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. 2019 Oct 21;12:1179545X19875105. doi: 10.1177/1179545X19875105

Table 3.

Common adverse events reported by 3 trials conducted on avatrombopag.

Adverse events Adverse events reported from 3 selected studies
Terrault et al62
Terrault et al63
Kuter and Allen73
ADAPT-1
ADAPT-2
Cohort A
Cohort B
Multiple dose
Low-baseline platelet count
High-baseline platelet count
Low-baseline platelet count
High-baseline platelet count
Placebo (n = 16) 20 mg (n = 18) 40 mg (n = 16) 80 mg (n = 17) Placebo (n = 21) 10 mg (n = 21) 20 mg (n = 21) Placebo (n = 21) 1 mg (n = 6) 3 mg (n = 6) 10 mg (n = 6) 20 mg (n = 6) 50 mg (n = 6) 75 mg (n = 6) 100 mg (n = 6)
Placebo (n = 48) AVP 60 mg
(n = 89)
Placebo (n = 32) AVP 40 mg
(n = 58)
Placebo (n = 43) AVP 60 mg
(n = 70)
Placebo (n = 33) AVP 40 mg
(n = 57)
Patients with any TEAEs 31 (64.6%) 53 (59.6%) 18 (56.25%) 31 (53.4%) 22 (51.2%) 36 (51.4%) 15 (45.5%) 28 (49.12%) 12 (75%) 17 (94.4%) 13 (81.3%) 13 (76.5%) 16 (76.2%) 17 (81.0%) 18 (85.7%) 7 (33.3%) 2 (33.3%) 1 (16.7%) 2 (33.3%) 1 (16.7%) 1 (16.7%) 2 (33.3%) 2 (33.3%)
Drug therapy-related TEAEs 7 (14.6%) 12 (13.5%) 2 (6.3%) 4 (6.9%) 9 (20.9%) 6 (8.6%) 2 (6.1%) 4 (7.0%)
Dysgeusia 2 (9.5%) 1 (16.7%) 1 (16.7%) 1 (16.7%) 1 (16.7%) 0 1 (16.7%) 1 (16.7%)
Flatulence 2 (9.5%) 1 (16.7%) 0 0 0 0 0 (16.7%)
Diarrhea 1 (2.1%) 4 (4.5%) 2 (6.3%) 1 (1.7%) 3 (7.0%) 3 (4.3%) 0 2 (3.5%) 0 2 (11.1%) 1 (6.3%) 1 (5.9%) 2 (9.5%) 0 3 (14.3%) 1 (4.8%) 0 0 0 0 0 0 (16.7%)
Headache 3 (6.3%) 5 (5.6%) 2 (6.3%) 6 (10.3%) 4 (9.3%) 2 (2.9%) 1 (3.0%) 2 (3.5%) 2 (12.5%) 2 (11.1%) 2 (12.5%) 1 (5.9%) 3 (14.3%) 1 (4.8%) 3 (14.3%)
Somnolence 1 (4.8%) 0 0 0 1 (16.7%) 1 (16.7%) 0 0
Nausea 2 (4.2%) 4 (4.5%) 2 (6.3%) 5 (8.6%) 5 (11.6%) 6 (8.6%) 6 (8.6%) 3 (5.3%) 2 (12.5%) 1 (5.6%) 2 (12.5%) 2 (11.8%) 3 (14.3%) 5 (23.8%) 2 (9.5%) 1 (4.8%) 0 1 (16.7) 0 0 0 0 0
Vomiting 0 1 (5.6%) 2 (12.5%) 3 (17.6%) 1 (4.8%) 0 1 (4.8%)
Lethargy 0 0 0 1 (16.7%) 0 0 0 0
Muscle contraction 0 0 0 0 0 0 0 1 (16.7%)
Portal hypertensive gastropathy 0 4 (22.2%) 2 (12.5%) 0 2 (9.5%) 3 (14.3%) 0
Abdominal pain 3 (6.3%) 8 (9.0%) 3 (9.4%) 6 (10.3%) 3 (7.0%) 2 (2.9%) 1 (3.0%) 2 (3.5%) 0 4 (22.2%) 1 (6.3%) 1 (5.9%) 3 (14.3%) 2 (9.5%) 0
Fatigue 1 (2.1%) 6 (6.7%) 1 (3.1%) 1 (1.7%) 3 (7.0%) 1 (1.4%) 0 2 (3.5%) 1 (6.3%) 4 (22.2%) 1 (6.3%) 0 4 (19%) 2 (9.5%) 2 (9.5%)
Edema peripheral 2 (4.2%) 3 (3.4%) 1 (3.1%) 3 (5.2%) 2 (6.1%) 0 3 (9.1%) 0
Pyrexia 6 (12.5%) 7 (7.9%) 2 (6.3%) 5 (8.6%) 2 (4.7%) 11 (15.7%) 4 (12.1) 4 (7.0%) 2 (12.5%) 0 0 2 (11.8%) 3 (14.3%) 1 (4.8%) 0
Dyspepsia 2 (4.2) 0 2 (6.3) 0 0 2 (12.5) 0 0 2 (11.8%) 3 (14.3%) 1 (4.8%) 0
Dizziness 3 (7.0%) 3 (4.3%) 1 (3.0%) 0 1 (6.3%) 2 (11.1%) 0 1 (5.9%) 1 (4.8%) 3 (14.3%) 1 (4.8%)

Abbreviation: TEAEs indicate treatment-emergent adverse events; AVP -avatrombopag.