Patient-Reported Outcomes 6

  • Prespecified secondary endpoints included time to deterioration (TTD) of patient-reported physical functioning, role functioning, and global health status/quality of life (GHS/QoL) on the EORTC QLQ-C30
  • Prespecified exploratory endpoints included TTD of patient-reported symptoms of appetite loss, diarrhea, fatigue, pain, and jaundice in both the EORTC QLQ-C30 and QLQ-HCC18
  • TTD was defined per the protocol as time from randomization to first deterioration (worsening from baseline by ≥10 pts)
    • Maintained for at least two consecutive timepoints or one timepoint followed by death from any cause within 3 weeks in all of the EORTC QLQ-C30 and QLQ-HCC18 subscales
  • These endpoints were not formally tested for statistical significance
  • These results should be interpreted with caution due to the open-label design of the study


TTD of QoL and functioning scales based on the EORTC QLQ-C30 questionnaire 3,6


TTD of symptoms based on the EORTC QLQ-C30 and QLQ-HCC18 questionnaires 7

CI=confidence interval; EORTC QLQ-C30=European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire; EORTC QLQ-HCC18=European Organisation for Research and Treatment of Cancer Quality of Life of Hepatocellular Carcinoma Patients questionnaire; HR=hazard ratio; QoL=quality of life.