Real-life Enfortumab Vedotin Outcomes as First-line Urothelial Carcinoma Treatment in the Non-interventional Observational and Nationwide French Study

ENCePP Code of conduct

N/A

Data sources

• Data source(s):
  Other data source
• Data source(s), other:
  Part 1; Data will be re-used from the EAP baseline CRF and extracted from medical charts of patients treated at sites that took part in the French EV+P EAP.; Part 2; Data will be re-used from the EAP baseline CRF and extracted from the SNDS.; The SNDS covers the entire French population (65.3 million inhabitants) and contains exhaustive data on all reimbursements for health-related expenses, including medicinal products (through standard reimbursement and compassionate use, such as EAP) and outpatient medical and nursing care prescribed or performed by healthcare professionals, as well as demographic data such as age, sex, area of residence (postcode), vital status and complementary universal health insurance.; In addition, data extracted from medical charts in the subset of patients who participate in Part 1 will be re-used, allowing the use of complementary information in these patients (e.g., dose adjustments extracted from medical charts and long-term OS documented from the SNDS).
• Data sources (types):
  Non-interventional study

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No