Table 8.
Composite endpoints
| Arm A | Arm B | Arm C | |
|---|---|---|---|
| n | n | n | |
| DVT proximal | 0 | 0 | 0 |
| DVT distal | 0 | 0 | 2 |
| PE | 0 | 0 | 0 |
| Death on study | 0 | 0 | 0 |
| Exact Odds Ratios | |||
| Unadjusted | Estimate | 95 % Confidence Limits | p-value |
| Odds Ratio | (median unbiased) | ||
| Arm A vs. Arm C | 0.397 | 0 – 3.344 | 0.480 |
| Arm B vs. Arm C | 0.387 | 0 - 3.259 | 0.476 |
| Noninferiority Analysis of Risk Difference | |||
| Risk Difference | Estimate | 95 % Confidence Limits | p-value* |
| Arm C vs. Arm A | −0.0180 | −0.0428 – 0.0067 | <0.0001 |
| Arm C vs. Arm B | −0.0180 | −0.0428 – 0.0067 | <0.0001 |
*Using a noninferiority limit of -0.015