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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2015-002610-76
    Trial protocol
    		 BE   FR   ES   NL  
    Global end of trial date
    16 Jul 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jun 2021
    First version publication date
    31 Jan 2021
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    CR108075
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02846532
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, Raritan, United States,
    Public contact
    Clinical Registry group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Aug 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jul 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to characterize the single- and multiple-dose pharmacokinetic (PK) and PK/pharmacodynamic (PD) profiles after oral rivaroxaban therapy administered to pediatric subjects 2 to 8 years of age with single ventricle physiology who had 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 the same population as in Part A (Part B).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety evaluations included bleeding events, adverse events, adverse events of special interest (AESIs), clinical laboratory tests (hematology, serum chemistry etc.), other safety observations were performed throughout the study for all subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Brazil: 17
    Country: Number of subjects enrolled
    Canada: 6
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    Japan: 9
    Country: Number of subjects enrolled
    Mexico: 8
    Country: Number of subjects enrolled
    Malaysia: 10
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    United States: 40
    Worldwide total number of subjects
    112
    EEA total number of subjects
    16
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    112
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 112 subjects were enrolled in the study, out of which 12 were enrolled in Part A and 100 in Part B and 107 completed the study.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rivaroxaban (Part A)
    Arm description
    		 Subjects were enrolled to receive rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension as per subjects age and body weight adjusted dosing (target exposure to match that of rivaroxaban 10 mg given once daily in adults) with the regular twice daily regimen (morning and evening dosing), initially up to 12 Days. The single and multiple-dose rivaroxaban pharmacokinetics (PK), pharmacodynamics (PD), and initial safety and tolerability data available from each subject was assessed prior to continue 12 months of rivaroxaban therapy of Part A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rivaroxaban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Rivaroxaban was administered twice daily as a 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension (age- and body weight-adjusted dosing).

    Arm title
    		 Rivaroxaban (Part B)
    Arm description
    		 Subjects who were randomized to receive rivaroxaban as 0.1 % (1 mg/ml) oral suspension as per subjects age and body weight adjusted dosing (target exposure to match that of rivaroxaban 10 mg given once daily in adults) with the regular twice daily regimen (morning and evening dosing). The single and multiple-dose rivaroxaban PK, PD, safety and tolerability data available from each subject was assessed during 12 months of rivaroxaban therapy of Part B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rivaroxaban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Rivaroxaban was administered twice daily as a 0.1% (1 mg/ml) oral suspension (age- and body weight-adjusted dosing).

    Arm title
    		 Aspirin (Part B)
    Arm description
    		 Subjects who were randomized to receive Aspirin 5 milligram per kilogram (ml/kg) once daily up to 12 months.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Aspirin
    Investigational medicinal product code
    Other name
    Acetylsalicylic acid (ASA)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Aspirin was administered approximately as 5 milligram per kilogram (mg/kg) once daily dose up to 12 months.

    Number of subjects in period 1
    		Rivaroxaban (Part A) Rivaroxaban (Part B) Aspirin (Part B)
    Started
    12
    66
    34
    Completed
    11
    63
    33
    Not completed
    1
    3
    1
         Other
    1
    2
    -
         Lost to follow-up
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rivaroxaban (Part A)
    Reporting group description
    		 Subjects were enrolled to receive rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension as per subjects age and body weight adjusted dosing (target exposure to match that of rivaroxaban 10 mg given once daily in adults) with the regular twice daily regimen (morning and evening dosing), initially up to 12 Days. The single and multiple-dose rivaroxaban pharmacokinetics (PK), pharmacodynamics (PD), and initial safety and tolerability data available from each subject was assessed prior to continue 12 months of rivaroxaban therapy of Part A.

    Reporting group title
    Rivaroxaban (Part B)
    Reporting group description
    		 Subjects who were randomized to receive rivaroxaban as 0.1 % (1 mg/ml) oral suspension as per subjects age and body weight adjusted dosing (target exposure to match that of rivaroxaban 10 mg given once daily in adults) with the regular twice daily regimen (morning and evening dosing). The single and multiple-dose rivaroxaban PK, PD, safety and tolerability data available from each subject was assessed during 12 months of rivaroxaban therapy of Part B.

    Reporting group title
    Aspirin (Part B)
    Reporting group description
    		 Subjects who were randomized to receive Aspirin 5 milligram per kilogram (ml/kg) once daily up to 12 months.

