Renal Cell Carcinoma
Conditions
Keywords
Renal Cell Carcinoma, lenvatinib, everolimus, E7080, VEGF-targeted treatment
Brief summary
Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective response rate \[ORR\] at 24 weeks \[ORR24W\]) with an improved safety profile compared to lenvatinib 18 mg in combination with everolimus 5 mg (based on treatment-emergent intolerable Grade 2, or any greater than or equal to (\>=) Grade 3 adverse events (AEs) in the first 24 weeks after randomization).
Interventions
DRUGlenvatinib
lenvatinib capsules.
DRUGeverolimus
everolimus tablets.
Sponsors
Merck Sharp & Dohme LLC
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Study was initially double-blind.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological or cytological confirmation of predominant clear cell renal cell carcinoma (RCC) (original tissue diagnosis of RCC is acceptable) * Documented evidence of advanced RCC * One prior disease progression episode on or after vascular endothelial growth factor (VEGF)-targeted treatment (for example, but not limited to, sunitinib, sorafenib, pazopanib, cabozantinib, bevacizumab, axitinib, vatalanib, AV951/tivozanib) administered for the treatment of RCC. Prior programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) treatment in addition to 1 prior VEGF-targeted treatment is allowed. * At least 1 measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) meeting the following criteria: * Lymph node (LN) lesion that measures at least 1 dimension as \>=1.5 centimeter (cm) in the short axis; * Non-nodal lesion that measures \>=1.0 cm in the longest diameter; * The lesion is suitable for repeat measurement using computerized tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external beam radiotherapy (EBRT) or locoregional therapy must show radiographic evidence of disease progression based on RECIST 1.1 to be deemed a target lesion. * Male or female participants age \>=18 years (or any age \>=18 years if that age is considered to be an adult per the local jurisdiction) at the time of informed consent * Karnofsky Performance Status (KPS) of \>=70 * Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to (\<=) 150/90 millimeters of mercury (mmHg) at Screening and no change in antihypertensive medications within 1 week before Cycle 1/Day 1 * Adequate renal function defined as calculated creatinine clearance \>=30 milliliters per minute (mL/min) per the Cockcroft and Gault formula * Adequate bone marrow function defined by: * Absolute neutrophil count (ANC) \>=1500/millimeters cubed (mm\^3) (\>=1.5\*10\^9/Liters \[L\]); * Platelets \>=100,000/mm\^3 (\>=100\*10\^9/L); * Hemoglobin \>=9 grams per deciliter (g/dL) * Adequate blood coagulation function defined by International Normalized Ratio (INR) \<=1.5 (except for participants on warfarin therapy where INR must be \<=3.0 prior to randomization) * Adequate liver function defined by: * Total bilirubin \<=1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome; * Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \<=3\* the ULN (in the case of liver metastases \<=5\* the ULN). Participants with bone metastases with ALP values greater than 3 times can be included. * Participant must voluntarily agree to provide written informed consent * Participant must be willing and able to comply with all aspects of the protocol
Exclusion criteria
* More than 1 prior VEGF-targeted treatment for advanced RCC * Participants with Central Nervous System (CNS) metastases are not eligible, unless they have completed local therapy for at least 4 weeks and have discontinued the use of corticosteroids for this indication or are on a tapering regimen of corticosteroids (defined as \<=10 mg prednisolone equivalent) before starting treatment in this study. Any signs (example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment. * Active malignancy (except for RCC or definitively treated basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within the past 24 months * Any anti-cancer treatment (except for radiation therapy) within 21 days, or any investigational agent within 30 days prior to the first dose of study drug; participants should have recovered from any toxicity related to previous anti-cancer treatment to Common Toxicity Criteria (CTC) grade 0 or 1. * Prior radiation therapy within 21 days prior to the start of study treatment with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks prior to study treatment start * Known intolerance to study drug (or any of the excipients) and/or known hypersensitivity to rapamycins (example, sirolimus, everolimus, temsirolimus) or any of the excipients * Participants with proteinuria greater than (\>) 1+ on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein \>=1 g/24 hour will be ineligible. * Fasting total cholesterol ˃300 mg/dL (or ˃7.75 millimoles \[mmol\]/L) and/or fasting triglycerides level ˃2.5\* the ULN. Note: these participants can be included after initiation or adjustment of lipid-lowering medication. * Uncontrolled diabetes as defined by fasting glucose \>1.5 times the ULN. Note: these participants can be included after initiation or adjustment of glucose-lowering medication. * Prolongation of QT corrected (QTc) interval to \>480 milliseconds (ms) * Participants who have not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy * Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib or everolimus * Bleeding or thrombotic disorders or participants at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels (example, carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy. * Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug * Significant cardiovascular impairment within 6 months prior to the first dose of study drug; history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke, or cardiac arrhythmia associated with significant cardiovascular impairment or left ventricular ejection fraction (LVEF) below the institutional normal range as determined by screening multigated acquisition (MUGA) scan or echocardiogram. * Active infection (any infection requiring systemic treatment) * Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study * Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \[β-hCG\] (or human chorionic gonadotropin \[hCG\]) test with a minimum sensitivity of 25 International Units per Liter \[IU/L\] or equivalent units of β-hCG \[or hCG\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. * Females of childbearing potential who (Note: all females will be considered to be of childbearing potential unless they are postmenopausal \[amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause\] or have been sterilized surgically \[that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing\].): * do not agree to use a highly effective method of contraception for the entire study period and for up to 8 weeks after study drug discontinuation, that is: * total abstinence (if it is their preferred and usual lifestyle) * an intrauterine device (IUD) or hormone releasing system (IUS) * a contraceptive implant * an oral contraceptive (with additional barrier method) (Note: Participants must be on a stable dose of the same oral hormonal contraceptive product for at least 4 weeks before dosing with study drug and for the duration of the study.) OR * do not have a vasectomized partner with confirmed azoospermia For sites outside of the European Union, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double barrier methods of contraception, such as condom plus diaphragm or cervical/vault cap with spermicide.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate at Week 24 (ORR24W) | At Week 24 | ORR24W was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) at the Week 24 (after randomization) time point, during treatment or within 28 days after the last dose date but on or prior to the start of new anticancer therapy based on investigator assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10 millimeters (mm). PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be considered a BOR, all responses had to be confirmed no less than 4 weeks after the initial assessment of response. |
| Percentage of Participants With Intolerable Grade 2 or Any Grade >=Grade 3 TEAEs Within 24 Weeks | Up to Week 24 | TEAE was defined as an adverse event (AE) with an onset that had occurred after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With TEAEs and Serious TEAEs | From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) | TEAEs were defined as those adverse events (AEs) that occurred (or worsened, if present at Baseline) after the first dose of study drug through 28 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A serious adverse event (SAE) was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. |
| Percentage of Participants Who Discontinued Treatment Due to Toxicity | From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) | Percentage of participants who discontinued treatment due to toxicity, defined as the percentage of participants who discontinued study treatment due to TEAEs. Toxicity (except hypertension and non-infectious pneumonitis) was assessed according to NCI-CTCAE v4.03. |
| Time to Treatment Failure Due to Toxicity | From the date of randomization to the date of discontinuation of study treatment due to TEAEs, or date of data cut off for the primary analysis (up to 29 months) | Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date that a participant discontinued study treatment due to TEAEs. Toxicity (except hypertension and non-infectious pneumonitis) was assessed according to CTCAE v4.03. As planned, data for this secondary outcome measure was collected and analyzed till the primary analysis only. |
| Plasma Concentration of Lenvatinib | Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days) | PK sparse sampling was performed. As planned, the post-dose plasma sample was collected anytime between 0.5 to 4 hours at Cycle 1 Days 1 and 15, between 6 to 10 hours at Cycle 1 Days 1 and 15, and between 2 to 12 hours at Cycle 2 Day 1. Only one sample was collected for each post-dose category between specified timepoints. |
| Whole Blood Concentration of Everolimus | Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days) | PK sparse sampling was performed. As planned, the post-dose whole blood sample was collected anytime between 0.5 to 4 hours at Cycle 1 Days 1 and 15, between 6 to 10 hours at Cycle 1 Days 1 and 15, and between 2 to 12 hours at Cycle 2 Day 1. Only one sample was collected for each post-dose category between specified timepoints. |
| Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib Alone and When Coadministration With Everolimus in Renal Cell Carcinoma (RCC) Participants to Assess Drug-Drug Interaction | Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days) | Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The lenvatinib concentration data was pooled from studies E7080 -G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for lenvatinib was fitted to the pooled dataset. Individual lenvatinib CL/F value was derived from the final PK model. The outcome measure was assessed for lenvatinib 18 mg dose only. |
| Model Predicted Dose Normalized Area Under the Plasma Concentration-time Curve (AUC) for Lenvatinib Alone and When Coadministration With Everolimus in RCC Participants to Assess Drug-Drug Interaction | Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days) | Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The lenvatinib concentration data was pooled from studies E7080 -G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for lenvatinib was fitted to the pooled dataset. Individual lenvatinib AUC at steady state based on the starting dose was derived as a function of starting dose from the final PK model. The outcome measure was assessed for lenvatinib 18 mg dose only. |
| Progression-free Survival (PFS) | From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to date of data cutoff for the primary analysis (up to 29 months) | PFS was defined as the time from the date of randomization to the date of the first documentation of PD by investigator assessment or date of death, whichever occurred first according to RECIST v1.1. PD: at least 20% increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameter (SOD) of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Median PFS was analyzed using the Kaplan-Meier product-limit estimates for each treatment group and presented with 2-sided 95% confidence interval (CI). As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only. |
| Model Predicted Dose Normalized AUC for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction | Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days) | Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The everolimus concentration data was pooled from studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for everolimus was fitted to the pooled dataset. Individual everolimus AUC at steady state based on the starting dose was derived as a function of starting dose from the final PK model. |
| Overall Survival (OS) | From the date of randomization until the date of death from any cause, or up to date of data cut off for the primary analysis (up to 29 months) | OS was defined as the time from the date of randomization until the date of death from any cause. In the absence of confirmation of death, participants will be censored either at the date that the participant was last known to be alive or the date of data cutoff for the primary analysis, whichever comes earlier. Median OS was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only. |
| Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months) | The FKSI-DRS consisted of 9 items that experts and participants had indicated are important targets for the treatment of advanced kidney cancer, and that clinical experts had indicated are primarily disease-related, as opposed to treatment-related. Symptoms assessed on the FKSI-DRS included lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or hematuria. Each item was scored on a 5-point Likert-type scale (0 = not at all; 4 = very much) where total score ranged from 0 (worst) to 36 (best), where higher scores correspond to better outcomes. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only. |
| HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months) | The EORT QLQ-C30 consisted of 30 questions comprising 9 multiple-item scales and 6 single items. Multiple-item scales of QLQ-C30 consisted of 5 functional scales (physical, role, emotional, cognitive, and social) and 3 symptom scales (fatigue, nausea and vomiting, pain) and a global health status/QOL score. Six single-item scales of QLQ-C30 involved dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. First 28 questions used a 4-point scale (1 = Not at all to 4 = Very much); and last 2 questions used a 7-point scale (1 = Very poor to 7 = Excellent). Scores for all scales range from 0 to 100. For the overall HRQoL and functioning scales, a higher score was correlated with better HRQoL, whereas a higher score for symptom scales represented worse HRQoL. As pre-specified in protocol, data for secondary outcome measure was collected and analyzed till primary analysis only. |
| HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months) | The EQ-5D-3L is a health profile questionnaire assessing quality of life along 5 dimensions. Participants rate 5 dimensions 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 summed score ranges from 5-15 with 5 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. The EQ-5D index was calculated by applying preference-based weights (tariffs) to the scores of the five health state dimensions. Index values can range from -1 to 1, with 0 representing a health state equivalent to death and 1 representing perfect health. EQ-5D-3L also included an EQ visual analogue scale (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score was weighted with a range of -0.594 (worst) to 1.0 (best). |
| Progression-free Survival After Next Line of Therapy (PFS2) | From the time of randomization to the date of PD after next line of therapy or death from any cause or the date of data cutoff for the primary analysis, whichever occurs first (up to 29 months) | PFS2, defined as the time from randomization to the date of PD after next line of therapy or death from any cause, whichever occurred first based on investigator assessment according to RECIST v1.1. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Median PFS2 was analyzed using the Kaplan-Meier product-limit estimates for each treatment group and presented with 2-sided 95% CI. As pre-specified in protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only. |
| Model Predicted CL/F for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction | Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days) | Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The everolimus concentration data was pooled from studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for everolimus was fitted to the pooled dataset. Individual everolimus CL/F value was derived from the final PK model. |
| Objective Response Rate (ORR) | From date of randomization up to first documentation of PD or date of death, whichever occurred first or up to the date of data cut off for the primary analysis (up to 29 months) | ORR was defined as the percentage of participants with a BOR of CR or PR at the at the end of treatment based on investigator assessment according to RECIST v1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \<10 mm. PR: defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be considered a BOR, all responses had to be confirmed no less than 4 weeks after the initial assessment of response. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only. |
Countries
Australia, Canada, Czechia, Finland, Greece, Italy, Netherlands, Poland, Portugal, Romania, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
Participants took part in the study at 82 investigative sites in Australia, Korea, Taiwan, Czech, Poland, Romania, Russia, Finland, Greece, Italy, Netherlands, Portugal, Spain, United Kingdom, Canada and the United States from 17 August 2017 to 20 June 2024.
Pre-assignment details
A total of 489 participants were screened, of which 146 were screen failures and 343 were enrolled and randomized, out of which 341 participants were treated.
Participants by arm
| Arm | Count |
|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase. | 172 |
| Lenvatinib 18 mg + Everolimus 5 mg Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. | 171 |
| Total | 343 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 70 | 60 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Withdrawal by Subject | 10 | 5 |
Baseline characteristics
| Characteristic | Lenvatinib 18 mg + Everolimus 5 mg | Total | Lenvatinib 14 mg + Everolimus 5 mg |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 9.9 | 61.0 years STANDARD_DEVIATION 9.74 | 60.5 years STANDARD_DEVIATION 9.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 12 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 163 Participants | 331 Participants | 168 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 27 Participants | 60 Participants | 33 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 140 Participants | 277 Participants | 137 Participants |
| Sex: Female, Male Female | 42 Participants | 81 Participants | 39 Participants |
| Sex: Female, Male Male | 129 Participants | 262 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 71 / 173 | 60 / 168 |
| other Total, other adverse events | 172 / 173 | 166 / 168 |
| serious Total, serious adverse events | 92 / 173 | 87 / 168 |
Outcome results
Primary
Objective Response Rate at Week 24 (ORR24W)
ORR24W was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) at the Week 24 (after randomization) time point, during treatment or within 28 days after the last dose date but on or prior to the start of new anticancer therapy based on investigator assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10 millimeters (mm). PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be considered a BOR, all responses had to be confirmed no less than 4 weeks after the initial assessment of response.
