Patient-reported outcome assessments
intra-abdominal tumor, tumor, swelling, fatigue, Pain, pain
MUSCLE WEAKNESS, APPENDIX, DESMOID TUMOR, TUMOR
The GODDESSDTSS comprises 11 items assessing key signs and symptoms severity including pain, fatigue, swelling, muscle weakness, difficulty moving (items 1–7); a question referring to tumor location (item 8); and intra-abdominal-specific signs/symptoms (items 9–11) administered only to those reporting intra-abdominal tumor location in item 8. DTIS comprises 17 items assessing symptoms impact on functioning and daily living. DTSS items 1–7 and 9–11 are evaluated on an 11-point numeric rating scale (NRS) from 0 to 10 to measure severity from “none” to “as bad as you can imagine,” with a 24-h recall period; item 8 asks for the specific location of the desmoid tumor. DTIS items are evaluated either on a 5-point Likert scale ranging from “none of the time” to “all of the time” to measure frequency (items 1–9), or an 11-point NRS from 0 to 10 to measure severity from “none” to “as bad as you can imagine” (items 10–17), with a 7-day recall period. Higher scores indicate more severe symptomatology/impact. GODDESSOther PRO measures used in the analysis included the Brief Pain Inventory Short Form (BPI-SF) [All PRO measures were completed by the patients using home electronic PRO (ePRO) devices at screening, baseline (i.e., Cycle 1), and in 28-day cycles thereafter. For full details of the PRO measure assessment schedule, see Appendix 4 of the supplementary material.