Table 1.
Definition of Metrics.
| Metric | Definition |
|---|---|
| Trichotomized Best Response (Best TriTR) | Best objective status (CR/PR vs. Stable vs. Progression) |
| Confirmed Response | Two consecutive assessments of complete or partial response assessed at least 4 weeks apart (CR/PR vs. no CR/PR) |
| Trichotomized Response Status (TriTR) at a pre-defined timepoint | Objective status at the assessment closest to the pre-defined timepoint (CR/PR vs. Stable vs. Progression) |
| Total Sum of Measurements (TSM) | Sum of measurements at each assessment |
| Average Sum of Measurements (ASM) | Sum of measurements divided by the number of assessments |
| Relative change from baseline (RCB) | Sum of the relative changes since baseline, calculated as follows: divide the sum of measurements at each assessment by the sum of the baseline measurements and subtract 1; then sum this quantity over all assessments |
| Average relative change from baseline (ARCB) | RCB divided by the number of assessments |