Post Marketing Surveillance Study for ONIVYDE® in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 10
- 主要终点
- Number of Adverse Events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are prescribed ONIVYDE per investigator's judgment shall be included if:
- •Patient / legally authorized representative/ family member gave written informed consent
- •Patient is indicated for treatment according to ONIVYDE South Korea prescribing information
- •Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
- •Documented metastatic disease
- •Patient deemed not eligible or failed previous treatment with gemcitabine or gemcitabine containing therapy
- •Adequate hepatic, renal and hematological function
排除标准
- •Patients enrolled in Servier sponsored ONIVYDE Registry or any other Servier sponsored ONIVYDE study
- •Patients who have experienced severe hypersensitivity reaction to ONIVYDE or Irinotecan HCL
- •Patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation of interstitial lung disease. Patients with confirmed diagnosis of interstitial lung disease
研究组 & 干预措施
All Study Participants
Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE
干预措施: Leucovorin (Drug)
All Study Participants
Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE
干预措施: ONIVYDE (Drug)
All Study Participants
Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE
干预措施: 5-fluorouracil (Drug)
结局指标
主要结局
Number of Adverse Events (AEs)
时间窗: Throughout the study period approximately 4 years
Number of AEs by seriousness and severity
Grade 3 and 4 neutropenia cases
时间窗: Throughout the study period approximately 4 years
Frequency of Grade 3 and 4 neutropenia cases
次要结局
- Median Dose of Leucovorin(Throughout the study period approximately 4 years)
- Overall response(Throughout the study period approximately 4 years)
- Overall Survival(Throughout the study period approximately 4 years)
- Progression free survival(Throughout the study period approximately 4 years)
- Quality of Life assessment (EQ-5D-5 L Health Questionnaire)(Baseline, and then every 3 weeks, and at the end of study visit up to approximately 4 years)
- Median Dose of ONIVYDE(Throughout the study period approximately 4 years)
- Visit Information: Number of Visit Types(Throughout the study period approximately 4 years)
- Visit Information: Reason for Visits(Throughout the study period approximately 4 years)
- Median Dose of fluorouracil(Throughout the study period approximately 4 years)