TABLE 2.
TEAEs in MAD panels reported in greater than one participant treated with milvexian
AE, n (%) | Pooled placebo (n = 14) | Panel 7 milvexian 5 mg q.d. fasted (n = 6) | Panel 8 milvexian 20 mg q.d. fasted (n = 6) | Panel 9 milvexian 70 mg q.d. fasted (n = 6) | Panel 12 milvexian 35 mg b.i.d. fasted (n = 6) | Panel 10 milvexian 200 mg q.d. fasted (n = 6) | Panel 13 milvexian 200 mg b.i.d. fasted (n = 6) | Panel 11 milvexian 500 mg q.d. fed (n = 6) | All participants treated with milvexian (N = 42) |
---|---|---|---|---|---|---|---|---|---|
Any TEAE | 8 (57.1) | 4 (66.7) | 1 (16.7) | 5 (83.3) | 2 (33.3) | 4 (66.7) | 2 (33.3) | 3 (50.0) | 21 (50.0) |
Headache | 1 (7.1) | 2 (33.3) | 1 (16.7) | 2 (33.3) | 0 | 1 (16.7) | 0 | 0 | 6 (14.3) |
Diarrhea | 3 (21.4) | 1 (16.7) | 0 | 3 (50.0) | 0 | 1 (16.7) | 0 | 0 | 5 (11.9) |
Dizziness | 1 (7.1) | 0 | 0 | 1 (16.7) | 1 (16.7) | 0 | 1 (16.7) | 0 | 3 (7.1) |
Nausea | 1 (7.1) | 0 | 0 | 1 (16.7) | 0 | 2 (33.3) | 0 | 0 | 3 (7.1) |
Abdominal discomfort | 0 | 1 (16.7) | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 2 (4.8) |
Abdominal pain | 1 (7.1) | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 0 | 0 | 2 (4.8) |
Oropharyngeal pain | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (16.7) | 0 | 2 (4.8) |
Pain in extremity | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 0 | 0 | 2 (4.8) |
Abbreviations: AE, adverse event; MAD, multiple ascending dose; TEAE, treatment‐emergent adverse event.