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Drug-related AEs (>10%)

Plus 1 case of grade 4 diarrhea

Plus 1 case of grade 4 increased ALT

ALT, alanine aminotransferase; AST, aspartate aminotransferase

AE category, %

Afatinib (n=160)

Gefitinib (n=159)

All

Grade 3

All

Grade 3

Diarrhea

90.0

11.9

61.0

1.3

Rash/acne*

88.8

9.4

81.1

3.1

Stomatitis*

64.4

4.4

23.9

-

Paronychia*

55.6

1.9

17.0

0.6

Dry skin

32.5

-

37.1

-

Pruritus

23.1

-

22.6

-

Fatigue*

20.6

5.6

14.5

-

Decreased appetite

16.3

0.6

11.9

-

Nausea

16.3

1.3

13.8

-

Alopecia

10.6

-

15.1

-

Vomiting

10.6

-

3.8

0.6

ALT increased

9.4

-

23.9

7.5

AST increased

6.3

-

20.8

2.5

*Grouped terms of AEs