    Reporting group values
    		 Rivaroxaban (Part A) Rivaroxaban (Part B) Aspirin (Part B) Total
    Number of subjects
    		 12 66 34 112
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 12 66 34 112
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65 to 84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 2.5 ± 0.67 4.1 ± 1.74 4.2 ± 1.8 -
    Title for Gender
    Units: subjects
        Female
    		 5 30 11 46
        Male
    		 7 36 23 66

    End points

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    End points reporting groups
    Reporting group title
    Rivaroxaban (Part A)
    Reporting group description
    		 Subjects were enrolled to receive rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension as per subjects age and body weight adjusted dosing (target exposure to match that of rivaroxaban 10 mg given once daily in adults) with the regular twice daily regimen (morning and evening dosing), initially up to 12 Days. The single and multiple-dose rivaroxaban pharmacokinetics (PK), pharmacodynamics (PD), and initial safety and tolerability data available from each subject was assessed prior to continue 12 months of rivaroxaban therapy of Part A.

    Reporting group title
    Rivaroxaban (Part B)
    Reporting group description
    		 Subjects who were randomized to receive rivaroxaban as 0.1 % (1 mg/ml) oral suspension as per subjects age and body weight adjusted dosing (target exposure to match that of rivaroxaban 10 mg given once daily in adults) with the regular twice daily regimen (morning and evening dosing). The single and multiple-dose rivaroxaban PK, PD, safety and tolerability data available from each subject was assessed during 12 months of rivaroxaban therapy of Part B.

    Reporting group title
    Aspirin (Part B)
    Reporting group description
    		 Subjects who were randomized to receive Aspirin 5 milligram per kilogram (ml/kg) once daily up to 12 months.

    Primary: Percentage of Subjects with any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic)

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    End point title
    		 Percentage of Subjects with any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic) [1]
    End point 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. Full Analysis Set included all subjects in Part A who receive at least 1 dose of study agent and all subjects in Part B who are randomized and receive at least 1 dose of study agent.
    End point type
    Primary
    End point timeframe
    Up to 12 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Rivaroxaban (Part A) Rivaroxaban (Part B) Aspirin (Part B)
    Number of subjects analysed
    12
    64
    34
    Units: percentage of subjects
    number (not applicable)
        Ischemic stroke
    0
    0
    2.9
        Pulmonary embolism
    0
    1.6
    0
        Venous thrombosis
    8.3
    0
    5.9
        Arterial/intracardiac thrombosis
    0
    0
    0
        Other thrombosis
    0
    0
    0
    No statistical analyses for this end point

    Primary: Plasma Concentration of Rivaroxaban

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    End point title
    		 Plasma Concentration of Rivaroxaban [2] [3]
    End point description
    The plasma rivaroxaban concentrations for Parts A and B were evaluated. PK Analysis Set: All subjects who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations were included in the descriptive PK analysis. Here ‘99999’ indicates that the data was not analyzed for specified timepoints of the Part B. Here, 'n' (number of subjects analyzed) signifies the number of subjects evaluable at a specified timepoint.
    End point type
    Primary
    End point timeframe
    Part A: up to 4 hours postdose (Day 1), Pre-dose, up to 8 hours postdose (Day 4), Pre-dose, up to 4 hours postdose (Month 3); Part B: up to 4 hours postdose (Day 1), Pre-dose, up to 4 hours postdose (Month 3)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The statistics were not planned for any of the baseline periods.
    End point values
    		 Rivaroxaban (Part A) Rivaroxaban (Part B)
    Number of subjects analysed
    12
    64
    Units: microgram per liter (ug/L)
    arithmetic mean (standard deviation)
        Day 1: 0.5 - 1.5 hours postdose (n=12,60)
    46.69 ± 39.4
    92.86 ± 72.6
        Day 1: 1.5 - 4 hours postdose (n=12,61)
    86.62 ± 43.1
    103.61 ± 62.6
        Day 4: Up to 3 hours pre-dose (n=12,0)
    36.58 ± 37.4
    99999 ± 99999
        Day 4: 0.5 - 1.5 hours postdose (n=12,0)
    107.58 ± 54.2
    99999 ± 99999
        Day 4: 1.5 - 4 hours postdose (n=12,0)
    147.18 ± 116
    99999 ± 99999
        Day 4: 6 - 8 hours postdose (n=12,0)
    66.81 ± 64.6
    99999 ± 99999
        Month 3: Up to 3 hours pre-dose (n=10,52)
    38.23 ± 25.7
    29.41 ± 25.5
        Month 3: 0.5 - 1.5 hours postdose (n=10,55)
    86.25 ± 32.0
    94.12 ± 82.2
        Month 3: 2.5 - 4 hours postdose (n=10,57)
    96.67 ± 58.4
    102.99 ± 56.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Bleeding Events

