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| Name | Class |
|---|---|
| ADIR, a Servier Group company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Study Participants | Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONIVYDE | Drug | irinotecan liposome injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) | Number of AEs by seriousness and severity | Throughout the study period approximately 4 years |
| Grade 3 and 4 neutropenia cases | Frequency of Grade 3 and 4 neutropenia cases | Throughout the study period approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Visit Information: Number of Visit Types | Number of: Outpatient/office Visits, In-hospital Visits, Phone Visits, or Other Types Visits | Throughout the study period approximately 4 years |
| Visit Information: Reason for Visits |
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Inclusion Criteria:
Patients who are prescribed ONIVYDE per investigator's judgment shall be included if:
Exclusion Criteria:
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Patients in South Korea with a diagnosis of metastatic pancreatic cancer.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konyang University Hospital | Daejeon | 35365 | South Korea | |||
| National Cancer Center |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C584112 | irinotecan sucrosofate |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 5-fluorouracil |
| Drug |
a nucleoside metabolic inhibitor |
|
|
| Leucovorin | Drug | an active metabolite of folic acid |
|
|
Number of: Scheduled Visits, Emergency Visits, Other Types Visits
| Throughout the study period approximately 4 years |
| Median Dose of ONIVYDE | Median Dose of ONIVYDE administered during the study period | Throughout the study period approximately 4 years |
| Median Dose of fluorouracil | Median Dose of fluorouracil administered during the study period | Throughout the study period approximately 4 years |
| Median Dose of Leucovorin | Median Dose of Leucovorin administered during the study period | Throughout the study period approximately 4 years |
| Overall response | Response duration usually is measured from the time of initial response until documented tumor progression. | 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. | Throughout the study period approximately 4 years |
| Progression free survival | The time elapsed between treatment initiation and tumor progression or death from any cause. | 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. | Baseline, and then every 3 weeks, and at the end of study visit up to approximately 4 years |
| Gyeonggi-do |
| 10408 |
| South Korea |
| Severance Hospital, Yonsei University Health System - Gastroenterology | Seoul | 03722 | South Korea |
| Severance Hospital, Yonsei University Health System - Oncology | Seoul | 03722 | South Korea |
| ASAN Medical Center | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital, Yonsei University Health System | Seoul | 06273 | South Korea |
| Samsung Medical Center - Oncology | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St.Mary's Hospital | Seoul | 06591 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |