The purpose of this study is to characterize the safety of ONIVYDE when used under standard clinical practice in South Korea; and to describe effectiveness in patients receiving ONIVYDE in combination with 5-fluorouracil (5-FU) and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in South Korea.
Study Type
OBSERVATIONAL
Enrollment
94
irinotecan liposome injection
a nucleoside metabolic inhibitor
an active metabolite of folic acid
Konyang University Hospital
Daejeon, South Korea
National Cancer Center
Gyeonggi-do, South Korea
Severance Hospital, Yonsei University Health System - Gastroenterology
Seoul, South Korea
Number of Adverse Events (AEs)
Number of AEs by seriousness and severity
Time frame: Throughout the study period approximately 4 years
Grade 3 and 4 neutropenia cases
Frequency of Grade 3 and 4 neutropenia cases
Time frame: Throughout the study period approximately 4 years
Visit Information: Number of Visit Types
Number of: Outpatient/office Visits, In-hospital Visits, Phone Visits, or Other Types Visits
Time frame: Throughout the study period approximately 4 years
Visit Information: Reason for Visits
Number of: Scheduled Visits, Emergency Visits, Other Types Visits
Time frame: Throughout the study period approximately 4 years
Median Dose of ONIVYDE
Median Dose of ONIVYDE administered during the study period
Time frame: Throughout the study period approximately 4 years
Median Dose of fluorouracil
Median Dose of fluorouracil administered during the study period
Time frame: Throughout the study period approximately 4 years
Median Dose of Leucovorin
Median Dose of Leucovorin administered during the study period
Time frame: Throughout the study period approximately 4 years
Overall response
Response duration usually is measured from the time of initial response until documented tumor progression.
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Severance Hospital, Yonsei University Health System - Oncology
Seoul, South Korea
ASAN Medical Center
Seoul, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
Samsung Medical Center - Oncology
Seoul, South Korea
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Time frame: Throughout the study period approximately 4 years
Overall Survival
The time from enrollment to death from any cause, is a direct measure of clinical benefit to a patient.
Time frame: Throughout the study period approximately 4 years
Progression free survival
The time elapsed between treatment initiation and tumor progression or death from any cause.
Time frame: Throughout the study period approximately 4 years
Quality of Life assessment (EQ-5D-5 L Health Questionnaire)
The instrument that measures conceptual domains of quality of patients' well-being.
Time frame: Baseline, and then every 3 weeks, and at the end of study visit up to approximately 4 years