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

NCT07527832 | Not Yet Recruiting

• 1 other identifier: B7391010
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; Bevacizumab-Pfizer Biosimilar; haemorrhage; Japan

Outcome Measures

Primary Outcomes (1)

• Incidence rate of "haemorrhage"

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

Secondary Outcomes (13)

• Incidence rate of "hypertension, hypertensive crisis"

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

• Incidence rate of "proteinuria, nephrotic syndrome"

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

• Incidence rate of "bone-marrow depression"

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

• Incidence rate of "arterial thromboembolism"

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

• Incidence rate of "cardiac failure congestive"

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

Study Arms (2)

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.

Drug: Bevacizumab-Pfizer Biosimilar

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.

Drug: Avastin

Interventions

Avastin DRUG

As provided in real world practice

Control group in Comparative Analysis Set

Bevacizumab-Pfizer Biosimilar DRUG

As provided in real world practice

Exposed group in Comparative Analysis Set

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes individuals who have a diagnosis of colorectal cancer and have been treated with Bevacizumab-Pfizer Biosimilar or Avastin within a planned study period between 1 December 2019 and 30 November 2024.

You may qualify if:

• 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:
• Malignant neoplasm of colon: C18
• Malignant neoplasm of rectosigmoid junction: C19
• Malignant neoplasm of rectum: C20
• 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)
• years of age or older at the index date (Day 0)

You may not qualify if:

• "Common"
• 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
• "Haemorrhage"
• 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)
• "Hypertension, hypertensive crisis" Have definitive diagnosis code of "hypertension, hypertensive crisis" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
• "Proteinuria, nephrotic syndrome" Have definitive diagnosis code of "proteinuria, nephrotic syndrome" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
• "Bone-marrow depression" Have definitive diagnosis code of "bone-marrow depression" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
• "Arterial thromboembolism" Have definitive diagnosis code of "arterial thromboembolism" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
• "Cardiac failure congestive" Have definitive diagnosis code of "cardiac failure congestive" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
• "Wound healing delayed" Have definitive diagnosis code of "wound healing delayed" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
• "Gastrointestinal perforation" Have definitive diagnosis code of "gastrointestinal perforation" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
• "Venous thromboembolism" Have definitive diagnosis code of "venous thromboembolism" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)
• "Fistula" Have definitive diagnosis code of "fistula" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Hemorrhage

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share