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Abstract Page 1 Line 15 to 17 | The composite of symptomatic venous thromboembolic events or asymptomatic deterioration occurred in 1 (1.4 %) rivaroxaban patient and in 1 (5.3 %) UFH/warfarin patient (absolute risk difference, 3.9 % [95 % confidence interval, -3.4–23.8]). | The composite of symptomatic venous thromboembolic events or asymptomatic deterioration occurred in 1 (1.3 %) rivaroxaban patient and in 1 (5.3 %) UFH/warfarin patient (absolute risk reduction, 4.0 % [95 % confidence interval, -2.9-24.0]). |
Method Right side Page 3 Line 23 to 25 | Crude percentages and absolute differences and their 95 % confidence intervals were calculated. | Crude percentages and absolute reduction and their 95 % confidence intervals were calculated. |
Result Left side Page 5 Line 2 to 4 | A single patient in the rivaroxaban group (1/78; 1.4 %) developed symptomatic recurrent VTE compared with none of the 19 patients allocated to control treatment. | A single patient in the rivaroxaban group (1/78; 1.3 %) developed symptomatic recurrent VTE compared with none of the 19 patients allocated to control treatment. |
Result Left side Page 5 Line 9 to 12 | VTE and asymptomatic deterioration at the end of intended treatment occurred in 1 (1.4 %) rivaroxaban patient and in 1 (5.3 %) control patient, with an absolute risk difference of 3.9 % (95 % confidence interval −3.4 to 23.8). | VTE and asymptomatic deterioration at the end of intended treatment occurred in 1 (1.3 %) rivaroxaban patient and in 1 (5.3 %) control patient, with an absolute risk reduction of 4.0 % (95 % confidence interval −2.9 to 24.0) compared to control. |
Result Right side Page 5 Line 5 to 8 | At day 22, the combined venous ultrasound and lung imaging result in patients with DVT and/or PE showed normalization in 20 (26.7 %) of the 75 rivaroxaban recipients and in 3 (15.8 %) of the 19 control patients. | At day 22, the combined venous ultrasound and lung imaging result in evaluable patients with DVT and/or PE showed normalization in 20 (26.7 %) of the 75 rivaroxaban recipients and in 3 (15.8 %) of the 19 control patients. |
Result Page 5 Table 2 Footnote | bid, twice daily, DVT, deep vein thrombosis; od, once daily; PE, pulmonary embolism; UFH, unfractionated heparin; VTE, venous thromboembolism. *Symptomatic recurrent VTE during first 22 days. | bid, twice daily, DVT, deep vein thrombosis; od, once daily; PE, pulmonary embolism; UFH, unfractionated heparin; VTE, venous thromboembolism.
Patients assessed as "not evaluable" were excluded from these analyses. *Symptomatic recurrent VTE during first 22 days. |
Result Page 6, Table 3 Line 21 | 2 (2.9) | 2 (2.8) |
Result Page 6 Table 3 Footnote | bid, twice daily, DVT, deep vein thrombosis; od, once daily; PE, pulmonary embolism; UFH, unfractionated heparin; VTE, venous thromboembolism. *Symptomatic recurrent VTE during the entire intended treatment period. | bid, twice daily, DVT, deep vein thrombosis; od, once daily; PE, pulmonary embolism; UFH, unfractionated heparin; VTE, venous thromboembolism.
Patients assessed as "not evaluable" were excluded from these analyses. *Symptomatic recurrent VTE during the entire intended treatment period. |
Discussion Page 6 Left side Line 9 to 12 | The lower limit of the confidence interval (i.e. –3.4 %) around the absolute difference in the composite efficacy outcome suggests that an important deterioration in treatment effect can be excluded for rivaroxaban. | The lower limit of the confidence interval (i.e. –2.9 %) around the absolute reduction in the composite efficacy outcome suggests that an important deterioration in treatment effect can be excluded for rivaroxaban. |
Open Access 01.12.2016 | Erratum
Erratum to: ‘Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism – the J-EINSTEIN DVT and PE program’
Erschienen in: Thrombosis Journal | Ausgabe 1/2016