Apixaban for the Acute Treatment of Venous Thromboembolis... | NCT02464969

ID	Type	Description	Link
2014-002606-20	EudraCT Number
CV185-325	Other Identifier	Alias Study Number

Status Module

Name	Class
Pfizer	INDUSTRY

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Apixaban	Experimental	Subjects between birth to <18 years will be dosed on a body weight tiered regimen. Subjects ≥35kg will receive 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg will receive 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg will receive 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg will receive 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg will receive 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg will receive 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg will receive 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg will receive 0.6mg twice daily for 7 days and 0.3mg BID thereafter;PK cohort neonates ≥ 2.6kg will receive 0.1mg BID. Dose will be adjusted as determined by PK measurements (ie, to 0.2mg BID, 0.1mg daily or dose will stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis,subjects will receive 0.2mg BID for 7 days and 0.1mg BID thereafter.	Drug: Apixaban Drug: Standard of Care

Name	Type	Description	Arm Group Labels	Other Names
Apixaban	Drug	Tablet or Solution	Apixaban
Standard of Care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Composite of Major and Clinically Relevant Non-Major (CRNM) Bleeding	Bleeding definitions are based on the Perinatal and Paediatric Haemostasis Subcommittee of the International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding includes: (i) fatal bleeding; (ii) clinically overt bleeding with a decrease in Hgb of at least 20 g/L (2 g/dL) in 24 hours; (iii) retroperitoneal, pulmonary, intracranial, or central nervous system bleeding; and (iv) bleeding requiring surgical intervention in an operating suite (including interventional radiology). Clinically relevant non-major bleeding includes: (i) overt bleeding requiring a blood product not attributable to the participant's underlying condition; and (ii) bleeding requiring medical or surgical intervention to restore hemostasis, other than in an operating suite.	From first dose (Day 1) up to 114 days
Percentage of Participants With Symptomatic and Asymptomatic Recurrent Venous Thromboembolism (VTE) and VTE-Related Mortality	Recurrent VTE, defined as either contiguous progression or non-contiguous new thrombus and including, but not limited to deep vein thrombosis (DVT), pulmonary embolism (PE) and paradoxical embolism. 95% CI was from the Agresti-Coull method.	From first dose (Day 1) up to 114 days

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Died	Death due to any cause was assessed. 95% CI was calculated using the Agresti-Coull method.	From first dose (Day 1) up to 114 days
Percentage of Participants With Venous Thromboembolism (VTE)-Related Mortality

Eligibility Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Cardiology Clinic		Birmingham	Alabama	35233	United States
University of Alabama

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42392108	Derived	Brandao LR, Driscoll J, Newburger JW, Holzhauer S, Ahuja S, Rubio AE, Gaitonde P, Robertson A, Polinsky M, Revkin JH, Masiukiewicz U, O'Brien SH, Mitchell LG; Pediatric Apixaban VTE Study Investigators. Apixaban for the treatment of venous thromboembolic events in paediatric patients: an open-label, multicentre, randomised, controlled descriptive trial. Lancet Haematol. 2026 Jul;13(7):e471-e483. doi: 10.1016/S2352-3026(26)00107-9.

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Participants Receiving Apixaban	Participants between birth to <18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 28, 2022

Arm/Group Information

ID	Title	Description
BG000	Participants Receiving Apixaban	Participants between birth to <18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.
BG001	Participants Treated With Standard of Care	Participants were treated with unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For participants under 2 years of age, standard of care was limited to unfractionated heparin or low molecular weight heparin.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00011.10± 6.51 BG00111.68± 6.02 BG00211.29± 6.35

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00085 BG00143 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00012 BG00113 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000120 BG00155 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Composite of Major and Clinically Relevant Non-Major (CRNM) Bleeding

Bleeding definitions are based on the Perinatal and Paediatric Haemostasis Subcommittee of the International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding includes: (i) fatal bleeding; (ii) clinically overt bleeding with a decrease in Hgb of at least 20 g/L (2 g/dL) in 24 hours; (iii) retroperitoneal, pulmonary, intracranial, or central nervous system bleeding; and (iv) bleeding requiring surgical intervention in an operating suite (including interventional radiology). Clinically relevant non-major bleeding includes: (i) overt bleeding requiring a blood product not attributable to the participant's underlying condition; and (ii) bleeding requiring medical or surgical intervention to restore hemostasis, other than in an operating suite.

