Kidney Neoplasms
Conditions
Keywords
Axitinib in First & Second Line Treatment of Patients With Metastatic Renal Cell Cancer
Brief summary
The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.
Interventions
axitinib will be given at a starting dose of 5 mg BID with continuous dosing
DRUGSorafenib
sorafenib will be given at a dose of 400 mg BID continuous dosing
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically documented metastatic renal cell cancer with a component of clear cell histology. * Evidence of measurable disease. * Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.
Exclusion criteria
* Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy. * Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS): First-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) | Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease \[PD\]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is \>= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. |
| Progression Free Survival (PFS): Second-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) | Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease \[PD\]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is \>= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Objective Response (OR): First-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) | Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. |
| Percentage of Participants With Objective Response (OR): Second-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) | Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. |
| Duration of Response (DR): First-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) | Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. |
| Duration of Response (DR): Second-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) | Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. |
| Overall Survival (OS): First-Line Participants | Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) | Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). |
| Overall Survival (OS): Second-Line Participants | Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) | Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) | FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). |
| Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) | FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). |
| Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) | FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate). |
| Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) | FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate). |
| Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state. |
| Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state. |
Countries
Bosnia and Herzegovina, Bulgaria, Chile, China, India, Malaysia, Mexico, Philippines, Romania, Russia, South Africa, Taiwan, Ukraine, United States
Participant flow
Recruitment details
First-line participants included all treatment-naive participants with metastatic renal cell cancer (mRCC) from global and second-line participants included all previously-treated Asian participants with mRCC.
Pre-assignment details
All China participants were excluded from safety analysis due to inability to obtain timely approval to use data in accordance with Human Genetic Resources Administration of China (HGRAC) regulation.
Participants by arm
| Arm | Count |
|---|---|
| Axitinib (First-line Participants) Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | 192 |
| Sorafenib (First-line Participants) Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | 96 |
| Axitinib (Second-line Participants) Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | 135 |
| Sorafenib (Second-line Participants) Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | 69 |
| Total | 492 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 1 | 0 |
| Overall Study | Data not disclosed due to lack of HGRAC filings | 16 | 8 | 124 | 64 |
| Overall Study | Death | 116 | 63 | 8 | 3 |
| Overall Study | Global deterioration of health status | 2 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 11 | 2 | 0 | 0 |
| Overall Study | Objective progression or relapse | 6 | 2 | 0 | 0 |
| Overall Study | Other | 26 | 15 | 1 | 2 |
| Overall Study | Participant refused continued treatment for reason other than adverse events | 11 | 5 | 1 | 0 |
| Overall Study | Randomized but not treated | 3 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Axitinib (First-line Participants) | Sorafenib (First-line Participants) | Axitinib (Second-line Participants) | Sorafenib (Second-line Participants) |
|---|---|---|---|---|---|
| Age, Customized Greater than or equal to (>=) 65 years | 107 Participants | 50 Participants | 19 Participants | 25 Participants | 13 Participants |
| Age, Customized Less than (<) 65 years | 385 Participants | 142 Participants | 77 Participants | 110 Participants | 56 Participants |
| Sex: Female, Male Female | 141 Participants | 58 Participants | 22 Participants | 41 Participants | 20 Participants |
| Sex: Female, Male Male | 351 Participants | 134 Participants | 74 Participants | 94 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 117 / 173 | 63 / 88 | 9 / 11 | 3 / 5 |
| other Total, other adverse events | 161 / 173 | 83 / 88 | 11 / 11 | 5 / 5 |
| serious Total, serious adverse events | 77 / 173 | 26 / 88 | 6 / 11 | 3 / 5 |
Outcome results
Primary
Progression Free Survival (PFS): First-Line Participants
Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease \[PD\]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is \>= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.
Time frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
Population: FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib (First-line Participants) | Progression Free Survival (PFS): First-Line Participants | 10.1 months |
| Sorafenib (First-line Participants) | Progression Free Survival (PFS): First-Line Participants | 6.5 months |
Comparison: First-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1).95% CI: [0.559, 1.053]
Primary
Progression Free Survival (PFS): Second-Line Participants
Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease \[PD\]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is \>= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.
