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Table 3 Treatment-related adverse events

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)
Grade 3b All Grades
Any TRAE 51 (58) 87 (99)
Diarrhea 19 (22) 86 (98)
Rash/acnea 18 (20) 81 (92)
Stomatitisa 13 (15) 67 (76)
Pruritus 2 (2) 40 (45)
Paronychiaa 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)
  1. AE adverse event, CTCAE Common Terminology Criteria for Adverse Events, MedDRA Medical Dictionary for Regulatory Activities, TRAE treatment-related adverse event
  2. 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