Pfizer
Tokyo, Japan
NCT Number: NCT07527832
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.
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Notify Me15 year and older
All sexes
Observational
Tokyo, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Exclusion criteria
Patients meeting any of the following criteria will not be included in the study.
"Common"
"Haemorrhage"
"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)
As provided in real world practice
As provided in real world practice
Time frame: From index date (Day 0) up to 90 days after last prescription
Time frame: From index date (Day 0) up to 90 days after last prescription
Time frame: From index date (Day 0) up to 90 days after last prescription
Time frame: From index date (Day 0) up to 90 days after last prescription
Time frame: From index date (Day 0) up to 90 days after last prescription
Time frame: From index date (Day 0) up to 90 days after last prescription
Time frame: From index date (Day 0) up to 90 days after last prescription
Time frame: From index date (Day 0) up to 90 days after last prescription
Time frame: From index date (Day 0) up to 90 days after last prescription
Time frame: From index date (Day 0) up to 90 days after last prescription
Time frame: From index date (Day 0) up to next day after last prescription
Time frame: From index date (Day 0) up to 90 days after last prescription
Time frame: From index date (Day 0) up to 90 days after last prescription
Time frame: From index date (Day 0) up to 90 days after last prescription
Pfizer
Industry
BEVACIZUMAB BS INTRAVENOUS INFUSION 100MG, 400MG [PFIZER] POST-MARKETING DATABASE STUDY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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