Time frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
Population: FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib (First-line Participants) | Progression Free Survival (PFS): Second-Line Participants | 6.5 months |
| Sorafenib (First-line Participants) | Progression Free Survival (PFS): Second-Line Participants | 4.8 months |
Comparison: Second-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1) and prior treatment (sunitinib versus cytokine-containing regimen).95% CI: [0.506, 1.058]
Secondary
Duration of Response (DR): First-Line Participants
Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
Population: DR was calculated for the subgroup of participants from the FAS treatment-naive population, with a confirmed objective tumor response (CR or PR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib (First-line Participants) | Duration of Response (DR): First-Line Participants | 14.7 months |
| Sorafenib (First-line Participants) | Duration of Response (DR): First-Line Participants | 14.3 months |
Secondary
Duration of Response (DR): Second-Line Participants
Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
Population: DR was calculated for the subgroup of participants from the FAS previously-treated population, with a confirmed objective tumor response (CR or PR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib (First-line Participants) | Duration of Response (DR): Second-Line Participants | NA months |
| Sorafenib (First-line Participants) | Duration of Response (DR): Second-Line Participants | 8.7 months |
Secondary
Overall Survival (OS): First-Line Participants
Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time frame: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
Population: FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib (First-line Participants) | Overall Survival (OS): First-Line Participants | NA months |
| Sorafenib (First-line Participants) | Overall Survival (OS): First-Line Participants | NA months |
Secondary
Overall Survival (OS): Second-Line Participants
Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time frame: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
Population: FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib (First-line Participants) | Overall Survival (OS): Second-Line Participants | 17.2 months |
| Sorafenib (First-line Participants) | Overall Survival (OS): Second-Line Participants | 18.1 months |
Secondary
Percentage of Participants With Objective Response (OR): First-Line Participants
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Time frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
Population: FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axitinib (First-line Participants) | Percentage of Participants With Objective Response (OR): First-Line Participants | 32.3 percentage of participants |
| Sorafenib (First-line Participants) | Percentage of Participants With Objective Response (OR): First-Line Participants | 14.6 percentage of participants |
Secondary
Percentage of Participants With Objective Response (OR): Second-Line Participants
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Time frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
Population: FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axitinib (First-line Participants) | Percentage of Participants With Objective Response (OR): Second-Line Participants | 23.7 percentage of participants |
| Sorafenib (First-line Participants) | Percentage of Participants With Objective Response (OR): Second-Line Participants | 10.1 percentage of participants |
Other Pre-specified
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)
Population: FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C10 D1 | 0.682 units on a scale | Standard Deviation 0.277 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C4 D1 | 0.696 units on a scale | Standard Deviation 0.235 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C19 D1 | 0.713 units on a scale | Standard Deviation 0.256 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C11 D1 | 0.698 units on a scale | Standard Deviation 0.26 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C20 D1 | 0.699 units on a scale | Standard Deviation 0.261 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C7 D1 | 0.685 units on a scale | Standard Deviation 0.225 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C23 D1 | 0.736 units on a scale | Standard Deviation 0.275 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | End of treatment | 0.635 units on a scale | Standard Deviation 0.268 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C12 D1 | 0.708 units on a scale | Standard Deviation 0.227 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C2 D1 | 0.709 units on a scale | Standard Deviation 0.214 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C1 D1 | 0.710 units on a scale | Standard Deviation 0.254 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C3 D1 | 0.694 units on a scale | Standard Deviation 0.251 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C13 D1 | 0.708 units on a scale | Standard Deviation 0.253 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C6 D1 | 0.683 units on a scale | Standard Deviation 0.263 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C8 D1 | 0.678 units on a scale | Standard Deviation 0.274 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C14 D1 | 0.703 units on a scale | Standard Deviation 0.26 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C5 D1 | 0.708 units on a scale | Standard Deviation 0.221 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C17 D1 | 0.706 units on a scale | Standard Deviation 0.25 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C18 D1 | 0.699 units on a scale | Standard Deviation 0.259 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C15 D1 | 0.689 units on a scale | Standard Deviation 0.269 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C21 D1 | 0.712 units on a scale | Standard Deviation 0.232 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C9 D1 | 0.704 units on a scale | Standard Deviation 0.239 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C22 D1 | 0.737 units on a scale | Standard Deviation 0.255 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C16 D1 | 0.702 units on a scale | Standard Deviation 0.244 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | Follow-up | 0.545 units on a scale | Standard Deviation 0.434 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C17 D1 | 0.738 units on a scale | Standard Deviation 0.25 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C2 D1 | 0.693 units on a scale | Standard Deviation 0.237 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C4 D1 | 0.668 units on a scale | Standard Deviation 0.265 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C5 D1 | 0.673 units on a scale | Standard Deviation 0.269 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C7 D1 | 0.676 units on a scale | Standard Deviation 0.255 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C8 D1 | 0.717 units on a scale | Standard Deviation 0.244 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C10 D1 | 0.723 units on a scale | Standard Deviation 0.238 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C11 