Main adverse events
death, Toxic deaths, Febrile neutropenia, febrile neutropenia, toxicity, Death, respiratory distress, sepsis, diabetes
FEBRILE NEUTROPENIA, FEBRILE NEUTROPENIA, SECONDARY, SEPSIS, HYPERTENSION, DIABETES
Table The study has been prematurely stopped upon IDMC decision following the third death due to treatment toxicity (febrile neutropenia) after 121 patients were randomized: 1 in Arm A and 2 in Arm B, secondary to febrile neutropenia. Toxic deaths following febrile neutropenia were observed. Patients were 68-year-old, 67-year-old and 80-year-old female patients, each with known diabetes and hypertension. Febrile neutropenia occurred during the first cycle at day 9 and day 10 of vinorelbine + anastrozole for those in Arm B, and at day 30 for the patient in Arm A. Death occurred on day 17 and day 19 in Arm B, and on day 40 in Arm A. Patients experienced: 1) a rapidly unfavorable evolution of sepsis respiratory distress due to 