Primary Study Endpoint

Overall Survival

  • The primary endpoint overall survival (OS) was defined as the time from the date of randomisation to death from any cause

Secondary Study Endpoints

Safety and toxicity

  • Adverse events were reported according to National Cancer Institute criteria (National Cancer Institute Common Terminology criteria for Adverse Events (NCI CTCAE) Version 4.0)

Quality of Life

  • General and liver disease-specific quality of life scores were calculated using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire QLQ-C30 version 3 and the HCC-specific QLQ-HCC 18 questionnaire

Progression-free survival

  • PFS was defined as the time between the date of randomisation to the date of disease progression or death

Response rate

  • Response assessment included Complete Response (CR), Partial Response (PR), stable disease, or disease progression
  • Response rate was defined as the proportion of patients having a best response over time of CR or PR
  • Response rate was determined from serial CT scans using Response Evaluation Criteria in Solid Tumours (RECIST), modified RECIST, European Association for the Study of the Liver (EASL) criteria for HCC, and Choi criteria
  • Radiological examinations were conducted by abdominal radiologists at each centre

Healthcare costs

  • The cost of therapy from the hospital’s perspective was estimated by including all the resources that are directly attributable to the procedure (that is, equipment, tests, total work time, and so on), which was assigned a value based on the purchase price by the hospital
  • The mean overall cost per patient from the payer’s perspective included the relative stay index and readmissions during the patient’s follow-up period
  • Calculation of the incremental cost-effectiveness ratio per year of survival or the incremental cost-utility ratio between radioembolisation and sorafenib will be complemented by the bootstrap resampling method and an acceptability curve for the cost-effectiveness ratio
  • The results of the healthcare costs analysis will be published separately


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