JRCT ID: jRCT2031250738
Registered date:17/02/2026
Post-Marketing Database Study of Bevacizumab BS
Basic Information
| Recruitment status | Not Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Colorectal cancer, Breast cancer, Ovarian cancer, Malignant glioma |
| Date of first enrollment | 16/11/2022 |
| Target sample size | 18000 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Incidence of venous thromboembolism (VTE) |
|---|---|
| Secondary Outcome | none |
Key inclusion & exclusion criteria
| Age minimum | >= 20age old |
|---|---|
| Age maximum | Not applicable |
| Gender | |
| Include criteria | Patients included in the MDV database (from November 1, 2020 to February 28, 2025) who were diagnosed with colorectal cancer, breast cancer, ovarian cancer, or malignant glioma and prescribed either the study drug or comparator drugs, and who met the inclusion criteria and did not meet the exclusion criteria. Inclusion Criteria -Patients with a prescription record of Bevacizumab Biosimilar (CTNK) or Avastin on or after November 16, 2022 (the launch date of the study drug). -Age >= 20 years at the index date. -Patients with medical records available in the database for at least 90 days prior to the index date. -Patients with one of the following ICD-10 codes at the index date: C18: Malignant neoplasm of colon C19: Malignant neoplasm of rectosigmoid junction C20: Malignant neoplasm of rectum C50: Malignant neoplasm of breast C56: Malignant neoplasm of ovary C71: Malignant neoplasm of brain |
| Exclude criteria | -Patients who received at least one prescription of a bevacizumab preparation during the LBP period. -Patients who, on the index date, were prescribed both the study drug and the comparator drug, or patients who, on the index date, were prescribed the study or comparator drugs together with another bevacizumab preparation. -Patients who, during the LBP period, had a medical encounter corresponding to treatment for PE/DVT and, in the same month, had at least one diagnostic code for PE/DVT. |
Related Information
| Primary Sponsor | Sekine Keiko |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Keiko Sekine |
| Address | 1-1, MARUNOUCHI 2-CHOME, CHIYODA-KU, TOKYO 100-0005, JAPAN Tokyo Japan 100-0005 |
| Telephone | +81-80-7021-7086 |
| keiko.sekine@nipponkayaku.co.jp | |
| Affiliation | NIPPON KAYAKU CO. LTD. |
| Scientific contact | |
| Name | Keiko Sekine |
| Address | 1-1, MARUNOUCHI 2-CHOME, CHIYODA-KU, TOKYO 100-0005, JAPAN Tokyo Japan 100-0005 |
| Telephone | +81-80-7021-7086 |
| keiko.sekine@nipponkayaku.co.jp | |
| Affiliation | NIPPON KAYAKU CO. LTD. |