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

Table 3 Treatment-related adverse events

AE	Treatment Set (N = 88)
AE	Grade 3^b	All Grades
Any TRAE	51 (58)	87 (99)
Diarrhea	19 (22)	86 (98)
Rash/acne^a	18 (20)	81 (92)
Stomatitis^a	13 (15)	67 (76)
Pruritus	2 (2)	40 (45)
Paronychia^a	8 (9)	36 (41)
Nail disorder	3 (3)	30 (34)
Decreased appetite	5 (6)	20 (23)
Dry skin	0	18 (20)
Nasal inflammation	0	9 (10)
Palmar-plantar erythrodysesthesia syndrome	1 (1)	8 (9)
Nausea	1 (1)	7 (8)
Abdominal pain upper	0	5 (6)
Alopecia	0	5 (6)
Fatigue	2 (2)	5 (6)
Rhinorrhea	0	5 (6)
Scab	0	5 (6)
Skin hyperpigmentation	0	5 (6)

AE adverse event, CTCAE Common Terminology Criteria for Adverse Events, MedDRA Medical Dictionary for Regulatory Activities, TRAE treatment-related adverse event
Shown are n (%) TRAEs in > 5% of patients at any grade in the patient treatment set. TRAEs are shown by MedDRA version 21.1 preferred terms and highest grade according to CTCAE version 3. ^aCategory of specific grouped preferred terms as specified in the Patients and Methods; ^bNo CTCAE grade 4 or 5 TRAEs were reported

ISSN: 1471-2407