The safety data set (as-treated) consist of all randomized participants who received at least one dose of study drug. 95% CI was calculated using the Agresti-Coull method.

Posted

Number

95% Confidence Interval

percentage of participants

From first dose (Day 1) up to 114 days

ID	Title	Description
OG000	Participants Receiving Apixaban	Participants between birth to <18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.
OG001	Participants Treated With Standard of Care	Participants were treated with unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For participants under 2 years of age, standard of care was limited to unfractionated heparin or low molecular weight heparin.

Units	Counts
Participants	OG000152 OG00173

Title

Denominators

Categories

Title	Measurements
	OG0001.3(0.1 to 5.0) OG0011.4(0.0 to 8.1)

Primary

Percentage of Participants With Symptomatic and Asymptomatic Recurrent Venous Thromboembolism (VTE) and VTE-Related Mortality

Recurrent VTE, defined as either contiguous progression or non-contiguous new thrombus and including, but not limited to deep vein thrombosis (DVT), pulmonary embolism (PE) and paradoxical embolism. 95% CI was from the Agresti-Coull method.

The Full Analysis Set contains all randomized participants and also those assigned to apixaban post-protocol amendment 8.

Posted

Number

95% Confidence Interval

percentage of participants

From first dose (Day 1) up to 114 days

ID	Title	Description
OG000	Participants Receiving Apixaban	Participants between birth to <18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.

Secondary

Percentage of Participants Who Died

Death due to any cause was assessed. 95% CI was calculated using the Agresti-Coull method.

The Full Analysis Set contains all randomized participants and also those assigned to apixaban post-PA8.

Posted

Number

95% Confidence Interval

percentage of participants

From first dose (Day 1) up to 114 days

ID	Title	Description
OG000	Participants Receiving Apixaban	Participants between birth to <18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.
OG001	Participants Treated With Standard of Care	Participants were treated with unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For participants under 2 years of age, standard of care was limited to unfractionated heparin or low molecular weight heparin.

Secondary

Percentage of Participants With Venous Thromboembolism (VTE)-Related Mortality

Participants were assessed for death due to Venous Thromboembolism (VTE).

The Full Analysis Set contains all randomized participants and also those assigned to apixaban post-PA8.

Posted

Number

percentage of participants

From first dose (Day 1) up to 114 days

ID	Title	Description
OG000	Participants Receiving Apixaban	Participants between birth to <18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.
OG001	Participants Treated With Standard of Care	Participants were treated with unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For participants under 2 years of age, standard of care was limited to unfractionated heparin or low molecular weight heparin.

Secondary

Number of Participants With Index Venous Thromboembolism (VTE) Status

Index VTE status was defined as the last image obtained during the Main treatment phase for each participant's comparison to baseline imaging. Index VTE status was classified as Recurrence-contiguous; Recurrence-new; Unchanged; Regression; Resolution; Indeterminate/Nondiagnostic. Participants could have multiple concomitant index events. Regression was defined as (ie, unequivocal decrease [>50%] of the total volume/mass of the thrombus compared to the index event)

The Full Analysis Set contains all randomized participants and also those assigned to apixaban post-PA8. Excluding participants with a negative or Non-Diagnostic Index Event

Posted

Count of Participants

Participants

From first dose (Day 1) up to 91 days

ID	Title	Description
OG000	Participants Receiving Apixaban	Participants between birth to <18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.

Secondary

Percentage of Participants With Stroke

Participants were assessed for incidence of stroke.

The Full Analysis Set contains all randomized participants and also those assigned to apixaban post-PA8.

Posted

Number

percentage of participants

From first dose (Day 1) up to 114 days

ID	Title	Description
OG000	Participants Receiving Apixaban	Participants between birth to <18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.
OG001	Participants Treated With Standard of Care	Participants were treated with unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For participants under 2 years of age, standard of care was limited to unfractionated heparin or low molecular weight heparin.

Secondary

Percentage of Participants With Symptomatic and Asymptomatic Recurrent Venous Thromboembolism (VTE)

The Full Analysis Set contains all randomized participants and also those assigned to apixaban post-protocol amendment 8.

Posted

Number

95% Confidence Interval

percentage of participants

From first dose (Day 1) up to 114 days

ID	Title	Description
OG000	Participants Receiving Apixaban	Participants between birth to <18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.

Secondary

Number of Participants With New Symptomatic or Asymptomatic Deep Vein Thrombosis (DVT) and New Symptomatic or Asymptomatic Pulmonary Embolism (PE)

Participants were assessed for incidence of Symptomatic or Asymptomatic Deep Vein Thrombosis (DVT) and New Symptomatic or Asymptomatic Pulmonary Embolism (PE).

