The aim of this phase 4 study is to evaluate the safety profile of ONIVYDE in China mainland. Primary objective To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects: 1. Quantify the rate of grade ≥3 neutropenia (primary objective) 2. Serious adverse events and serious adverse drug reactions 3. Adverse events and adverse drug reactions Secondary objective To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland. (1) Overall survival (2) Overall response (3) Progression free survival (4) Quality of life assessment
Study Type
OBSERVATIONAL
Enrollment
120
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
(1) Quantify the rate of grade ≥3 neutropenia (primary objective)
Time frame: From enrolment until 30 days after last ONIVYDE administration
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
(2) Serious adverse events and serious adverse drug reactions
Time frame: From enrolment until 30 days after last ONIVYDE administration
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
(3) Adverse events and adverse drug reactions
Time frame: From enrolment until 30 days after last ONIVYDE administration
To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
(1) Overall survival
Time frame: From FPI to 12 months after LPI
To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
(2) Overall response
Time frame: From FPI to 12 months after LPI
To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
(3) Progression free survival
Time frame: From FPI to 12 months after LPI
To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
(4) Quality of life assessment(e.g.Karnofsky Performance Status (KPS))
Time frame: From FPI to 12 months after LPI
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