Unique ID issued by UMIN | UMIN000048892 |
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Receipt number | R000055680 |
Scientific Title | Integrated Analysis of Post Marketing Survey for Nivolumab |
Date of disclosure of the study information | 2022/09/09 |
Last modified on | 2023/12/22 14:20:34 |
Integrated Analysis of Post Marketing Survey for Nivolumab
Integrated Analysis of Post Marketing Survey for Nivolumab
Integrated Analysis of Post Marketing Survey for Nivolumab
Integrated Analysis of Post Marketing Survey for Nivolumab
Japan |
Unresectable malignant melanoma
/Unresectable,advanced or recurrent Non-Small Cell Lung Cancer
/Unresectable or metastatic renal cell cancer
/Recurrent or distant metastatic head and neck cancer
/Unresectable advanced or recurrent gastric/gastroesophageal junction cancer that has progressed after chemotherapy
Gastroenterology | Pneumology | Hematology and clinical oncology |
Gastrointestinal surgery | Chest surgery | Dermatology |
Oto-rhino-laryngology | Urology | Oral surgery |
Malignancy
NO
To clarify the safety profile(incidence of adverse events, time of onset, exacerbation/relapse/risk factors of complications/past diseases, etc. of nivolumab monotherapy in patients with various complications/histories (Autoimmune disease, tuberculosis, hepatitis B, hepatitis C), elderly patients, or patients with a history of vaccination.To characterize risk factors for the development of irAEs with a high risk of becoming serious.
Safety
Safety profile of Nivolumab in patients with various complications/past history (autoimmune disease, tuberculosis, hepatitis B, hepatitis C), elderly patients, and vaccinated patients (incidence of adverse events, incidence of special interest, time of onset, etc.)Risk factors for the development of irAEs with a high risk of becoming serious
Safety profile in the overall population"incidence of adverse events,incidence of adverse event of special interest,time of onset, etc."/Risk factors for recurrence/aggravation of various complications/past histories"autoimmune disease,tuberculosis,hepatitisB,hepatitis C"Safety profile in each autoimmune disease"number of events,number of events of Grade3 or more and outcome"
Others,meta-analysis etc
Not applicable |
Not applicable |
Male and Female
In the post marketing survey of nivolumab for each of the following cancer types, patients who met the criteria for safety analysis among the population in which fixed CRFs were collected.
/Unresectable malignant melanoma
/Unresectable,advanced or recurrent NSCLC
/Unresectable or metastatic renal cell cancer
/Recurrent or distant metastatic head and neck cancer
/Unresectable advanced or recurrent gastric/gastroesophageal
junction cancer that has progressed after chemotherapy
Of the patients who met the criteria for the safety analysis set, those for whom the site approval was not obtained for the use of PMS data.
7421
1st name | Hiroki |
Middle name | |
Last name | Matsumoto |
Ono Pharmaceutical Co., Ltd.
Oncology Medical , Medical Affairs
541-8564
8-2,Kyuutaromachi 1-chome, Chuo-ku osaka-shi, Osaka
06-6263-2992
hi.matsumoto@ono.co.jp
1st name | Kenji |
Middle name | |
Last name | Hiraizumi |
Ono Pharmaceutical Co., Ltd.
Oncology Medical , Medical Affairs
541-8564
8-2,Kyuutaromachi 1-chome, Chuo-ku osaka-shi, Osaka
06-6263-2992
hiraizumi@ono.co.jp
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb K.K.
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb K.K.
Profit organization
Ono Pharmaceutical CO.,LTD. "Medical and Health Research Involving Human Subjects" Ethics Committee
8-2,Kyuutaromachi1-chome,Chuo-ku, osaka-shi,Osaka
06-6263-2992
n.nishiwaki@ono.co.jp
NO
2022 | Year | 09 | Month | 09 | Day |
Unpublished
No longer recruiting
2022 | Year | 07 | Month | 01 | Day |
2022 | Year | 07 | Month | 01 | Day |
2022 | Year | 10 | Month | 01 | Day |
2024 | Year | 06 | Month | 30 | Day |
None
2022 | Year | 09 | Month | 09 | Day |
2023 | Year | 12 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055680
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