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

JRCT ID: jRCT2031220642

Registered date:16/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast and gastric cancer
• Date of first enrollment: 01/01/2008
• Target sample size: 75
• Study type: Observational

Outcome(s)

• Primary Outcome: Occurrence of heart disorder

Secondary Outcome

1) Heart failure
2) 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 (November 1, 2018 to March 31, 2028), there is a prescription for either Herceptin or Trastuzumab BS "Daiichi Sankyo". The earliest date of prescription of the Herceptin or Trastuzumab BS "Daiichi Sankyo" during the enrollment period will be defined as the "cohort entry date".
2) There is a diagnosis of breast or gastric cancer during the enrollment period.
3) There is a diagnosis of breast or gastric cancer during on the same month as the cohort entry date during the enrollment period.
4) 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 is a diagnosis of heart disorder before the day prior to the cohort entry date.
2) There is no medical record after the day following the cohort entry date.
3) There are several prescriptions of trastuzumab (Trastuzumab BS "Daiichi Sankyo", Herceptin, other trastuzumab) on the cohort entry date.

Related Information

• Primary Sponsor: Tanabe Hirokazu