D1 | 0.748 units on a scale | Standard Deviation 0.199 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C12 D1 | 0.742 units on a scale | Standard Deviation 0.218 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C13 D1 | 0.761 units on a scale | Standard Deviation 0.22 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C14 D1 | 0.731 units on a scale | Standard Deviation 0.254 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C15 D1 | 0.755 units on a scale | Standard Deviation 0.225 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C1 D1 | 0.712 units on a scale | Standard Deviation 0.272 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C18 D1 | 0.777 units on a scale | Standard Deviation 0.191 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C19 D1 | 0.762 units on a scale | Standard Deviation 0.261 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C22 D1 | 0.774 units on a scale | Standard Deviation 0.177 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | End of treatment | 0.588 units on a scale | Standard Deviation 0.291 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | Follow-up | 0.618 units on a scale | Standard Deviation 0.254 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C3 D1 | 0.687 units on a scale | Standard Deviation 0.261 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C6 D1 | 0.641 units on a scale | Standard Deviation 0.281 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C9 D1 | 0.729 units on a scale | Standard Deviation 0.202 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C16 D1 | 0.775 units on a scale | Standard Deviation 0.186 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C20 D1 | 0.710 units on a scale | Standard Deviation 0.3 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C21 D1 | 0.702 units on a scale | Standard Deviation 0.307 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | C23 D1 | 0.789 units on a scale | Standard Deviation 0.187 |
Other Pre-specified
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)
Population: FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C5 D1 | 0.780 units on a scale | Standard Deviation 0.203 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C8 D1 | 0.758 units on a scale | Standard Deviation 0.241 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C1 D1 | 0.812 units on a scale | Standard Deviation 0.225 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C10 D1 | 0.768 units on a scale | Standard Deviation 0.243 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C4 D1 | 0.737 units on a scale | Standard Deviation 0.272 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C11 D1 | 0.792 units on a scale | Standard Deviation 0.21 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C15 D1 | 0.819 units on a scale | Standard Deviation 0.151 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C13 D1 | 0.786 units on a scale | Standard Deviation 0.217 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C3 D1 | 0.772 units on a scale | Standard Deviation 0.206 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C14 D1 | 0.833 units on a scale | Standard Deviation 0.162 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C16 D1 | 0.811 units on a scale | Standard Deviation 0.186 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C9 D1 | 0.796 units on a scale | Standard Deviation 0.203 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C17 D1 | 0.834 units on a scale | Standard Deviation 0.158 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C12 D1 | 0.797 units on a scale | Standard Deviation 0.201 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C19 D1 | 0.830 units on a scale | Standard Deviation 0.148 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C6 D1 | 0.767 units on a scale | Standard Deviation 0.251 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C20 D1 | 0.832 units on a scale | Standard Deviation 0.163 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C18 D1 | 0.830 units on a scale | Standard Deviation 0.164 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C21 D1 | 0.859 units on a scale | Standard Deviation 0.155 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | End of treatment | 0.582 units on a scale | Standard Deviation 0.406 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C7 D1 | 0.762 units on a scale | Standard Deviation 0.252 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | Follow-up | 0.429 units on a scale | Standard Deviation 0.358 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C2 D1 | 0.769 units on a scale | Standard Deviation 0.218 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | Follow-up | 0.418 units on a scale | Standard Deviation 0.565 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C3 D1 | 0.755 units on a scale | Standard Deviation 0.278 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C8 D1 | 0.733 units on a scale | Standard Deviation 0.339 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C12 D1 | 0.837 units on a scale | Standard Deviation 0.157 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C14 D1 | 0.871 units on a scale | Standard Deviation 0.131 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C15 D1 | 0.829 units on a scale | Standard Deviation 0.152 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C17 D1 | 0.865 units on a scale | Standard Deviation 0.122 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C21 D1 | 0.852 units on a scale | Standard Deviation 0.176 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C1 D1 | 0.831 units on a scale | Standard Deviation 0.186 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C2 D1 | 0.754 units on a scale | Standard Deviation 0.251 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C4 D1 | 0.759 units on a scale | Standard Deviation 0.211 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C5 D1 | 0.768 units on a scale | Standard Deviation 0.275 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C6 D1 | 0.753 units on a scale | Standard Deviation 0.245 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C7 D1 | 0.768 units on a scale | Standard Deviation 0.239 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C9 D1 | 0.794 units on a scale | Standard Deviation 0.262 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C10 D1 | 0.820 units on a scale | Standard Deviation 0.169 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C11 D1 | 0.848 units on a scale | Standard Deviation 0.158 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C13 D1 | 0.814 units on a scale | Standard Deviation 0.156 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C16 D1 | 0.828 units on a scale | Standard Deviation 0.142 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C18 D1 | 0.829 units on a scale | Standard Deviation 0.16 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C19 D1 | 0.861 units on a scale | Standard Deviation 0.139 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | C20 D1 | 0.923 units on a scale | Standard Deviation 0.129 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | End of treatment | 0.623 units on a scale | Standard Deviation 0.296 |
Other Pre-specified
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.
