A phase II study of first-line afatinib for patients aged ≥75 years with EGFR mutation-positive advanced non-small cell lung cancer: North East Japan Study Group trial NEJ027

Table 4 Treatment-related adverse events

Adverse event	Any grades	Grade 1 or 2	Grade 3 or 4
Any	38 (100)	10 (26.3)	28 (73.7)
Diarrhoea	36 (94.7)	25 (65.8)	11 (28.9)
Rash/acne^a	30 (78.9)	24 (63.2)	6 (15.8)
Paronychia	26 (68.4)	17 (44.7)	9 (23.7)
Stomatitis	26 (68.4)	21 (55.3)	5 (13.2)
Appetite loss	13 (34.2)	8 (21.1)	5 (13.2)
Vomiting	6 (15.8)	5 (13.2)	1 (2.6)
Pneumonitis	5 (13.2)	3 (7.9)	2 (5.3)^b
Fatigue	5 (13.2)	5 (13.2)	0
Nausea	4 (10.5)	4 (10.5)	0
Oedema	4 (10.5)	4 (10.5)	0
Infection	4 (10.5)	3 (7.9)	1 (2.6)
ALT/AST increased	9 (23.7)	8 (21.1)	1 (2.6)
Creatinine increased	8 (21.1)	8 (21.1)	0
Anaemia	8 (21.1)	7 (18.4)	1 (2.6)
Hypoalbuminemia	8 (21.1)	8 (21.1)	0
Thrombocytopenia	6 (15.8)	6 (15.8)	0
Hypokalaemia	6 (15.8)	5 (13.2)	1 (2.6)
Leukocytopenia	4 (10.5)	4 (10.5)	0

Abbreviations: ALT alanine aminotransferase, AST aspartate aminotransferase, TRAE treatment-related adverse event
Data are n (%) TRAEs in > 10% of patients in the safety analysis set (n = 38) listed by Medical Dictionary for Regulatory Activities (MedDRA) preferred terms and grade by Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
^aIncludes papulopustular rash, rash pustular, and rash acneiform
^bIncludes one patient with grade 4 pneumonitis

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