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. 2021 Sep 24;15(2):330–342. doi: 10.1111/cts.13148

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.