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Multiple intratumoral mIL-12 gene electrotransfer resulted in 50% tumor cures, with a temporary increase of the complete response percentage up to 57.1% at day 15.
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Adequately powered RCTs were included if they assessed at least one of the following common efficacy end points (primary and secondary): 1) the percentage of patients achieving complete response (CR); 2) the percentage of patients achieving no emetic episodes; and 3) the percentage of patients achieving no episodes of nausea.
The relative decreases in FDG uptake and CT HU as measured in an ROI of patients with either stable disease or partial or complete response are given as percentage values.
The primary outcomes analyzed were the number and percentage of complete response letters with deficiencies in each of the domains and subdomains and the number and percentage of such statements that appeared in the associated press releases.
The OR rate (ORR) was expressed as the sum of the percentage of complete response (CR) and partial response (PR).
The primary objective of the study was the percentage of complete response rate considering its potential prognostic significance.
Longer (6-month) compared with shorter (3-month) abiraterone acetate administration achieved a greater percentage of pathologic complete response (CR) (10% vs. 4%, respectively), near pathologic CR (24% vs. 11%, respectively), and any disease shrinkage, as assessed by a composite endpoint of true pathologic CR plus near CR (15% vs. 34%, respectively) [ 56].
Objective response rate (ORR) was defined as percentage of patients showing complete response (CR) or partial response (PR) as best response according to RECIST.
Disease control rate was defined as the percentage of patients with complete response (CR), partial response (PR), and stable disease (SD) for at least 8 weeks.
The primary end point was the percentage of patients with complete response (no emesis and no rescue therapy) in the overall phase.
In terms of clinical response the percentage of patients showing complete response (CR), incomplete response/stable disease of primary lesion (IR/SD), and progressive disease (PD) was 19.2, 69.2, and 11.5%, respectively.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com