There is a medical need for improving treatment of poor performance status patients with EGFR driver mutations and documenting safety and tolerability of existing agents.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
1200.208.10032 Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib
Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.
Time frame: Up to 98 days
Percentage of Patients With Occurrence of CTCAE Grade 3 or Higher Diarrhoea, Rash/Acne+, Stomatitis+ and Paronychia+ (+ Represents Grouped Term)
Percentage of patients with occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher diarrhoea, rash/acne+, stomatitis+ and paronychia+ (+ represents grouped term).
Time frame: Up to 98 days
Time to First Dose Reduction of Afatinib Caused by Adverse Events (AEs)
Time to first dose reduction of afatinib caused by Adverse Events (AEs) defined as time from the date of the first administration of afatinib to the first dose reduction of afatinib caused by AEs.
Time frame: Up to 98 days
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