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Table 1 Outcomes, measures and methods of analysis

From: Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial

Outcome Hypothesis/outcome measure Methods of analysis
Primary outcome
 Feasibility of NGS 80% of patients will present a validated sequencing report including a clinical recommendation from the MTB within 7 weeks from the receipt of the blood and tumor samples Binomial test/ Confidence Interval
Main secondary outcomes
 Overall survival (OS) Improvement of OS in NGS arm Kaplan-Meir/Log-rank test
 Progression-free survival (PFS) Improvement of PFS in NGS arm Kaplan-Meir/Log-rank test
 Patients with targetable genomic alterations Count and proportion of patients Confidence Interval
 Antitumor activity under targeted therapy (objective response, best overall response, disease control rate) Count and proportion of patients following RECIST1.1 criteria. Confidence Interval