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

1,000 participantsStarted 2026-05-01

Plain-language summary

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.

Who can participate

Age range15 Years

SexALL

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Inclusion criteria

✓. Having definitive diagnosis code of colorectal cancer \[International Classification of Diseases (ICD)-10 code: C18, C19 or C20\] on the index month or within 6 months before index month \[-6 month to 0 month (index month)\]. An inpatient or outpatient visit assigned a diagnosis code consistent with colorectal cancer using ICD-10 coding:
✓. Having at least one medical record between 180 days and 1 day before the index date (Day -180 to -1) and having at least one medical record prior to 181 days before the index date (Day -181 and before)
✓. 15 years of age or older at the index date (Day 0)

Exclusion criteria

✕. Having initial prescriptions for Bevacizumab-Pfizer biosimilar and Avastin on the same date (index date for both drugs being identical)
✕. Having the prescription of Other Bevacizumab Biosimilars on the same date as the earlier index date of Bevacizumab-Pfizer biosimilar or Avastin
✕. Have definitive diagnosis code of major haemorrhage between 180 days and 1 day before the index date (Day -180 to 1): between 6 months and 1 month before the month in which the index date is included (Month -6 to -1) Major haemorrhage: basic condition and any of additional conditions (2, 5 or 6). The outcome incidence date is the earliest date of the composite criteria between 180 days and 1 day before the index date (Day -180 to 1): between 6 months and 1 month before the month in which the index date is included (Month -6 to -1)
✕. Have diagnosis code of minor haemorrhage between 30 days and 1 day before the index date (Day -30 to -1): 1 month before the month in which the index date is included (Month -1) Minor haemorrhage: basic condition and any of additional conditions (1, 3 or 4). The outcome incidence date is the earliest date of the composite criteria between 30 days and 1 day before the index date (Day -30 to -1): 1 month before the month in which the index date is included (Month -1)

What they're measuring

Incidence rate of "haemorrhage"

Timeframe: From index date (Day 0) up to 90 days after last prescription

Trial details

NCT IDNCT07527832

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-05-31

Contact for this trial

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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