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 1

Efficacy analyses—pooled data from ADAPT-1 and ADAPT-2 (full 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
Proportion of subjects not requiring a platelet transfusion or rescue procedure for bleeding
	91	160	67	117	158	277
Responders^†	26 (28.6)	107 (66.9)	24 (35.8)	103 (88.0)	50 (31.7)	210 (75.8)
95% CI	(19.3, 37.9)	(59.6, 74.2)	(24.3, 47.3)	(82.2, 93.9)	(24.4, 38.9)	(70.8, 80.9)
-value	<0.0001		<0.0001		<0.0001
Proportion of subjects who achieved a platelet count ≥50 × 10^9/L on Procedure Day
	91	160	67	117	158	277
Responders^‡	5 (5.5)	109 (68.1)	20 (29.9)	106 (90.6)	25 (15.8)	215 (77.6)
95% CI	(0.8, 10.2)	(60.9, 75.3)	(18.9, 40.8)	(85.3, 95.9)	(10.1, 21.5)	(72.7, 82.4)
-value	<0.0001		<0.0001		<0.0001
Change in platelet count from Baseline to Procedure Day^§
	91	157	65	116	156	273
Mean (SD) × 10^9/L	1.8 (8.31)	31.7 (24.83)	3.5 (12.60)	41.0 (30.43)	2.5 (10.31)	35.6 (27.68)
Median × 10^9/L	0.5	28.0	0.5	37.8	0.5	31.0
-value	<0.0001		<0.0001		<0.0001

CI = Confidence interval, Max = maximum, Min = minimum, SD = standard deviation. ^†Responders are defined as the subjects not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure; two-sided 95% confidence interval based on normal approximation. -value is based on Cochran–Mantel–Haenszel Test stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort. ^‡Responders are defined as the subjects who achieved platelet count ≥50 × 10⁹/L on the Procedure Day. ^§Last-observation-carried-forward is used for subjects with missing platelet count on the Procedure Day. -value is based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.