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    End point title
    		 Percentage of Subjects with Bleeding Events
    End point 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. Safety analysis set.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Rivaroxaban (Part A) Rivaroxaban (Part B) Aspirin (Part B)
    Number of subjects analysed
    12
    64
    34
    Units: percentage of subjects
    number (not applicable)
        Major Bleeding
    0
    1.6
    0
        Clinically relevant non-major bleeding
    8.3
    6.3
    8.8
        Trivial bleeding
    25.0
    32.8
    35.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment-emergent Adverse Event (TEAE)

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    End point title
    		 Percentage of Subjects with Treatment-emergent Adverse Event (TEAE)
    End point 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 subject 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. Safety Analysis Set: all subjects in Part A who receive at least 1 dose of study agent and all subjects in Part B who are randomized and receive at least 1 dose of study agent.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Rivaroxaban (Part A) Rivaroxaban (Part B) Aspirin (Part B)
    Number of subjects analysed
    12
    64
    34
    Units: percentage of subjects
        number (not applicable)
    91.7
    85.9
    85.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 14 months
    Adverse event reporting additional description
    The safety population consisted of all subjects in Part A who received at least 1 dose of study drug and all subjects in Part B who were randomized and received at least 1 dose of study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Rivaroxaban (Part A)
    Reporting group description
    		 Subjects were randomized to receive rivaroxaban as 0.1 percent (%) (1 milligram per milliliter [mg/ml]) oral suspension as per subjects age and body weight adjusted dosing (which is equivalent dose to 10 mg once daily in adults) with the regular twice daily regimen (morning and evening dosing), initially up to 12 Days. The single and multiple-dose rivaroxaban pharmacokinetics (PK), pharmacodynamics (PD), and initial safety and tolerability data available from each subject was assessed prior to continue 12 months of rivaroxaban therapy of Part A.

    Reporting group title
    Rivaroxaban (Part B)
    Reporting group description
    		 Subjects were randomized to receive rivaroxaban as 0.1 % (1 mg/ml) oral suspension as per subjects age and body weight adjusted dosing (which is equivalent dose to 10 mg once daily in adults) with the regular twice daily regimen (morning and evening dosing). The single and multiple-dose rivaroxaban PK, PD, safety and tolerability data available from each subject was assessed during 12 months of rivaroxaban therapy of Part B.

    Reporting group title
    Aspirin (Part B)
    Reporting group description
    		 Subjects were randomized to receive Aspirin 5 milligram per kilogram (mg/kg) once daily up to 12 months.

