Safety
death, nausea, neutropenia, TEAEs, rash
DRUG WITHDRAWAL, ADVERSE EVENT, NEUTROPENIA
Overall, 19 (95%) patients experienced one or more TEAE. No serious TEAEs nor TEAEs associated with death were reported.TEAEs with DS‐1205c plus gefitinib combination therapy and DS‐1205c monotherapy are summarized in Table TEAEs by system organ class and preferred term in DS‐1205c/gefitinib combination therapy and DS‐1205c monotherapy in the safety analysis set (Abbreviations: BID, twice daily; TEAE, treatment‐emergent adverse event.One subject in Cohort 5 had a TEAE (Grade 2 rash) associated with drug withdrawal. No subjects had TEAEs associated with dose reduction. Seven patients (35%) had TEAEs associated with dose interruption. Of the 19 evaluable patients, DLT was experienced in two patients: one patient in Cohort 3 (800 mg BID) with Grade 3 neutropenia and one in Cohort 5 (1200 mg BID) with Grade 3 nausea, respectively.TEAEs were Grade 1 (TEAEs (≥Grade 3) by system organ class and preferred term in DS‐1205c/gefitinib combination therapy and DS‐1205c monotherapy in the safety analysis set (Abbreviations: BID, twice daily; TEAE, treatment‐emergent adverse event.