Large study reviews bleeding risks of common cancer drug in japanese patients
NCT ID NCT07527832
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at the safety of Bevacizumab-Pfizer Biosimilar, a drug used to treat colorectal cancer, by analyzing medical records from 1,000 patients in Japan. Researchers focused on side effects like bleeding, high blood pressure, and kidney problems. The goal was to understand how safe the drug is in everyday hospital use, not to test a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
1,000 people
The number who actually took part.
- Started
-
Apr 2026
- Finished
-
May 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
-
15 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Colorectal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Pfizer
Tokyo, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a lab test tell which chemo works for colon cancer?
- Can MRI and computer models predict how well cancer drugs reach tumors?
- Gut bacteria may hold clues to why some cancer treatments work better
- Burning the edges: a new way to stop colon polyps from coming back
- Missed Follow-Up colonoscopies: do they raise the risk of advanced growths?
- A 2.2 mm scope could spot cancerous tissue in minutes, not days