{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"139"}]}],"title":"Cycle 3 day 1 change <8 points"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"40"}]}],"title":"Cycle 3 day 1 change ≥8 points"}],"denoms":[{"counts":[{"groupId":"OG000","value":"174"},{"groupId":"OG001","value":"179"}],"units":"Participants"}],"description":"PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value. At the cut-off date for this analysis, one more patient data has been gained.","groups":[{"description":"Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.","id":"OG000","title":"Sorafenib (Nexavar, BAY43-9006)"},{"description":"Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 Day 1 or, for those discontinuing prior to that visit, at the end of study. It was summarized as number of patients with change from baseline \\<8 to ≥8 points for each treatment group up to the cutoff date of 09 Feb 2007.","reportingStatus":"POSTED","timeFrame":"from randomization to end of treatment up to the data cutoff date approximately 23 months after start of enrollment","title":"Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire","type":"POST_HOC","unitOfMeasure":"Participants"}