Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-25 @ 1:05 PM
NCT ID:
NCT02907359
Group ID:
EG001
Title:
Treatment Choice
Description:
Participants received one of the three treatment choice options:
1. LDAC 20 mg/m\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice.
2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles.
3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals.
Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.
Deaths Number Affected:
122
Deaths Number At Risk:
None
Serious Number Affected:
65
Serious Number At Risk:
122
Other Number Affected:
107
Other Number At Risk:
122
Study:
NCT02907359
Results Section:
NCT02907359
Adverse Events Module:
NCT02907359