Unique ID issued by UMIN | UMIN000041175 |
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Receipt number | R000047015 |
Scientific Title | A cohort study on the safety of bevacizumab in combination with neoadjuvant chemotherapy in the initial treatment of advanced ovarian cancer using a Japanese healthcare database |
Date of disclosure of the study information | 2020/07/27 |
Last modified on | 2022/12/05 17:01:46 |
A cohort study on the safety of bevacizumab in combination with neoadjuvant chemotherapy in the initial treatment of advanced ovarian cancer using a Japanese healthcare database
A cohort study on the safety of bevacizumab in combination with neoadjuvant chemotherapy in the initial treatment of advanced ovarian cancer using a Japanese healthcare database
A cohort study on the safety of bevacizumab in combination with neoadjuvant chemotherapy in the initial treatment of advanced ovarian cancer using a Japanese healthcare database
A cohort study on the safety of bevacizumab in combination with neoadjuvant chemotherapy in the initial treatment of advanced ovarian cancer using a Japanese healthcare database
Japan |
Advanced ovarian cancer
Obstetrics and Gynecology |
Malignancy
NO
To reveal the safety information of bevacizumab in combination with neoadjuvant chemotherapy
Safety
The incidence of gastrointestinal perforation of neoadjuvant chemotherapy in combination with or without bevacizumab in the initial treatment of advanced ovarian cancer, and the risk ratio and risk difference of bevacizumab in combination with neoadjuvant chemotherapy compared to chemotherapy alone
Observational
Not applicable |
Not applicable |
Female
Patients with ovarian cancer, fallopian tube cancer or peritoneal cancer from April 1, 2008 to January 29, 2020
Patients with cancer other than ovarian cancer, fallopian tube cancer or peritoneal cancer
48000
1st name | Kaori |
Middle name | |
Last name | Ouchi |
Chugai Pharmaceutical Co., Ltd.
Medical Affairs Div.
103-8324
1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo 103-8324, Japan
03-3273-0866
cma-clinicaltrial@chugai-pharm.co.jp
1st name | Co., Ltd. |
Middle name | |
Last name | Chugai Pharmaceutical |
Medical Affairs Div.
Medical Science Dept.
103-8324
1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo 103-8324, Japan
03-3273-0866
cma-clinicaltrial@chugai-pharm.co.jp
Chugai Pharmaceutical Co., Ltd.
Chugai Pharmaceutical Co., Ltd.
Profit organization
Japan
Non-Profit Organization MINS
15-14 Dogenzaka 1-Chome, Shibuya-ku, Tokyo, Japan
03-6416-1868
npo-mins@j-irb.com
NO
2020 | Year | 07 | Month | 27 | Day |
N/A
Unpublished
https://pubmed.ncbi.nlm.nih.gov/36245228/
7839
PTX+CBDCA (TC) was most commonly used as first-line treatment. TC+Bev was used in 9.3% and 11.6% of patients in the NAC and PDS groups, respectively. The proportion of patients with risk factors for GI perforation in the TC+Bev group of NAC was lower compared to patients without Bev. The incidence of GI perforation in the NAC group was 0.38% in patients receiving TC+Bev and 0.18% in patients receiving TC without Bev (risk ratio=2.13; 95%CI=0.19 to 23.36; risk difference=0.20; 95%CI=-0.58 to 0.97).
2022 | Year | 12 | Month | 05 | Day |
2022 | Year | 09 | Month | 30 | Day |
Patients diagnosed with ovarian, fallopian tube or peritoneal cancer and first treated between 1 April 2008 and 29 January 2020
(Patients with suspected recurrence and patients diagnosed with other cancers are excluded)
Patients were divided into two groups: the NAC group (IDS after NAC) and the PDS group (adjuvant chemotherapy after PDS). 2864 patients in the NAC group and 2760 patients in the PDS group were selected from each group from 22 November 2013 to 30 January 2019, considering the approval date of Bev and the observation period. Cases treated with the CBDCA+PTX (TC) combination therapy and TC+Bev combination therapy were selected for adverse event analysis.
None
Incidence rates, risk ratios and risk differences for gastrointestinal perforation during the first treatment period in advanced ovarian cancer first-line NAC with and without Bev combination therapy
None
None
Completed
2020 | Year | 05 | Month | 27 | Day |
2020 | Year | 05 | Month | 27 | Day |
2008 | Year | 04 | Month | 01 | Day |
2020 | Year | 01 | Month | 29 | Day |
A cohort study using a Japanese healthcare database
2020 | Year | 07 | Month | 21 | Day |
2022 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047015
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