Table 1.
Event Rate per 100 Patient Years by Time Spent Below, In, and Above Therapeutic Range
| Below | In | Above | ||||
|---|---|---|---|---|---|---|
| Events | Baseline | (Range) | Baseline | (Range) | Baseline | (Range) |
| Thromboembolic first events | ||||||
| Fatal | 0.05 | (0–0.30) | 0.01 | (0–0.05) | 0.00 | (0–0.05) |
| Life-threatening | 1.58 | (1.0–6.0) | 0.47 | (0–1.0) | 0.11 | (0–1.0) |
| Serious | 14.68 | (8.0–16.0) | 2.52 | (1.0–6.0) | 2.29 | (1.0–6.0) |
| Thromboembolic subsequent events | ||||||
| Fatal | 0.01 | (0–0.3) | 0.00 | (0–0.05) | 0.01 | (0–0.05) |
| Life-threatening | 0.32 | (0–5.0) | 0.04 | (0–1.0) | 0.44 | (0–1.0) |
| Serious | 2.45 | (0–6.0) | 0.88 | (0–6.0) | 1.60 | (1.0–6.0) |
| Hemorrhagic first events | ||||||
| Fatal | 0.05 | (0–0.3) | 0.04 | (0–0.3) | 0.20 | (0–0.6) |
| Life-threatening | 0.61 | (0–1.0) | 0.49 | (0–1.0) | 2.66 | (0.5–4.0) |
| Serious | 5.87 | (3.0–8.0) | 5.12 | (3.0–8.0) | 12.83 | (10.0–20.0) |
| Hemorrhagic subsequent events | ||||||
| Fatal | 0.02 | (0–0.3) | 0.02 | (0–0.3) | 0.07 | (0–0.6) |
| Life-threatening | 0.30 | (0–1.0) | 0.25 | (0–1.0) | 0.96 | (0.5–4.0) |
| Serious | 1.30 | (0–8.0) | 1.85 | (0–8.0) | 5.73 | (3.0–20.0) |