Safety

• Neutropenia

Onset of neutropenia generally occurred within 17 days and were reversible with dose interruption, dose reduction or discontinuation. ⁽¹⁾

20-33%

required dose
reductions⁽¹⁾

0.8%

needed to
discontinue treatment⁽²⁾

• Hepatobiliary toxicity

Onset of grade 3 and 4 AST/ALT elevations generally occurred within 3 months and resolved within a median of 21 days. ⁽²⁾

12.3%

required dose interruptions or adjustments

0.3%

needed to discontinue treatment due to hepatotoxicity,
2,4% due to abnormal LFTs

* To normalisation or grade ≤2 ⁽²⁾

• QTcF prolongation

Onset of QTcF prolongation generally occurred within 15 days and were reversible with dose interruption and/or dose reduction. ⁽²⁾

2.9%

required dose interruptions or reductions⁽¹⁾

<1%

needed to discontinue treatment⁽²⁾