Colorectal Cancer
Conditions
Keywords
colorectal cancer, Bevacizumab-Pfizer Biosimilar, haemorrhage, Japan
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.
Interventions
DRUGBevacizumab-Pfizer Biosimilar
As provided in real world practice
DRUGAvastin
As provided in real world practice
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of "haemorrhage" | From index date (Day 0) up to 90 days after last prescription |
Secondary
| 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 |
Countries
Japan
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed