Trial Outcomes & Findings for Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure (NCT NCT02846532)

Last Updated: 2025-03-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

112 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2025-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Rivaroxaban (Part A) Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \[mg/ml\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \[\<\] 8 kilograms \[kg\] participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg; and 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Overall Study STARTED	12	66	34
Overall Study COMPLETED	11	63	33
Overall Study NOT COMPLETED	1	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Rivaroxaban (Part A) Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \[mg/ml\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \[\<\] 8 kilograms \[kg\] participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg; and 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Overall Study Lost to Follow-up	0	1	1
Overall Study Withdrawal by Subject	1	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) n=66 Participants 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.	Aspirin (Part B) n=34 Participants Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.	Total n=112 Participants Total of all reporting groups
Age, Continuous	2.5 years STANDARD_DEVIATION 0.67 • n=93 Participants	4.1 years STANDARD_DEVIATION 1.74 • n=4 Participants	4.2 years STANDARD_DEVIATION 1.8 • n=27 Participants	3.9 years STANDARD_DEVIATION 1.74 • n=483 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	30 Participants n=4 Participants	11 Participants n=27 Participants	46 Participants n=483 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	36 Participants n=4 Participants	23 Participants n=27 Participants	66 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	22 Participants n=4 Participants	11 Participants n=27 Participants	34 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=93 Participants	42 Participants n=4 Participants	19 Participants n=27 Participants	72 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants	6 Participants n=483 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	14 Participants n=4 Participants	7 Participants n=27 Participants	21 Participants n=483 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=93 Participants	8 Participants n=4 Participants	1 Participants n=27 Participants	12 Participants n=483 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race/Ethnicity, Customized White	8 Participants n=93 Participants	40 Participants n=4 Participants	20 Participants n=27 Participants	68 Participants n=483 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	5 Participants n=483 Participants
Race/Ethnicity, Customized Other	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	6 Participants n=483 Participants
Region of Enrollment ARGENTINA	0 Participants n=93 Participants	5 Participants n=4 Participants	1 Participants n=27 Participants	6 Participants n=483 Participants
Region of Enrollment BELGIUM	0 Participants n=93 Participants	5 Participants n=4 Participants	4 Participants n=27 Participants	9 Participants n=483 Participants
Region of Enrollment BRAZIL	0 Participants n=93 Participants	7 Participants n=4 Participants	10 Participants n=27 Participants	17 Participants n=483 Participants
Region of Enrollment CANADA	0 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	6 Participants n=483 Participants
Region of Enrollment JAPAN	0 Participants n=93 Participants	8 Participants n=4 Participants	1 Participants n=27 Participants	9 Participants n=483 Participants
Region of Enrollment MALAYSIA	0 Participants n=93 Participants	5 Participants n=4 Participants	5 Participants n=27 Participants	10 Participants n=483 Participants
Region of Enrollment MEXICO	0 Participants n=93 Participants	6 Participants n=4 Participants	2 Participants n=27 Participants	8 Participants n=483 Participants
Region of Enrollment NETHERLANDS	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Region of Enrollment SPAIN	5 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	6 Participants n=483 Participants
Region of Enrollment UNITED STATES	7 Participants n=93 Participants	25 Participants n=4 Participants	8 Participants n=27 Participants	40 Participants n=483 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: 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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) n=64 Participants 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.	Aspirin (Part B) n=34 Participants Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic) Any thrombotic event	8.3 percentage of participants	1.6 percentage of participants	8.8 percentage of participants
Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic) Ischemic stroke	0 percentage of participants	0 percentage of participants	2.9 percentage of participants
Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic) Pulmonary embolism	0 percentage of participants	1.6 percentage of participants	0 percentage of participants
Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic) Venous thrombosis	8.3 percentage of participants	0 percentage of participants	5.9 percentage of participants
Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic) Arterial/intracardiac thrombosis	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic) Other thrombosis	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Day 1: 0.5-1.5 hours postdose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) n=60 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Plasma Concentration of Rivaroxaban at Day 1 (0.5-1.5 Hours Postdose)	46.69 micrograms per liter (mcg/L) Standard Deviation 39.4	92.86 micrograms per liter (mcg/L) Standard Deviation 72.6	—