Time frame: At Week 24
Population: Per-protocol analysis set 1 (PPAS1) included all randomized participants minus the 32 participants who had received \>=2 incorrect lenvatinib doses due to interactive voice and web response system (IxRS) issues.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Objective Response Rate at Week 24 (ORR24W) | 32.1 percentage of participants |
| Lenvatinib 18 mg + Everolimus 5 mg | Objective Response Rate at Week 24 (ORR24W) | 34.8 percentage of participants |
p-value: 0.267690% CI: [0.59, 1.32]Cochran-Mantel-Haenszel
Primary
Percentage of Participants With Intolerable Grade 2 or Any Grade >=Grade 3 TEAEs Within 24 Weeks
TEAE was defined as an adverse event (AE) with an onset that had occurred after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
Time frame: Up to Week 24
Population: Per-protocol safety analysis set included all randomized and treated participants minus 32 participants who had received \>=2 incorrect lenvatinib doses due to IxRS issues according to actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Percentage of Participants With Intolerable Grade 2 or Any Grade >=Grade 3 TEAEs Within 24 Weeks | 82.8 percentage of participants |
| Lenvatinib 18 mg + Everolimus 5 mg | Percentage of Participants With Intolerable Grade 2 or Any Grade >=Grade 3 TEAEs Within 24 Weeks | 79.6 percentage of participants |
p-value: 0.476395% CI: [-5.5, 11.9]Cochran-Mantel-Haenszel
Secondary
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores
The FKSI-DRS consisted of 9 items that experts and participants had indicated are important targets for the treatment of advanced kidney cancer, and that clinical experts had indicated are primarily disease-related, as opposed to treatment-related. Symptoms assessed on the FKSI-DRS included lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or hematuria. Each item was scored on a 5-point Likert-type scale (0 = not at all; 4 = very much) where total score ranged from 0 (worst) to 36 (best), where higher scores correspond to better outcomes. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.
Time frame: At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months)
Population: Quality of Life (QoL) analysis set consisted of all participants who had any QoL data. Here overall number of participants analyzed are the participants who were evaluable for the outcome measure and number analyzed were the participants who were evaluable at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 18 Day 1 | 29.81 score on a scale | Standard Deviation 4.293 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 26 Day 1 | 28.75 score on a scale | Standard Deviation 4.862 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 27 Day 1 | 29.83 score on a scale | Standard Deviation 5.345 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 28 Day 1 | 30.50 score on a scale | Standard Deviation 4.435 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 29 Day 1 | 29.50 score on a scale | Standard Deviation 4.359 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 30 Day 1 | 30.75 score on a scale | Standard Deviation 4.031 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 31 Day 1 | 31 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Off-treatment Visit | 27.42 score on a scale | Standard Deviation 5.953 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Baseline | 29.69 score on a scale | Standard Deviation 4.819 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 2 Day 1 | 28.43 score on a scale | Standard Deviation 5.269 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 3 Day 1 | 28.26 score on a scale | Standard Deviation 5.344 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 4 Day 1 | 27.97 score on a scale | Standard Deviation 5.524 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 5 Day 1 | 28 score on a scale | Standard Deviation 5.68 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 6 Day 1 | 28.63 score on a scale | Standard Deviation 5.185 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 7 Day 1 | 28.31 score on a scale | Standard Deviation 5.486 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 8 Day 1 | 28.36 score on a scale | Standard Deviation 6.204 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 9 Day 1 | 28.58 score on a scale | Standard Deviation 5.562 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 10 Day 1 | 29.10 score on a scale | Standard Deviation 5.294 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 11 Day 1 | 29.56 score on a scale | Standard Deviation 5.035 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 12 Day 1 | 29.34 score on a scale | Standard Deviation 5.149 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 13 Day 1 | 29.26 score on a scale | Standard Deviation 4.851 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 14 Day 1 | 29.81 score on a scale | Standard Deviation 4.752 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 15 Day 1 | 30.09 score on a scale | Standard Deviation 5.121 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 16 Day 1 | 29.93 score on a scale | Standard Deviation 5.293 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 17 Day 1 | 29.36 score on a scale | Standard Deviation 5.233 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 19 Day 1 | 28.48 score on a scale | Standard Deviation 6.216 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 20 Day 1 | 28.77 score on a scale | Standard Deviation 6.058 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 21 Day 1 | 29.35 score on a scale | Standard Deviation 4.707 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 22 Day 1 | 30.32 score on a scale | Standard Deviation 4.978 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 23 Day 1 | 30.53 score on a scale | Standard Deviation 3.998 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 24 Day 1 | 29.47 score on a scale | Standard Deviation 5.041 |
| Lenvatinib 14 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 25 Day 1 | 27.92 score on a scale | Standard Deviation 6.388 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 25 Day 1 | 31.69 score on a scale | Standard Deviation 4.27 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 26 Day 1 | 29.82 score on a scale | Standard Deviation 6.422 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 10 Day 1 | 30.70 score on a scale | Standard Deviation 4.297 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 27 Day 1 | 32.86 score on a scale | Standard Deviation 2.854 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 18 Day 1 | 31.41 score on a scale | Standard Deviation 4.639 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 28 Day 1 | 33.67 score on a scale | Standard Deviation 1.862 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 11 Day 1 | 30.09 score on a scale | Standard Deviation 5.316 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 29 Day 1 | 33.40 score on a scale | Standard Deviation 1.342 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 23 Day 1 | 30.29 score on a scale | Standard Deviation 5.544 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 30 Day 1 | 36 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 12 Day 1 | 30.75 score on a scale | Standard Deviation 5.127 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 19 Day 1 | 30.82 score on a scale | Standard Deviation 4.469 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Off-treatment Visit | 27.86 score on a scale | Standard Deviation 6.5 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 13 Day 1 | 30.93 score on a scale | Standard Deviation 4.201 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Baseline | 29 score on a scale | Standard Deviation 5.886 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 22 Day 1 | 30.59 score on a scale | Standard Deviation 5.168 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 2 Day 1 | 28.31 score on a scale | Standard Deviation 5.162 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 14 Day 1 | 31.06 score on a scale | Standard Deviation 4.83 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 3 Day 1 | 28.80 score on a scale | Standard Deviation 5.455 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 20 Day 1 | 30.69 score on a scale | Standard Deviation 4.575 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 4 Day 1 | 29.11 score on a scale | Standard Deviation 5.183 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 15 Day 1 | 30.52 score on a scale | Standard Deviation 4.417 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 5 Day 1 | 29.14 score on a scale | Standard Deviation 5.081 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 24 Day 1 | 31.58 score on a scale | Standard Deviation 3.977 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 6 Day 1 | 29.46 score on a scale | Standard Deviation 5.107 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 16 Day 1 | 30.91 score on a scale | Standard Deviation 4.704 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 7 Day 1 | 29.58 score on a scale | Standard Deviation 4.803 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 21 Day 1 | 32 score on a scale | Standard Deviation 3.243 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 8 Day 1 | 29.85 score on a scale | Standard Deviation 4.61 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 17 Day 1 | 31.52 score on a scale | Standard Deviation 4.875 |
| Lenvatinib 18 mg + Everolimus 5 mg | Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores | Cycle 9 Day 1 | 29.84 score on a scale | Standard Deviation 5.005 |
Secondary
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores
The EORT QLQ-C30 consisted of 30 questions comprising 9 multiple-item scales and 6 single items. Multiple-item scales of QLQ-C30 consisted of 5 functional scales (physical, role, emotional, cognitive, and social) and 3 symptom scales (fatigue, nausea and vomiting, pain) and a global health status/QOL score. Six single-item scales of QLQ-C30 involved dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. First 28 questions used a 4-point scale (1 = Not at all to 4 = Very much); and last 2 questions used a 7-point scale (1 = Very poor to 7 = Excellent). Scores for all scales range from 0 to 100. For the overall HRQoL and functioning scales, a higher score was correlated with better HRQoL, whereas a higher score for symptom scales represented worse HRQoL. As pre-specified in protocol, data for secondary outcome measure was collected and analyzed till primary analysis only.
Time frame: At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months)
Population: QoL analysis set consisted of all participants who had any QoL data. Here, overall number of participants analyzed are the participants who were evaluable for the outcome measure and number analyzed were the participants who were evaluable at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 3 Day 1 | 56.43 score on a scale | Standard Deviation 24.065 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 21 Day 1 | 12.82 score on a scale | Standard Deviation 20.714 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 25 Day 1 | 83.33 score on a scale | Standard Deviation 18.119 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 22 Day 1 | 7.02 score on a scale | Standard Deviation 11.541 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 9 Day 1 | 74.54 score on a scale | Standard Deviation 19.389 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 23 Day 1 | 5.56 score on a scale | Standard Deviation 12.062 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 26 Day 1 | 77.08 score on a scale | Standard Deviation 23.038 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 24 Day 1 | 6.67 score on a scale | Standard Deviation 13.801 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 4 Day 1 | 58.71 score on a scale | Standard Deviation 19.754 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 25 Day 1 | 13.89 score on a scale | Standard Deviation 21.122 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 27 Day 1 | 80.56 score on a scale | Standard Deviation 16.387 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 26 Day 1 | 4.17 score on a scale | Standard Deviation 7.715 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 24 Day 1 | 77.33 score on a scale | Standard Deviation 16.676 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 27 Day 1 | 5.56 score on a scale | Standard Deviation 13.608 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 28 Day 1 | 75 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 28 Day 1 | 12.50 score on a scale | Standard Deviation 15.957 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 5 Day 1 | 59.38 score on a scale | Standard Deviation 21.67 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 29 Day 1 | 16.67 score on a scale | Standard Deviation 13.608 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 29 Day 1 | 75 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 30 Day 1 | 8.33 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 2 Day 1 | 73.54 score on a scale | Standard Deviation 19.857 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 31 Day 1 | 16.67 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Off-treatment Visit | 13.33 score on a scale | Standard Deviation 22.564 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 30 Day 1 | 75 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Baseline | 23.39 score on a scale | Standard Deviation 25.41 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 6 Day 1 | 58.75 score on a scale | Standard Deviation 21.028 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 2 Day 1 | 26.79 score on a scale | Standard Deviation 25.85 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 31 Day 1 | 66.67 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 3 Day 1 | 27.63 score on a scale | Standard Deviation 24.103 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Off-treatment Visit | 69.62 score on a scale | Standard Deviation 27.304 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 4 Day 1 | 26.67 score on a scale | Standard Deviation 24.788 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 25 Day 1 | 72.78 score on a scale | Standard Deviation 15.688 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 5 Day 1 | 29.04 score on a scale | Standard Deviation 26.805 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Baseline | 87.91 score on a scale | Standard Deviation 15.764 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 6 Day 1 | 26.29 score on a scale | Standard Deviation 24.887 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 7 Day 1 | 58.72 score on a scale | Standard Deviation 20.134 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 7 Day 1 | 28.04 score on a scale | Standard Deviation 23.189 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 2 Day 1 | 87.15 score on a scale | Standard Deviation 15.661 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 8 Day 1 | 27.38 score on a scale | Standard Deviation 23.722 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 10 Day 1 | 75.06 score on a scale | Standard Deviation 18.908 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 9 Day 1 | 27.11 score on a scale | Standard Deviation 23.393 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 3 Day 1 | 84.45 score on a scale | Standard Deviation 19.049 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 10 Day 1 | 26.95 score on a scale | Standard Deviation 22.603 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 8 Day 1 | 58.68 score on a scale | Standard Deviation 20.409 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 11 Day 1 | 27.29 score on a scale | Standard Deviation 22.319 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 4 Day 1 | 83.58 score on a scale | Standard Deviation 19.461 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 12 Day 1 | 26.41 score on a scale | Standard Deviation 21.018 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 26 Day 1 | 76.67 score on a scale | Standard Deviation 6.172 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 13 Day 1 | 24.40 score on a scale | Standard Deviation 20.092 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 5 Day 1 | 83.99 score on a scale | Standard Deviation 17.239 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 14 Day 1 | 22.11 score on a scale | Standard Deviation 22.666 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 9 Day 1 | 58.97 score on a scale | Standard Deviation 18.726 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 15 Day 1 | 24.24 score on a scale | Standard Deviation 23.966 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 6 Day 1 | 84.71 score on a scale | Standard Deviation 16.886 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 16 Day 1 | 29.67 score on a scale | Standard Deviation 25.417 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 30 Day 1 | 54.17 score on a scale | Standard Deviation 15.957 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 17 Day 1 | 27.78 score on a scale | Standard Deviation 25.198 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 7 Day 1 | 82.40 score on a scale | Standard Deviation 18.855 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 18 Day 1 | 25.27 score on a scale | Standard Deviation 20.125 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 10 Day 1 | 63.13 score on a scale | Standard Deviation 19.612 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 19 Day 1 | 31.48 score on a scale | Standard Deviation 23.266 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 8 Day 1 | 81.97 score on a scale | Standard Deviation 21.227 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 20 Day 1 | 29.63 score on a scale | Standard Deviation 23.266 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 27 Day 1 | 76.67 score on a scale | Standard Deviation 6.992 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 21 Day 1 | 26.92 score on a scale | Standard Deviation 23.131 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 9 Day 1 | 83.70 score on a scale | Standard Deviation 18.084 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 22 Day 1 | 23.68 score on a scale | Standard Deviation 17.843 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 11 Day 1 | 60.87 score on a scale | Standard Deviation 18.705 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 23 Day 1 | 21.11 score on a scale | Standard Deviation 14.729 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 10 Day 1 | 85.39 score on a scale | Standard Deviation 17.947 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 24 Day 1 | 22.22 score on a scale | Standard Deviation 20.574 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 11 Day 1 | 73.72 score on a scale | Standard Deviation 18.073 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 25 Day 1 | 27.78 score on a scale | Standard Deviation 23.925 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 11 Day 1 | 84.06 score on a scale | Standard Deviation 18.176 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 26 Day 1 | 27.08 score on a scale | Standard Deviation 21.708 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 12 Day 1 | 57.81 score on a scale | Standard Deviation 18.891 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 27 Day 1 | 25 score on a scale | Standard Deviation 20.412 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 12 Day 1 | 85.42 score on a scale | Standard Deviation 16.4 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 28 Day 1 | 25 score on a scale | Standard Deviation 21.517 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 28 Day 1 | 78.33 score on a scale | Standard Deviation 3.333 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 29 Day 1 | 25 score on a scale | Standard Deviation 21.517 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 13 Day 1 | 83.93 score on a scale | Standard Deviation 17.685 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 30 Day 1 | 25 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 13 Day 1 | 59.39 score on a scale | Standard Deviation 19.047 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 31 Day 1 | 33.33 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Off-treatment Visit | 28.33 score on a scale | Standard Deviation 27.354 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 14 Day 1 | 85.71 score on a scale | Standard Deviation 18.634 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Baseline | 21.18 score on a scale | Standard Deviation 25.562 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 3 Day 1 | 72.74 score on a scale | Standard Deviation 21.227 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 2 Day 1 | 18.90 score on a scale | Standard Deviation 24.248 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 15 Day 1 | 84.85 score on a scale | Standard Deviation 18.264 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 3 Day 1 | 20.63 score on a scale | Standard Deviation 24.155 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 14 Day 1 | 61.56 score on a scale | Standard Deviation 17.498 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 4 Day 1 | 19.90 score on a scale | Standard Deviation 24.224 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 16 Day 1 | 83.74 score on a scale | Standard Deviation 18.062 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 5 Day 1 | 19.16 score on a scale | Standard Deviation 23.201 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 29 Day 1 | 78.33 score on a scale | Standard Deviation 3.333 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 6 Day 1 | 16.67 score on a scale | Standard Deviation 21.104 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 17 Day 1 | 82.87 score on a scale | Standard Deviation 18.033 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 7 Day 1 | 19.37 score on a scale | Standard Deviation 23.922 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 15 Day 1 | 62.98 score on a scale | Standard Deviation 16.795 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 8 Day 1 | 19.24 score on a scale | Standard