NDB Analysis of ILD and OSE for Datroway

Event Profile and Proper Management of ILD and OSE Associated with Datroway in Japan Using National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031260195

Enrollment

1500

Registered

2026-06-05

Start date

2027-04-15

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 Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with a prescription of the study drug during the inclusion period (March 19, 2025 to March 31, 2026). 2) Patients with presence of a breast cancer diagnosis (includes suspected diagnoses) in the same month as the cohort entry date.

Exclusion criteria

Exclusion criteria: 1) Patients who have prescriptions of any anticancer drug other than the study drug on the cohort entry date.

Design outcomes

Primary

Measure	Time frame
Interstitial lung disease (ILD) event Ocular surface events (OSE) related event	—

Secondary

Measure	Time frame
Proper management of ILD and OSE Treatment for OSE	—

Contacts

Public ContactGPSP for Contact

Daiichi Sankyo Co., Ltd.

contact-epis_JP@daiichisankyo.com+81-3-6225-1193

Outcome results