NCT07527832已完成不适用
BEVACIZUMAB BS INTRAVENOUS INFUSION 100MG, 400MG [PFIZER] POST-MARKETING DATABASE STUDY
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence rate of "haemorrhage"
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- •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)
- •15 years of age or older at the index date (Day 0)
排除标准
- •Patients meeting any of the following criteria will not be included in the study.
- •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)
- •"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)
研究组 & 干预措施
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 2. Patients without any use of Bevacizumab product (Avastin, Bevacizumab-Pfizer Biosimilar, other Bevacizumab Biosimilars) before index date.
干预措施: Bevacizumab-Pfizer Biosimilar (Drug)
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 2. Patients without any use of Bevacizumab product (Avastin, Bevacizumab-Pfizer Biosimilar, other Bevacizumab Biosimilars) before index date.
干预措施: Avastin (Drug)
结局指标
主要结局
Incidence rate of "haemorrhage"
时间窗: From index date (Day 0) up to 90 days after last prescription
次要结局
- Incidence rate of "arterial thromboembolism"(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 "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 "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)
研究者
研究点 (1)
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