Deviation 23.489 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 18 Day 1 | 83.87 score on a scale | Standard Deviation 17.994 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 9 Day 1 | 15.93 score on a scale | Standard Deviation 20.74 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 12 Day 1 | 75.52 score on a scale | Standard Deviation 17.08 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 10 Day 1 | 17.92 score on a scale | Standard Deviation 21.832 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 19 Day 1 | 80.25 score on a scale | Standard Deviation 18.511 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 11 Day 1 | 18.63 score on a scale | Standard Deviation 23.31 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 16 Day 1 | 61.59 score on a scale | Standard Deviation 17.567 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 12 Day 1 | 13.54 score on a scale | Standard Deviation 21.998 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 20 Day 1 | 82.10 score on a scale | Standard Deviation 17.25 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 13 Day 1 | 13.69 score on a scale | Standard Deviation 20.867 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 30 Day 1 | 76.67 score on a scale | Standard Deviation 3.849 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 14 Day 1 | 15.65 score on a scale | Standard Deviation 21.626 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 21 Day 1 | 81.41 score on a scale | Standard Deviation 19.623 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 15 Day 1 | 15.15 score on a scale | Standard Deviation 19.628 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 17 Day 1 | 60.88 score on a scale | Standard Deviation 16.882 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 16 Day 1 | 16.26 score on a scale | Standard Deviation 22.512 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 22 Day 1 | 88.60 score on a scale | Standard Deviation 14.754 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 17 Day 1 | 15.74 score on a scale | Standard Deviation 20.293 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 20 Day 1 | 70.37 score on a scale | Standard Deviation 23.266 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 18 Day 1 | 16.13 score on a scale | Standard Deviation 20.854 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 23 Day 1 | 83.33 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 19 Day 1 | 15.38 score on a scale | Standard Deviation 21.563 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 18 Day 1 | 59.68 score on a scale | Standard Deviation 16.258 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 20 Day 1 | 23.46 score on a scale | Standard Deviation 20.286 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 24 Day 1 | 84.44 score on a scale | Standard Deviation 16.019 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 21 Day 1 | 15.38 score on a scale | Standard Deviation 16.946 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 31 Day 1 | 80 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 22 Day 1 | 17.54 score on a scale | Standard Deviation 20.393 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 25 Day 1 | 84.72 score on a scale | Standard Deviation 15.006 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 23 Day 1 | 13.33 score on a scale | Standard Deviation 21.082 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 19 Day 1 | 58.33 score on a scale | Standard Deviation 19.747 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 24 Day 1 | 20 score on a scale | Standard Deviation 21.082 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 26 Day 1 | 89.58 score on a scale | Standard Deviation 12.4 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 25 Day 1 | 22.22 score on a scale | Standard Deviation 29.588 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Off-treatment Visit | 64.50 score on a scale | Standard Deviation 25.891 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 26 Day 1 | 16.67 score on a scale | Standard Deviation 17.817 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 27 Day 1 | 83.33 score on a scale | Standard Deviation 14.907 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 27 Day 1 | 11.11 score on a scale | Standard Deviation 17.213 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 20 Day 1 | 58.95 score on a scale | Standard Deviation 18.479 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 28 Day 1 | 16.67 score on a scale | Standard Deviation 19.245 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 28 Day 1 | 91.67 score on a scale | Standard Deviation 9.623 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 29 Day 1 | 25 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 13 Day 1 | 74.55 score on a scale | Standard Deviation 17.874 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 30 Day 1 | 16.67 score on a scale | Standard Deviation 19.245 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 29 Day 1 | 91.67 score on a scale | Standard Deviation 9.623 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 31 Day 1 | 33.33 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Off-treatment Visit | 24.68 score on a scale | Standard Deviation 27.254 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 21 Day 1 | 57.05 score on a scale | Standard Deviation 18.362 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Baseline | 23.08 score on a scale | Standard Deviation 26.972 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 30 Day 1 | 87.50 score on a scale | Standard Deviation 15.957 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 2 Day 1 | 26.11 score on a scale | Standard Deviation 27.038 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Baseline | 73.78 score on a scale | Standard Deviation 27.471 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 3 Day 1 | 30.39 score on a scale | Standard Deviation 29.435 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 31 Day 1 | 83.33 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 4 Day 1 | 26.57 score on a scale | Standard Deviation 28.057 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Off-treatment Visit | 75.21 score on a scale | Standard Deviation 25.846 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 5 Day 1 | 23.02 score on a scale | Standard Deviation 26.487 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 22 Day 1 | 62.72 score on a scale | Standard Deviation 14.532 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 6 Day 1 | 24.86 score on a scale | Standard Deviation 26.955 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Baseline | 77.29 score on a scale | Standard Deviation 25.678 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 7 Day 1 | 25.08 score on a scale | Standard Deviation 27.651 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 4 Day 1 | 70.90 score on a scale | Standard Deviation 20.873 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 8 Day 1 | 26.46 score on a scale | Standard Deviation 28.843 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 2 Day 1 | 73.46 score on a scale | Standard Deviation 25.386 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 9 Day 1 | 25.56 score on a scale | Standard Deviation 27.392 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 23 Day 1 | 60 score on a scale | Standard Deviation 15.494 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 10 Day 1 | 24.58 score on a scale | Standard Deviation 25.844 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 3 Day 1 | 72.04 score on a scale | Standard Deviation 26.229 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 11 Day 1 | 24.02 score on a scale | Standard Deviation 26.918 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 2 Day 1 | 68.25 score on a scale | Standard Deviation 27.951 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 12 Day 1 | 23.44 score on a scale | Standard Deviation 23.518 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 4 Day 1 | 71.43 score on a scale | Standard Deviation 24.837 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 13 Day 1 | 21.43 score on a scale | Standard Deviation 21.489 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 24 Day 1 | 64.44 score on a scale | Standard Deviation 17.385 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 14 Day 1 | 18.06 score on a scale | Standard Deviation 23.778 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 5 Day 1 | 71.78 score on a scale | Standard Deviation 25.589 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 15 Day 1 | 18.94 score on a scale | Standard Deviation 20.832 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 14 Day 1 | 75.78 score on a scale | Standard Deviation 16.925 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 16 Day 1 | 20.33 score on a scale | Standard Deviation 20.921 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 6 Day 1 | 70.80 score on a scale | Standard Deviation 26.812 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 17 Day 1 | 17.59 score on a scale | Standard Deviation 16.877 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 25 Day 1 | 58.33 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 18 Day 1 | 27.96 score on a scale | Standard Deviation 25.958 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 7 Day 1 | 71.70 score on a scale | Standard Deviation 26.544 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 19 Day 1 | 24.69 score on a scale | Standard Deviation 25.474 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 3 Day 1 | 67 score on a scale | Standard Deviation 28.136 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 20 Day 1 | 25.93 score on a scale | Standard Deviation 25.036 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 8 Day 1 | 70.24 score on a scale | Standard Deviation 28.139 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 21 Day 1 | 23.08 score on a scale | Standard Deviation 27.919 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 26 Day 1 | 59.38 score on a scale | Standard Deviation 15.064 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 22 Day 1 | 21.05 score on a scale | Standard Deviation 19.909 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 9 Day 1 | 72.16 score on a scale | Standard Deviation 25.946 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 23 Day 1 | 26.67 score on a scale | Standard Deviation 22.537 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 31 Day 1 | 33.33 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 24 Day 1 | 24.44 score on a scale | Standard Deviation 26.627 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 10 Day 1 | 72.43 score on a scale | Standard Deviation 28.156 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 25 Day 1 | 16.67 score on a scale | Standard Deviation 17.408 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 27 Day 1 | 59.72 score on a scale | Standard Deviation 18.572 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 26 Day 1 | 16.67 score on a scale | Standard Deviation 17.817 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 11 Day 1 | 73.91 score on a scale | Standard Deviation 25.801 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 27 Day 1 | 22.22 score on a scale | Standard Deviation 17.213 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 4 Day 1 | 66.67 score on a scale | Standard Deviation 27.993 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 28 Day 1 | 25 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 12 Day 1 | 76.56 score on a scale | Standard Deviation 24.073 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 29 Day 1 | 25 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 21 Day 1 | 69.23 score on a scale | Standard Deviation 21.956 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 30 Day 1 | 25 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 13 Day 1 | 72.92 score on a scale | Standard Deviation 23.476 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 31 Day 1 | 33.33 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Off-treatment Visit | 32.05 score on a scale | Standard Deviation 32.43 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 15 Day 1 | 75.45 score on a scale | Standard Deviation 16.629 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Baseline | 15.79 score on a scale | Standard Deviation 24.606 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 14 Day 1 | 72.79 score on a scale | Standard Deviation 22.997 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 2 Day 1 | 26.79 score on a scale | Standard Deviation 31.129 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 22 Day 1 | 75.44 score on a scale | Standard Deviation 20.313 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 3 Day 1 | 31.97 score on a scale | Standard Deviation 31.905 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 15 Day 1 | 72.73 score on a scale | Standard Deviation 25.942 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 4 Day 1 | 32.09 score on a scale | Standard Deviation 31.239 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 5 Day 1 | 67.32 score on a scale | Standard Deviation 28.479 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 5 Day 1 | 30.47 score on a scale | Standard Deviation 29.881 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 16 Day 1 | 73.17 score on a scale | Standard Deviation 24.403 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 6 Day 1 | 30.35 score on a scale | Standard Deviation 31.365 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 23 Day 1 | 73.33 score on a scale | Standard Deviation 25.04 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 7 Day 1 | 29.28 score on a scale | Standard Deviation 31.956 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 17 Day 1 | 70.37 score on a scale | Standard Deviation 22.222 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 8 Day 1 | 29.25 score on a scale | Standard Deviation 31.483 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 5 Day 1 | 72.80 score on a scale | Standard Deviation 19.284 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 9 Day 1 | 29.30 score on a scale | Standard Deviation 30.565 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 18 Day 1 | 76.88 score on a scale | Standard Deviation 20.493 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 10 Day 1 | 27.57 score on a scale | Standard Deviation 29.716 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 24 Day 1 | 78.89 score on a scale | Standard Deviation 16.019 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 11 Day 1 | 24.15 score on a scale | Standard Deviation 27.938 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 19 Day 1 | 74.07 score on a scale | Standard Deviation 22.329 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 12 Day 1 | 22.05 score on a scale | Standard Deviation 24.493 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 6 Day 1 | 68.16 score on a scale | Standard Deviation 27.245 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 13 Day 1 | 23.21 score on a scale | Standard Deviation 25.362 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 20 Day 1 | 75.31 score on a scale | Standard Deviation 24.183 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 14 Day 1 | 19.73 score on a scale | Standard Deviation 24.456 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 25 Day 1 | 77.78 score on a scale | Standard Deviation 17.885 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 15 Day 1 | 17.42 score on a scale | Standard Deviation 23.282 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 21 Day 1 | 73.72 score on a scale | Standard Deviation 18.362 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 16 Day 1 | 23.58 score on a scale | Standard Deviation 27.125 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 16 Day 1 | 73.46 score on a scale | Standard Deviation 17.129 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 17 Day 1 | 20.37 score on a scale | Standard Deviation 21.496 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 22 Day 1 | 79.82 score on a scale | Standard Deviation 17.194 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 18 Day 1 | 19.35 score on a scale | Standard Deviation 22.401 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 26 Day 1 | 75 score on a scale | Standard Deviation 12.599 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 19 Day 1 | 19.75 score on a scale | Standard Deviation 23.13 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 23 Day 1 | 82.22 score on a scale | Standard Deviation 18.33 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 20 Day 1 | 23.46 score on a scale | Standard Deviation 25.844 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 7 Day 1 | 66.51 score on a scale | Standard Deviation 27.424 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 21 Day 1 | 23.08 score on a scale | Standard Deviation 20.59 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 24 Day 1 | 83.33 score on a scale | Standard Deviation 17.817 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 22 Day 1 | 17.54 score on a scale | Standard Deviation 20.393 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 27 Day 1 | 77.78 score on a scale | Standard Deviation 13.608 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 23 Day 1 | 17.78 score on a scale | Standard Deviation 24.774 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 25 Day 1 | 87.50 score on a scale | Standard Deviation 12.563 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 24 Day 1 | 13.33 score on a scale | Standard Deviation 24.56 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Off-treatment Visit | 51.04 score on a scale | Standard Deviation 23.133 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 25 Day 1 | 19.44 score on a scale | Standard Deviation 22.285 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 26 Day 1 | 83.33 score on a scale | Standard Deviation 15.43 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 26 Day 1 | 29.17 score on a scale | Standard Deviation 27.817 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 28 Day 1 | 79.17 score on a scale | Standard Deviation 15.957 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 27 Day 1 | 16.67 score on a scale | Standard Deviation 18.257 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 27 Day 1 | 80.56 score on a scale | Standard Deviation 12.546 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 28 Day 1 | 8.33 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 8 Day 1 | 68.20 score on a scale | Standard Deviation 27.712 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 29 Day 1 | 16.67 score on a scale | Standard Deviation 19.245 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 28 Day 1 | 83.33 score on a scale | Standard Deviation 19.245 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 30 Day 1 | 8.33 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 29 Day 1 | 75 score on a scale | Standard Deviation 9.623 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 31 Day 1 | 0 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Off-treatment Visit | 29.58 score on a scale | Standard Deviation 31.82 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 29 Day 1 | 79.17 score on a scale | Standard Deviation 15.957 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Baseline | 15.98 score on a scale | Standard Deviation 24.876 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 17 Day 1 | 71.85 score on a scale | Standard Deviation 17.896 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 2 Day 1 | 10.40 score on a scale | Standard Deviation 20.274 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 30 Day 1 | 70.83 score on a scale | Standard Deviation 8.333 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 3 Day 1 | 9.52 score on a scale | Standard Deviation 20.644 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 30 Day 1 | 87.50 score on a scale | Standard Deviation 15.957 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 4 Day 1 | 11.11 score on a scale | Standard Deviation 21.93 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 31 Day 1 | 100 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 5 Day 1 | 12.24 score on a scale | Standard Deviation 20.438 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Off-treatment Visit | 64.58 score on a scale | Standard Deviation 31.419 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 6 Day 1 | 8.47 score on a scale | Standard Deviation 16.905 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 9 Day 1 | 67.58 score on a scale | Standard Deviation 26.101 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 7 Day 1 | 11.01 score on a scale | Standard Deviation 22.874 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Baseline | 31.32 score on a scale | Standard Deviation 21.379 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 8 Day 1 | 9.62 score on a scale | Standard Deviation 18.608 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 31 Day 1 | 66.67 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 9 Day 1 | 6.23 score on a scale | Standard Deviation 15.644 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 2 Day 1 | 39.21 score on a scale | Standard Deviation 22.171 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 10 Day 1 | 6.58 score on a scale | Standard Deviation 13.354 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Off-treatment Visit | 60.97 score on a scale | Standard Deviation 31.79 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 11 Day 1 | 6.76 score on a scale | Standard Deviation 15.739 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 3 Day 1 | 40.09 score on a scale | Standard Deviation 24.095 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 12 Day 1 | 5.64 score on a scale | Standard Deviation 13.906 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 6 Day 1 | 72.17 score on a scale | Standard Deviation 21.694 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 13 Day 1 | 3.64 score on a scale | Standard Deviation 12.294 