Table 1 Subgroup analysis of the treatment-related adverse events (TRAEs)

Any grade increased ALT

6

1.48

1.06-2.06

0.02

Fixed

33%

0.19

Any grade increased AST

6

1.68

1.18-2.39

0.004

Fixed

41%

0.13

Any grade in pruritus

6

1.09

0.87-1.37

0.46

Fixed

0%

0.53

Any grade in diarrhea

6

1.47

1.18-1.83

0.005

Fixed

23%

0.26

Any grade in fatigue

6

1.06

0.88-1.29

0.53

Fixed

19%

0.29

Any grade in nausea

5

1.34

0.99-1.81

0.06

Fixed

0%

0.63

Any grade in hypothyroidism

5

1.40

1.01-1.94

0.04

Fixed

0%

0.78

Any grade in decreased appetite

5

1.16

0.81-1.64

0.42

Fixed

11%

0.35

Any grade in vomiting

4

1.77

1.11-2.84

0.02

Fixed

27%

0.25

Any grade in rash

6

1.29

0.98-1.70

0.07

Fixed

19%

0.29

Grade 3 or higher increased ALT

6

2.25

1.26-4.00

0.006

Fixed

0%

0.45

Grade 3 or higher increased AST

6

1.89

0.91-3.91

0.09

Fixed

12%

0.34

Grade 3 or higher in pruritus

6

0.82

0.22-3.10

0.77

Fixed

0%

0.53

Grade 3 or higher in diarrhea

6

2.90

1.63-5.15

< 0.001

Fixed

0%

0.85

Grade 3 or higher in fatigue

6

1.37

0.53-3.54

0.51

Fixed

19%

0.29

Grade 3 or higher in nausea

5

2.45

0.71-8.51

0.16

Fixed

0%

0.41

Grade 3 or higher in vomiting

4

1.63

0.39-6.79

0.50

Fixed

0%

0.51

Grade 3 or higher in rash

6

1.69

0.39-7.26

0.48

Fixed

0%

0.51