Time frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)
Population: FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C4 D1 | 72.179 units on a scale | Standard Deviation 16.98 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C2 D1 | 71.714 units on a scale | Standard Deviation 16.583 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C11 D1 | 72.763 units on a scale | Standard Deviation 18.174 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C6 D1 | 71.574 units on a scale | Standard Deviation 18.929 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C9 D1 | 72.690 units on a scale | Standard Deviation 18.789 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C7 D1 | 71.050 units on a scale | Standard Deviation 18.967 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C12 D1 | 73.610 units on a scale | Standard Deviation 18.275 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C13 D1 | 73.030 units on a scale | Standard Deviation 18.348 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C3 D1 | 72.006 units on a scale | Standard Deviation 16.971 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C14 D1 | 73.147 units on a scale | Standard Deviation 17.546 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C17 D1 | 73.090 units on a scale | Standard Deviation 17.717 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C15 D1 | 74.494 units on a scale | Standard Deviation 17.938 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C18 D1 | 73.817 units on a scale | Standard Deviation 17.288 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C8 D1 | 71.031 units on a scale | Standard Deviation 19.081 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C16 D1 | 73.878 units on a scale | Standard Deviation 18.289 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C20 D1 | 74.244 units on a scale | Standard Deviation 17.044 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C5 D1 | 72.451 units on a scale | Standard Deviation 18.237 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C21 D1 | 75.694 units on a scale | Standard Deviation 11.918 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C19 D1 | 72.089 units on a scale | Standard Deviation 18.169 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C23 D1 | 77.143 units on a scale | Standard Deviation 12.697 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C22 D1 | 78.000 units on a scale | Standard Deviation 12.544 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | End of treatment | 67.254 units on a scale | Standard Deviation 19.495 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C10 D1 | 72.910 units on a scale | Standard Deviation 19.354 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | Follow-up | 69.195 units on a scale | Standard Deviation 20.366 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C1 D1 | 71.181 units on a scale | Standard Deviation 19.641 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | Follow-up | 64.885 units on a scale | Standard Deviation 19.916 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C3 D1 | 71.241 units on a scale | Standard Deviation 16.252 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C4 D1 | 72.086 units on a scale | Standard Deviation 14.904 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C6 D1 | 69.944 units on a scale | Standard Deviation 17.535 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C7 D1 | 73.923 units on a scale | Standard Deviation 13.998 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C8 D1 | 73.183 units on a scale | Standard Deviation 16.674 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C10 D1 | 72.400 units on a scale | Standard Deviation 18.814 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C11 D1 | 72.271 units on a scale | Standard Deviation 18.512 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C14 D1 | 75.108 units on a scale | Standard Deviation 18.371 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C15 D1 | 74.405 units on a scale | Standard Deviation 17.65 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C16 D1 | 75.818 units on a scale | Standard Deviation 17.716 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C22 D1 | 73.917 units on a scale | Standard Deviation 15.9 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C1 D1 | 72.362 units on a scale | Standard Deviation 16.466 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C5 D1 | 73.615 units on a scale | Standard Deviation 14.665 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C9 D1 | 73.780 units on a scale | Standard Deviation 16.18 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C12 D1 | 75.295 units on a scale | Standard Deviation 17.052 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C13 D1 | 75.432 units on a scale | Standard Deviation 17.907 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C17 D1 | 74.333 units on a scale | Standard Deviation 18.654 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C18 D1 | 75.571 units on a scale | Standard Deviation 18.55 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C19 D1 | 75.125 units on a scale | Standard Deviation 20.919 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C20 D1 | 74.190 units on a scale | Standard Deviation 20.425 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C21 D1 | 70.500 units on a scale | Standard Deviation 21.637 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C23 D1 | 72.571 units on a scale | Standard Deviation 14.82 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | End of treatment | 67.048 units on a scale | Standard Deviation 22.57 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | C2 D1 | 72.422 units on a scale | Standard Deviation 14.576 |
Other Pre-specified
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.