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 4 Day 1 | 40.21 score on a scale | Standard Deviation 23.504 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 14 Day 1 | 5.44 score on a scale | Standard Deviation 14.186 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Baseline | 79.35 score on a scale | Standard Deviation 19.704 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 15 Day 1 | 5.43 score on a scale | Standard Deviation 17.714 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 5 Day 1 | 37.54 score on a scale | Standard Deviation 23.329 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 16 Day 1 | 5.98 score on a scale | Standard Deviation 16.879 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 10 Day 1 | 68.52 score on a scale | Standard Deviation 27.131 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 17 Day 1 | 11.11 score on a scale | Standard Deviation 22.537 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 6 Day 1 | 38.80 score on a scale | Standard Deviation 23.246 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 18 Day 1 | 7.53 score on a scale | Standard Deviation 14.167 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 2 Day 1 | 79.41 score on a scale | Standard Deviation 19.465 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 19 Day 1 | 9.88 score on a scale | Standard Deviation 18.057 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 7 Day 1 | 38.06 score on a scale | Standard Deviation 21.85 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 20 Day 1 | 8.64 score on a scale | Standard Deviation 17.523 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 18 Day 1 | 75.48 score on a scale | Standard Deviation 17.838 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 21 Day 1 | 8.97 score on a scale | Standard Deviation 17.783 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 8 Day 1 | 36.14 score on a scale | Standard Deviation 22.852 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 22 Day 1 | 7.02 score on a scale | Standard Deviation 13.962 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 3 Day 1 | 78.47 score on a scale | Standard Deviation 21.642 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 23 Day 1 | 6.67 score on a scale | Standard Deviation 13.801 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 9 Day 1 | 35.90 score on a scale | Standard Deviation 21.281 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 24 Day 1 | 4.44 score on a scale | Standard Deviation 17.213 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 11 Day 1 | 69.57 score on a scale | Standard Deviation 25.237 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 25 Day 1 | 5.56 score on a scale | Standard Deviation 12.975 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 10 Day 1 | 34.57 score on a scale | Standard Deviation 22.635 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 26 Day 1 | 8.33 score on a scale | Standard Deviation 15.43 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 4 Day 1 | 78.26 score on a scale | Standard Deviation 18.854 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 27 Day 1 | 16.67 score on a scale | Standard Deviation 27.889 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 11 Day 1 | 32.37 score on a scale | Standard Deviation 20.851 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 28 Day 1 | 25.00 score on a scale | Standard Deviation 31.914 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 29 Day 1 | 56.25 score on a scale | Standard Deviation 18.478 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 29 Day 1 | 25.00 score on a scale | Standard Deviation 31.914 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 12 Day 1 | 32.82 score on a scale | Standard Deviation 20.264 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 30 Day 1 | 16.67 score on a scale | Standard Deviation 33.333 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 5 Day 1 | 75.85 score on a scale | Standard Deviation 21.767 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 31 Day 1 | 33.33 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Off-treatment Visit | 13.33 score on a scale | Standard Deviation 23.481 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 13 Day 1 | 35.52 score on a scale | Standard Deviation 18.882 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Baseline | 6.43 score on a scale | Standard Deviation 15.045 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 12 Day 1 | 70.51 score on a scale | Standard Deviation 24.785 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 2 Day 1 | 22.29 score on a scale | Standard Deviation 29.572 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 14 Day 1 | 30.84 score on a scale | Standard Deviation 21.429 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 3 Day 1 | 32.21 score on a scale | Standard Deviation 30.858 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 6 Day 1 | 80.60 score on a scale | Standard Deviation 18.703 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 4 Day 1 | 35.59 score on a scale | Standard Deviation 33.634 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 15 Day 1 | 28.03 score on a scale | Standard Deviation 20.682 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 5 Day 1 | 28.61 score on a scale | Standard Deviation 28.085 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 19 Day 1 | 76.67 score on a scale | Standard Deviation 15.771 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 6 Day 1 | 31.96 score on a scale | Standard Deviation 30.55 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 16 Day 1 | 33.33 score on a scale | Standard Deviation 22.361 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 7 Day 1 | 33.64 score on a scale | Standard Deviation 31.885 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 7 Day 1 | 77.18 score on a scale | Standard Deviation 19.571 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 8 Day 1 | 29.55 score on a scale | Standard Deviation 28.818 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 17 Day 1 | 33.33 score on a scale | Standard Deviation 21.902 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 9 Day 1 | 34.43 score on a scale | Standard Deviation 33.129 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 13 Day 1 | 69.64 score on a scale | Standard Deviation 24.434 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 10 Day 1 | 29.22 score on a scale | Standard Deviation 29.992 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 18 Day 1 | 34.05 score on a scale | Standard Deviation 22.024 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 11 Day 1 | 28.02 score on a scale | Standard Deviation 28.367 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 8 Day 1 | 79.08 score on a scale | Standard Deviation 19.744 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 12 Day 1 | 28.49 score on a scale | Standard Deviation 31.273 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 19 Day 1 | 37.04 score on a scale | Standard Deviation 23.061 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 13 Day 1 | 26.19 score on a scale | Standard Deviation 28.223 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 7 Day 1 | 73.02 score on a scale | Standard Deviation 20.769 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 14 Day 1 | 26.53 score on a scale | Standard Deviation 25.44 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 20 Day 1 | 34.57 score on a scale | Standard Deviation 19.812 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 15 Day 1 | 29.55 score on a scale | Standard Deviation 29.828 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 9 Day 1 | 78.75 score on a scale | Standard Deviation 22.127 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 16 Day 1 | 20.33 score on a scale | Standard Deviation 27.767 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 21 Day 1 | 34.19 score on a scale | Standard Deviation 20.828 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 17 Day 1 | 21.30 score on a scale | Standard Deviation 24.107 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 14 Day 1 | 71.09 score on a scale | Standard Deviation 24.242 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 18 Day 1 | 21.51 score on a scale | Standard Deviation 25.164 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 22 Day 1 | 26.32 score on a scale | Standard Deviation 18.596 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 19 Day 1 | 23.46 score on a scale | Standard Deviation 28.963 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 10 Day 1 | 80.04 score on a scale | Standard Deviation 19.44 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 20 Day 1 | 19.75 score on a scale | Standard Deviation 23.13 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 23 Day 1 | 26.67 score on a scale | Standard Deviation 20.053 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 21 Day 1 | 20.51 score on a scale | Standard Deviation 26.795 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 20 Day 1 | 73.09 score on a scale | Standard Deviation 22.071 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 22 Day 1 | 17.54 score on a scale | Standard Deviation 20.393 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 24 Day 1 | 28.15 score on a scale | Standard Deviation 20.082 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 23 Day 1 | 15.56 score on a scale | Standard Deviation 17.213 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 11 Day 1 | 82.25 score on a scale | Standard Deviation 20.558 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 24 Day 1 | 11.11 score on a scale | Standard Deviation 16.265 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 25 Day 1 | 33.33 score on a scale | Standard Deviation 19.534 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 25 Day 1 | 19.44 score on a scale | Standard Deviation 22.285 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 15 Day 1 | 72.73 score on a scale | Standard Deviation 22.184 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 26 Day 1 | 25.00 score on a scale | Standard Deviation 29.547 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 26 Day 1 | 26.39 score on a scale | Standard Deviation 17.755 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 27 Day 1 | 33.33 score on a scale | Standard Deviation 21.082 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 12 Day 1 | 81.51 score on a scale | Standard Deviation 19.157 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 28 Day 1 | 16.67 score on a scale | Standard Deviation 19.245 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 27 Day 1 | 27.78 score on a scale | Standard Deviation 16.851 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 29 Day 1 | 8.33 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Baseline | 76.36 score on a scale | Standard Deviation 19.282 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 30 Day 1 | 16.67 score on a scale | Standard Deviation 19.245 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 28 Day 1 | 22.22 score on a scale | Standard Deviation 15.713 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 31 Day 1 | 33.33 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Off-treatment Visit | 18.33 score on a scale | Standard Deviation 25.38 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 13 Day 1 | 79.32 score on a scale | Standard Deviation 17.908 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Baseline | 21.76 score on a scale | Standard Deviation 28.382 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 29 Day 1 | 22.22 score on a scale | Standard Deviation 15.713 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 2 Day 1 | 21.08 score on a scale | Standard Deviation 28.177 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 16 Day 1 | 70.33 score on a scale | Standard Deviation 23.426 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 3 Day 1 | 23.13 score on a scale | Standard Deviation 27.201 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 30 Day 1 | 25 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 4 Day 1 | 22.90 score on a scale | Standard Deviation 27.761 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 14 Day 1 | 81.35 score on a scale | Standard Deviation 16.782 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 5 Day 1 | 22.93 score on a scale | Standard Deviation 28.213 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 31 Day 1 | 33.33 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 6 Day 1 | 25.00 score on a scale | Standard Deviation 27.416 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Off-treatment Visit | 43.47 score on a scale | Standard Deviation 28.173 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 7 Day 1 | 30.16 score on a scale | Standard Deviation 31.866 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 21 Day 1 | 74.62 score on a scale | Standard Deviation 18.668 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 8 Day 1 | 25.43 score on a scale | Standard Deviation 29.176 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Baseline | 7.60 score on a scale | Standard Deviation 17.265 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 9 Day 1 | 25.56 score on a scale | Standard Deviation 30.002 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 15 Day 1 | 80.30 score on a scale | Standard Deviation 18.336 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 10 Day 1 | 22.50 score on a scale | Standard Deviation 27.952 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 2 Day 1 | 11.50 score on a scale | Standard Deviation 18.229 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 11 Day 1 | 26.26 score on a scale | Standard Deviation 30.108 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 17 Day 1 | 65.74 score on a scale | Standard Deviation 22.868 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 12 Day 1 | 24.87 score on a scale | Standard Deviation 28.061 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 3 Day 1 | 14.86 score on a scale | Standard Deviation 24.057 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 13 Day 1 | 23.03 score on a scale | Standard Deviation 26.351 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 16 Day 1 | 81.50 score on a scale | Standard Deviation 17.432 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 14 Day 1 | 20.83 score on a scale | Standard Deviation 22.413 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 4 Day 1 | 15.80 score on a scale | Standard Deviation 21.386 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 15 Day 1 | 21.71 score on a scale | Standard Deviation 27.103 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 8 Day 1 | 72.77 score on a scale | Standard Deviation 20.422 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 16 Day 1 | 21.67 score on a scale | Standard Deviation 25.654 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 5 Day 1 | 12.07 score on a scale | Standard Deviation 17.017 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 17 Day 1 | 23.81 score on a scale | Standard Deviation 27.501 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 17 Day 1 | 79.63 score on a scale | Standard Deviation 19.664 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 18 Day 1 | 17.20 score on a scale | Standard Deviation 18.995 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 6 Day 1 | 12.74 score on a scale | Standard Deviation 19.215 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 19 Day 1 | 18.52 score on a scale | Standard Deviation 19.245 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 18 Day 1 | 67.74 score on a scale | Standard Deviation 20.609 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 20 Day 1 | 16.05 score on a scale | Standard Deviation 21.424 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 7 Day 1 | 12.46 score on a scale | Standard Deviation 18.612 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 21 Day 1 | 19.23 score on a scale | Standard Deviation 21.444 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 18 Day 1 | 81.90 score on a scale | Standard Deviation 15.33 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 22 Day 1 | 24.56 score on a scale | Standard Deviation 24.45 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 8 Day 1 | 13.10 score on a scale | Standard Deviation 21.836 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 23 Day 1 | 17.78 score on a scale | Standard Deviation 17.213 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 22 Day 1 | 80.35 score on a scale | Standard Deviation 14.483 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 24 Day 1 | 17.78 score on a scale | Standard Deviation 21.331 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 9 Day 1 | 12.27 score on a scale | Standard Deviation 20.005 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 25 Day 1 | 16.67 score on a scale | Standard Deviation 22.473 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 19 Day 1 | 81.17 score on a scale | Standard Deviation 15.945 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 26 Day 1 | 20.83 score on a scale | Standard Deviation 24.801 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 10 Day 1 | 15.02 score on a scale | Standard Deviation 22.299 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 27 Day 1 | 16.67 score on a scale | Standard Deviation 18.257 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 19 Day 1 | 67.28 score on a scale | Standard Deviation 28.3 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 28 Day 1 | 25.00 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 11 Day 1 | 11.11 score on a scale | Standard Deviation 18.002 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 29 Day 1 | 25.00 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 20 Day 1 | 80.25 score on a scale | Standard Deviation 17.925 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 30 Day 1 | 25.00 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 12 Day 1 | 12.82 score on a scale | Standard Deviation 19.042 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 31 Day 1 | 0 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Off-treatment Visit | 31.65 score on a scale | Standard Deviation 32.423 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Baseline | 63.35 score on a scale | Standard Deviation 22.02 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 13 Day 1 | 12.20 score on a scale | Standard Deviation 18.934 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 21 Day 1 | 81.73 score on a scale | Standard Deviation 15.279 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 14 Day 1 | 14.97 score on a scale | Standard Deviation 21.849 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 28 Day 1 | 58.33 score on a scale | Standard Deviation 21.517 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 15 Day 1 | 14.02 score on a scale | Standard Deviation 20.631 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 22 Day 1 | 85.09 score on a scale | Standard Deviation 16.096 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 16 Day 1 | 11.38 score on a scale | Standard Deviation 19.874 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 2 Day 1 | 58.60 score on a scale | Standard Deviation 21.234 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 17 Day 1 | 14.35 score on a scale | Standard Deviation 22.94 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 23 Day 1 | 86.67 score on a scale | Standard Deviation 15.366 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 18 Day 1 | 10.75 score on a scale | Standard Deviation 22.587 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 23 Day 1 | 79.56 score on a scale | Standard Deviation 14.357 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 19 Day 1 | 16.67 score on a scale | Standard Deviation 27.347 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 24 Day 1 | 88.89 score on a scale | Standard Deviation 14.319 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 20 Day 1 | 16.67 score on a scale | Standard Deviation 23.113 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Off-treatment Visit | 25.11 score on a scale | Standard Deviation 30.318 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 27 Day 1 | 71.43 score on a scale | Standard Deviation 18.545 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 28 Day 1 | 77.78 score on a scale | Standard Deviation 13.608 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 29 Day 1 | 75 score on a scale | Standard Deviation 16.667 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 30 Day 1 | 66.67 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Off-treatment Visit | 56.05 score on a scale | Standard Deviation 22.363 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Baseline | 76.60 score on a scale | Standard Deviation 21.855 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 2 Day 1 | 75.38 score on a scale | Standard Deviation 19.706 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 3 Day 1 | 76.15 score on a scale | Standard Deviation 19.16 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 4 Day 1 | 75.40 score on a scale | Standard Deviation 20.155 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 5 Day 1 | 77.85 score on a scale | Standard Deviation 18.342 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 6 Day 1 | 77.76 score on a scale | Standard Deviation 18.562 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 7 Day 1 | 78.41 score on a scale | Standard Deviation 18.034 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 8 Day 1 | 79.11 score on a scale | Standard Deviation 17.707 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 9 Day 1 | 80.60 score on a scale | Standard Deviation 16.041 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 10 Day 1 | 81.20 score on a scale | Standard Deviation 16.271 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 11 Day 1 | 81.13 score on a scale | Standard Deviation 16.638 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 12 Day 1 | 83.01 score on a scale | Standard Deviation 15.254 