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Table 2 Summary of TEAEs independent of relatedness

From: An open-label expanded access program of afatinib in EGFR tyrosine kinase inhibitor-naïve patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR mutations

AE

Treatment Set

(N = 88)

Any AE

88 (100)

 Leading to dose reduction

49 (56)

 Leading to discontinuation

8 (9)

SAE

37 (42)

 Fatal

7 (8)

 Immediately-life threatening

1 (1)

 Disability incapacity

0

 Requiring hospitalization

37 (42)

 Prolonging hospitalization

3 (3)

 Congenital anomaly

0

 Other

2 (2)

Highest CTCAE grade

 Grade 1

2 (2)

 Grade 2

22 (25)

 Grade 3

55 (63)

 Grade 4

2 (2)

 Grade 5

7 (8)

  1. AE adverse event, CTCAE Common Terminology Criteria for Adverse Events, SAE serious adverse event, TEAE treatment-emergent adverse events
  2. Data shown are n (%)