Table 6.

IND hepatic safety reports in subjects with breast cancer (AR18-CT-101)

Age, years	Event	CTCAE grade	DRC causality determination	Action taken	Outcomeb
63	Bilirubin increase	3	Unrelated; due to bile duct obstruction from liver metastases requiring biliary stenting	Drug discontinued	Improved
57	Bilirubin increased	3	Unrelated; due to progressive liver and bone metastases	NAa	Not resolved
60	AST/ALT increased	3	Unrelated; due to progression of disease with malignant ascites and pleural effusion that later improved with start of gemcitabine and eribulin	NAa	Resolved
42	AST increased	3	Unrelated; due to progressive liver metastases	NAa	Not resolved

ALT alanine aminotransferase, AST aspartate aminotransferase, CTCAE Common Terminology Criteria for Adverse Events, version 4.03, DRC data review committee, NA not applicable, TESAE treatment-emergent serious adverse event

^aNo action taken because ONA-ER was already discontinued for progressive disease

^bOutcome as per TESAE site report—does not necessarily represent final clinical study report