Survey of Bevacizumab BS "Daiichi Sankyo" - Cohort study using EBM Provider-

JRCT ID: jRCT2031220643

Registered date:16/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colon and rectal cancer
• Date of first enrollment: 01/04/2008
• Target sample size: 500
• Study type: Observational

Outcome(s)

• Primary Outcome: Occurrence of hypertension
• Secondary Outcome: Other safety specification

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria will be enrolled.
1) During the enrollment period (December 1, 2019 to March 31, 2024), there is a prescription for either Avastin or Bevacizumab BS "Daiichi Sankyo". The earliest date of prescription of the Avastin or Bevacizumab BS "Daiichi Sankyo" during the enrollment period will be defined as the "cohort entry date".
2) There is a diagnosis of colon or rectal cancer during on the same month as the cohort entry date.
3) The earliest medical record date after the data period start date is at least 90 days before the cohort entry date.

Exclude criteria

Exclude patients who meet any of the following criteria:
1) There are prescriptions of bevacizumab (Bevacizumab BS "Daiichi Sankyo", Avastin, other bevacizumab) from the start of the survey period to the day before the cohort entry date.
2) There is a diagnosis of cancer except for colon or rectal cancer during on the same month as the cohort entry date.
3) There is a diagnosis of hypertension that meets the outcome definition from the start of the survey period to the day before the cohort entry date.
4) There are several prescriptions of bevacizumab (Bevacizumab BS "Daiichi Sankyo", Avastin, other bevacizumab) on the cohort entry date.
5) There is no medical record after the day following the cohort entry date.

Related Information

• Primary Sponsor: Tanabe Hirokazu