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

Survey on the occurrence of each safety specification after administration of Trastuzumab BS "Daiichi Sankyo" - Cohort study using EBM Provider-

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031220642

Enrollment

3075

Registered

2023-02-16

Start date

2008-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast and gastric cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria will be enrolled. 1) During the enrollment period (November 1, 2018 to November 30, 2024), 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Occurrence of heart disorder	—

Secondary

Measure	Time frame
1) Heart failure 2) Other safety specification	—

Contacts

Public ContactGPSP Contact

Daiichi Sankyo Co.,Ltd.

contact_gpsp_jp@daiichisankyo.com+81-3-6225-1059

Outcome results