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 13 Day 1 | 80.24 score on a scale | Standard Deviation 16.873 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 14 Day 1 | 82.39 score on a scale | Standard Deviation 16.387 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 15 Day 1 | 80.92 score on a scale | Standard Deviation 17.283 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 16 Day 1 | 81.74 score on a scale | Standard Deviation 15.982 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 17 Day 1 | 82.33 score on a scale | Standard Deviation 15.657 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 18 Day 1 | 81.52 score on a scale | Standard Deviation 16.135 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 19 Day 1 | 81.57 score on a scale | Standard Deviation 16.002 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 20 Day 1 | 82.80 score on a scale | Standard Deviation 13.854 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 21 Day 1 | 84.29 score on a scale | Standard Deviation 12.335 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 22 Day 1 | 82.72 score on a scale | Standard Deviation 15.164 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 23 Day 1 | 81.39 score on a scale | Standard Deviation 17.248 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 24 Day 1 | 83.86 score on a scale | Standard Deviation 13.755 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 25 Day 1 | 84.17 score on a scale | Standard Deviation 15.753 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 26 Day 1 | 71.79 score on a scale | Standard Deviation 29.833 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 27 Day 1 | 85.71 score on a scale | Standard Deviation 16.523 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 28 Day 1 | 90 score on a scale | Standard Deviation 15.635 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 29 Day 1 | 86.67 score on a scale | Standard Deviation 16.33 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Cycle 30 Day 1 | 100 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Physical Functioning Score; Off-treatment Visit | 70.41 score on a scale | Standard Deviation 25.139 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Baseline | 75.72 score on a scale | Standard Deviation 27.932 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 2 Day 1 | 69.33 score on a scale | Standard Deviation 27.449 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 3 Day 1 | 72.18 score on a scale | Standard Deviation 25.63 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 4 Day 1 | 73.60 score on a scale | Standard Deviation 26.169 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 5 Day 1 | 72.44 score on a scale | Standard Deviation 25.143 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 6 Day 1 | 73.75 score on a scale | Standard Deviation 27.557 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 7 Day 1 | 73.97 score on a scale | Standard Deviation 25.205 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 8 Day 1 | 75.60 score on a scale | Standard Deviation 26.139 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 9 Day 1 | 75.91 score on a scale | Standard Deviation 25.242 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 10 Day 1 | 76.89 score on a scale | Standard Deviation 24.027 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 11 Day 1 | 79.11 score on a scale | Standard Deviation 23.691 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 12 Day 1 | 80.91 score on a scale | Standard Deviation 22.953 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 13 Day 1 | 80 score on a scale | Standard Deviation 24.721 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 14 Day 1 | 81.13 score on a scale | Standard Deviation 23.121 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 15 Day 1 | 74.84 score on a scale | Standard Deviation 25.685 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 16 Day 1 | 79.08 score on a scale | Standard Deviation 21.272 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 17 Day 1 | 83.75 score on a scale | Standard Deviation 18.292 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 18 Day 1 | 82.35 score on a scale | Standard Deviation 22.073 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Baseline | 63.58 score on a scale | Standard Deviation 21.34 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 2 Day 1 | 60.93 score on a scale | Standard Deviation 20.28 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 3 Day 1 | 61.85 score on a scale | Standard Deviation 20.202 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 4 Day 1 | 62.62 score on a scale | Standard Deviation 19.641 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 5 Day 1 | 63.76 score on a scale | Standard Deviation 20.339 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 6 Day 1 | 63.73 score on a scale | Standard Deviation 19.756 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 7 Day 1 | 62.54 score on a scale | Standard Deviation 20.153 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 8 Day 1 | 62.11 score on a scale | Standard Deviation 20.271 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 9 Day 1 | 63.77 score on a scale | Standard Deviation 20.429 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 10 Day 1 | 66.44 score on a scale | Standard Deviation 19.012 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 11 Day 1 | 65.86 score on a scale | Standard Deviation 21.173 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 12 Day 1 | 66.94 score on a scale | Standard Deviation 18.409 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 13 Day 1 | 68.94 score on a scale | Standard Deviation 18.388 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 14 Day 1 | 70.35 score on a scale | Standard Deviation 15.605 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 15 Day 1 | 66.83 score on a scale | Standard Deviation 16.955 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 16 Day 1 | 64.54 score on a scale | Standard Deviation 19.386 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 17 Day 1 | 67.71 score on a scale | Standard Deviation 18.794 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 18 Day 1 | 68.38 score on a scale | Standard Deviation 17.859 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 19 Day 1 | 66.67 score on a scale | Standard Deviation 15.215 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 20 Day 1 | 66.40 score on a scale | Standard Deviation 15.736 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 21 Day 1 | 71.13 score on a scale | Standard Deviation 15.463 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 22 Day 1 | 66.05 score on a scale | Standard Deviation 17.438 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 23 Day 1 | 66.67 score on a scale | Standard Deviation 14.948 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 24 Day 1 | 65.79 score on a scale | Standard Deviation 18.818 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 25 Day 1 | 69.79 score on a scale | Standard Deviation 14.868 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Global Health Status/QoL Score; Cycle 26 Day 1 | 60.90 score on a scale | Standard Deviation 18.442 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 20 Day 1 | 79.57 score on a scale | Standard Deviation 24.612 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 21 Day 1 | 81.55 score on a scale | Standard Deviation 19.948 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 22 Day 1 | 77.78 score on a scale | Standard Deviation 22.169 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 23 Day 1 | 79.86 score on a scale | Standard Deviation 23.56 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 24 Day 1 | 83.33 score on a scale | Standard Deviation 19.245 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 25 Day 1 | 82.29 score on a scale | Standard Deviation 23.936 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 26 Day 1 | 69.23 score on a scale | Standard Deviation 31.066 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 27 Day 1 | 90.48 score on a scale | Standard Deviation 16.265 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 28 Day 1 | 97.22 score on a scale | Standard Deviation 6.804 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 29 Day 1 | 96.67 score on a scale | Standard Deviation 7.454 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 30 Day 1 | 100 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Off-treatment Visit | 63.51 score on a scale | Standard Deviation 31.656 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Baseline | 80.06 score on a scale | Standard Deviation 19.729 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 2 Day 1 | 82.06 score on a scale | Standard Deviation 19.167 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 3 Day 1 | 82.90 score on a scale | Standard Deviation 19.314 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 4 Day 1 | 84.19 score on a scale | Standard Deviation 18.517 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 5 Day 1 | 84.52 score on a scale | Standard Deviation 15.766 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 6 Day 1 | 84.38 score on a scale | Standard Deviation 18.365 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 7 Day 1 | 84.29 score on a scale | Standard Deviation 16.356 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 8 Day 1 | 84.88 score on a scale | Standard Deviation 18.215 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 9 Day 1 | 85.96 score on a scale | Standard Deviation 17.512 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 10 Day 1 | 87.84 score on a scale | Standard Deviation 15.433 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 11 Day 1 | 87.15 score on a scale | Standard Deviation 16.247 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 12 Day 1 | 86.67 score on a scale | Standard Deviation 15.358 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 13 Day 1 | 87.27 score on a scale | Standard Deviation 15.783 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 14 Day 1 | 87.50 score on a scale | Standard Deviation 17.11 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 15 Day 1 | 87.25 score on a scale | Standard Deviation 15.398 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 16 Day 1 | 87.41 score on a scale | Standard Deviation 14.935 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 17 Day 1 | 87.08 score on a scale | Standard Deviation 16.118 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 18 Day 1 | 86.76 score on a scale | Standard Deviation 16.555 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 19 Day 1 | 84.80 score on a scale | Standard Deviation 18.403 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 20 Day 1 | 86.56 score on a scale | Standard Deviation 17.437 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 21 Day 1 | 88.99 score on a scale | Standard Deviation 14.174 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 22 Day 1 | 89.20 score on a scale | Standard Deviation 15.644 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 23 Day 1 | 87.15 score on a scale | Standard Deviation 15.922 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 24 Day 1 | 87.28 score on a scale | Standard Deviation 13.712 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 25 Day 1 | 90.63 score on a scale | Standard Deviation 12.5 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 26 Day 1 | 85.26 score on a scale | Standard Deviation 23.362 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 27 Day 1 | 95.24 score on a scale | Standard Deviation 12.599 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 28 Day 1 | 100 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 29 Day 1 | 100 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Cycle 30 Day 1 | 100 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Emotional Functioning Score; Off-treatment Visit | 73.87 score on a scale | Standard Deviation 25.145 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Baseline | 89.51 score on a scale | Standard Deviation 15.529 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 2 Day 1 | 88.85 score on a scale | Standard Deviation 18.025 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 3 Day 1 | 87.47 score on a scale | Standard Deviation 17.946 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 4 Day 1 | 90.32 score on a scale | Standard Deviation 13.692 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 5 Day 1 | 87.43 score on a scale | Standard Deviation 17.086 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 6 Day 1 | 87.68 score on a scale | Standard Deviation 18.47 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 7 Day 1 | 87.94 score on a scale | Standard Deviation 14.708 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 8 Day 1 | 88.49 score on a scale | Standard Deviation 16.38 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 9 Day 1 | 87.68 score on a scale | Standard Deviation 17.095 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 10 Day 1 | 90.44 score on a scale | Standard Deviation 13.747 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 11 Day 1 | 88.89 score on a scale | Standard Deviation 15.824 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 12 Day 1 | 88.61 score on a scale | Standard Deviation 17.758 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 13 Day 1 | 89.70 score on a scale | Standard Deviation 12.624 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 14 Day 1 | 87.18 score on a scale | Standard Deviation 16.375 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 15 Day 1 | 83.99 score on a scale | Standard Deviation 17.308 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 16 Day 1 | 89.36 score on a scale | Standard Deviation 13.649 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 17 Day 1 | 89.58 score on a scale | Standard Deviation 14.465 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 18 Day 1 | 90.20 score on a scale | Standard Deviation 15.417 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 19 Day 1 | 89.22 score on a scale | Standard Deviation 14.727 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 20 Day 1 | 91.94 score on a scale | Standard Deviation 12.073 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 21 Day 1 | 88.10 score on a scale | Standard Deviation 12.715 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 22 Day 1 | 90.12 score on a scale | Standard Deviation 12.454 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 23 Day 1 | 88.19 score on a scale | Standard Deviation 14.311 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 24 Day 1 | 92.11 score on a scale | Standard Deviation 8.55 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 25 Day 1 | 98.96 score on a scale | Standard Deviation 4.167 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 26 Day 1 | 92.31 score on a scale | Standard Deviation 11.004 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 27 Day 1 | 95.24 score on a scale | Standard Deviation 12.599 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 28 Day 1 | 100 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 29 Day 1 | 100 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Cycle 30 Day 1 | 100 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Cognitive Functioning Score; Off-treatment Visit | 80.41 score on a scale | Standard Deviation 23.304 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Baseline | 78.29 score on a scale | Standard Deviation 27.243 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 2 Day 1 | 77.15 score on a scale | Standard Deviation 27.19 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 3 Day 1 | 77.19 score on a scale | Standard Deviation 25.309 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 4 Day 1 | 77.33 score on a scale | Standard Deviation 25.311 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 5 Day 1 | 79.63 score on a scale | Standard Deviation 23.934 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 6 Day 1 | 78.71 score on a scale | Standard Deviation 25.758 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 7 Day 1 | 77.30 score on a scale | Standard Deviation 24.691 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 8 Day 1 | 79.04 score on a scale | Standard Deviation 24.565 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 9 Day 1 | 78.62 score on a scale | Standard Deviation 20.573 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 10 Day 1 | 85.14 score on a scale | Standard Deviation 19.422 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 11 Day 1 | 85.19 score on a scale | Standard Deviation 19.086 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 12 Day 1 | 83.89 score on a scale | Standard Deviation 23.161 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 13 Day 1 | 83.94 score on a scale | Standard Deviation 21.508 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 14 Day 1 | 83.97 score on a scale | Standard Deviation 19.792 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 15 Day 1 | 81.37 score on a scale | Standard Deviation 22.273 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 16 Day 1 | 80.80 score on a scale | Standard Deviation 22.489 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 17 Day 1 | 80.42 score on a scale | Standard Deviation 24.134 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 18 Day 1 | 82.84 score on a scale | Standard Deviation 21.116 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 19 Day 1 | 80.88 score on a scale | Standard Deviation 25.667 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 20 Day 1 | 81.72 score on a scale | Standard Deviation 22.092 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 21 Day 1 | 82.14 score on a scale | Standard Deviation 24.398 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 22 Day 1 | 82.10 score on a scale | Standard Deviation 20.634 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 23 Day 1 | 83.33 score on a scale | Standard Deviation 22.522 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 24 Day 1 | 84.21 score on a scale | Standard Deviation 19.621 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 25 Day 1 | 84.38 score on a scale | Standard Deviation 18.727 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 26 Day 1 | 76.92 score on a scale | Standard Deviation 31.578 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 27 Day 1 | 95.24 score on a scale | Standard Deviation 12.599 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 28 Day 1 | 100 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 29 Day 1 | 100 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Cycle 30 Day 1 | 100 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Social Functioning Score; Off-treatment Visit | 66.89 score on a scale | Standard Deviation 32.453 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Baseline | 31.76 score on a scale | Standard Deviation 25.224 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 2 Day 1 | 36.74 score on a scale | Standard Deviation 23.665 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 3 Day 1 | 36.62 score on a scale | Standard Deviation 24.031 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 4 Day 1 | 32.68 score on a scale | Standard Deviation 23.829 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 5 Day 1 | 35.17 score on a scale | Standard Deviation 22.431 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 6 Day 1 | 33.19 score on a scale | Standard Deviation 23.696 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 7 Day 1 | 30.79 score on a scale | Standard Deviation 21.859 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 8 Day 1 | 30.81 score on a scale | Standard Deviation 23.268 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 9 Day 1 | 30.80 score on a scale | Standard Deviation 21.293 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 10 Day 1 | 27.11 score on a scale | Standard Deviation 20.278 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 11 Day 1 | 27.46 score on a scale | Standard Deviation 22.788 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 12 Day 1 | 23.48 score on a scale | Standard Deviation 21.302 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 13 Day 1 | 25.05 score on a scale | Standard Deviation 21.3 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 14 Day 1 | 25.58 score on a scale | Standard Deviation 20.276 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 15 Day 1 | 28.98 score on a scale | Standard Deviation 23.315 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 16 Day 1 | 25.53 score on a scale | Standard Deviation 20.581 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 17 Day 1 | 25 score on a scale | Standard Deviation 20.09 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 18 Day 1 | 24.84 score on a scale | Standard Deviation 19.546 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 19 Day 1 | 27.45 score on a scale | Standard Deviation 22.595 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 20 Day 1 | 27.24 score on a scale | Standard Deviation 22.192 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 21 Day 1 | 23.02 score on a scale | Standard Deviation 17.088 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 22 Day 1 | 26.75 score on a scale | Standard Deviation 20.033 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 23 Day 1 | 29.17 score on a scale | Standard Deviation 21.934 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 24 Day 1 | 26.90 score on a scale | Standard Deviation 17.496 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 25 Day 1 | 25.69 score on a scale | Standard Deviation 19.338 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 26 Day 1 | 37.61 score on a scale | Standard Deviation 28.16 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 27 Day 1 | 20.63 score on a scale | Standard Deviation 20.716 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 28 Day 1 | 16.67 score on a scale | Standard Deviation 19.563 