NCT07527832Befejeződött
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 3.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 1000 (tényleges)
- Első benyújtás
- 2026. ápr. 7.
- Kezdés
- 2026. ápr. 20.
- Elsődleges befejezés
- 2026. máj. 27.
- Fő szponzor
- Pfizer
- Betegségek
- Vastagbélrák, Gyermekkori daganatok
- NCT-szám
- NCT07527832
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 1000
- 2026. ápr. 20. és az elsődleges befejezés (2026. máj. 27.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Having initial prescriptions for Bevacizumab-Pfizer biosimilar and Avastin on the same date (index date for both drugs being identical)
- 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)
Más betegség
- Having the prescription of Other Bevacizumab Biosimilars on the same date as the earlier index date of Bevacizumab-Pfizer biosimilar or Avastin
- "Haemorrhage"
Egyéb
- "Common"
Kiket keres a vizsgálat
- 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)
Életkor a regiszterben: 15 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Pfizer Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Tokyo | Japán | Ismeretlen állapot |
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