An Observational Study to Learn About the Medicine - BEVACIZUMAB BS [Pfizer] in Colorectal Cancer Patients From Japan.

Sponsor
Pfizer
Study ID
NCT07527832
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to look at the safety of BEVACIZUMAB BS \[Pfizer\] when it was used to colorectal cancer patients in real-world clinical setting in Japan. The study population includes individuals who have a diagnosis of colorectal cancer and have been treated with Bevacizumab-Pfizer Biosimilar or Avastin between 1 December 2019 and 30 November 2024. Data source is the Medical Data Vision (MDV) database - a hospital-based claims database in Japan.

Key Dates

First listed
Apr 14, 2026
Start date
Apr 20, 2026
Status verified
Jun 2026
Primary completion
May 27, 2026
Completion
May 27, 2026

Study Design

Enrollment
1,000 participants (actual)

Arms

  • Arm: Exposed group in Comparative Analysis Set
    1. All patients treated with Bevacizumab-Pfizer Biosimilar between 1 December 2019 and 30 November 2024. The first prescription date is set as the index date (Day 0). AND 2. Patients without any use of Bevacizumab product (Avastin, Bevacizumab-Pfizer Biosimilar, other Bevacizumab Biosimilars) before index date.
  • Arm: Control group in Comparative Analysis Set
    1. All patients treated with Avastin between 1 December 2019 and 30 November 2024. The first prescription date is set as the index date (Day 0). AND 2. Patients without any use of Bevacizumab product (Avastin, Bevacizumab-Pfizer Biosimilar, other Bevacizumab Biosimilars) before index date.

Primary Outcome Measure

Incidence rate of "haemorrhage" [ Time Frame: From index date (Day 0) up to 90 days after last prescription ]

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