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 29 Day 1 | 15.56 score on a scale | Standard Deviation 14.907 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Cycle 30 Day 1 | 11.11 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Fatigue Score; Off-treatment Visit | 38.89 score on a scale | Standard Deviation 28.977 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Baseline | 6.28 score on a scale | Standard Deviation 14.51 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 2 Day 1 | 9.56 score on a scale | Standard Deviation 17.943 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 3 Day 1 | 9.74 score on a scale | Standard Deviation 18.219 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 4 Day 1 | 12.17 score on a scale | Standard Deviation 18.906 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 5 Day 1 | 11.42 score on a scale | Standard Deviation 18.27 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 6 Day 1 | 10.14 score on a scale | Standard Deviation 18.996 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 7 Day 1 | 8.57 score on a scale | Standard Deviation 13.696 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 8 Day 1 | 10.14 score on a scale | Standard Deviation 15.508 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 9 Day 1 | 9.96 score on a scale | Standard Deviation 17.306 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 10 Day 1 | 7.78 score on a scale | Standard Deviation 16.287 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 11 Day 1 | 8.69 score on a scale | Standard Deviation 15.394 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 12 Day 1 | 6.99 score on a scale | Standard Deviation 14.645 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 13 Day 1 | 6.97 score on a scale | Standard Deviation 13.867 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 14 Day 1 | 7.55 score on a scale | Standard Deviation 16.527 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 15 Day 1 | 8.82 score on a scale | Standard Deviation 15.038 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 16 Day 1 | 9.22 score on a scale | Standard Deviation 15.467 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 17 Day 1 | 5 score on a scale | Standard Deviation 13.183 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 18 Day 1 | 9.31 score on a scale | Standard Deviation 15.457 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 19 Day 1 | 7.35 score on a scale | Standard Deviation 15.457 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 20 Day 1 | 10.22 score on a scale | Standard Deviation 15.915 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 21 Day 1 | 7.74 score on a scale | Standard Deviation 12.408 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 22 Day 1 | 8.64 score on a scale | Standard Deviation 13.374 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 23 Day 1 | 6.25 score on a scale | Standard Deviation 11.849 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 24 Day 1 | 7.89 score on a scale | Standard Deviation 17.004 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 25 Day 1 | 2.08 score on a scale | Standard Deviation 8.333 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 26 Day 1 | 14.10 score on a scale | Standard Deviation 24.387 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 27 Day 1 | 16.67 score on a scale | Standard Deviation 28.868 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 28 Day 1 | 8.33 score on a scale | Standard Deviation 20.412 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 29 Day 1 | 0 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Cycle 30 Day 1 | 0 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Nausea and Vomiting Score; Off-treatment Visit | 6.76 score on a scale | Standard Deviation 13.207 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Baseline | 23.77 score on a scale | Standard Deviation 26.323 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 2 Day 1 | 27.04 score on a scale | Standard Deviation 23.862 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 3 Day 1 | 25 score on a scale | Standard Deviation 24.046 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 4 Day 1 | 22.87 score on a scale | Standard Deviation 21.486 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 5 Day 1 | 22.97 score on a scale | Standard Deviation 22.314 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 6 Day 1 | 22.50 score on a scale | Standard Deviation 25.716 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 7 Day 1 | 23.65 score on a scale | Standard Deviation 22.142 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 8 Day 1 | 23.20 score on a scale | Standard Deviation 24.949 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 9 Day 1 | 21.01 score on a scale | Standard Deviation 20.053 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 10 Day 1 | 19.33 score on a scale | Standard Deviation 18.792 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 11 Day 1 | 18.06 score on a scale | Standard Deviation 20.508 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 12 Day 1 | 18.55 score on a scale | Standard Deviation 19.814 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 13 Day 1 | 18.48 score on a scale | Standard Deviation 20.203 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 14 Day 1 | 16.04 score on a scale | Standard Deviation 19.601 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 15 Day 1 | 17.65 score on a scale | Standard Deviation 18.078 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 16 Day 1 | 18.44 score on a scale | Standard Deviation 20.628 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 17 Day 1 | 17.50 score on a scale | Standard Deviation 19.954 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 18 Day 1 | 16.67 score on a scale | Standard Deviation 18.803 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 19 Day 1 | 19.61 score on a scale | Standard Deviation 22.274 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 20 Day 1 | 19.35 score on a scale | Standard Deviation 21.558 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 21 Day 1 | 17.86 score on a scale | Standard Deviation 21.721 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 22 Day 1 | 22.84 score on a scale | Standard Deviation 24.085 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 23 Day 1 | 18.06 score on a scale | Standard Deviation 23.527 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 24 Day 1 | 14.91 score on a scale | Standard Deviation 19.16 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 25 Day 1 | 15.63 score on a scale | Standard Deviation 19.691 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 26 Day 1 | 21.79 score on a scale | Standard Deviation 27.542 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 27 Day 1 | 11.90 score on a scale | Standard Deviation 24.934 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 28 Day 1 | 2.78 score on a scale | Standard Deviation 6.804 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 29 Day 1 | 6.67 score on a scale | Standard Deviation 14.907 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Cycle 30 Day 1 | 0 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Pain Score; Off-treatment Visit | 27.70 score on a scale | Standard Deviation 28.171 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Baseline | 22.22 score on a scale | Standard Deviation 26.006 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 2 Day 1 | 19.56 score on a scale | Standard Deviation 23.865 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 3 Day 1 | 19.72 score on a scale | Standard Deviation 23.871 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 4 Day 1 | 17.52 score on a scale | Standard Deviation 20.643 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 5 Day 1 | 15.75 score on a scale | Standard Deviation 20.925 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 6 Day 1 | 18.89 score on a scale | Standard Deviation 23.957 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 7 Day 1 | 15.87 score on a scale | Standard Deviation 21.728 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 8 Day 1 | 14.09 score on a scale | Standard Deviation 20.319 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 9 Day 1 | 14.49 score on a scale | Standard Deviation 21.712 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 10 Day 1 | 11.56 score on a scale | Standard Deviation 19.369 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 11 Day 1 | 15.02 score on a scale | Standard Deviation 23.764 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 12 Day 1 | 12.90 score on a scale | Standard Deviation 22.057 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 13 Day 1 | 10.91 score on a scale | Standard Deviation 20.341 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 14 Day 1 | 10.69 score on a scale | Standard Deviation 20.437 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 15 Day 1 | 12.42 score on a scale | Standard Deviation 21.04 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 16 Day 1 | 9.93 score on a scale | Standard Deviation 16.904 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 17 Day 1 | 10 score on a scale | Standard Deviation 20.255 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 18 Day 1 | 10.78 score on a scale | Standard Deviation 17.829 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 19 Day 1 | 9.80 score on a scale | Standard Deviation 17.465 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 20 Day 1 | 11.83 score on a scale | Standard Deviation 16.212 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 21 Day 1 | 7.14 score on a scale | Standard Deviation 13.929 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 22 Day 1 | 12.35 score on a scale | Standard Deviation 18.829 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 23 Day 1 | 11.11 score on a scale | Standard Deviation 18.822 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 24 Day 1 | 12.28 score on a scale | Standard Deviation 16.52 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 25 Day 1 | 8.33 score on a scale | Standard Deviation 14.907 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 26 Day 1 | 15.38 score on a scale | Standard Deviation 22.008 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 27 Day 1 | 14.29 score on a scale | Standard Deviation 17.817 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 28 Day 1 | 16.67 score on a scale | Standard Deviation 18.257 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 29 Day 1 | 20 score on a scale | Standard Deviation 18.257 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Cycle 30 Day 1 | 0 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Dyspnea Score; Off-treatment Visit | 21.62 score on a scale | Standard Deviation 28.898 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Baseline | 22.84 score on a scale | Standard Deviation 27.671 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 2 Day 1 | 19.91 score on a scale | Standard Deviation 25.386 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 3 Day 1 | 23 score on a scale | Standard Deviation 25.477 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 4 Day 1 | 20.19 score on a scale | Standard Deviation 24.036 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 5 Day 1 | 22.05 score on a scale | Standard Deviation 24.205 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 6 Day 1 | 17.50 score on a scale | Standard Deviation 22.019 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 7 Day 1 | 20 score on a scale | Standard Deviation 25.149 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 8 Day 1 | 19.59 score on a scale | Standard Deviation 25.346 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 9 Day 1 | 16.67 score on a scale | Standard Deviation 21.255 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 10 Day 1 | 18.22 score on a scale | Standard Deviation 22.789 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 11 Day 1 | 17.37 score on a scale | Standard Deviation 24.468 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 12 Day 1 | 13.98 score on a scale | Standard Deviation 22.216 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 13 Day 1 | 13.33 score on a scale | Standard Deviation 21.849 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 14 Day 1 | 11.95 score on a scale | Standard Deviation 21.774 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 15 Day 1 | 16 score on a scale | Standard Deviation 23.561 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 16 Day 1 | 14.89 score on a scale | Standard Deviation 21.768 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 17 Day 1 | 13.33 score on a scale | Standard Deviation 21.082 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 18 Day 1 | 11.76 score on a scale | Standard Deviation 19.903 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 19 Day 1 | 13.73 score on a scale | Standard Deviation 21.893 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 20 Day 1 | 12.90 score on a scale | Standard Deviation 20.507 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 21 Day 1 | 10.71 score on a scale | Standard Deviation 18.265 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 22 Day 1 | 6.17 score on a scale | Standard Deviation 16.111 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 23 Day 1 | 11.11 score on a scale | Standard Deviation 23.399 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 24 Day 1 | 12.28 score on a scale | Standard Deviation 19.909 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 25 Day 1 | 12.50 score on a scale | Standard Deviation 20.638 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 26 Day 1 | 20.51 score on a scale | Standard Deviation 32.026 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 27 Day 1 | 9.52 score on a scale | Standard Deviation 16.265 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 28 Day 1 | 11.11 score on a scale | Standard Deviation 17.213 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 29 Day 1 | 13.33 score on a scale | Standard Deviation 18.257 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Cycle 30 Day 1 | 0 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Insomnia Score; Off-treatment Visit | 28.83 score on a scale | Standard Deviation 31.85 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Baseline | 18.31 score on a scale | Standard Deviation 27.06 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 2 Day 1 | 27.56 score on a scale | Standard Deviation 32.02 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 3 Day 1 | 29.81 score on a scale | Standard Deviation 31.687 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 4 Day 1 | 30.90 score on a scale | Standard Deviation 32.749 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 5 Day 1 | 30.67 score on a scale | Standard Deviation 32.129 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 6 Day 1 | 26.11 score on a scale | Standard Deviation 29.996 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 7 Day 1 | 26.98 score on a scale | Standard Deviation 28.154 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 8 Day 1 | 25.00 score on a scale | Standard Deviation 26.491 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 9 Day 1 | 25.36 score on a scale | Standard Deviation 27.678 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 10 Day 1 | 22.22 score on a scale | Standard Deviation 22.815 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 11 Day 1 | 22.07 score on a scale | Standard Deviation 26.988 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 12 Day 1 | 18.82 score on a scale | Standard Deviation 25.336 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 13 Day 1 | 17.28 score on a scale | Standard Deviation 21.221 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 14 Day 1 | 17.61 score on a scale | Standard Deviation 24.111 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 15 Day 1 | 24.18 score on a scale | Standard Deviation 30.608 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 16 Day 1 | 22.70 score on a scale | Standard Deviation 27.014 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 17 Day 1 | 22.50 score on a scale | Standard Deviation 25.473 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 18 Day 1 | 22.22 score on a scale | Standard Deviation 24.533 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 19 Day 1 | 20.59 score on a scale | Standard Deviation 25.969 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 20 Day 1 | 21.51 score on a scale | Standard Deviation 30.488 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 21 Day 1 | 15.48 score on a scale | Standard Deviation 21.242 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 22 Day 1 | 17.28 score on a scale | Standard Deviation 25.099 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 23 Day 1 | 20.83 score on a scale | Standard Deviation 27.474 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 24 Day 1 | 15.79 score on a scale | Standard Deviation 25.744 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 25 Day 1 | 18.75 score on a scale | Standard Deviation 29.736 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 26 Day 1 | 23.08 score on a scale | Standard Deviation 34.385 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 27 Day 1 | 9.52 score on a scale | Standard Deviation 16.265 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 28 Day 1 | 11.11 score on a scale | Standard Deviation 17.213 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 29 Day 1 | 0 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Cycle 30 Day 1 | 0 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Appetite Loss Score; Off-treatment Visit | 25.23 score on a scale | Standard Deviation 32.082 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Baseline | 12.55 score on a scale | Standard Deviation 23.501 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 2 Day 1 | 11.11 score on a scale | Standard Deviation 21.035 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 3 Day 1 | 10.80 score on a scale | Standard Deviation 20.456 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 4 Day 1 | 9.80 score on a scale | Standard Deviation 19.081 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 5 Day 1 | 9.87 score on a scale | Standard Deviation 19.411 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 6 Day 1 | 8.47 score on a scale | Standard Deviation 19.09 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 7 Day 1 | 7.44 score on a scale | Standard Deviation 16.785 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 8 Day 1 | 7.22 score on a scale | Standard Deviation 14.614 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 9 Day 1 | 9.42 score on a scale | Standard Deviation 19.967 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 10 Day 1 | 8.00 score on a scale | Standard Deviation 18.042 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 11 Day 1 | 7.98 score on a scale | Standard Deviation 18.227 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 12 Day 1 | 9.68 score on a scale | Standard Deviation 18.492 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 13 Day 1 | 9.09 score on a scale | Standard Deviation 18.653 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 14 Day 1 | 7.69 score on a scale | Standard Deviation 16.978 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 15 Day 1 | 9.33 score on a scale | Standard Deviation 19.095 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 16 Day 1 | 9.93 score on a scale | Standard Deviation 18.277 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 17 Day 1 | 5.00 score on a scale | Standard Deviation 12.054 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 18 Day 1 | 7.84 score on a scale | Standard Deviation 16.532 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 19 Day 1 | 9.80 score on a scale | Standard Deviation 20.969 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 20 Day 1 | 8.60 score on a scale | Standard Deviation 22.718 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 21 Day 1 | 7.14 score on a scale | Standard Deviation 16.623 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 22 Day 1 | 7.41 score on a scale | Standard Deviation 19.245 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 23 Day 1 | 11.11 score on a scale | Standard Deviation 21.234 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 24 Day 1 | 8.77 score on a scale | Standard Deviation 21.779 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 25 Day 1 | 18.75 score on a scale | Standard Deviation 29.736 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 26 Day 1 | 15.38 score on a scale | Standard Deviation 25.875 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 27 Day 1 | 0 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 28 Day 1 | 0 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 29 Day 1 | 0 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Cycle 30 Day 1 | 0 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Constipation Score; Off-treatment Visit | 12.61 score on a scale | Standard Deviation 21.863 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Baseline | 6.79 score on a scale | Standard Deviation 15.823 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 2 Day 1 | 17.66 score on a scale | Standard Deviation 26.333 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 3 Day 1 | 27.19 score on a scale | Standard Deviation 32.023 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 4 Day 1 | 29.41 score on a scale | Standard Deviation 28.991 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 5 Day 1 | 29.33 score on a scale | Standard Deviation 29.207 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 6 Day 1 | 26.89 score on a scale | Standard Deviation 27.541 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 7 Day 1 | 31.75 score on a scale | Standard Deviation 27.881 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 8 Day 1 | 31.27 score on a scale | Standard Deviation 28.793 