PRIMARY outcome

Timeframe: Day 1: 1.5-4 hours postdose

Population: 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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) n=61 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Plasma Concentration of Rivaroxaban at Day 1 (1.5-4 Hours Postdose)	86.62 mcg/L Standard Deviation 43.1	103.61 mcg/L Standard Deviation 62.6	—

PRIMARY outcome

Timeframe: Day 4: Up to 3 hours predose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Plasma Concentration of Rivaroxaban at Day 4 (Up to 3 Hours Predose)	36.58 mcg/L Standard Deviation 37.4	—	—

PRIMARY outcome

Timeframe: Day 4: 0.5-1.5 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Plasma Concentration of Rivaroxaban at Day 4 (0.5-1.5 Hours Postdose)	107.58 mcg/L Standard Deviation 54.2	—	—

PRIMARY outcome

Timeframe: Day 4: 1.5-4 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Plasma Concentration of Rivaroxaban at Day 4 (1.5-4 Hours Postdose)	147.18 mcg/L Standard Deviation 116	—	—

PRIMARY outcome

Timeframe: Day 4: 6-8 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Plasma Concentration of Rivaroxaban at Day 4 (6-8 Hours Postdose)	66.81 mcg/L Standard Deviation 64.6	—	—

PRIMARY outcome

Timeframe: Month 3: Up to 3 hours predose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=10 Participants 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.	Rivaroxaban (Part B) n=52 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Plasma Concentration of Rivaroxaban at Month 3 (Up to 3 Hours Predose)	38.23 mcg/L Standard Deviation 25.7	29.41 mcg/L Standard Deviation 25.5	—

PRIMARY outcome

Timeframe: Month 3: 0.5-1.5 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=10 Participants 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.	Rivaroxaban (Part B) n=55 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Plasma Concentration of Rivaroxaban at Month 3 (0.5-1.5 Hours Postdose)	86.25 mcg/L Standard Deviation 32.0	94.12 mcg/L Standard Deviation 82.2	—

PRIMARY outcome

Timeframe: Month 3: 2.5-4 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=10 Participants 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.	Rivaroxaban (Part B) n=57 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Plasma Concentration of Rivaroxaban at Month 3 (2.5-4 Hours Postdose)	96.67 mcg/L Standard Deviation 58.4	102.99 mcg/L Standard Deviation 56.0	—

PRIMARY outcome

Timeframe: Up to 12 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) n=64 Participants 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.	Aspirin (Part B) n=34 Participants Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Percentage of Participants With Bleeding Events Any bleeding event	33.3 percentage of participants	35.9 percentage of participants	41.2 percentage of participants
Percentage of Participants With Bleeding Events Major Bleeding	0 percentage of participants	1.6 percentage of participants	0 percentage of participants
Percentage of Participants With Bleeding Events Clinically relevant non-major bleeding	8.3 percentage of participants	6.3 percentage of participants	8.8 percentage of participants
Percentage of Participants With Bleeding Events Trivial bleeding	25.0 percentage of participants	32.8 percentage of participants	35.3 percentage of participants

PRIMARY outcome

Timeframe: Day 1: 0.5-1.5 hours postdose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) n=56 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Absolute Prothrombin Time (PT) at Day 1 (0.5-1.5 Hours Postdose)	15.46 seconds Standard Deviation 1.90	18.02 seconds Standard Deviation 2.58	—

PRIMARY outcome

Timeframe: Day 1: 1.5-4 hours postdose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) n=55 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Absolute PT at Day 1 (1.5-4 Hours Postdose)	16.58 seconds Standard Deviation 1.84	18.76 seconds Standard Deviation 2.25	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Absolute PT at Day 4 (Up to 3 Hours Predose)	15.21 seconds Standard Deviation 1.54	—	—

PRIMARY outcome

Timeframe: Day 4: 0.5-1.5 hours postdose

Population: 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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Absolute PT at Day 4 (0.5-1.5 Hours Postdose)	17.95 seconds Standard Deviation 2.10	—	—

PRIMARY outcome

Timeframe: Day 4: 1.5-4 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Absolute PT at Day 4 (1.5-4 Hours Postdose)	18.73 seconds Standard Deviation 3.30	—	—

