Table 7.
Incidence of Bleeding Events in 6-Month, Phase 3 Mipomersen Trials
| Treatment period | Placebo | MIPO |
|---|---|---|
| n | 129 | 261 |
| Any bleeding event,an (%) | 2 (1.6) | 3 (1.1) |
| Antithrombotic agent, yes, n (%) | 2 (1.6) | 2 (0.8) |
Table shows any bleeding event reported as possibly related, related, or of unknown relationship to study drug during the treatment period.
a
Analysis was based on terms listed in the standard MedDRA query. Events reported under the system organ class, general disorders, and administration site conditions are reported in the appendix (Supplementary Table S11).