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. 2022 Jun 6;28(5):702–712. doi: 10.1111/hae.14595

TABLE 4.

Spontaneous bleeds during the study (safety population)

Spontaneous bleeds Cohort 1 (100 mg) (n = 8) Cohort 2 (225 mg) (n = 8) Cohort 3 (400 mg) (n = 8) Total (N = 24)
Participants with spontaneous bleeds, n (%) 7 (87.5) 7 (87.5) a 3 (37.5) 17 (70.8)
Number of spontaneous bleeds, n (%) 79 37 12 128
Mild 69 (87.3) 16 (43.2) 7 (58.3) 92 (71.9)
Moderate 10 (12.7) 20 (54.1) 5 (41.7) 35 (38.0)
Severe 0 1 (2.7) 0 1 (2.9)
Treated 65 (82.3) 25 (67.6) 11 (91.7) 101 (78.9)
Untreated 14 (17.7) 12 (32.4) 1 (8.3) 27 (21.1)

Data are shown for each participant based on their initial dose cohort.

a

Number of bleeds recorded for n = 7 participants in Cohort 2.