Efficacy and safety analysis in the obese subgroup
| . | No. of events (%) [95% CI] . | RR (95% CI) . | P value . | |
|---|---|---|---|---|
| Apixaban (n = 42) . | SOC (n = 40) . | |||
| Primary efficacy end point: composite of DVT, PE, CSVT, and VTE-related death | 1 (2.38) [0.00-13.44] | 10 (25.00) [14.02-40.26] | 0.09 (0.01-0.97) | .007 |
| DVT | ||||
| Nonfatal clinically unsuspected | 1 | 9 | ||
| Nonfatal symptomatic | ||||
| PE | 0 | 0 | ||
| CSVT | 0 | 1 | ||
| VTE | 0 | 0 | ||
| Primary safety end point: major bleeding | 1 (2.38) [0.00-13.44] | 2 (5.00) [0.50-17.39] | NE | .53 |
| Secondary safety endpoint: composite of major and CRNM bleeding | 3 (7.14) [1.77-19.70] | 2 (5.00) [0.50-17.39] | NE | .69 |
| . | No. of events (%) [95% CI] . | RR (95% CI) . | P value . | |
|---|---|---|---|---|
| Apixaban (n = 42) . | SOC (n = 40) . | |||
| Primary efficacy end point: composite of DVT, PE, CSVT, and VTE-related death | 1 (2.38) [0.00-13.44] | 10 (25.00) [14.02-40.26] | 0.09 (0.01-0.97) | .007 |
| DVT | ||||
| Nonfatal clinically unsuspected | 1 | 9 | ||
| Nonfatal symptomatic | ||||
| PE | 0 | 0 | ||
| CSVT | 0 | 1 | ||
| VTE | 0 | 0 | ||
| Primary safety end point: major bleeding | 1 (2.38) [0.00-13.44] | 2 (5.00) [0.50-17.39] | NE | .53 |
| Secondary safety endpoint: composite of major and CRNM bleeding | 3 (7.14) [1.77-19.70] | 2 (5.00) [0.50-17.39] | NE | .69 |
CI for single-event rates is constructed based on the Agresti-Coull method.
P value is nominal.
95% CIs for the ratio of event rates are computed based on the Mantel-Haenszel method stratified by age (<10 years, ≥10 to <18 years), sex (male, female), and subtype (T-cell, B-cell precursor, or other). Major bleeding: as defined by the ISTH for pediatric clinical trials in VTE (1) fatal bleeding; (2) clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (ie, 2 g/dL) in 24 hours; (3) bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the central nervous system; and/or (4) bleeding that requires surgical intervention in an operating suite, including interventional radiology. CRNM bleeding was defined as (1) overt bleeding for which blood product is administered and not directly attributable to the patient’s underlying medical condition and/or (2) bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room.
CSVT, cerebral sinus venous thrombosis; DVT, deep vein thrombosis; ISTH, International Society on Thrombosis and Haemostasis; NE, not estimable; PE, pulmonary embolism.