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 9 Day 1 | 28.62 score on a scale | Standard Deviation 28.637 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 10 Day 1 | 29.33 score on a scale | Standard Deviation 25.088 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 11 Day 1 | 26.85 score on a scale | Standard Deviation 26.619 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 12 Day 1 | 22.78 score on a scale | Standard Deviation 23.363 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 13 Day 1 | 23.03 score on a scale | Standard Deviation 25.558 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 14 Day 1 | 24.36 score on a scale | Standard Deviation 22.008 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 15 Day 1 | 30.07 score on a scale | Standard Deviation 26.038 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 16 Day 1 | 23.40 score on a scale | Standard Deviation 21.886 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 17 Day 1 | 29.17 score on a scale | Standard Deviation 28.432 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 18 Day 1 | 25.49 score on a scale | Standard Deviation 23.296 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 19 Day 1 | 21.57 score on a scale | Standard Deviation 21.528 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 20 Day 1 | 22.58 score on a scale | Standard Deviation 23.392 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 21 Day 1 | 21.43 score on a scale | Standard Deviation 18.624 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 22 Day 1 | 24.69 score on a scale | Standard Deviation 19.812 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 23 Day 1 | 22.22 score on a scale | Standard Deviation 16.051 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 24 Day 1 | 19.30 score on a scale | Standard Deviation 16.909 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 25 Day 1 | 18.75 score on a scale | Standard Deviation 17.078 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 26 Day 1 | 17.95 score on a scale | Standard Deviation 17.296 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 27 Day 1 | 33.33 score on a scale | Standard Deviation 19.245 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 28 Day 1 | 22.22 score on a scale | Standard Deviation 17.213 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 29 Day 1 | 20.00 score on a scale | Standard Deviation 18.257 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Cycle 30 Day 1 | 0 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Diarrhea Score; Off-treatment Visit | 12.16 score on a scale | Standard Deviation 19.565 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Baseline | 20.37 score on a scale | Standard Deviation 29.076 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 2 Day 1 | 15.01 score on a scale | Standard Deviation 24.852 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 3 Day 1 | 18.20 score on a scale | Standard Deviation 27.451 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 4 Day 1 | 16.42 score on a scale | Standard Deviation 25.113 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 5 Day 1 | 18.78 score on a scale | Standard Deviation 29.058 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 6 Day 1 | 17.80 score on a scale | Standard Deviation 25.666 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 7 Day 1 | 15.87 score on a scale | Standard Deviation 24.062 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 8 Day 1 | 17.53 score on a scale | Standard Deviation 24.576 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 9 Day 1 | 16.67 score on a scale | Standard Deviation 23.44 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 10 Day 1 | 17.35 score on a scale | Standard Deviation 24.913 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 11 Day 1 | 16.20 score on a scale | Standard Deviation 24.382 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 12 Day 1 | 16.11 score on a scale | Standard Deviation 24.156 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 13 Day 1 | 19.14 score on a scale | Standard Deviation 25.577 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 14 Day 1 | 17.31 score on a scale | Standard Deviation 25.127 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 15 Day 1 | 19.61 score on a scale | Standard Deviation 26.813 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 16 Day 1 | 17.02 score on a scale | Standard Deviation 24.937 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 17 Day 1 | 19.17 score on a scale | Standard Deviation 27.099 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 18 Day 1 | 19.61 score on a scale | Standard Deviation 28.566 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 19 Day 1 | 20.59 score on a scale | Standard Deviation 28.444 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 20 Day 1 | 20.43 score on a scale | Standard Deviation 30.644 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 21 Day 1 | 20.24 score on a scale | Standard Deviation 27.725 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 22 Day 1 | 20.99 score on a scale | Standard Deviation 29.451 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 23 Day 1 | 23.61 score on a scale | Standard Deviation 31.819 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 24 Day 1 | 19.30 score on a scale | Standard Deviation 25.618 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 25 Day 1 | 16.67 score on a scale | Standard Deviation 24.343 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 26 Day 1 | 20.51 score on a scale | Standard Deviation 32.026 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 27 Day 1 | 0 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 28 Day 1 | 0 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 29 Day 1 | 0 score on a scale | Standard Deviation 0 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Financial Difficulties Score; Cycle 30 Day 1 | 0 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores | Role Functioning Score; Cycle 19 Day 1 | 77.45 score on a scale | Standard Deviation 23.883 |
Secondary
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS)
The EQ-5D-3L is a health profile questionnaire assessing quality of life along 5 dimensions. Participants rate 5 dimensions 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 summed score ranges from 5-15 with 5 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. The EQ-5D index was calculated by applying preference-based weights (tariffs) to the scores of the five health state dimensions. Index values can range from -1 to 1, with 0 representing a health state equivalent to death and 1 representing perfect health. EQ-5D-3L also included an EQ visual analogue scale (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score was weighted with a range of -0.594 (worst) to 1.0 (best).
Time frame: At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months)
Population: QoL analysis set consisted of all participants who had any QoL data. Here overall number of participants analyzed are the participants who were evaluable for the outcome measure and number analyzed were the participants who were evaluable at given time points. . As pre-specified in protocol, data for this secondary outcome measure was collected and analyzed till primary analysis only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Baseline | 0.76 score on a scale | Standard Deviation 0.216 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 3 Day 1 | 0.73 score on a scale | Standard Deviation 0.232 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 4 Day 1 | 0.73 score on a scale | Standard Deviation 0.213 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 5 Day 1 | 0.73 score on a scale | Standard Deviation 0.212 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 6 Day 1 | 0.73 score on a scale | Standard Deviation 0.22 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 7 Day 1 | 0.71 score on a scale | Standard Deviation 0.219 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 8 Day 1 | 0.75 score on a scale | Standard Deviation 0.187 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 9 Day 1 | 0.73 score on a scale | Standard Deviation 0.192 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 10 Day 1 | 0.76 score on a scale | Standard Deviation 0.186 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 11 Day 1 | 0.77 score on a scale | Standard Deviation 0.185 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 12 Day 1 | 0.77 score on a scale | Standard Deviation 0.173 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 13 Day 1 | 0.76 score on a scale | Standard Deviation 0.157 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 14 Day 1 | 0.77 score on a scale | Standard Deviation 0.186 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 15 Day 1 | 0.76 score on a scale | Standard Deviation 0.191 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 16 Day 1 | 0.73 score on a scale | Standard Deviation 0.179 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 17 Day 1 | 0.73 score on a scale | Standard Deviation 0.211 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 18 Day 1 | 0.76 score on a scale | Standard Deviation 0.148 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 19 Day 1 | 0.69 score on a scale | Standard Deviation 0.266 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 20 Day 1 | 0.70 score on a scale | Standard Deviation 0.259 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 21 Day 1 | 0.73 score on a scale | Standard Deviation 0.223 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 22 Day 1 | 0.74 score on a scale | Standard Deviation 0.157 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 23 Day 1 | 0.74 score on a scale | Standard Deviation 0.149 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 24 Day 1 | 0.75 score on a scale | Standard Deviation 0.172 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 25 Day 1 | 0.70 score on a scale | Standard Deviation 0.245 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 26 Day 1 | 0.72 score on a scale | Standard Deviation 0.17 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 27 Day 1 | 0.77 score on a scale | Standard Deviation 0.135 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 28 Day 1 | 0.73 score on a scale | Standard Deviation 0.112 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 29 Day 1 | 0.74 score on a scale | Standard Deviation 0.12 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 30 Day 1 | 0.61 score on a scale | Standard Deviation 0.391 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 31 Day 1 | 0.87 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Off-treatment Visit | 0.61 score on a scale | Standard Deviation 0.331 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Baseline | 68.57 score on a scale | Standard Deviation 18.348 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 2 Day 1 | 66.05 score on a scale | Standard Deviation 18.531 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 3 Day 1 | 66.22 score on a scale | Standard Deviation 17.804 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 4 Day 1 | 65.69 score on a scale | Standard Deviation 18.265 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 5 Day 1 | 65.86 score on a scale | Standard Deviation 18.908 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 6 Day 1 | 65.53 score on a scale | Standard Deviation 20.027 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 7 Day 1 | 65.74 score on a scale | Standard Deviation 18.063 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 8 Day 1 | 64.16 score on a scale | Standard Deviation 18.969 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 9 Day 1 | 65.51 score on a scale | Standard Deviation 17.67 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 10 Day 1 | 66.92 score on a scale | Standard Deviation 17.747 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 11 Day 1 | 67.74 score on a scale | Standard Deviation 16.85 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 12 Day 1 | 66.46 score on a scale | Standard Deviation 18.68 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 13 Day 1 | 65.64 score on a scale | Standard Deviation 19.69 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 14 Day 1 | 66.41 score on a scale | Standard Deviation 17.839 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 15 Day 1 | 67.05 score on a scale | Standard Deviation 17.847 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 16 Day 1 | 66.54 score on a scale | Standard Deviation 18.118 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 17 Day 1 | 65.78 score on a scale | Standard Deviation 17.755 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 18 Day 1 | 64.70 score on a scale | Standard Deviation 18.17 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 19 Day 1 | 62.15 score on a scale | Standard Deviation 20.676 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 20 Day 1 | 62.70 score on a scale | Standard Deviation 19.779 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 21 Day 1 | 62.12 score on a scale | Standard Deviation 17.974 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 22 Day 1 | 65.21 score on a scale | Standard Deviation 14.722 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 23 Day 1 | 67.73 score on a scale | Standard Deviation 15.65 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 24 Day 1 | 65.27 score on a scale | Standard Deviation 19.381 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 25 Day 1 | 60.58 score on a scale | Standard Deviation 19.313 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 26 Day 1 | 64.13 score on a scale | Standard Deviation 16.313 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 27 Day 1 | 61.83 score on a scale | Standard Deviation 18.357 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 28 Day 1 | 54.25 score on a scale | Standard Deviation 8.694 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 29 Day 1 | 52.75 score on a scale | Standard Deviation 12.093 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 30 Day 1 | 51.75 score on a scale | Standard Deviation 11.295 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 31 Day 1 | 35 score on a scale | — |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Off-treatment Visit | 58.48 score on a scale | Standard Deviation 23.516 |
| Lenvatinib 14 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 2 Day 1 | 0.76 score on a scale | Standard Deviation 0.178 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Baseline | 0.78 score on a scale | Standard Deviation 0.232 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 16 Day 1 | 72.80 score on a scale | Standard Deviation 17.733 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 2 Day 1 | 0.76 score on a scale | Standard Deviation 0.23 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Baseline | 70.01 score on a scale | Standard Deviation 20.552 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 3 Day 1 | 0.78 score on a scale | Standard Deviation 0.239 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 24 Day 1 | 71.21 score on a scale | Standard Deviation 21.212 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 4 Day 1 | 0.78 score on a scale | Standard Deviation 0.236 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 2 Day 1 | 69.52 score on a scale | Standard Deviation 19.155 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 5 Day 1 | 0.78 score on a scale | Standard Deviation 0.199 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 17 Day 1 | 73.80 score on a scale | Standard Deviation 17.593 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 6 Day 1 | 0.77 score on a scale | Standard Deviation 0.225 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 3 Day 1 | 70.71 score on a scale | Standard Deviation 17.648 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 7 Day 1 | 0.78 score on a scale | Standard Deviation 0.196 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 28 Day 1 | 77.50 score on a scale | Standard Deviation 20.907 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 8 Day 1 | 0.80 score on a scale | Standard Deviation 0.187 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 4 Day 1 | 69.66 score on a scale | Standard Deviation 17.784 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 9 Day 1 | 0.79 score on a scale | Standard Deviation 0.192 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 18 Day 1 | 73.71 score on a scale | Standard Deviation 16.665 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 10 Day 1 | 0.81 score on a scale | Standard Deviation 0.177 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 5 Day 1 | 70.30 score on a scale | Standard Deviation 19.492 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 11 Day 1 | 0.82 score on a scale | Standard Deviation 0.82 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 25 Day 1 | 72.81 score on a scale | Standard Deviation 16.897 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 12 Day 1 | 0.83 score on a scale | Standard Deviation 0.161 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 6 Day 1 | 71.73 score on a scale | Standard Deviation 17.366 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 13 Day 1 | 0.82 score on a scale | Standard Deviation 0.179 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 19 Day 1 | 71.76 score on a scale | Standard Deviation 19.272 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 14 Day 1 | 0.83 score on a scale | Standard Deviation 0.163 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 7 Day 1 | 70.39 score on a scale | Standard Deviation 19.387 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 15 Day 1 | 0.81 score on a scale | Standard Deviation 0.165 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 30 Day 1 | 50 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 16 Day 1 | 0.81 score on a scale | Standard Deviation 0.212 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 8 Day 1 | 70.40 score on a scale | Standard Deviation 20.13 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 17 Day 1 | 0.83 score on a scale | Standard Deviation 0.158 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 20 Day 1 | 72.07 score on a scale | Standard Deviation 19.293 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 18 Day 1 | 0.84 score on a scale | Standard Deviation 0.177 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 9 Day 1 | 69.92 score on a scale | Standard Deviation 19.452 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 19 Day 1 | 0.79 score on a scale | Standard Deviation 0.205 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 26 Day 1 | 65.23 score on a scale | Standard Deviation 25.652 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 20 Day 1 | 0.82 score on a scale | Standard Deviation 0.167 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 10 Day 1 | 73.18 score on a scale | Standard Deviation 20.167 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 21 Day 1 | 0.83 score on a scale | Standard Deviation 0.18 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 21 Day 1 | 76.46 score on a scale | Standard Deviation 16.836 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 22 Day 1 | 0.85 score on a scale | Standard Deviation 0.173 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 11 Day 1 | 73.21 score on a scale | Standard Deviation 19.31 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 23 Day 1 | 0.82 score on a scale | Standard Deviation 0.242 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 29 Day 1 | 74 score on a scale | Standard Deviation 21.036 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 24 Day 1 | 0.84 score on a scale | Standard Deviation 0.156 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 12 Day 1 | 74.46 score on a scale | Standard Deviation 17.139 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 25 Day 1 | 0.83 score on a scale | Standard Deviation 0.175 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 22 Day 1 | 74.44 score on a scale | Standard Deviation 16.86 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 26 Day 1 | 0.73 score on a scale | Standard Deviation 0.438 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 13 Day 1 | 74.35 score on a scale | Standard Deviation 17.766 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 27 Day 1 | 0.93 score on a scale | Standard Deviation 0.117 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 27 Day 1 | 77.43 score on a scale | Standard Deviation 16.762 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 28 Day 1 | 0.97 score on a scale | Standard Deviation 0.067 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 14 Day 1 | 74.40 score on a scale | Standard Deviation 17.678 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 29 Day 1 | 0.96 score on a scale | Standard Deviation 0.075 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 23 Day 1 | 73.67 score on a scale | Standard Deviation 17.704 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Cycle 30 Day 1 | 1 score on a scale | — |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Cycle 15 Day 1 | 72.58 score on a scale | Standard Deviation 19.06 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-VAS Score; Off-treatment Visit | 62.66 score on a scale | Standard Deviation 22.252 |
| Lenvatinib 18 mg + Everolimus 5 mg | HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) | EQ-5D Index Score; Off-treatment Visit | 0.68 score on a scale | Standard Deviation 0.314 |
Secondary
Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib Alone and When Coadministration With Everolimus in Renal Cell Carcinoma (RCC) Participants to Assess Drug-Drug Interaction
Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The lenvatinib concentration data was pooled from studies E7080 -G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for lenvatinib was fitted to the pooled dataset. Individual lenvatinib CL/F value was derived from the final PK model. The outcome measure was assessed for lenvatinib 18 mg dose only.
