Carcinoma, Renal Cell
Conditions
Brief summary
The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).
Interventions
DRUGInterferon-alfa
3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity
DRUGSU011248
50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed renal cell carcinoma of clear cell histology with metastases * Evidence of measurable disease by radiographic technique * Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 or 1
Exclusion criteria
* Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC * History of or known brain metastases * Serious acute or chronic illness or recent history of significant cardiac abnormality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS), Core Radiology Assessment | Day 28 of each 6-week cycle: duration of treatment phase | Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods. |
| Progression-Free Survival (PFS), Investigator's Assessment | Day 28 of each 6-week cycle: duration of treatment phase | Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Clinic visit or telephone contact every 2 months until death | Overall survival (OS) = time from date of randomization to date of death due to any cause. For patients not expiring, survival time was censored at the last date they were known to be alive. Patients lacking data beyond randomization had their survival times censored at the date of randomization with a duration of 1 day. |
| Time to Tumor Progression (TTP), Core Radiology Assessment | Randomization to first documentation of tumor progression: duration of treatment phase | TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day. |
| Time to Tumor Progression (TTP), Investigator's Assessment | Randomization to first documentation of tumor progression: duration of treatment phase | TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than the study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day. |
| Duration of Response (DR), Core Radiology Assessement | Day 28 of each cycle: duraton of treatment phase | Duration of response (DR) = time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression. |
| Duration of Response (DR), Investigator's Assessment | Day 28 of each cycle: duration of treatment phase | Duration of response (DR) = time from the first documentation of objective tumor response to the first documentaion of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression. |
| FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) subscale of the FKSI to measure advanced kidney cancer disease related symptoms. Includes 9 items: lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria. Each question was answered on a five-point Likert-type scale ranging from 0 (not at all) to 4 (very much). Score = the sum score of the item scores in the subscale; total range: 0 to 36. A score greater than 0 indicates the difference favored sunitinib. |
| FACT-Kidney Symptom Index (FKSI) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | FACT-Kidney Symptom Index (FKSI) subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions; some questions overlap with the FACT-G questions. Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). |
| Functional Assessment of Cancer Therapy-General (FACT-G) | Day 1 & 28 of each cycle: duration of treatment phase | Functional Assessment of Cancer Therapy-General (FACT-G): core questionnaire of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system that has been validated in a variety of cancer populations. 27 questions grouped into 4 domains that measure a patient's physical, functional, social and family, and emotional well-being. Five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = sum score of item scores in the subscale; total range: 0 to 108 with higher score indicating better quality of life. |
| Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | Physical well-being (PWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates better physical well-being. |
| Incremental Cost Effectiveness Ratio (ICER) | post study measurement | Incremental cost effectiveness ratio (ICER) of sunitinib compared to IFN-a as first-line treatment for MRCC, defined as the ratio of the incremental cost of treatment over the incremental effectiveness; effectiveness measured as quality adjusted life year (QALY) gain. This objective was not addressed in the clinical study report, but an interim analysis of cost-effectiveness was presented separately. These results were not available for inclusion at the time of this posting. |
| Objective Response, Core Radiology Assessment | Day 28 of each 6-week cycle: duration of treatment phase | Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR or PR) = those that persisted on repeat imaging study \>= 4 weeks after initial documentation of response. |
| Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | Emotional well-being (EWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 24; lower score indicates better emotional well-being. |
| Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | Functional well-being (FWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; higher score indicates greater functional well-being. |
| EuroQoL Five Dimension (EQ-5D) Health State Index | Day 1 & 28 of each cycle: duration of treatment phase | EQ-5D Health State Index: a brief, self-administered generic health status instrument. Respondents were asked to describe their current health state on each of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety or depression) on a three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A maximum score of 1 can be derived from these 5 dimensions by score conversion; range: -0.39 (worst health state)to 1.00 (best health state). This descriptive system classifies respondents into one of 243 possible distinct health states (EQ-5D descriptive system). |
| Euro-QoL Visual Analog Scale (EQ-VAS) | Day 1 & 28 of each cycle: duration of treatment phase | EQ-VAS: overall self-rating rating of the patient's current health state using a 20 cm Visual Analog Scale (EQ-VAS), also called the health state thermometer) is a metric measurement (in 2 mm interval) from the visual analog scale which ranges between 0 (worse imaginable health state) and 100 (best imaginable health state). |
| Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Day 1 & Day 28, Cycle 1 to Cycle 4 | Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter \[pg/ml\]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded. |
| Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis | Day 1 & Day 28, Cycle 1 to Cycle 4 | Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter \[pg/ml\]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded. |
| Ctrough Concentrations of SU011248 | Day 28 of Cycle 1 to Cycle 4 | Subject observed Ctrough (trough drug) concentrations of SU011248 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter \[ng/mL\]). |
| Ctrough Concentrations of Metabolite SU012662 | Day 28 of Cycle 1 to Cycle 4 | Subject observed Ctrough (trough drug) concentrations of active metabolite SU012662 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter \[ng/mL\]). |
| Ctrough Concentrations of SU011248 and Active Metabolite SU012662 | Day 28 of Cycle 1 to Cycle 4 | Subject observed Ctrough (trough drug) concentrations of total drug (SU011248 and its active metabolite SU012662) per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter \[ng/mL\]). |
| Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | Social/family well-being (SWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates less social/family well-being. |
| Objective Response, Investigator's Assessment | Day 28 of each 6-week cycle: duration of treatment phase | Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses = those that persist on repeat imaging study \>= 4 weeks after initial documentation of response. |
Countries
Australia, Brazil, Canada, France, Germany, Italy, Poland, Russia, Spain, United Kingdom, United States
Participant flow
Recruitment details
A total of 101 medical centers took part in the study between 10 August 2004 and 19 September 2008.