The Full Analysis Set contains all randomized participants and also those assigned to apixaban post-PA8.

Posted

Count of Participants

Participants

From first dose (Day 1) up to 114 days

ID	Title	Description
OG000	Participants Receiving Apixaban	Participants between birth to <18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.
OG001	Participants Treated With Standard of Care

Secondary

Percentage of Participants With Other Symptomatic and Asymptomatic Venous Thromboembolism (VTE)

Other VTE included events such as cerebral sinovenous thrombosis, renal vein thrombosis, portal vein thrombosis, catheter-related VTE, and splanchnic thrombosis. If VTE event type was blank, it was included in the Other VTE. 95% CI was from the Agresti-Coull method.

The Full Analysis Set contains all randomized participants and also those assigned to apixaban post-protocol amendment 8.

Posted

Number

95% Confidence Interval

percentage of participants

From first dose (Day 1) up to 114 days

ID	Title	Description
OG000	Participants Receiving Apixaban	Participants between birth to <18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.

Secondary

Number of Participants With Clinically Relevant Non-Major (CRNM) Bleeding, Major Bleeding and Minor Bleeding

The safety data set (as-treated) consist of all randomized participants who received at least one dose of study drug.

Posted

Count of Participants

Participants

From first dose (Day 1) up to 114 days

ID	Title	Description
OG000	Participants Receiving Apixaban	Participants between birth to <18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.

Secondary

Blood Concentration of Apixaban (ng/mL)

Blood samples were collected to assess the apixaban concentration at specified timepoints. Day 1 PK concentrations were only collected for participants in the Birth to ≤27 days arm. The lower limit of quantification (LLOQ) is 1.0 ng/mL for plasma samples, and 0.5 ng/mL for dried blood samples.

The PK analysis population is defined as all participants randomized to and treated with apixaban who have at least 1 concentration of apixaban. Participants with sample size of quantifiable values (≥ LLOQ) at the specified timepoints were analyzed.

Posted

Mean

Standard Deviation

nanogram per millilitre (ng/mL)

3 hour (H), 12 H, 24 H at Day 3; pre and post dose at Day 14 and Day 42

ID	Title	Description
OG000	Participants Between Age 12 to < 18 Years	Participants between age 12 to < 18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter.
OG001	Participants Between Age 2 - < 12 Years

Secondary

Concentration of Plasma Anti-Factor Xa (ng/mL)

Blood samples were collected to assess the Anti-Factor Xa concentration at specified timepoints. Day 1 PK concentrations were only collected for participants in the Birth to ≤27 days arm. The lower limit of quantification (LLOQ) is 35.0 ng/mL.

Posted

Mean

Standard Deviation

nanogram per millilitre (ng/mL)

Pre and post dose at Day 14 and Day 42

ID	Title	Description
OG000	Participants Between Age 12 to < 18 Years	Participants between age 12 to < 18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter.
OG001	Participants Between Age 2 - < 12 Years	Participants between age 2 - < 12 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Participants Receiving Apixaban	Participants between birth to <18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.	2	155	40	152	132	152
EG001	Participants Treated With Standard of Care	Participants were treated with unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For participants under 2 years of age, standard of care was limited to unfractionated heparin or low molecular weight heparin.	1	74	17	73	59	73

