Table 6.
Responder analysis based on various MID methods
| FACT-M Subscales and Summary scores | Percentage of responders[a] at Week 7 by MID calculation method | |||
|---|---|---|---|---|
| SEM[b] | Anchor[c] | Minimum threshold | Maximum threshold | |
| FACT-G subscales | ||||
| Physical well-being (PWB) | 18.4 | 32.7 | 32.7 | 18.4 |
| Social/Family well-being (SWB) | 22.4 | 53.1 | 53.1 | 18.4 |
| Emotional well-being (EWB) | 34.7 | 34.7 | 44.9 | 26.5 |
| Functional well-being (FWB) | 30.6 | 30.6 | 34.7 | 22.4 |
| Melanoma-specific subscales | ||||
| Melanoma Subscale (MS) | 22.4 | 26.5 | 34.7 | 20.4 |
| Melanoma surgery scale (MSS) | 22.4 | 22.4 | 30.6 | 20.4 |
| Summary scales | ||||
| FACT-M TOI | 24.5 | 22.4 | 30.6 | 14.3 |
| FACT-G total score | 30.6 | 34.7 | 34.7 | 20.4 |
| FACT-M total score | 28.6 | 28.6 | 28.6 | 14.3 |
| MCC-Specific scores | ||||
| Physical Function score (PF) | 18.4 | 26.5 | 26.5 | 12.2 |
| Psychological Impact score (PI) | 38.8 | 51.0 | 51.0 | 26.5 |
| MCC summary score | 24.5 | 30.6 | 30.6 | 18.4 |
MCC Merkel cell carcinoma, MID Minimally important difference, PAS PRO analysis set, SEM Standard error of measurement, TOI Trial Outcome Index
Percentage of responders were assessed in the PAS (N = 70)
[a]A responder is defined as a patient whose score had changed relative to baseline by an amount greater than or equal to the MID; [b]SEM was calculated using Cronbach's alpha for internal consistency reliability; [c]Reduction in tumor size ≥30% was used as the anchor for MID thresholds