Avatrombopag, an Alternate Treatment Option to Reduce Platelet Transfusions in Patients with Thrombocytopenia and Chronic Liver Disease-Integrated Analyses of 2 Phase 3 Studies

Table 2

Treatment-emergent adverse events—pooled data from ADAPT-1 and ADAPT-2 (safety analysis set).

Category	Low Baseline Platelet Count Cohort (<40 × 10^9/L)		High Baseline Platelet Count Cohort (≥40 to <50 × 10^9/L)		Combined Baseline Platelet Count Cohort (<50 × 10^9/L)
	Placebo ()	Avatrombopag 60 mg ()	Placebo ()	Avatrombopag 40 mg ()	Placebo ()	Avatrombopag 40 mg ()
Any TEAE, (%)	53 (58.2)	89 (56.0)	33 (50.8)	59 (51.3)	86 (55.1)	148 (54.0)
Treatment-related TEAEs, (%)	16 (17.6)	18 (11.3)	4 (6.2)	8 (7.0)	20 (12.8)	26 (9.5)
CTCAE grade 3 TEAEs, (%)	12 (13.2)	13 (8.2)	4 (6.2)	17 (14.8)	16 (10.3)	30 (10.9)
Serious TEAEs, (%)	12 (13.2)	11 (6.9)	2 (3.1)	9 (7.8)	14 (9.0)	20 (7.3)
TEAEs leading to study drug withdrawal, (%)	0	2 (1.3)	0	0	0	2 (0.7)
Most frequently reported TEAEs (≥5%), (%)
Pyrexia (fever)	8 (8.8)	18 (11.3)	6 (9.2)	9 (7.8)	14 (9.0)	27 (9.9)
Abdominal pain	6 (6.6)	10 (6.3)	4 (6.2)	8 (7.0)	10 (6.4)	18 (6.6)
Nausea	7 (7.7)	10 (6.3)	4 (6.2)	8 (7.0)	11 (7.1)	18 (6.6)
Headache	7 (7.7)	7 (4.4)	3 (4.6)	8 (7.0)	10 (6.4)	15 (5.5)
Abdominal pain upper	5 (5.5)	6 (3.8)	3 (4.6)	2 (1.7)	8 (5.1)	8 (2.9)
Procedural pain	2 (2.2)	8 (5.0)	0	0	2 (1.3)	8 (2.9)

TEAE = treatment-emergent adverse event; CTCAE = Common Terminology Criteria for Adverse Events. A TEAE is defined as an adverse event that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug.