Table 2.
Bleeding events (safety population)
| Outcome | PK cohort IONIS-FXIRx 300 mg (n = 6) |
Randomized cohorts |
||
|---|---|---|---|---|
| Pooled placebo (n = 13) | IONIS-FXIRx 200 mg (n = 15) |
IONIS-FXIRx 300 mg (n = 15) |
||
| Major bleeding, n (%) | 1 (16.7) | 1 (7.7) | 0 (0.0) | 1 (6.7) |
| [95% CI]a | [0.4%–64.1%] | [0.2%,–6.0%] | [0.0%–21.8%] | [0.2%–31.9%] |
| Minor bleeding, n (%) | 0 (0.0) | 1 (7.7) | 1 (6.7) | 6 (40.0) |
| [95% CI]a | [0.0%–45.9%] | [0.2%–36.0%] | [0.2%–31.9%] | [16.3%–67.7%] |
| Any bleeding, n (%) | 1 (16.7) | 2 (15.4) | 1 (6.7) | 7 (46.7) |
| [95% CI]a | [0.4%–64.1%] | [1.9%–45.4%] | [0.2%–31.9%] | [21.3%–73.4%] |
PK, pharmacokinetics.
a
Exact binomial 95% CI.