%)		0/64 (0%)		1/34 (2.9%)
Infections and infestations
Bronchitis	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Gastroenteritis Viral	0/12 (0%)		1/64 (1.6%)		0/34 (0%)
Influenza	0/12 (0%)		1/64 (1.6%)		1/34 (2.9%)
Laryngitis	1/12 (8.3%)		1/64 (1.6%)		0/34 (0%)
Pneumonia	1/12 (8.3%)		1/64 (1.6%)		1/34 (2.9%)
Stoma Site Cellulitis	0/12 (0%)		1/64 (1.6%)		0/34 (0%)
Vaccination Site Abscess	0/12 (0%)		1/64 (1.6%)		0/34 (0%)
Viral Infection	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Viral Upper Respiratory Tract Infection	0/12 (0%)		0/64 (0%)		1/34 (2.9%)
Wound Abscess	0/12 (0%)		0/64 (0%)		1/34 (2.9%)
Injury, poisoning and procedural complications
Stoma Site Pain	0/12 (0%)		1/64 (1.6%)		0/34 (0%)
Investigations
Investigation	0/12 (0%)		1/64 (1.6%)		0/34 (0%)
Weight Decreased	0/12 (0%)		1/64 (1.6%)		0/34 (0%)
Nervous system disorders
Partial Seizures with Secondary Generalisation	0/12 (0%)		1/64 (1.6%)		0/34 (0%)
Seizure	0/12 (0%)		1/64 (1.6%)		1/34 (2.9%)
Syncope	0/12 (0%)		0/64 (0%)		1/34 (2.9%)
Respiratory, thoracic and mediastinal disorders
Bronchospasm	0/12 (0%)		0/64 (0%)		1/34 (2.9%)
Chylothorax	0/12 (0%)		1/64 (1.6%)		0/34 (0%)
Pleural Effusion	2/12 (16.7%)		9/64 (14.1%)		2/34 (5.9%)
Vascular disorders
Shock Haemorrhagic	0/12 (0%)		1/64 (1.6%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Rivaroxaban (Part A)		Rivaroxaban (Part B)		Aspirin (Part B)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/12 (91.7%)		48/64 (75%)		26/34 (76.5%)
Blood and lymphatic system disorders
Increased Tendency to Bruise	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Neutropenia	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Gastrointestinal disorders
Constipation	0/12 (0%)		0/64 (0%)		2/34 (5.9%)
Diarrhoea	2/12 (16.7%)		3/64 (4.7%)		2/34 (5.9%)
Gingival Bleeding	1/12 (8.3%)		2/64 (3.1%)		0/34 (0%)
Tooth Loss	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Vomiting	3/12 (25%)		9/64 (14.1%)		3/34 (8.8%)
General disorders
Pyrexia	0/12 (0%)		16/64 (25%)		7/34 (20.6%)
Infections and infestations
Bronchitis	2/12 (16.7%)		3/64 (4.7%)		0/34 (0%)
Cellulitis	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Ear Infection	0/12 (0%)		3/64 (4.7%)		2/34 (5.9%)
Gastroenteritis	0/12 (0%)		5/64 (7.8%)		0/34 (0%)
Gastroenteritis Viral	1/12 (8.3%)		3/64 (4.7%)		1/34 (2.9%)
Influenza	0/12 (0%)		4/64 (6.3%)		1/34 (2.9%)
Nasopharyngitis	1/12 (8.3%)		14/64 (21.9%)		6/34 (17.6%)
Otitis Media	0/12 (0%)		4/64 (6.3%)		3/34 (8.8%)
Pharyngitis	0/12 (0%)		5/64 (7.8%)		1/34 (2.9%)
Pharyngitis Streptococcal	1/12 (8.3%)		0/64 (0%)		1/34 (2.9%)
Pharyngotonsillitis	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Pneumonia	0/12 (0%)		2/64 (3.1%)		2/34 (5.9%)
Respiratory Tract Infection	1/12 (8.3%)		2/64 (3.1%)		2/34 (5.9%)
Rhinitis	0/12 (0%)		1/64 (1.6%)		2/34 (5.9%)
Sinusitis	0/12 (0%)		5/64 (7.8%)		2/34 (5.9%)
Upper Respiratory Tract Infection	2/12 (16.7%)		9/64 (14.1%)		5/34 (14.7%)
Urinary Tract Infection	1/12 (8.3%)		1/64 (1.6%)		0/34 (0%)
Viral Infection	2/12 (16.7%)		2/64 (3.1%)		1/34 (2.9%)
Viral Upper Respiratory Tract Infection	3/12 (25%)		0/64 (0%)		1/34 (2.9%)
Injury, poisoning and procedural complications
Arthropod Bite	1/12 (8.3%)		2/64 (3.1%)		1/34 (2.9%)
Fall	0/12 (0%)		2/64 (3.1%)		5/34 (14.7%)
Injury	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Ligament Sprain	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Skin Abrasion	0/12 (0%)		4/64 (6.3%)		1/34 (2.9%)
Skin Laceration	1/12 (8.3%)		0/64 (0%)		2/34 (5.9%)
Traumatic Haemorrhage	0/12 (0%)		0/64 (0%)		2/34 (5.9%)
Wound Haemorrhage	1/12 (8.3%)		1/64 (1.6%)		0/34 (0%)
Metabolism and nutrition disorders
Hypokalaemia	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Hyponatraemia	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Renal and urinary disorders
Acute Kidney Injury	1/12 (8.3%)		0/64 (0%)		0/34 (0%)
Respiratory, thoracic and mediastinal disorders
Catarrh	1/12 (8.3%)		1/64 (1.6%)		0/34 (0%)
Chylothorax	1/12 (8.3%)		1/64 (1.6%)		0/34 (0%)
Cough	0/12 (0%)		12/64 (18.8%)		4/34 (11.8%)
Epistaxis	0/12 (0%)		6/64 (9.4%)		3/34 (8.8%)
Pleural Effusion	1/12 (8.3%)		3/64 (4.7%)		0/34 (0%)
Rhinorrhoea	0/12 (0%)		3/64 (4.7%)		2/34 (5.9%)
Skin and subcutaneous tissue disorders
Dermatitis Diaper	2/12 (16.7%)		0/64 (0%)		0/34 (0%)
Ecchymosis	0/12 (0%)		6/64 (9.4%)		5/34 (14.7%)
Rash	2/12 (16.7%)		4/64 (6.3%)		2/34 (5.9%)
Urticaria	0/12 (0%)		1/64 (1.6%)		2/34 (5.9%)
Vascular disorders
Haematoma	2/12 (16.7%)		2/64 (3.1%)		1/34 (2.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.