Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

To describe the real-world effectiveness

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Non-interventional primary and secondary data collection
Study drug and medical condition

Name of medicine

PADCEV

Study drug International non-proprietary name (INN) or common name

ENFORTUMAB VEDOTIN

Anatomical Therapeutic Chemical (ATC) code

(L01FX13) enfortumab vedotin
enfortumab vedotin

Medical condition to be studied

Transitional cell carcinoma

Additional medical condition(s)

Locally advanced or metastatic urothelial cancer
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

200
Study design details

Main study objective

To describe the safety and tolerability of EV, in a real-world setting.

Outcomes

To describe the safety and tolerability of EV, in a real-world setting, To describe real-world effectiveness of EV based on: o How EV drug-related AEs impacted course of treatment o Characteristics of patients treated with EV in real-world clinical practice o Real-world treatment patterns of EV o Real-world effectiveness of EV.

Data analysis plan

No hypothesis will be tested in this study as it is a descriptive, non-interventional retrospective study.