    Serious adverse events
    		 Rivaroxaban (Part A) Rivaroxaban (Part B) Aspirin (Part B)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 12 (50.00%)
    18 / 64 (28.13%)
    8 / 34 (23.53%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Investigation
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight Decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Stoma Site Pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Shock Haemorrhagic
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Failure Congestive
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Partial Seizures with Secondary Generalisation
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 64 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Swelling Face
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 64 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Periorbital Oedema
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 64 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chylothorax
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    2 / 12 (16.67%)
    9 / 64 (14.06%)
    2 / 34 (5.88%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 64 (1.56%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stoma Site Cellulitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vaccination Site Abscess
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 64 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound Abscess
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 64 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Rivaroxaban (Part A) Rivaroxaban (Part B) Aspirin (Part B)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 12 (91.67%)
    55 / 64 (85.94%)
    29 / 34 (85.29%)
    Injury, poisoning and procedural complications
    Arthropod Bite
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 64 (3.13%)
    1 / 34 (2.94%)
         occurrences all number
    1
    2
    1
    Fall
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 64 (3.13%)
    5 / 34 (14.71%)
         occurrences all number
    0
    2
    8
    Injury
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Ligament Sprain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Skin Abrasion
         subjects affected / exposed
    0 / 12 (0.00%)
    4 / 64 (6.25%)
    1 / 34 (2.94%)
         occurrences all number
    0
    14
    1
    Skin Laceration
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    1
    0
    2
    Traumatic Haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 64 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    2
    Wound Haemorrhage
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    2 / 12 (16.67%)
    2 / 64 (3.13%)
    1 / 34 (2.94%)
         occurrences all number
    2
    2
    1
    Blood and lymphatic system disorders
    Increased Tendency to Bruise
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 12 (0.00%)
    16 / 64 (25.00%)
    7 / 34 (20.59%)
         occurrences all number
    0
    35
    15
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 64 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    2
    Diarrhoea
         subjects affected / exposed
    2 / 12 (16.67%)
    3 / 64 (4.69%)
    2 / 34 (5.88%)
         occurrences all number
    2
    5
    2
    Gingival Bleeding
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 64 (3.13%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    0
    Tooth Loss
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    3 / 12 (25.00%)
    10 / 64 (15.63%)
    3 / 34 (8.82%)
         occurrences all number
    5
    20
    3
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences all number
    5
    1
    0
    Chylothorax
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    Cough
         subjects affected / exposed
    0 / 12 (0.00%)
    12 / 64 (18.75%)
    4 / 34 (11.76%)
         occurrences all number
    0
    15
    4
    Epistaxis
         subjects affected / exposed
    0 / 12 (0.00%)
    6 / 64 (9.38%)
    3 / 34 (8.82%)
         occurrences all number
    0
    21
    4
    Pleural Effusion
         subjects affected / exposed
    1 / 12 (8.33%)
    4 / 64 (6.25%)
    0 / 34 (0.00%)
         occurrences all number
    1
    6
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 64 (4.69%)
    2 / 34 (5.88%)
         occurrences all number
    0
    4
    2
    Skin and subcutaneous tissue disorders
    Dermatitis Diaper
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    0
    Ecchymosis
         subjects affected / exposed
    0 / 12 (0.00%)
    6 / 64 (9.38%)
    5 / 34 (14.71%)
         occurrences all number
    0
    44
    25
    Rash
         subjects affected / exposed
    2 / 12 (16.67%)
    4 / 64 (6.25%)
    2 / 34 (5.88%)
         occurrences all number
    2
    6
    2
    Urticaria
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    2 / 34 (5.88%)
         occurrences all number
    0
    1
    4
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal Stiffness
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in Extremity
         subjects affected / exposed
    0 / 12 (0.00%)
    4 / 64 (6.25%)
    0 / 34 (0.00%)
         occurrences all number
    0
    4
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 12 (16.67%)
    3 / 64 (4.69%)
    0 / 34 (0.00%)
         occurrences all number
    3
    3
    0
    Cellulitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Ear Infection
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 64 (4.69%)
    2 / 34 (5.88%)
         occurrences all number
    0
    3
    3
    Gastroenteritis
         subjects affected / exposed
    0 / 12 (0.00%)
    5 / 64 (7.81%)
    0 / 34 (0.00%)
         occurrences all number
    0
    7
    0
    Gastroenteritis Viral
         subjects affected / exposed
    1 / 12 (8.33%)
    3 / 64 (4.69%)
    1 / 34 (2.94%)
         occurrences all number
    1
    3
    2
    Influenza
         subjects affected / exposed
    0 / 12 (0.00%)
    4 / 64 (6.25%)
    1 / 34 (2.94%)
         occurrences all number
    0
    4
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    14 / 64 (21.88%)
    6 / 34 (17.65%)
         occurrences all number
    1
    27
    19
    Otitis Media
         subjects affected / exposed
    0 / 12 (0.00%)
    4 / 64 (6.25%)
    3 / 34 (8.82%)
         occurrences all number
    0
    7
    4
    Pharyngitis
         subjects affected / exposed
    0 / 12 (0.00%)
    5 / 64 (7.81%)
    1 / 34 (2.94%)
         occurrences all number
    0
    7
    1
    Pharyngitis Streptococcal
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    0
    1
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 64 (3.13%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    3
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 64 (3.13%)
    2 / 34 (5.88%)
         occurrences all number
    1
    4
    3
    Rhinitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 64 (1.56%)
    2 / 34 (5.88%)
         occurrences all number
    0
    1
    2
    Sinusitis
         subjects affected / exposed
    0 / 12 (0.00%)
    5 / 64 (7.81%)
    2 / 34 (5.88%)
         occurrences all number
    0
    9
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 12 (16.67%)
    9 / 64 (14.06%)
    5 / 34 (14.71%)
         occurrences all number
    4
    17
    6
    Urinary Tract Infection
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 64 (1.56%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    Viral Infection
         subjects affected / exposed
    2 / 12 (16.67%)
    2 / 64 (3.13%)
    1 / 34 (2.94%)
         occurrences all number
    6
    3
    2
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 12 (25.00%)
    0 / 64 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    3
    0
    6
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 64 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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