Time frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)
Population: FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | Follow-up | 58.154 units on a scale | Standard Deviation 20.76 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C7 D1 | 82.900 units on a scale | Standard Deviation 13.287 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C8 D1 | 83.382 units on a scale | Standard Deviation 12.636 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C13 D1 | 82.927 units on a scale | Standard Deviation 17.317 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C14 D1 | 86.520 units on a scale | Standard Deviation 10.831 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C15 D1 | 85.841 units on a scale | Standard Deviation 11.783 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C19 D1 | 89.500 units on a scale | Standard Deviation 8.684 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C20 D1 | 90.333 units on a scale | Standard Deviation 8.679 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C21 D1 | 90.313 units on a scale | Standard Deviation 9.741 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | End of treatment | 75.568 units on a scale | Standard Deviation 17.934 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C1 D1 | 82.799 units on a scale | Standard Deviation 13.351 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C3 D1 | 80.895 units on a scale | Standard Deviation 13.387 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C4 D1 | 81.138 units on a scale | Standard Deviation 13.508 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C5 D1 | 83.018 units on a scale | Standard Deviation 12.829 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C6 D1 | 82.222 units on a scale | Standard Deviation 13.793 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C9 D1 | 84.171 units on a scale | Standard Deviation 11.26 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C10 D1 | 83.041 units on a scale | Standard Deviation 13.042 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C11 D1 | 84.136 units on a scale | Standard Deviation 14.231 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C12 D1 | 84.305 units on a scale | Standard Deviation 13.211 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C16 D1 | 87.579 units on a scale | Standard Deviation 10.391 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C17 D1 | 88.424 units on a scale | Standard Deviation 10.866 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C18 D1 | 86.586 units on a scale | Standard Deviation 13.605 |
| Axitinib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C2 D1 | 81.102 units on a scale | Standard Deviation 13.895 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C1 D1 | 82.058 units on a scale | Standard Deviation 14.021 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C2 D1 | 78.231 units on a scale | Standard Deviation 15.823 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C6 D1 | 80.829 units on a scale | Standard Deviation 15.091 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C10 D1 | 82.778 units on a scale | Standard Deviation 11.44 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C7 D1 | 80.868 units on a scale | Standard Deviation 16.14 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C3 D1 | 80.534 units on a scale | Standard Deviation 16.453 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C8 D1 | 81.000 units on a scale | Standard Deviation 14.606 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C12 D1 | 83.500 units on a scale | Standard Deviation 12.188 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C18 D1 | 83.125 units on a scale | Standard Deviation 8.839 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C13 D1 | 83.300 units on a scale | Standard Deviation 11.263 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C4 D1 | 81.245 units on a scale | Standard Deviation 14.59 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C14 D1 | 86.667 units on a scale | Standard Deviation 8.715 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C11 D1 | 83.000 units on a scale | Standard Deviation 11.832 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C15 D1 | 86.462 units on a scale | Standard Deviation 8.678 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C5 D1 | 80.250 units on a scale | Standard Deviation 15.495 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C19 D1 | 82.143 units on a scale | Standard Deviation 11.495 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C17 D1 | 84.300 units on a scale | Standard Deviation 10.328 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C20 D1 | 86.000 units on a scale | Standard Deviation 9.695 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | End of treatment | 74.741 units on a scale | Standard Deviation 17.623 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C21 D1 | 84.167 units on a scale | Standard Deviation 9.704 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C9 D1 | 83.788 units on a scale | Standard Deviation 10.349 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | Follow-up | 64.333 units on a scale | Standard Deviation 25.564 |
| Sorafenib (First-line Participants) | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | C16 D1 | 86.083 units on a scale | Standard Deviation 8.816 |
Other Pre-specified
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants
FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).
