RE:RE:RE:RE:RE:RE:Principal investigator for TH1902 “In practice, unevaluable patients at the time of analysis are nevertheless expected to occur. Here, an unevaluable patient is defined as a patient whose response to treatment cannot be determined due to the occurrence of some concurrent uncontrolled event which modifies the therapeutic evaluation schedule. Non-evaluability may occur despite the efforts of the investigators to follow the evaluation schedule as carefully as possible. Such situation is exemplified in our clinical example where the Magnetic resonance imaging (MRI) exam can be postponed for several weeks due to the critical condition of the patient. In some cases, the non evaluability can be informative such as the occurence of a toxicity that requires to stop the treatment.”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4569274/
qwerty22 wrote:
I don't think evaluable is how you are defining it. In a well run trial the bar should be set very low. For example receiving one dose should be about all a patient needs to be evaluable. Having said that in an interim update I think there is wiggle room. So if patients haven't yet reached a scan and are still ongoing it seems reasonable to leave them out for that update but not for the final readout.
"toxicity, illness, death" I don't believe would ever b3 a valid reason to leave out patients.
scarlet1967 wrote: "Of the 18 response-evaluable patients in this heavily treated patient population with advanced or metastatic cancers..."
so they are excluding none evaluable patients all the patients who drop off due to toxicity, illness, death etc. how many at what stage(cycle), why?