Unique ID issued by UMIN | UMIN000041015 |
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Receipt number | R000046793 |
Scientific Title | Onivyde I.V. infusion 43 mg General Drug Use-Results Survey (Unresectable pancreatic cancer after disease progression following cancer chemotherapy) |
Date of disclosure of the study information | 2020/07/07 |
Last modified on | 2024/01/19 10:45:50 |
Onivyde I.V. infusion 43 mg General Drug Use-Results Survey (Unresectable pancreatic cancer after disease progression following cancer chemotherapy)
Onivyde General Drug Use-Results Survey (Pancreatic cancer)
Onivyde I.V. infusion 43 mg General Drug Use-Results Survey (Unresectable pancreatic cancer after disease progression following cancer chemotherapy)
Onivyde General Drug Use-Results Survey (Pancreatic cancer)
Japan |
Pancreatic cancer
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To investigate Safety and Effectiveness of Onivyde I.V. Infusion 43 mg in patients with Unresectable Pancreatic Cancer after disease progression following cancer chemotherapy in clinical practice and to detect issues expeditiously.
Safety
Exploratory
Not applicable
Overall incidence of each ADRs and AEs (Safety Specifications of the Survey related)
Observational
Not applicable |
Not applicable |
Male and Female
Patients who are administered Onivyde for the first time to Unresectable pancreatic cancer after disease progression following cancer chemotherapy per standard clinical practice and per prescribing information. In addition, patients who are given consent to participation in the survey.
No given consent to participation in the survey.
300
1st name | Satoshi |
Middle name | |
Last name | KAMEYAMA |
NIHON SERVIER CO., LTD.
MEDICAL AFFAIRS
113-0033
Hongo MK Bldg., 1-28-34, Hongo, Bunkyo-ku, Tokyo, Japan
07024933214
satoshi.kameyama@servier.com
1st name | Satoshi |
Middle name | |
Last name | KAMEYAMA |
NIHON SERVIER CO., LTD.
MEDICAL AFFAIRS
113-0033
Hongo MK Bldg., 1-28-34, Hongo, Bunkyo-ku, Tokyo, Japan
07024933214
satoshi.kameyama@servier.com
NIHON SERVIER CO., LTD.
NIHON SERVIER CO., LTD.
Profit organization
NIHON SERVIER CO., LTD.
Hongo MK Bldg., 1-28-34, Hongo, Bunkyo-ku, Tokyo, Japan
07024933214
satoshi.kameyama@servier.com
NO
2020 | Year | 07 | Month | 07 | Day |
Unpublished
326
Completed
2020 | Year | 04 | Month | 30 | Day |
2020 | Year | 04 | Month | 30 | Day |
2020 | Year | 06 | Month | 01 | Day |
2023 | Year | 12 | Month | 31 | Day |
The survey will be conducted to be followed GPSP Ministerial Ordinance, relevant regulations and Operating Procedures to ensure the quality of the survey.
2020 | Year | 07 | Month | 06 | Day |
2024 | Year | 01 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046793
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