RE:how can an NR become not an NR?DJDawg wrote: I'm happy with the most recent data but I have a dumb question. How does a NR patient get revised to a PR or NR. If you look at the 270 day data (copied from Eoganatch post), 14 NR's became 12 NR's. I thought that an NR implied malignancy in the urine cytology AND visible disease on cystoscopy. I can see that a PR could be revised if the cells found in the urine cytology are found to come from a location in urethra or ureter (outside the field of treatment of TLT + light). I just don't get how you revise a NR when it implies that they visualized some tumour in the bladder.
Thoughts?
- maybe a site investigator give a patient an NR designation because they saw something with the scope and then revised it later based on second opinion from a top investigator?
Any other explanations?
| May 30, 2022 - Number of Patients | | | |
| | | | | | |
| | 90 Days | 180 Days | 270 Days | 360 Days | 450 Days |
| CR | 17 | 16 | 10 | 5 | 5 |
| PR | 8 | 7 | 2 | 4 | 2 |
| NR | 12 | 9 | 14 | 14 | 15 |
| | | | | | |
| Total Evaluable | 37 | 32 | 26 | 23 | 22 |
| | | | | | |
| August 29, 2022 - Number of Patients | | | |
| | | | | | |
| | 90 Days | 180 Days | 270 Days | 360 Days | 450 Days |
| CR | 19 | 16 | 13 | 9 | 5 |
| PR | 6 | 9 | 7 | 3 | 3 |
| NR | 13 | 9 | 12 | 14 | 16 |
| | | | | | |
| Total Evaluable | 38 | 34 | 32 | 26 | 24 |
I should probably just leave it alone but I won't because my "fuzzy" logic can't balance the numbers.
What tends to confuse me is what I consider the "missing" category - I have probably said this before. I assume "Total Evaluable" is not actually "Total Patients in the Trial". The title says "Number of Patients" but then they use the term "Total Evaluable" in totaling the columns. Is there a difference?
For example:
As of May 30, 2022 the Total Evaluable number at 90 days is 37.
And, as of May 30, 2022 the number at 180 days is 32.
As of Aug 29, 2022 (90 days later) everyone has moved 90 days so I assume those 37 patients that were at 90 days are now at 180 days, but the number at 180 days, as posted, is only 34. Where are the other 3? I just have trouble rationalizing the numbers -- i.e. my logic works in a different mode -- so I tend to just give them a quick scan to avoid getting overly confused and knowing there will be lots of massaging.
On May 30,2022 the number having achieved 90 days is 37.
On August 29,2022 - 90 days later - the number having achieved 90 days is 38.
So in a 90 day period we had one additional patient achieve the 90 day mark but 3 less achieve the 180 day mark?
Please tell me what is wrong with my logic - front to back, back to front? - so I possibly can
better understand what I see.
"What is the difference between the number of subjects enrolled and the number evaluable?"
"The Enrolled total is the number of subjects who consent to participate in the study. For a retrospective study, it would be the number of charts reviewed or specimens received. The Evaluable number is the total of the subjects that reach the required endpoint for the study.
Example: 100 subjects might enroll, 10 fail screening, and 20 drop out before the final study visit that is required for assessing the primary efficacy endpoint. The enrolled number is 100, the evaluable number is 80 and 90 subjects will be included in the safety analysis."
So if 450 days is the end point is it correct in using "Evaluable" at all time intervals?
Yes - totally confused in the format and presentation of the data! I'm sure it will generate a fair amount of response.