Time frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)
Population: FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C3 D1 | 43.366 units on a scale | Standard Deviation 7.192 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C14 D1 | 43.789 units on a scale | Standard Deviation 7.985 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C8 D1 | 42.534 units on a scale | Standard Deviation 7.51 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C15 D1 | 44.176 units on a scale | Standard Deviation 8.055 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C5 D1 | 43.211 units on a scale | Standard Deviation 7.578 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C16 D1 | 44.232 units on a scale | Standard Deviation 7.515 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C9 D1 | 42.778 units on a scale | Standard Deviation 8.229 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C17 D1 | 43.897 units on a scale | Standard Deviation 8.456 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C2 D1 | 43.328 units on a scale | Standard Deviation 7.63 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C18 D1 | 43.761 units on a scale | Standard Deviation 8.019 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C10 D1 | 43.120 units on a scale | Standard Deviation 7.966 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C19 D1 | 43.737 units on a scale | Standard Deviation 7.413 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C6 D1 | 42.787 units on a scale | Standard Deviation 8.098 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C20 D1 | 43.733 units on a scale | Standard Deviation 7.605 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C11 D1 | 43.264 units on a scale | Standard Deviation 7.837 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C21 D1 | 45.417 units on a scale | Standard Deviation 6.24 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C4 D1 | 42.932 units on a scale | Standard Deviation 7.566 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C22 D1 | 47.000 units on a scale | Standard Deviation 5.985 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C12 D1 | 43.962 units on a scale | Standard Deviation 7.243 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C23 D1 | 47.571 units on a scale | Standard Deviation 6.357 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C7 D1 | 42.474 units on a scale | Standard Deviation 7.926 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | End of treatment | 39.052 units on a scale | Standard Deviation 9.109 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C13 D1 | 44.141 units on a scale | Standard Deviation 7.289 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | Follow-up | 39.683 units on a scale | Standard Deviation 11.132 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C1 D1 | 43.869 units on a scale | Standard Deviation 8.117 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | Follow-up | 40.038 units on a scale | Standard Deviation 9.897 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C1 D1 | 43.865 units on a scale | Standard Deviation 6.723 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C2 D1 | 43.969 units on a scale | Standard Deviation 6.286 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C3 D1 | 43.345 units on a scale | Standard Deviation 6.878 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C4 D1 | 42.926 units on a scale | Standard Deviation 7.324 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C5 D1 | 44.022 units on a scale | Standard Deviation 6.714 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C6 D1 | 42.344 units on a scale | Standard Deviation 6.685 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C7 D1 | 43.446 units on a scale | Standard Deviation 6.931 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C8 D1 | 44.077 units on a scale | Standard Deviation 6.986 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C9 D1 | 44.051 units on a scale | Standard Deviation 7.234 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C10 D1 | 44.018 units on a scale | Standard Deviation 6.751 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C11 D1 | 45.000 units on a scale | Standard Deviation 6.13 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C12 D1 | 45.318 units on a scale | Standard Deviation 6.44 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C13 D1 | 45.787 units on a scale | Standard Deviation 6.526 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C14 D1 | 45.459 units on a scale | Standard Deviation 6.535 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C15 D1 | 45.514 units on a scale | Standard Deviation 5.914 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C16 D1 | 46.000 units on a scale | Standard Deviation 5.651 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C17 D1 | 46.400 units on a scale | Standard Deviation 6.262 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C18 D1 | 45.357 units on a scale | Standard Deviation 6.983 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C19 D1 | 45.583 units on a scale | Standard Deviation 7.366 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C20 D1 | 44.333 units on a scale | Standard Deviation 7.066 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C21 D1 | 43.500 units on a scale | Standard Deviation 7.687 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C22 D1 | 45.833 units on a scale | Standard Deviation 5.937 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | C23 D1 | 45.714 units on a scale | Standard Deviation 6.651 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | End of treatment | 39.524 units on a scale | Standard Deviation 8.896 |
Other Pre-specified
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants
FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).
Time frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)
Population: FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C1 D1 | 46.753 units on a scale | Standard Deviation 6.692 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C2 D1 | 46.217 units on a scale | Standard Deviation 7.028 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C3 D1 | 45.968 units on a scale | Standard Deviation 7.237 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C4 D1 | 45.060 units on a scale | Standard Deviation 8.04 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C5 D1 | 45.775 units on a scale | Standard Deviation 7.797 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C6 D1 | 45.407 units on a scale | Standard Deviation 7.274 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C7 D1 | 45.709 units on a scale | Standard Deviation 8.263 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C8 D1 | 45.169 units on a scale | Standard Deviation 7.609 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C9 D1 | 45.829 units on a scale | Standard Deviation 7.442 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C10 D1 | 45.608 units on a scale | Standard Deviation 8.299 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C11 D1 | 45.833 units on a scale | Standard Deviation 7.599 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C12 D1 | 45.797 units on a scale | Standard Deviation 6.967 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C13 D1 | 46.727 units on a scale | Standard Deviation 7.307 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C14 D1 | 47.740 units on a scale | Standard Deviation 7.094 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C15 D1 | 48.023 units on a scale | Standard Deviation 6.297 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C16 D1 | 48.184 units on a scale | Standard Deviation 6.186 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C17 D1 | 47.909 units on a scale | Standard Deviation 6.866 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C18 D1 | 48.138 units on a scale | Standard Deviation 6.791 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C19 D1 | 48.636 units on a scale | Standard Deviation 5.206 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C20 D1 | 48.810 units on a scale | Standard Deviation 6.478 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C21 D1 | 50.188 units on a scale | Standard Deviation 5.588 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | End of treatment | 41.432 units on a scale | Standard Deviation 9.188 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | Follow-up | 35.385 units on a scale | Standard Deviation 7.795 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C12 