Safety
bleeding, DLTs, neutropenia, neutropenic fever, toxicity, toxicities, thrombocytopenia, infection, Cancer
ADVERSE EVENT, BLEEDING, NEUTROPENIA, FEBRILE NEUTROPENIA, NEUTROPENIC FEVER, THROMBOCYTOPENIA, INFECTION, CANCER
Safety data were recorded throughout the study until 30 days after the last adavosertib treatment, using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.03.DLTs were evaluated during the first 28 days (5/9 schedule) or the first 21 days (5/2 schedule) of treatment. Patients who received less than 80% of the planned adavosertib dose for the treatment cycle were not included in the analysis unless it was due to a DLT. DLTs were defined as toxicities related to adavosertib treatment that met at least one of the following criteria: hematologic toxicities, such as neutropenia or thrombocytopenia (grade ≥ 4 for at least 7 days, including infection with febrile neutropenia); neutropenic fever (grade ≥ 3); thrombocytopenia (grade ≥ 3) with bleeding (grade ≥ 2); non-hematologic toxicity (grade ≥ 3); liver function tests – grade ≥ 3 total bilirubin, alanine aminotransferase or aspartate aminotransferase, or alkaline phosphatase lasting for > 48 h, or any change in liver function tests consistent with Hy’s Law; and any other clinically significant and/or unacceptable toxicity that did not respond to supportive care, resulted in a disruption of the dosing schedule of more than 7 days, or was judged to be a DLT by the investigator in collaboration with the medical monitor.