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cold type haemolytic anaemia	Blood and lymphatic system disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v26.1	Non-systematic Assessment	EG0003 affected152 at risk EG0012 affected73 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Sickle cell anaemia with crisis	Blood and lymphatic system disorders	MedDRA v26.1	Non-systematic Assessment	EG0002 affected152 at risk EG0010 affected73 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Cardiac arrest	Cardiac disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Cardiogenic shock	Cardiac disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Eye movement disorder	Eye disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Colitis	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Constipation	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Haematemesis	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Haematochezia	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0002 affected152 at risk EG0010 affected73 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Stomatitis	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Chest pain	General disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Death	General disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Mucosal inflammation	General disorders	MedDRA v26.1	Non-systematic Assessment	EG0002 affected152 at risk EG0010 affected73 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Non-cardiac chest pain	General disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0011 affected73 at risk
Peripheral swelling	General disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Pyrexia	General disorders	MedDRA v26.1	Non-systematic Assessment	EG0004 affected152 at risk EG0011 affected73 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Transplant rejection	Immune system disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Atypical pneumonia	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Cellulitis	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Device related bacteraemia	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Escherichia pyelonephritis	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Infective pulmonary exacerbation of cystic fibrosis	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Meningitis bacterial	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Mycoplasma infection	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Osteomyelitis	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Pneumonia viral	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Pyomyositis	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Rhinovirus infection	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Sepsis	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Toxic shock syndrome	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Varicella	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Shunt thrombosis	Injury, poisoning and procedural complications	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Suture rupture	Injury, poisoning and procedural complications	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Alanine aminotransferase increased	Investigations	MedDRA v26.1	Non-systematic Assessment	EG0003 affected152 at risk EG0010 affected73 at risk
Blood urea increased	Investigations	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Medical observation	Investigations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Weight increased	Investigations	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Connective tissue disorder	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Cytarabine syndrome	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Embryonal rhabdomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Cerebral venous sinus thrombosis	Nervous system disorders	MedDRA v26.1	Non-systematic Assessment	EG0002 affected152 at risk EG0010 affected73 at risk
Complex regional pain syndrome	Nervous system disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Headache	Nervous system disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Seizure	Nervous system disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Thoracic outlet syndrome	Nervous system disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Device malfunction	Product Issues	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Depression	Psychiatric disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Munchausen's syndrome	Psychiatric disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Selective eating disorder	Psychiatric disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Polyuria	Renal and urinary disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Heavy menstrual bleeding	Reproductive system and breast disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Acute chest syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0011 affected73 at risk
Axillary vein thrombosis	Vascular disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Post thrombotic syndrome	Vascular disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk
Superficial vein thrombosis	Vascular disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG0010 affected73 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v26.1	Non-systematic Assessment	EG0005 affected152 at risk EG0018 affected73 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v26.1	Non-systematic Assessment	EG0003 affected152 at risk EG0014 affected73 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v26.1	Non-systematic Assessment	EG0005 affected152 at risk EG0014 affected73 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0014 affected73 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG00011 affected152 at risk EG0015 affected73 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0008 affected152 at risk EG0014 affected73 at risk
Constipation	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG00010 affected152 at risk EG0013 affected73 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG00015 affected152 at risk EG0016 affected73 at risk
Nausea	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG00012 affected152 at risk EG0015 affected73 at risk
Vomiting	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG00022 affected152 at risk EG0014 affected73 at risk
Fatigue	General disorders	MedDRA v26.1	Non-systematic Assessment	EG0005 affected152 at risk EG0014 affected73 at risk
Injection site bruising	General disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 affected152 at risk EG00112 affected73 at risk
Injection site haemorrhage	General disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 affected152 at risk EG0014 affected73 at risk
Non-cardiac chest pain	General disorders	MedDRA v26.1	Non-systematic Assessment	EG00012 affected152 at risk EG0015 affected73 at risk
Pyrexia	General disorders	MedDRA v26.1	Non-systematic Assessment	EG00011 affected152 at risk EG0017 affected73 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v26.1	Non-systematic Assessment	EG00011 affected152 at risk EG0012 affected73 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA v26.1	Non-systematic Assessment	EG00014 affected152 at risk EG00110 affected73 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v26.1	Non-systematic Assessment	EG0003 affected152 at risk EG0014 affected73 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Non-systematic Assessment	EG00011 affected152 at risk EG0013 affected73 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Non-systematic Assessment	EG0008 affected152 at risk EG0012 affected73 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Non-systematic Assessment	EG00015 affected152 at risk EG0016 affected73 at risk
Headache	Nervous system disorders	MedDRA v26.1	Non-systematic Assessment	EG00027 affected152 at risk EG00110 affected73 at risk
Heavy menstrual bleeding	Reproductive system and breast disorders	MedDRA v26.1	Non-systematic Assessment	EG00016 affected152 at risk EG0013 affected73 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Non-systematic Assessment	EG00012 affected152 at risk EG0011 affected73 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0009 affected152 at risk EG0016 affected73 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Non-systematic Assessment	EG00027 affected152 at risk EG00114 affected73 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Non-systematic Assessment	EG00010 affected152 at risk EG0012 affected73 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0009 affected152 at risk EG0016 affected73 at risk

Participants between age 2 - < 12 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter.

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

ID	Term
D054556	Venous Thromboembolism
D013923	Thromboembolism
D013927	Thrombosis
D004617	Embolism