Pre-assignment details
Subjects were to be followed until survival data was mature (median duration of follow-up: 123 weeks).
Participants by arm
| Arm | Count |
|---|---|
| SU011248 50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered. | 375 |
| IFN-α Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity. | 375 |
| Total | 750 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 76 | 86 |
| Overall Study | Completed on marketed sunitinub | 3 | 0 |
| Overall Study | Crossover to SU011248 | 0 | 25 |
| Overall Study | Decision of sponsor | 32 | 4 |
| Overall Study | Lack of Efficacy | 240 | 219 |
| Overall Study | Protocol Violation | 2 | 2 |
| Overall Study | Randomized: did not take study drug | 0 | 15 |
| Overall Study | Withdrawal by Subject | 22 | 24 |
Baseline characteristics
| Characteristic | SU011248 | IFN-α | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 152 Participants | 123 Participants | 275 Participants |
| Age, Categorical Between 18 and 65 years | 223 Participants | 252 Participants | 475 Participants |
| Sex: Female, Male Female | 108 Participants | 106 Participants | 214 Participants |
| Sex: Female, Male Male | 267 Participants | 269 Participants | 536 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 368 / 375 | 344 / 360 |
| serious Total, serious adverse events | 170 / 375 | 93 / 360 |
Outcome results
Primary
Progression-Free Survival (PFS), Core Radiology Assessment
Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods.
Time frame: Day 28 of each 6-week cycle: duration of treatment phase
Population: Intent to treat (ITT) population: all patients who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SU011248 | Progression-Free Survival (PFS), Core Radiology Assessment | 48.3 weeks |
| IFN-α | Progression-Free Survival (PFS), Core Radiology Assessment | 22.1 weeks |
Comparison: Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α). Progression-free survival (PFS) was assessed in each treatment arm using the Kaplan-Meier method.p-value: <0.000195% CI: [0.4316, 0.643]Log Rank
Comparison: Stratified analysis: Hazard Ratio (SU011248 vs IFN-a).p-value: <0.0000195% CI: [0.4196, 0.6288]Log Rank
Primary
Progression-Free Survival (PFS), Investigator's Assessment
Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods.
Time frame: Day 28 of each 6-week cycle: duration of treatment phase
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SU011248 | Progression-Free Survival (PFS), Investigator's Assessment | 47.7 weeks |
| IFN-α | Progression-Free Survival (PFS), Investigator's Assessment | 22.1 weeks |
Comparison: Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).p-value: <0.000195% CI: [0.4532, 0.6444]Log Rank
Comparison: Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).p-value: <0.0000195% CI: [0.4536, 0.6473]Log Rank
Secondary
Ctrough Concentrations of Metabolite SU012662
Subject observed Ctrough (trough drug) concentrations of active metabolite SU012662 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter \[ng/mL\]).
