5-Azacytidine to Treat Acute Myeloid Leukemia in Elderly or Frail Patients Not Suitable for Intensive Chemotherapy. A Multicenter Phase II Trial.

简要总结

详细描述

主要结局

次要结局

• Overall survival(is defined as the time from trial registration until death from any cause.)
• Time to response(is defined as the time from trial registration until the date the criteria for either CR or PR are first met)
• Event-free survival(is defined as the time from trial registration until progression, relapse or death from any cause, whichever occurs first.)
• Adverse events according to NCI CTCAE v3.0(according to NCI CTCAE v3.0)
• Time to hematological improvement (HI)(is calculated for patients with HI and is defined as the time from trial registration until the date the criteria for HI are first met.)
• Duration of HI(is defined as the time from the date when the criteria for HI were first met until the date of relapse or death from any cause.)
• Response duration(is defined as the time from the date when the criteria for either CR or PR were first met until the date of relapse or death from any cause.)
• Best response status(within 6 months)
• Adjusted hospitalization time(is defined as the time (nights) spent in hospital as a proportion of treatment duration (days).)