Table 3. AUB rates in pediatric studies... | American Society of Hematology

Table 3.

AUB rates in pediatric studies of rivaroxaban for treatment of VTE

Reference (duration)	Study design/population	Study drug/comparator	Number of girls, ages 6-17 y*	Menorrhagia, n (%)
EINSTEIN-Jr phase II¹¹ (30 d)	Single-arm study of children with VTE initially treated with LMWH, VKA, or fondaparinux	Rivaroxaban (age and weight based, therapeutic dosing)	19	3 of 19 (15.8%)
EINSTEIN-Jr phase III¹² (3 mo)	Randomized (2:1), open-label, parallel group trial in children with acute VTE grouped by age	Rivaroxaban (age and weight based, therapeutic dosing)	121	23 of 121 (19.0%)
EINSTEIN-Jr phase III¹² (3 mo)		Standard anticoagulants (heparin, LMWH, and/or VKA)	70	5 of 70 (7.1%)

Reference (duration)	Study design/population	Study drug/comparator	Number of girls, ages 6-17 y*	Menorrhagia, n (%)
EINSTEIN-Jr phase II¹¹ (30 d)	Single-arm study of children with VTE initially treated with LMWH, VKA, or fondaparinux	Rivaroxaban (age and weight based, therapeutic dosing)	19	3 of 19 (15.8%)
EINSTEIN-Jr phase III¹² (3 mo)	Randomized (2:1), open-label, parallel group trial in children with acute VTE grouped by age	Rivaroxaban (age and weight based, therapeutic dosing)	121	23 of 121 (19.0%)
EINSTEIN-Jr phase III¹² (3 mo)		Standard anticoagulants (heparin, LMWH, and/or VKA)	70	5 of 70 (7.1%)

Only girls from 6- to 17-year-old age groups are reported here; younger girls are excluded because they would be premenarchal.

No uterine MB or CRNMB in pediatric studies occurred; all bleeding was menorrhagia classified as grade 1-2 (minor bleeding).