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

BEVACIZUMAB BS INTRAVENOUS INFUSION 100MG, 400MG [PFIZER] POST-MARKETING DATABASE STUDY

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Bevacizumab-Pfizer Biosimilar; Drug: Avastin

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. 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
2. 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)
3. 15 years of age or older at the index date (Day 0)

Exclusion criteria Patients meeting any of the following criteria will not be included in the study.

"Common"

1. Having initial prescriptions for Bevacizumab-Pfizer biosimilar and Avastin on the same date (index date for both drugs being identical)
2. Having the prescription of Other Bevacizumab Biosimilars on the same date as the earlier index date of Bevacizumab-Pfizer biosimilar or Avastin

"Haemorrhage"

1. 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)
2. 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)

"Shock, anaphylaxis, hypersensitivity reactions, infusion reaction" Have definitive diagnosis code of "shock, anaphylaxis, hypersensitivity reactions, infusion reaction" between 180 days and 1 day before 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)

"Interstitial pneumonia" Have definitive diagnosis code of "interstitial pneumonia" before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)

"Cardiac disorders (excluding "cardiac failure congestive" and "arterial thromboembolism")" Have definitive diagnosis code of "cardiac disorders (excluding "cardiac failure congestive" and "arterial thromboembolism") before index date (Day -1 and before): before the month in which the index date is included (Month -1 and before)

"Infections" Have a date of hospitalization due to infection and definitive diagnosis code of "infections" between 180 days and 1 day before index date (Day -180 to -1)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposed group in Comparative Analysis Set; 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; Patients without any use of Bevacizumab product (Avastin, Bevacizumab-Pfizer Biosimilar, other Bevacizumab Biosimilars) before index date.	Drug: Bevacizumab-Pfizer Biosimilar; As provided in real world practice
Control group in Comparative Analysis Set; 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; Patients without any use of Bevacizumab product (Avastin, Bevacizumab-Pfizer Biosimilar, other Bevacizumab Biosimilars) before index date.	Drug: Avastin; As provided in real world practice

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Incidence rate of "wound healing delayed"	From index date (Day 0) up to 90 days after last prescription
Incidence rate of "gastrointestinal perforation"	From index date (Day 0) up to 90 days after last prescription
Incidence rate of "venous thromboembolism"	From index date (Day 0) up to 90 days after last prescription
Incidence rate of "fistula"	From index date (Day 0) up to 90 days after last prescription
Incidence rate of "shock, anaphylaxis, hypersensitivity reactions, infusion reaction"	From index date (Day 0) up to next day after last prescription
Incidence rate of "interstitial pneumonia"	From index date (Day 0) up to 90 days after last prescription
Incidence rate of "cardiac disorders (excluding "cardiac failure congestive" and "arterial thromboembolism")"	From index date (Day 0) up to 90 days after last prescription
Incidence rate of "infections"	From index date (Day 0) up to 90 days after last prescription

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Actual): May 27, 2026
• Study Completion (Actual): May 27, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: colorectal cancer; Japan; haemorrhage; Bevacizumab-Pfizer Biosimilar
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Hemorrhage; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab
• Other Study ID Numbers: B7391010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No