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16 If endoscopic examination or tumor marker evaluation were not carried out, the response was considered "not evaluable".
These patients were considered not evaluable when determining antimicrobial adequacy and were excluded from the analysis.
Ten patients were considered not evaluable; that is, eight went off study early because of toxicity, one patient died early because of progressive disease, and in one patient the lesions were too small.
Among eligible patients five patients were considered not evaluable for response (two refused further treatment, one received anastrozole instead of letrozole and two did not achieve postmenopausal status within 3 months and were submitted to surgery).
Improvements to the abstraction tool included clarification of the definition of which images were considered not evaluable due to the inability to clearly visualise the C7 and L1 vertebra.
Twelve out of 196 patients initially included were considered not evaluable because the biopsy was not performed (n = 4) or results obtained showed normal tissue (n = 3), benign disease (n = 3) or a second neoplasm (n = 2) (Fig. 1).
Similar(54)
If two or more of a maximum of six evaluable patients experienced a DLT within a cohort, that dose was considered not tolerated.
Two patients who were withdrawn from the study because of the appearance of toxicity in cycle 1 were considered as not evaluable.
Samples harboring cells scored as tumor cells in both AE1AE3-incubated slides and in the corresponding negative control slides were considered as not evaluable and excluded from conclusion.
On the other hand, 60% (15/25) and 40% (10/25) of DLBCL frozen samples were classified as ABC and GC type, respectively, according to the classifier of Wright et al. based on gene expression profiling data, with four cases considered as not evaluable.
Patients for whom the course of NEW-FILL® was not followed by a monitoring visit at 12 18 months after the last injection session or whose evaluation visit at 12 18 months was not evaluable were considered as lost to follow-up.
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