Apixaban for the Acute Treatment of Venous Thromboembolism in Children

Inclusion Criteria:

1. 3 months to <18 years of age with a minimum weight of 6 kg at the time of
randomization.

2. Presence of an index VTE which is confirmed by imaging.

3. Intention to manage the index VTE with anticoagulation treatment for at least 12
weeks.

Exclusion Criteria:

1. Anticoagulant treatment for the index VTE for greater than 7 days prior to
randomization.

2. Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index
VTE.

3. A mechanical heart valve.

4. Active bleeding or high risk of bleeding at the time of randomization.

5. Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to
randomization.

6. Abnormal baseline liver function at randomization.

7. Inadequate renal function at the time of randomization.

8. Platelet count <50×109 per L at randomization.

9. Uncontrolled severe hypertension at the time of randomization.

10. Use of prohibited concomitant medication at the time of randomization.

11. Female subjects who are either pregnant or breastfeeding a child.