PRIMARY outcome

Timeframe: Day 4: 6-8 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Absolute PT at Day 4 (6-8 Hours Postdose)	16.13 seconds Standard Deviation 2.13	—	—

PRIMARY outcome

Timeframe: Month 3: Up to 3 hours predose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) n=56 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Absolute PT at Month 3 (Up to 3 Hours Predose)	17.59 seconds Standard Deviation 2.65	16.45 seconds Standard Deviation 2.27	—

PRIMARY outcome

Timeframe: Month 3: 0.5-1.5 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=8 Participants 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.	Rivaroxaban (Part B) n=48 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Absolute PT at Month 3 (0.5-1.5 Hours Postdose)	20.13 seconds Standard Deviation 3.55	18.89 seconds Standard Deviation 3.69	—

PRIMARY outcome

Timeframe: Month 3: 2.5-4 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=7 Participants 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.	Rivaroxaban (Part B) n=51 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Absolute PT at Month 3 (2.5-4 Hours Postdose)	19.14 seconds Standard Deviation 2.61	19.69 seconds Standard Deviation 2.81	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) n=56 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Activated Partial Thromboplastin Time (aPTT) at Day 1 (0.5-1.5 Hours Postdose)	31.4 seconds Standard Deviation 4.68	30.69 seconds Standard Deviation 8.23	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) n=55 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
aPTT at Day 1 (1.5-4 Hours Postdose)	32.83 seconds Standard Deviation 3.79	30.25 seconds Standard Deviation 3.80	—

PRIMARY outcome

Timeframe: Day 4: Up to 3 hours predose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
aPTT at Day 4 (Up to 3 Hours Predose)	33.08 seconds Standard Deviation 5.68	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
aPTT at Day 4 (0.5-1.5 Hours Postdose)	36.17 seconds Standard Deviation 6.99	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
aPTT at Day 4 (1.5-4 Hours Postdose)	37.58 seconds Standard Deviation 8.45	—	—

PRIMARY outcome

Timeframe: Day 4: 6-8 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
aPTT at Day 4 (6-8 Hours Postdose)	32.83 seconds Standard Deviation 5.94	—	—

PRIMARY outcome

Timeframe: Month 3: Up to 3 hours predose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) n=51 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
aPTT at Month 3 (Up to 3 Hours Predose)	25.36 seconds Standard Deviation 3.76	28.70 seconds Standard Deviation 3.76	—

PRIMARY outcome

Timeframe: Month 3: 0.5-1.5 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=8 Participants 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.	Rivaroxaban (Part B) n=48 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
aPTT at Month 3 (0.5-1.5 Hours Postdose)	26.60 seconds Standard Deviation 2.55	31.15 seconds Standard Deviation 4.17	—

PRIMARY outcome

Timeframe: Month 3: 2.5-4 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=7 Participants 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.	Rivaroxaban (Part B) n=51 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
aPTT at Month 3 (2.5-4 Hours Postdose)	26.74 seconds Standard Deviation 1.79	31.67 seconds Standard Deviation 3.58	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=6 Participants 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.	Rivaroxaban (Part B) n=43 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Anti-FXa at Day 1 (0.5-1.5 Hours Postdose)	66.93 mcg/L Standard Deviation 23.9	99.46 mcg/L Standard Deviation 60.6	—

PRIMARY outcome

Timeframe: Day 1: 1.5-4 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=11 Participants 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.	Rivaroxaban (Part B) n=52 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Anti-FXa at Day 1 (1.5-4 Hours Postdose)	74.06 mcg/L Standard Deviation 32.4	104.57 mcg/L Standard Deviation 55.5	—

PRIMARY outcome

Timeframe: Day 4: 6-8 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=11 Participants 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.	Rivaroxaban (Part B) Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \<8 kg participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg and; 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Anti-FXa at Day 4 (6-8 Hours Postdose)	74.21 mcg/L Standard Deviation 60.6	—	—

PRIMARY outcome

Timeframe: Month 3: Up to 3 hours predose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=3 Participants 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.	Rivaroxaban (Part B) n=17 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Anti-FXa at Month 3 (Up to 3 Hours Predose)	60.51 mcg/L Standard Deviation 29.4	53.41 mcg/L Standard Deviation 15.0	—

