Special drug use-results survey on BALVERSA

Special drug use-results survey on BALVERSA - BAL1L

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059331

Enrollment

Registered

2025-10-08

Start date

2025-11-01

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

unresectable urothelial carcinoma with FGFR3 gene mutations or fusion genes that has progressed after cancer chemotherapy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with unresectable urothelial carcinoma with FGFR3 gene mutation or fusion that has progressed after cancer chemotherapy who have received BALVERSA for the first time will be included.

Exclusion criteria

Exclusion criteria: Patients with a history of the use of BALVERSA

Design outcomes

Primary

Measure	Time frame
1_Occurrence of adverse reactions included in safety specifications 2_Occurrence status of adverse reactions of eye disorder, skin disorder, and skin disorder (excluding hand and foot syndrome) 3_Factors that may affect adverse reactions in the safety specifications (e.g., occurrence by patient background) * 4_Factors that may affect adverse reactions of eye disorders, skin disorders, and skin disorders (excluding hand and foot syndrome) (e.g., occurrence status by patient background) * *: Tabulation and analysis will be performed when there are more than 5 cases.	—

Measure

Time frame

1_Occurrence of adverse reactions included in safety specifications 2_Occurrence status of adverse reactions of eye disorder, skin disorder, and skin disorder (excluding hand and foot syndrome) 3_Factors that may affect adverse reactions in the safety specifications (e.g., occurrence by patient background) * 4_Factors that may affect adverse reactions of eye disorders, skin disorders, and skin disorders (excluding hand and foot syndrome) (e.g., occurrence status by patient background) * *: Tabulation and analysis will be performed when there are more than 5 cases.

—

Countries

Japan

Contacts

Public ContactSayuri Harada

Janssen Pharmaceutical K.K. Post-Approval Delivery Unit

sharada8@its.jnj.com080-1288-9551

Outcome results