NIPH Clinical Trials Search

JAPANESE
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) studiedColorectal cancer, Breast cancer, Ovarian cancer, Malignant glioma
Date of first enrollment16/11/2022
Target sample size18000
Countries of recruitment
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeIncidence of venous thromboembolism (VTE)
Secondary Outcomenone

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Gender
Include criteriaPatients 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

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
E-mail 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
E-mail keiko.sekine@nipponkayaku.co.jp
Affiliation NIPPON KAYAKU CO. LTD.