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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 (%)