PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. SD was when a case does not qualify for either PR or PD. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. For participants whose best overall response (BOR) was SD, the duration of SD was defined as the time from the date of randomization to the first documented PD or death, whichever occurred first. Clinical Benefit Rate (CBR) ĬBR was defined as the percentage of participants with a best overall response of CR or PR or durable SD (duration of SD >=23 weeks after randomization).As planned, data for this pre-specified endpoint was collected and analyzed up to the primary completion date. SD was when a case does not qualify for either PR or PD and was new non-target lesions. Best overall response of SD must have been >=7 weeks after randomization. Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib ĭCR was defined as the percentage of participants with a best overall response of CR or PR, or stable disease (SD).As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date. EQ-5D-3L also included an EQ health utilities index (HUI) where 1.00 indicated perfect health while a score of 0.00 indicated death. Total index EQ-5D-3L summary score was weighted with a range of -0.594 (worst) to 1.0 (best). Decrease from baseline in EQ-5D-3L signifies improvement. EQ-5D-3L also included an EQ visual analogue scale (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). The summed score ranges from 3-15 with "3" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems 2=some problems 3=extreme problems). The EuroQol five dimension health questionnaire (EQ-5D-3L) assesses quality of life along 5 dimensions. Time to Clinically Meaningful Worsening of HRQoL Assessed Using EuroQol Five Dimension Health Questionnaire (EQ-5D-3L).A high score for a functional scale represented a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represented a high QoL, but a high score for a symptom scale/item represented a high level of symptomatology/problem. Each individual item ranges from 1 to 4, where 1 = "not at all" and 4 = "very much." All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. EORTC QLQ-HCC 18 questionnaire included 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. The EORTC QLQ-HCC-18 was an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30.
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