The purpose of this observational study is to provide data on the incidence and severity of infusion-related reactions during and immediately following each infusion of VYXEOS during the first induction.
Study Type
OBSERVATIONAL
Enrollment
52
VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes.
Franciscan Physician Network Oncology and Hematology Specialists
Indianapolis, Indiana, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Tulane University Hospital & Clinic
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Infusion-Related Reactions on Day 1
The investigator will assess each AE and indicate if it as an infusion-related reaction.
Time frame: Day 1
Incidence of Infusion-Related Reactions Occurring until One Day after the Last Infusion
The number and percentage of patients assessed by the investigator to have had any AEs assessed to be an infusion-related reaction occurring until 1 day after the last infusion.
Time frame: 1 day after the last infusion
Changes in Vital Signs
Descriptive statistics for observed vital signs will be provided for each infusion
Time frame: Up to 180 minutes after the start of infusion
Incidence of Treatment-emergent Adverse Events (TEAEs)
Treatment-emergent adverse events (TEAEs) are defined as any AE starting after the initiation of the first infusion of VYXEOS
Time frame: 1 day after the last infusion
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University of Maryland
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States