JRCT ID: jRCT2031260195
Registered date:05/06/2026
NDB Analysis of ILD and OSE for Datroway
Basic Information
| Recruitment status | Not Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Breast Cancer |
| Date of first enrollment | 15/04/2027 |
| Target sample size | 1500 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Interstitial lung disease (ILD) event Ocular surface events (OSE) related event |
|---|---|
| Secondary Outcome | Proper management of ILD and OSE Treatment for OSE |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include 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. |
| Exclude criteria | 1) Patients who have prescriptions of any anticancer drug other than the study drug on the cohort entry date. |
Related Information
| Primary Sponsor | Tanabe Hirokazu |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | GPSP for Contact |
| Address | 3-5-1,Nihonbashi Honcho,Chuo-Ku, Tokyo Tokyo Japan 103-8426 |
| Telephone | +81-3-6225-1193 |
| contact-epis_JP@daiichisankyo.com | |
| Affiliation | Daiichi Sankyo Co., Ltd. |
| Scientific contact | |
| Name | Hirokazu Tanabe |
| Address | 3-5-1,Nihonbashi Honcho,Chuo-Ku, Tokyo Tokyo Japan 103-8426 |
| Telephone | +81-3-6225-1193 |
| contact-epis_JP@daiichisankyo.com | |
| Affiliation | Daiichi Sankyo Co., Ltd. |