Table 3.

Prevalence of adverse events in avatrombopag trials

Study	Population and study type	Percentage experiencing at least one TEAE (drug vs placebo)	Most common TEAEs	Percentage experiencing at least one SAE (drug vs placebo)	Most common non-thrombocytopenia SAEs	Notes
Nomoto et al.29	Healthy subjects PK/PD	Japanese: 41.7% vs NRa White: 20.8% vs NR	Headache	0% vs NRa	N/Aa	Incidence of TEAEs was not dose dependent
Bussel et al.21	Chronic ITP Phase II	100% vs NR	Headache, fatigue, epistaxis, confusion, diarrhea, and arthralgia	19% vs NR	N/Aa	Four patients reported 5 thrombotic events
Jurczak et al.27	Chronic ITP Phase III	96.9% vs 58.8%	Headache, confusion, URTI, arthralgia, epistasis and fatigue	28.1% vs 5.9%	Headache, vomiting, severe thrombocytopenia
Terrault et al.26	CLD and thrombocytopenia Phase II	83.8% vs 75.7%	Nausea, fatigue, headache	17.2% vs 10.8%	Ascites, hepatic encephalopathy, gastrointestinal bleeding, infections
Terrault et al.9	CLD and thrombocytopenia Phase III	54% vs 55%	Abdominal pain, dyspepsia, nausea, pyrexia, dizziness, headache	7% vs 9%	Hyponatremia and gastrointestinal hemorrhage.	3 thrombotic events were reported, 1 in avatrombopag arm and 2 in placebo arm

Note: ^aStudies did not report/define SAEs.

Abbreviations: TEAE, treatment-emergent adverse event; SAE, serious adverse event; NR, not reported; N/A, not applicable.