ADSTILADRIN Early Utilization and Outcomes in the Real World Setting

简要总结

主要结局

次要结局

• Duration of CR in patients with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who achieve CR(Up to 2 years)
• High-grade recurrence-free survival(Up to 2 years)
• Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation(1 year)
• Incidence of and time to cystectomy(Up to 2 years)
• Progression-free survival (PFS)(Up to 2 years)
• Overall Survival (OS)(Up to 2 years)
• Mortality due to bladder cancer(Up to 2 years)
• Prior treatments and outcomes before starting ADSTILADRIN treatment(Before starting ADSTILADRIN treatment)
• Number of ADSTILADRIN instillations received and time intervals between instillations(Up to 2 years)
• Reasons for discontinuation of ADSTILADRIN treatment(End of trial (up to 2 years))
• Concomitant therapies for bladder cancer and major comorbidities(Up to 2 years)
• Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician(3 months)
• Patients' caregiver experience as measured by WPAI:CG (administered at the same timepoints as the patients)(Up to 2 years)
• Subsequent line of therapy following ADSTILADRIN discontinuation(Up to 2 years)
• Customized patient baseline and follow-up experience surveys (before first ADSTILADRIN instillation and before each instillation thereafter)(Before first ADSTILADRIN instillation and before each instillation thereafter)
• Quality of life surveys (EQ-5D-5L before first ADSTILADRIN instillation)(Before first ADSTILADRIN instillation)
• Customized physician surveys (at 1 month following first patient first instillation of ADSTILADRIN, or as soon as possible upon site activation, and at 12 and 24 months post first patient first instillation at each respective site)(Up to 2 years)
• Type, incidence, relatedness to ADSTILADRIN, severity grading (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), and seriousness of adverse events collected(End of trial (up to 2 years))
• Proportion of patients with pre-specified biomarker tested in the routine care setting, along with timing, type of sampling and laboratory results(End of trial (up to 2 years))