Table 3.
The proportion of patients with bleeding by treatment group: all-treated-patients population, Study 1 (TKR)
| Study 1 (TKR) | |||||
|---|---|---|---|---|---|
| Types of bleeding (%) | Placebo | Fondaparinux | |||
| 0.75 mg | 1.5 mg | 2.5 mg | 3.0 mg | ||
| n = 87 | n = 86 | n = 85 | n = 84 | n = 84 | |
| Major bleeding | 1 (1.1) | 0 | 0 | 1 (1.2) | 1 (1.2) |
| [0.0 – 6.2] | [0.0 – 4.2] | [0.0 – 4.2] | [0.0 – 6.5] | [0.0 – 6.5] | |
| Minor bleeding only | 3 (3.4) | 0 | 5 (5.9) | 2 (2.4) | 3 (3.6) |
| [0.7 – 9.7] | [0.0 – 4.2] | [1.9 – 13.2] | [0.3 – 8.3] | [0.7 – 10.1] | |
| Any bleeding | 4 (4.6) | 0 | 5 (5.9) | 3 (3.6) | 4 (4.8) |
| [1.3 – 11.4] | [0.0 – 4.2] | [1.9 – 13.2] | [0.7 – 10.1] | [1.3 – 11.7] | |
| Any bleeding Cochran-Armitage (P)a | 0.57 | ||||
| Study 2(THR) | |||||
| Types of bleeding (%) | Placebo | Fondaparinux | |||
| 0.75 mg | 1.5 mg | 2.5 mg | 3.0 mg | ||
| n = 82 | n = 80 | n = 80 | n = 81 | n = 83 | |
| Major Bleeding | 0 | 1 (1.3) | 0 | 2 (2.5) | 0 |
| [0.0 – 4.4] | [0.0 – 6.8] | [0.0 – 4.5] | [0.3 – 8.6] | [0.0 – 4.3] | |
| Minor bleeding only | 0 | 3 (3.8) | 2 (2.5) | 4 (4.9) | 0 |
| [0.0 – 4.4] | [0.8 – 10.6] | [0.3 – 8.7] | [1.4 – 12.2] | [0.0 – 4.3] | |
| Any bleeding | 0 | 4 (5.0) | 2 (2.5) | 6 (7.4)* | 0 |
| [0.0 – 4.4] | [1.4 12.3] | [0.3 – 8.7] | [2.8 – 15.4] | [0.0 – 4.3] | |
| Any bleeding Cochran-Armitage (P)a | 0.54 | ||||
n (%), [95% CI]
A significant dose-response relationship in bleeding was not observed with the 0.75 mg to 3.0 mg fondaparinux dose range in either of the studies.
a Comparisons across all 5 treatment populations, using the values of the doses as score (0, 0.75, 1.5, 2.5, and 3.0)
* P = 0.013 vs placebo group
THR: total hip replacement; TKR: total knee replacement