A Multi-center, Single-arm, Prospective Non-interventional Study to Investigate the Safety Profiles and Effectiveness of Liposomal Irinotecan (ONIVYDE®) in Combination with 5-fluorouracil (5-FU) and Leucovorin (LV) in Chinese Patients with Metastatic Pancreatic Cancer As Approval Condition (SEOPAC)
The adult patient (≥18 years of age) has given written informed consent to participate in the study.
The patient has been prescribed for ONIVYDE treatment according to the ONIVYDE China mainland SmPC.
Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas.
Documented metastatic disease.
You may not be if
Patients who have experienced a severe hypersensitivity reaction to ONIVYDE or Irinotecan HCL.
Patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation or confirmed diagnostic of interstitial lung disease.
Pregnant or nursing (lactating) women.
Patients without highly effective methods of contraception during study treatment until 3 months after the last dose of the study drug, Specially,7 months for women of childbearing potential and 4 months for male with partners of childbearing potential after the last dose of the study drug.
Other additional exclusions may be applied by the investigator according to the contexts, in order to ensure that the study population will be non-interventional but representative of all eligible subjects.
Clareo Health | A Multi-center, Single-arm, Prospective Non-interventional Study to Investigate the Safety Profiles and Effectiveness of Liposomal Irinotecan (ONIVYDE®) in Combination with 5-fluorouracil (5-FU) and Leucovorin (LV) in Chinese Patients with Metastatic Pancreatic Cancer As Approval Condition (SEOPAC)
