Unique ID issued by UMIN | UMIN000033312 |
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Receipt number | R000037973 |
Scientific Title | EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW |
Date of disclosure of the study information | 2018/07/06 |
Last modified on | 2022/11/16 16:27:32 |
EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW
EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW
EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW
EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW
Japan |
Patients with RCC with distant metastasis treated with nivolumab under real clinical practice.
Urology |
Malignancy
NO
The purpose of this study on patients with metastatic renal cell carcinoma (RCC), who started treatment with nivolumab in clinical practice in Japan, is to collect data on the use of nivolumab under actual clinical conditions and clarifies the following.
Others
To describe actual usage and pattern of nivolumab in advanced/metastatic RCC patients in clinical practice; such as treatment frequency, treatment-history before and after nivolumab use, treatment period, treatment line, changes related to management of adverse events (AEs), etc
To assess overall effectiveness (overall survival [OS], progression-free survival [PFS], objective response rate [ORR], duration of response [DOR]) and safety of nivolumab in advanced/metastatic RCC patients
To describe actual usage and pattern of nivolumab in advanced/metastatic RCC patients in clinical practice; such as treatment frequency, treatment-history before and after nivolumab use, treatment period, treatment line, changes related to management of adverse events (AEs), etc
To assess overall effectiveness (overall survival [OS], progression-free survival [PFS], objective response rate [ORR], duration of response [DOR]) and safety of nivolumab in advanced/metastatic RCC patients
Effectiveness and safety by special subgroup; brain metastasis and non-clear cell RCC etc
Effectiveness and safety in post-nivolumab treatment; treatment-history, regimen/response/AE etc
Observational
20 | years-old | <= |
Not applicable |
Male and Female
A patient with RCC with distant metastasis treated for the first time with nivolumab between 01 Feb 2017 and 31 Oct 2017.
Patients who have participated in some trials with immuno-checkpoint blockade before or after treatment with nivolumab after diagnosis with RCC.
200
1st name | Hiroaki |
Middle name | |
Last name | Ito |
Bristol-Myers Squibb
Japan Medical & Development, Oncology Medical
1000004
1-2-1 Otemachi, Chiyoda-ku, Tokyo 100-0004
03-6705-7000
hiroaki.ito@bms.com
1st name | Mayu |
Middle name | |
Last name | Kakiuchi |
Mebix, Inc
Oncology Group
1050001
Toranomon, Minato-ku, Tokyo 3-8-21 Toranomon33 Mori Building 10F
03-4362-4504
rcc-outcome@mebix.co.jp
Bristol-Myers Squibb
Ono Pharmaceutical CO.,LTD.
Bristol-Myers Squibb
Ono Pharmaceutical CO.,LTD.
Profit organization
Mebix, Inc
Toranomon, Minato-ku, Tokyo 3-8-21 Toranomon33 Mori Building 10F
03-4362-4504
rcc-outcome@mebix.co.jp
NO
2018 | Year | 07 | Month | 06 | Day |
Partially published
200
Completed
2018 | Year | 03 | Month | 26 | Day |
2018 | Year | 01 | Month | 31 | Day |
2018 | Year | 08 | Month | 01 | Day |
2020 | Year | 10 | Month | 31 | Day |
This study is a non-interventional, medical record review of clinical data collected from Japanese patients using an electronic data collection (EDC) system.
2018 | Year | 07 | Month | 06 | Day |
2022 | Year | 11 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037973
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