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Re: None

Sunday, 09/17/2017 11:46:27 PM

Sunday, September 17, 2017 11:46:27 PM

Post# of 4159
The reason they will do a 6 month checkup (and why they were required to do a three month) is because it is written into the study to determine RFS. RFS is the exploratory outcome endpoint for the .35 dose patients.
  
The exploratory outcome endpoint in the Study is Recurrence-Free Survival (“RFS”). RFS is defined as the interval from Day 0 (Day of treatment with TLD-1433 Photo Dynamic Therapy (“PDT”)) to documented recurrence or death from any cause, whichever occurs first. Recurrence is defined as any new tumour growth (i.e. any biopsy-confirmed new or recurrent tumour)

Other Outcome Measures:
    Efficacy: Recurrence is defined as the interval from Day 0 to documented recurrence [ Time Frame: The overall efficacy will be evaluated during the course of the study (at 3 and 6 months) ]

https://clinicaltrials.gov/ct2/show/NCT03053635?term=1433&cond=bladder+cancer&rank=1