PRIMARY outcome

Timeframe: Month 3: 0.5-1.5 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \[mg/ml\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \[\<\] 8 kilograms \[kg\] participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg; and 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Rivaroxaban (Part B) n=37 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Anti-FXa at Month 3 (0.5-1.5 Hours Postdose)	—	110.90 mcg/L Standard Deviation 75.8	—

PRIMARY outcome

Timeframe: Month 3: 2.5-4 hours postdose

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \[mg/ml\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \[\<\] 8 kilograms \[kg\] participant received 2.2 mg; 8 to \<10 kg received 3.2 mg; 10 to \<12 kg received 3.4 mg; 12 to \<20 kg received 4.0 mg; and 20 to \<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.	Rivaroxaban (Part B) n=51 Participants 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.	Aspirin (Part B) Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Anti-FXa at Month 3 (2.5-4 Hours Postdose)	—	93.48 mcg/L Standard Deviation 50.3	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rivaroxaban (Part A) n=12 Participants 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.	Rivaroxaban (Part B) n=64 Participants 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.	Aspirin (Part B) n=34 Participants Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	91.7 percentage of participants	85.9 percentage of participants	85.3 percentage of participants

Adverse Events

Rivaroxaban (Part A)

Serious events: 6 serious events

Other events: 11 other events

Deaths: 0 deaths

Rivaroxaban (Part B)

Serious events: 19 serious events

Other events: 48 other events

Deaths: 0 deaths

Aspirin (Part B)

Serious events: 8 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

SR DIRECTOR

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Rivaroxaban (Part A) n=12 participants at risk 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.	Rivaroxaban (Part B) n=64 participants at risk 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.	Aspirin (Part B) n=34 participants at risk Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
Eye disorders Periorbital Oedema	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
General disorders Pyrexia	8.3% 1/12 • Up to 12 months 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.	0.00% 0/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
General disorders Swelling Face	0.00% 0/12 • Up to 12 months 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.	0.00% 0/64 • Up to 12 months 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.	2.9% 1/34 • Up to 12 months 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.
Infections and infestations Bronchitis	8.3% 1/12 • Up to 12 months 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.	0.00% 0/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
Infections and infestations Gastroenteritis Viral	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
Infections and infestations Influenza	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	2.9% 1/34 • Up to 12 months 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.
Infections and infestations Laryngitis	8.3% 1/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
Infections and infestations Pneumonia	8.3% 1/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	2.9% 1/34 • Up to 12 months 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.
Infections and infestations Stoma Site Cellulitis	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
Infections and infestations Vaccination Site Abscess	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
Infections and infestations Viral Infection	8.3% 1/12 • Up to 12 months 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.	0.00% 0/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/12 • Up to 12 months 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.	0.00% 0/64 • Up to 12 months 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.	2.9% 1/34 • Up to 12 months 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.
Infections and infestations Wound Abscess	0.00% 0/12 • Up to 12 months 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.	0.00% 0/64 • Up to 12 months 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.	2.9% 1/34 • Up to 12 months 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.
Injury, poisoning and procedural complications Stoma Site Pain	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
Investigations Investigation	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
Investigations Weight Decreased	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
Nervous system disorders Partial Seizures with Secondary Generalisation	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
Nervous system disorders Seizure	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	2.9% 1/34 • Up to 12 months 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.
Nervous system disorders Syncope	0.00% 0/12 • Up to 12 months 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.	0.00% 0/64 • Up to 12 months 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.	2.9% 1/34 • Up to 12 months 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.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/12 • Up to 12 months 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.	0.00% 0/64 • Up to 12 months 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.	2.9% 1/34 • Up to 12 months 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.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	16.7% 2/12 • Up to 12 months 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.	14.1% 9/64 • Up to 12 months 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.	5.9% 2/34 • Up to 12 months 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.
Vascular disorders Shock Haemorrhagic	0.00% 0/12 • Up to 12 months 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.	1.6% 1/64 • Up to 12 months 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.	0.00% 0/34 • Up to 12 months 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.