D1 | 48.091 units on a scale | Standard Deviation 6.414 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C1 D1 | 47.470 units on a scale | Standard Deviation 7.45 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C18 D1 | 49.125 units on a scale | Standard Deviation 5.139 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C2 D1 | 45.045 units on a scale | Standard Deviation 7.478 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C13 D1 | 47.600 units on a scale | Standard Deviation 5.762 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C3 D1 | 45.684 units on a scale | Standard Deviation 7.756 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C21 D1 | 50.000 units on a scale | Standard Deviation 5.177 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C4 D1 | 45.792 units on a scale | Standard Deviation 7.762 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C14 D1 | 49.133 units on a scale | Standard Deviation 5.235 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C5 D1 | 46.125 units on a scale | Standard Deviation 7.491 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C19 D1 | 48.571 units on a scale | Standard Deviation 7.458 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C6 D1 | 46.341 units on a scale | Standard Deviation 7.213 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C15 D1 | 49.308 units on a scale | Standard Deviation 4.111 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C7 D1 | 45.053 units on a scale | Standard Deviation 7.843 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | Follow-up | 38.583 units on a scale | Standard Deviation 11.556 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C8 D1 | 45.676 units on a scale | Standard Deviation 9.357 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C16 D1 | 50.500 units on a scale | Standard Deviation 3.989 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C9 D1 | 45.970 units on a scale | Standard Deviation 8.487 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C20 D1 | 50.500 units on a scale | Standard Deviation 4.637 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C10 D1 | 46.148 units on a scale | Standard Deviation 8.156 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C17 D1 | 49.000 units on a scale | Standard Deviation 5.869 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | C11 D1 | 47.227 units on a scale | Standard Deviation 6.611 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | End of treatment | 42.889 units on a scale | Standard Deviation 8.846 |
Other Pre-specified
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants
FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).
Time frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)
Population: FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C1 D1 | 28.691 units on a scale | Standard Deviation 5.392 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C2 D1 | 28.728 units on a scale | Standard Deviation 4.581 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C3 D1 ( | 29.171 units on a scale | Standard Deviation 4.093 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C4 D1 | 28.577 units on a scale | Standard Deviation 4.305 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C5 D1 | 29.020 units on a scale | Standard Deviation 4.257 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C6 D1 | 28.574 units on a scale | Standard Deviation 4.674 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C8 D1 | 28.557 units on a scale | Standard Deviation 4.308 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C9 D1 | 28.817 units on a scale | Standard Deviation 4.665 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C10 D1 | 29.057 units on a scale | Standard Deviation 4.484 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C11 D1 | 29.146 units on a scale | Standard Deviation 4.207 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C12 D1 | 29.648 units on a scale | Standard Deviation 3.752 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C17 D1 | 29.564 units on a scale | Standard Deviation 4.695 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C19 D1 | 29.737 units on a scale | Standard Deviation 4.414 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C20 D1 | 29.844 units on a scale | Standard Deviation 4.527 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C22 D1 | 31.696 units on a scale | Standard Deviation 3.081 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C7 D1 | 28.568 units on a scale | Standard Deviation 4.548 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C13 D1 | 29.545 units on a scale | Standard Deviation 4.056 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C14 D1 | 29.579 units on a scale | Standard Deviation 4.186 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C15 D1 | 29.859 units on a scale | Standard Deviation 4.438 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C16 D1 | 29.683 units on a scale | Standard Deviation 4.242 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C18 D1 | 29.380 units on a scale | Standard Deviation 4.752 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C21 D1 | 30.889 units on a scale | Standard Deviation 3.115 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C23 D1 | 31.357 units on a scale | Standard Deviation 3.388 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | End of treatment | 26.556 units on a scale | Standard Deviation 5.487 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | Follow-up | 26.805 units on a scale | Standard Deviation 6.373 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C15 D1 | 30.730 units on a scale | Standard Deviation 3.724 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C1 D1 | 29.653 units on a scale | Standard Deviation 4.699 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C23 D1 | 31.143 units on a scale | Standard Deviation 4.413 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C2 D1 | 29.963 units on a scale | Standard Deviation 3.817 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C21 D1 | 30.056 units on a scale | Standard Deviation 4.372 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C3 D1 ( | 29.750 units on a scale | Standard Deviation 4.095 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C17 D1 | 31.567 units on a scale | Standard Deviation 3.884 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C4 D1 | 29.642 units on a scale | Standard Deviation 4.244 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | End of treatment | 26.786 units on a scale | Standard Deviation 5.982 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C5 D1 | 30.255 units on a scale | Standard Deviation 3.668 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | Follow-up | 26.769 units on a scale | Standard Deviation 6.095 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C6 D1 | 29.153 units on a scale | Standard Deviation 4.009 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C7 D1 | 29.523 units on a scale | Standard Deviation 4.051 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C13 D1 | 31.483 units on a scale | Standard Deviation 3.602 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C8 D1 | 30.296 units on a scale | Standard Deviation 3.89 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C22 D1 | 31.000 units on a scale | Standard Deviation 3.275 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C9 D1 | 30.186 units on a scale | Standard Deviation 4.392 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C18 D1 | 31.107 units on a scale | Standard Deviation 4.425 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C10 D1 | 30.364 units on a scale | Standard Deviation 4.143 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C19 D1 | 31.417 units on a scale | Standard Deviation 3.911 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C11 D1 | 30.688 units on a scale | Standard Deviation 3.926 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C14 D1 | 31.027 units on a scale | Standard Deviation 3.79 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C12 D1 | 30.727 units on a scale | Standard Deviation 3.896 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C16 D1 | 31.515 units on a scale | Standard Deviation 3.242 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | C20 D1 | 30.762 units on a scale | Standard Deviation 4.122 |
Other Pre-specified
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants
FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).
