Table 6.
Incidence of Confirmed Platelet Reductions in Subjects Reporting Usage of Antithrombotic Concomitant Medications in 6-Month, Phase 3, Randomized Placebo-Controlled Trials
| Post-BSLN platelets confirmed,a n (%) | No usage of antithrombotic agents | Usage of antithrombotic agents | ||||
|---|---|---|---|---|---|---|
| Treatment period | Placebo (n = 43) | MIPO (n = 69) | Total (n = 112) | Placebo (n = 86) | MIPO (n = 192) | Total (n = 278) |
| (A) nb | 39 | 64 | 103 | 82 | 182 | 264 |
| LLN-100 K/μL | 1 (2.6) | 2 (3.1) | 3 (2.9) | 1 (1.2) | 10 (5.5) | 11 (4.2) |
| <100–75 K/μL | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| <75–50 K/μL | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| <50–25 K/μL | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| <25 K/μL | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| (B) n | 42 | 65 | 107 | 86 | 188 | 274 |
| <0.7 × BSLN | 0 (0) | 5 (7.7) | 5 (4.7) | 0 (0) | 14 (7.4) | 14 (5.1) |
| <0.5 × BSLN | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.5) | 1 (0.4) |
| N | 42 | 66 | 108 | 86 | 188 | 274 |
| <LLN | 2 (4.8) | 3 (4.5) | 5 (4.6) | 3 (3.5) | 13 (6.9) | 16 (5.8) |
| <75 K/μL | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.5) | 1 (0.4) |
| <50 K/μL | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Treatment period is defined as post first dose to last dose +10 days.
a
Confirmed event was defined as a consecutive abnormal laboratory value on next measurement after the initial observation. If there was no consecutive test to confirm, then the initial observation was presumed confirmed.
b
Number of subjects with normal BSLN platelet counts and with post-BSLN values. Lowest confirmed category was reported for each subject.