Skip to content

Post-Marketing Database Study of Bevacizumab BS

Cohort Study Using the MDV Database to Compare the Risk of Venous Thromboembolism Associated with Bevacizumab BS for I.V. Infusion 100 mg / 400mg CTNK versus Control Drugs

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT2031250738
Enrollment
18000
Registered
2026-02-17
Start date
2022-11-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer, Breast cancer, Ovarian cancer, Malignant glioma

Interventions

None listed

Sponsors

Sekine Keiko
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Incidence of venous thromboembolism (VTE)

Contacts

Public ContactKeiko Sekine

NIPPON KAYAKU CO. LTD.

keiko.sekine@nipponkayaku.co.jp+81-80-7021-7086

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026