Time frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)
Population: PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable lenvatinib plasma concentration data. Population included participants from E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and current study E7080-G000-218 (NCT03173560). Here, overall number of participants analyzed are the participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib Alone and When Coadministration With Everolimus in Renal Cell Carcinoma (RCC) Participants to Assess Drug-Drug Interaction | 6.37 liter per hour (L/h) | Standard Deviation 2.01 |
| Lenvatinib 18 mg + Everolimus 5 mg | Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib Alone and When Coadministration With Everolimus in Renal Cell Carcinoma (RCC) Participants to Assess Drug-Drug Interaction | 5.77 liter per hour (L/h) | Standard Deviation 2.01 |
Secondary
Model Predicted CL/F for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction
Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The everolimus concentration data was pooled from studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for everolimus was fitted to the pooled dataset. Individual everolimus CL/F value was derived from the final PK model.
Time frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)
Population: PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable everolimus whole blood concentration data. Population included participants from E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or current study E7080-G000-218 (NCT03173560). Here, overall number of participants analyzed are the participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Model Predicted CL/F for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction | 22.3 liter per hour (L/h) | Standard Deviation 10.5 |
| Lenvatinib 18 mg + Everolimus 5 mg | Model Predicted CL/F for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction | 19.4 liter per hour (L/h) | Standard Deviation 7.9 |
Secondary
Model Predicted Dose Normalized Area Under the Plasma Concentration-time Curve (AUC) for Lenvatinib Alone and When Coadministration With Everolimus in RCC Participants to Assess Drug-Drug Interaction
Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The lenvatinib concentration data was pooled from studies E7080 -G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for lenvatinib was fitted to the pooled dataset. Individual lenvatinib AUC at steady state based on the starting dose was derived as a function of starting dose from the final PK model. The outcome measure was assessed for lenvatinib 18 mg dose only.
Time frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)
Population: PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable lenvatinib plasma concentration data. Population included participants from E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and current study E7080-G000-218 (NCT03173560). Here, overall number of participants analyzed are the participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Model Predicted Dose Normalized Area Under the Plasma Concentration-time Curve (AUC) for Lenvatinib Alone and When Coadministration With Everolimus in RCC Participants to Assess Drug-Drug Interaction | 3693 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 1295 |
| Lenvatinib 18 mg + Everolimus 5 mg | Model Predicted Dose Normalized Area Under the Plasma Concentration-time Curve (AUC) for Lenvatinib Alone and When Coadministration With Everolimus in RCC Participants to Assess Drug-Drug Interaction | 4350 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 2934 |
Secondary
Model Predicted Dose Normalized AUC for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction
Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The everolimus concentration data was pooled from studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for everolimus was fitted to the pooled dataset. Individual everolimus AUC at steady state based on the starting dose was derived as a function of starting dose from the final PK model.
Time frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)
Population: PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable everolimus whole blood concentration data. Population included participants from E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or current study E7080-G000-218 (NCT03173560). Here, overall number of participants analyzed are the participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Model Predicted Dose Normalized AUC for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction | 507.4 ng*hour/mL | Standard Deviation 176.6 |
| Lenvatinib 18 mg + Everolimus 5 mg | Model Predicted Dose Normalized AUC for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction | 305.5 ng*hour/mL | Standard Deviation 174 |
Secondary
Number of Participants With TEAEs and Serious TEAEs
TEAEs were defined as those adverse events (AEs) that occurred (or worsened, if present at Baseline) after the first dose of study drug through 28 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A serious adverse event (SAE) was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.
Time frame: From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months)
Population: Safety analysis set (SAS) included all participants who were randomized and received at least 1 dose of study drug according to the treatment starting dose actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Number of Participants With TEAEs and Serious TEAEs | Participants With TEAEs | 173 Participants |
| Lenvatinib 14 mg + Everolimus 5 mg | Number of Participants With TEAEs and Serious TEAEs | Participants With Serious TEAEs | 92 Participants |
| Lenvatinib 18 mg + Everolimus 5 mg | Number of Participants With TEAEs and Serious TEAEs | Participants With TEAEs | 167 Participants |
| Lenvatinib 18 mg + Everolimus 5 mg | Number of Participants With TEAEs and Serious TEAEs | Participants With Serious TEAEs | 87 Participants |
Secondary
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a BOR of CR or PR at the at the end of treatment based on investigator assessment according to RECIST v1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \<10 mm. PR: defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be considered a BOR, all responses had to be confirmed no less than 4 weeks after the initial assessment of response. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.
Time frame: From date of randomization up to first documentation of PD or date of death, whichever occurred first or up to the date of data cut off for the primary analysis (up to 29 months)
Population: PPAS1 included all randomized participants minus the 32 participants who had received \>=2 incorrect lenvatinib doses due to IxRS issues.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Objective Response Rate (ORR) | 34.6 percentage of participants |
| Lenvatinib 18 mg + Everolimus 5 mg | Objective Response Rate (ORR) | 40.6 percentage of participants |
90% CI: [0.52, 1.14]
Secondary
Overall Survival (OS)
OS was defined as the time from the date of randomization until the date of death from any cause. In the absence of confirmation of death, participants will be censored either at the date that the participant was last known to be alive or the date of data cutoff for the primary analysis, whichever comes earlier. Median OS was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.
Time frame: From the date of randomization until the date of death from any cause, or up to date of data cut off for the primary analysis (up to 29 months)
Population: PPAS1 included all randomized participants minus the 32 participants who had received \>=2 incorrect lenvatinib doses due to IxRS issues.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Overall Survival (OS) | 27.0 months |
| Lenvatinib 18 mg + Everolimus 5 mg | Overall Survival (OS) | NA months |
Secondary
Percentage of Participants Who Discontinued Treatment Due to Toxicity
Percentage of participants who discontinued treatment due to toxicity, defined as the percentage of participants who discontinued study treatment due to TEAEs. Toxicity (except hypertension and non-infectious pneumonitis) was assessed according to NCI-CTCAE v4.03.
Time frame: From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months)
Population: FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Percentage of Participants Who Discontinued Treatment Due to Toxicity | 17.4 percentage of participants |
| Lenvatinib 18 mg + Everolimus 5 mg | Percentage of Participants Who Discontinued Treatment Due to Toxicity | 25.1 percentage of participants |
Secondary
Plasma Concentration of Lenvatinib
PK sparse sampling was performed. As planned, the post-dose plasma sample was collected anytime between 0.5 to 4 hours at Cycle 1 Days 1 and 15, between 6 to 10 hours at Cycle 1 Days 1 and 15, and between 2 to 12 hours at Cycle 2 Day 1. Only one sample was collected for each post-dose category between specified timepoints.
Time frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)
Population: Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable lenvatinib plasma or everolimus whole blood concentration data. Here, overall number of participants analyzed are the participants who were evaluable for the outcome measure and number analyzed were the participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 1 Day 15: Pre-dose | 53.7 nanogram per milliliter (ng/mL) | Standard Deviation 62.31 |
| Lenvatinib 14 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 1 Day 15: 6-10 hours post-dose | 177.8 nanogram per milliliter (ng/mL) | Standard Deviation 89.42 |
| Lenvatinib 14 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 1 Day 1: 6-10 hours post-dose | 136.3 nanogram per milliliter (ng/mL) | Standard Deviation 66.53 |
| Lenvatinib 14 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 2 Day 1: Pre-dose | 42.8 nanogram per milliliter (ng/mL) | Standard Deviation 42.84 |
| Lenvatinib 14 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 1 Day 15: 0.5-4 hours post-dose | 99.6 nanogram per milliliter (ng/mL) | Standard Deviation 102.54 |
| Lenvatinib 14 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 2 Day 1: 2-12 hours post-dose | 172.8 nanogram per milliliter (ng/mL) | Standard Deviation 130.9 |
| Lenvatinib 14 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 1 Day 1: 0.5-4 hours post-dose | 57.9 nanogram per milliliter (ng/mL) | Standard Deviation 96.54 |
| Lenvatinib 18 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 2 Day 1: 2-12 hours post-dose | 190.3 nanogram per milliliter (ng/mL) | Standard Deviation 114.85 |
| Lenvatinib 18 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 1 Day 1: 0.5-4 hours post-dose | 82.3 nanogram per milliliter (ng/mL) | Standard Deviation 119.89 |
| Lenvatinib 18 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 1 Day 1: 6-10 hours post-dose | 193.7 nanogram per milliliter (ng/mL) | Standard Deviation 93.08 |
| Lenvatinib 18 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 1 Day 15: Pre-dose | 64.0 nanogram per milliliter (ng/mL) | Standard Deviation 59.71 |
| Lenvatinib 18 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 1 Day 15: 0.5-4 hours post-dose | 133.4 nanogram per milliliter (ng/mL) | Standard Deviation 125.65 |
| Lenvatinib 18 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 1 Day 15: 6-10 hours post-dose | 236.2 nanogram per milliliter (ng/mL) | Standard Deviation 135.21 |
| Lenvatinib 18 mg + Everolimus 5 mg | Plasma Concentration of Lenvatinib | Cycle 2 Day 1: Pre-dose | 50.6 nanogram per milliliter (ng/mL) | Standard Deviation 46.06 |
Secondary
Progression-free Survival After Next Line of Therapy (PFS2)
PFS2, defined as the time from randomization to the date of PD after next line of therapy or death from any cause, whichever occurred first based on investigator assessment according to RECIST v1.1. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Median PFS2 was analyzed using the Kaplan-Meier product-limit estimates for each treatment group and presented with 2-sided 95% CI. As pre-specified in protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.
Time frame: From the time of randomization to the date of PD after next line of therapy or death from any cause or the date of data cutoff for the primary analysis, whichever occurs first (up to 29 months)
Population: PPAS1 included all randomized participants minus the 32 participants who had received \>=2 incorrect lenvatinib doses due to IxRS issues.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Progression-free Survival After Next Line of Therapy (PFS2) | 18.2 months |
| Lenvatinib 18 mg + Everolimus 5 mg | Progression-free Survival After Next Line of Therapy (PFS2) | 19.5 months |
Secondary
Progression-free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of the first documentation of PD by investigator assessment or date of death, whichever occurred first according to RECIST v1.1. PD: at least 20% increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameter (SOD) of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Median PFS was analyzed using the Kaplan-Meier product-limit estimates for each treatment group and presented with 2-sided 95% confidence interval (CI). As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.
Time frame: From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to date of data cutoff for the primary analysis (up to 29 months)
Population: PPAS1 included all randomized participants minus the 32 participants who had received \>=2 incorrect lenvatinib doses due to IxRS issues.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Progression-free Survival (PFS) | 11.1 months |
| Lenvatinib 18 mg + Everolimus 5 mg | Progression-free Survival (PFS) | 14.7 months |
90% CI: [1.08, 1.86]
Secondary
Time to Treatment Failure Due to Toxicity
Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date that a participant discontinued study treatment due to TEAEs. Toxicity (except hypertension and non-infectious pneumonitis) was assessed according to CTCAE v4.03. As planned, data for this secondary outcome measure was collected and analyzed till the primary analysis only.
Time frame: From the date of randomization to the date of discontinuation of study treatment due to TEAEs, or date of data cut off for the primary analysis (up to 29 months)
Population: FAS included all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Time to Treatment Failure Due to Toxicity | 3.15 months |
| Lenvatinib 18 mg + Everolimus 5 mg | Time to Treatment Failure Due to Toxicity | 5.70 months |
Secondary
Whole Blood Concentration of Everolimus
PK sparse sampling was performed. As planned, the post-dose whole blood sample was collected anytime between 0.5 to 4 hours at Cycle 1 Days 1 and 15, between 6 to 10 hours at Cycle 1 Days 1 and 15, and between 2 to 12 hours at Cycle 2 Day 1. Only one sample was collected for each post-dose category between specified timepoints.
Time frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)
Population: PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable lenvatinib plasma or everolimus whole blood concentration data. Here, overall number of participants analyzed are the participants who were evaluable for the outcome measure and number analyzed were the participants who were evaluable at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenvatinib 14 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 1 Day 15: Pre-dose | 8.4 ng/mL | Standard Deviation 4.84 |
| Lenvatinib 14 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 1 Day 15: 6-10 hours post-dose | 14.3 ng/mL | Standard Deviation 5.83 |
| Lenvatinib 14 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 1 Day 1: 6-10 hours post-dose | 9.2 ng/mL | Standard Deviation 6.6 |
| Lenvatinib 14 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 2 Day 1: Pre-dose | 7.8 ng/mL | Standard Deviation 5.44 |
| Lenvatinib 14 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 1 Day 15: 0.5-4 hours post-dose | 23.7 ng/mL | Standard Deviation 15.41 |
| Lenvatinib 14 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 2 Day 1: 2-12 hours post-dose | 22.9 ng/mL | Standard Deviation 12.67 |
| Lenvatinib 14 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 1 Day 1: 0.5-4 hours post-dose | 18.3 ng/mL | Standard Deviation 15.89 |
| Lenvatinib 18 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 2 Day 1: 2-12 hours post-dose | 19.5 ng/mL | Standard Deviation 9.74 |
| Lenvatinib 18 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 1 Day 1: 0.5-4 hours post-dose | 18.6 ng/mL | Standard Deviation 16.39 |
| Lenvatinib 18 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 1 Day 1: 6-10 hours post-dose | 8.4 ng/mL | Standard Deviation 5.64 |
| Lenvatinib 18 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 1 Day 15: Pre-dose | 7.4 ng/mL | Standard Deviation 5.51 |
| Lenvatinib 18 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 1 Day 15: 0.5-4 hours post-dose | 23.4 ng/mL | Standard Deviation 16.96 |
| Lenvatinib 18 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 1 Day 15: 6-10 hours post-dose | 14.3 ng/mL | Standard Deviation 9.22 |
| Lenvatinib 18 mg + Everolimus 5 mg | Whole Blood Concentration of Everolimus | Cycle 2 Day 1: Pre-dose | 5.9 ng/mL | Standard Deviation 4.02 |