Time frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)
Population: FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C21 D1 | 33.125 units on a scale | Standard Deviation 2.473 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C8 D1 | 30.966 units on a scale | Standard Deviation 4.144 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C1 D1 | 31.020 units on a scale | Standard Deviation 3.986 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C9 D1 | 31.012 units on a scale | Standard Deviation 3.783 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C10 D1 | 30.986 units on a scale | Standard Deviation 4.133 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C2 D1 | 30.600 units on a scale | Standard Deviation 3.892 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C3 D1 | 30.645 units on a scale | Standard Deviation 3.681 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C13 D1 | 31.418 units on a scale | Standard Deviation 3.775 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C14 D1 | 32.100 units on a scale | Standard Deviation 3.321 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C18 D1 | 31.931 units on a scale | Standard Deviation 3.116 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C15 D1 | 32.000 units on a scale | Standard Deviation 2.861 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C4 D1 | 30.103 units on a scale | Standard Deviation 4.558 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C16 D1 | 31.921 units on a scale | Standard Deviation 3.372 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C12 D1 | 31.356 units on a scale | Standard Deviation 3.443 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C17 D1 | 32.061 units on a scale | Standard Deviation 3.344 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C5 D1 | 30.676 units on a scale | Standard Deviation 4.271 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C19 D1 | 32.364 units on a scale | Standard Deviation 2.341 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C20 D1 | 31.905 units on a scale | Standard Deviation 2.998 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C6 D1 | 30.731 units on a scale | Standard Deviation 3.973 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | End of treatment | 28.216 units on a scale | Standard Deviation 5.662 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C11 D1 | 31.212 units on a scale | Standard Deviation 4.033 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | Follow-up | 24.692 units on a scale | Standard Deviation 4.366 |
| Axitinib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C7 D1 | 30.920 units on a scale | Standard Deviation 4.373 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C11 D1 | 32.045 units on a scale | Standard Deviation 3.579 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C2 D1 | 30.682 units on a scale | Standard Deviation 3.895 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C9 D1 | 30.667 units on a scale | Standard Deviation 4.884 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C10 D1 | 30.926 units on a scale | Standard Deviation 4.215 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C13 D1 | 32.100 units on a scale | Standard Deviation 2.989 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C18 D1 | 32.625 units on a scale | Standard Deviation 2.615 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C20 D1 | 33.500 units on a scale | Standard Deviation 2.168 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C3 D1 | 30.965 units on a scale | Standard Deviation 3.803 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C4 D1 | 30.679 units on a scale | Standard Deviation 3.98 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C5 D1 | 31.063 units on a scale | Standard Deviation 3.629 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C6 D1 | 31.439 units on a scale | Standard Deviation 4.249 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C7 D1 | 30.632 units on a scale | Standard Deviation 4.365 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C8 D1 | 30.703 units on a scale | Standard Deviation 5.195 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C1 D1 | 31.489 units on a scale | Standard Deviation 4.538 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C12 D1 | 32.000 units on a scale | Standard Deviation 3.338 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C14 D1 | 32.800 units on a scale | Standard Deviation 2.274 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C15 D1 | 32.769 units on a scale | Standard Deviation 2.279 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C16 D1 | 33.167 units on a scale | Standard Deviation 2.167 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C17 D1 | 32.800 units on a scale | Standard Deviation 2.898 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C19 D1 | 32.429 units on a scale | Standard Deviation 4.429 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | C21 D1 | 33.500 units on a scale | Standard Deviation 2.345 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | End of treatment | 29.519 units on a scale | Standard Deviation 4.661 |
| Sorafenib (First-line Participants) | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | Follow-up | 27.500 units on a scale | Standard Deviation 6.762 |