Study identification

EU PAS number

EUPAS104456

Study ID

104457

Official title and acronym

A Non-Interventional Post-Authorization Safety Study (NI-PASS) as an effectiveness check of a Patient Card for Padcev™

DARWIN EU® study

No

Study countries

France
Germany
Italy
Poland
Spain
Sweden
Switzerland

Study description

Padcev is a treatment for cancer in the bladder lining (urothelial cancer). Padcev is injected through a vein (known as an infusion). Padcev is now available in some countries in Europe.
People in this study will be adults with locally advanced (the cancer has spread to nearby tissue) or metastatic urothelial cancer. Metastatic means the cancer has spread to other parts of the body.
During their care, the person’s doctor will have prescribed Padcev treatment and other medicines to treat their cancer.
People in the study will be treated according to their clinic’s standard practice. This study is about collecting information only.
This study will survey people who know they are receiving Padcev treatment and have been given an information leaflet called a Patient Card.
The aim of the study is to check how well people understand the information on the Patient Card, including the risk of skin reactions that can be caused by Padcev treatment. Once a doctor has prescribed Padcev treatment, the patient (or their caregiver) will be asked if they would like to complete a survey. The survey will be completed on a computer and should take about 15 minutes to complete.

Study status

Finalised

Contact details

Samantha Kimball

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Astellas
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)