Table 3. Bleeding and Adverse Eventsa.
| Outcome | No. (%) of Patients | |||||||
|---|---|---|---|---|---|---|---|---|
| Postoperative Osocimab, mg/kg | Preoperative Osocimab, mg/kg | Enoxaparin (n = 102) | Apixaban (n = 100) | |||||
| 0.3 (n = 102) | 0.6 (n = 65) | 1.2 (n = 104) | 1.8 (n = 101) | 0.3 (n = 106) | 1.8 (n = 107) | |||
| Major or nonmajor bleeding, No. (%) [90% CI]b | 2 (2.0) [0.3 to 6] |
0 [0.0 to 4.5] | 1 (1.0) [0.0 to 4.5] |
3 (3.0) [0.8 to 7.5] |
2 (1.9) [0.3 to 5.8] |
5 (4.7) [1.8 to 9.5] |
6 (5.9) [2.6 to 11.3] |
2 (2.0) [0.4 to 6.2] |
| Risk difference | ||||||||
| vs Enoxaparin, % (90% CI) | 3.9 (–0.5 to 8.4) |
5.9 (2.1 to 9.7) |
4.9 (0.8 to 9.1) |
2.9 (–1.8 to 7.6) |
4.0 (–0.4 to 8.4) |
1.3 (–3.8 to 6.3) |
||
| vs Apixaban, % (90% CI) | 0.0 (–3.2 to 3.3) |
2.0 (–0.3 to 4.3) |
1.0 (–1.8 to 3.8) |
–1.0 (–4.6 to 2.6) |
0.1 (–3.1 to 3.3) |
–2.6 (–6.7 to 1.4) |
||
| Bleeding | ||||||||
| Major | 0 | 0 | 0 | 0 | 0 | 1 (0.9) | 0 | 0 |
| Clinically relevant nonmajor | 2 (2.0) | 0 | 1 (1.0) | 3 (3.0) | 2 (1.9) | 4 (3.7) | 6 (5.9) | 2 (2.0) |
| Intraoperative blood loss, median (IQR), mLc | 200 (100 to 300) | 200 (100 to 300) | 150 (70 to 250) | 200 (100 to 300) | 120 (50 to 260) | 130 (50 to 300) | 150 (75 to 300) | 150 (80 to 300) |
| Receipt of blood transfusiond | 16 (15.7) | 12 (18.5) | 12 (11.5) | 7 (6.9) | 15 (14.2) | 17 (15.9) | 24 (23.5) | 19 (19.0) |
| Adverse eventse | ||||||||
| Any | 71 (69.6) | 46 (70.8) | 72 (69.2) | 65 (64.4) | 74 (69.8) | 86 (80.4) | 75 (73.5) | 63 (63.0) |
| Serious | 3 (2.9) | 1 (1.5) | 3 (2.9) | 2 (2.0) | 3 (2.8) | 6 (5.6) | 6 (5.9) | 1 (1.0) |
| Any resulting in permanent discontinuation of study drug | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.0) | 0 |
| Platelets <lower limit of normal | 2 (2.0) | 6 (9.2) | 4 (3.8) | 6 (5.9) | 8 (7.5) | 10 (9.3) | 6 (5.9) | 2 (2.0) |
| Hypersensitivity and infusion-related reactionsf | 7 (6.9) | 3 (4.6) | 7 (6.7) | 3 (3.0) | 3 (2.8) | 5 (4.7) | 2 (2.0) | 3 (3.0) |
Abbreviations: IQR, interquartile range.
Major or clinically relevant nonmajor bleeding and adverse events were assessed in all patients who received at least 1 dose of study medication.
Major or clinically relevant nonmajor bleeding up to 10 to 13 days postoperatively, which corresponded to study days 12 to 15. No statistical hypothesis testing was defined; only confidence intervals were calculated. Major and clinically relevant nonmajor bleeding occurred before administration of study drug in 1 patient in the postoperative 0.3-mg/kg osocimab group, 1 patient in the postoperative 1.2-mg/kg osocimab group, and in 2 patients in the enoxaparin group (post hoc analysis).
Intraoperative blood loss as reported by the investigator.
Intraoperative blood loss and blood transfusions occurring after the first administration of study drug for patients receiving preoperative osocimab only.
From randomization until 10 to 13 days postoperatively, which corresponded to study days 12 to 15.
Clinical descriptions of infusion-related reactions are provided in Supplement 2.