Table 3.
Adverse events | Adverse events reported from 3 selected studies |
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Terrault et al62 |
Terrault et al63 |
Kuter and Allen73 |
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ADAPT-1 |
ADAPT-2 |
Cohort A |
Cohort B |
Multiple dose |
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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) |
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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.