To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
481
Patients received a daily dose of 40 milligrams (mg) of afatinib (Giotrif®), in the form of film-coated tablet over a 28 day cycle. Afatinib was taken orally with 250 milliliters (mL) of water at the same time of the day and without eating anything for at least 3 hours. Patients continued on treatment for as long as there was no disease progression or no other trial withdrawal criteria. The dose was reduced to 30 mg or 20 mg once daily when the initial dose was not tolerated by the patient.
Number of Patients With Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Number of patients with any treatment emergent adverse event (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time frame: From first drug administration to last drug administration plus 28 days of residual effect period. Up to 3866 days.
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