Time frame: Day 28 of Cycle 1 to Cycle 4
Population: As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | Ctrough Concentrations of Metabolite SU012662 | Cycle 1, Day 28 (n=31) | 27.10 ng/mL | Standard Deviation 17.28 |
| SU011248 | Ctrough Concentrations of Metabolite SU012662 | Cycle 2, Day 28 (n=36) | 27.35 ng/mL | Standard Deviation 15.42 |
| SU011248 | Ctrough Concentrations of Metabolite SU012662 | Cycle 3, Day 28 (n=36) | 26.11 ng/mL | Standard Deviation 16.15 |
| SU011248 | Ctrough Concentrations of Metabolite SU012662 | Cycle 4, Day 28 (n=32) | 22.11 ng/mL | Standard Deviation 12.67 |
| SU011248 | Ctrough Concentrations of Metabolite SU012662 | Dose-Corrected: Cycle 1, Day 28 (n=24) | 28.21 ng/mL | Standard Deviation 19.01 |
| SU011248 | Ctrough Concentrations of Metabolite SU012662 | Dose-Corrected: Cycle 2, Day 28 (n=28) | 28.32 ng/mL | Standard Deviation 13.74 |
| SU011248 | Ctrough Concentrations of Metabolite SU012662 | Dose-Corrected: Cycle 3, Day 28 (n=27) | 29.04 ng/mL | Standard Deviation 19.07 |
| SU011248 | Ctrough Concentrations of Metabolite SU012662 | Dose-Corrected: Cycle 4, Day 28 (n=26) | 25.99 ng/mL | Standard Deviation 16.25 |
Secondary
Ctrough Concentrations of SU011248
Subject observed Ctrough (trough drug) concentrations of SU011248 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter \[ng/mL\]).
Time frame: Day 28 of Cycle 1 to Cycle 4
Population: As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | Ctrough Concentrations of SU011248 | Cycle 1, Day 28 (n=31) | 57.26 ng/mL | Standard Deviation 31.37 |
| SU011248 | Ctrough Concentrations of SU011248 | Cycle 2, Day 28 (n=36) | 57.59 ng/mL | Standard Deviation 28.59 |
| SU011248 | Ctrough Concentrations of SU011248 | Cycle 3, Day 28 (n=36) | 50.26 ng/mL | Standard Deviation 24.89 |
| SU011248 | Ctrough Concentrations of SU011248 | Cycle 4, Day 28 (n=32) | 45.05 ng/mL | Standard Deviation 23.76 |
| SU011248 | Ctrough Concentrations of SU011248 | Dose-Corrected: Cycle 1, Day 28 (n=24) | 64.22 ng/mL | Standard Deviation 31.4 |
| SU011248 | Ctrough Concentrations of SU011248 | Dose-Corrected: Cycle 2, Day 28 (n=28) | 59.90 ng/mL | Standard Deviation 26.42 |
| SU011248 | Ctrough Concentrations of SU011248 | Dose-Corrected: Cycle 3, Day 28 (n=27) | 58.45 ng/mL | Standard Deviation 29.39 |
| SU011248 | Ctrough Concentrations of SU011248 | Dose-Corrected: Cycle 4, Day 28 (n=26) | 54.31 ng/mL | Standard Deviation 30.7 |
Secondary
Ctrough Concentrations of SU011248 and Active Metabolite SU012662
Subject observed Ctrough (trough drug) concentrations of total drug (SU011248 and its active metabolite SU012662) per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter \[ng/mL\]).
Time frame: Day 28 of Cycle 1 to Cycle 4
Population: As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | Ctrough Concentrations of SU011248 and Active Metabolite SU012662 | Cycle 1, Day 28 (n=31) | 84.36 ng/mL | Standard Deviation 46.06 |
| SU011248 | Ctrough Concentrations of SU011248 and Active Metabolite SU012662 | Cycle 2, Day 28 (n=36) | 84.94 ng/mL | Standard Deviation 41.18 |
| SU011248 | Ctrough Concentrations of SU011248 and Active Metabolite SU012662 | Cycle 3, Day 28 (n=36) | 76.37 ng/mL | Standard Deviation 38.86 |
| SU011248 | Ctrough Concentrations of SU011248 and Active Metabolite SU012662 | Cycle 4, Day 28 (n=32) | 67.15 ng/mL | Standard Deviation 34.13 |
| SU011248 | Ctrough Concentrations of SU011248 and Active Metabolite SU012662 | Dose-Corrected: Cycle 1, Day 28 (n=24) | 92.43 ng/mL | Standard Deviation 48.08 |
| SU011248 | Ctrough Concentrations of SU011248 and Active Metabolite SU012662 | Dose-Corrected: Cycle 2, Day 28 (n=28) | 88.22 ng/mL | Standard Deviation 36.34 |
| SU011248 | Ctrough Concentrations of SU011248 and Active Metabolite SU012662 | Dose-Corrected: Cycle 3, Day 28 (n=27) | 87.49 ng/mL | Standard Deviation 45.85 |
| SU011248 | Ctrough Concentrations of SU011248 and Active Metabolite SU012662 | Dose-Corrected: Cycle 4, Day 28 (n=27) | 80.30 ng/mL | Standard Deviation 44.76 |
Secondary
Duration of Response (DR), Core Radiology Assessement
Duration of response (DR) = time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.
Time frame: Day 28 of each cycle: duraton of treatment phase
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SU011248 | Duration of Response (DR), Core Radiology Assessement | 52.9 weeks |
| IFN-α | Duration of Response (DR), Core Radiology Assessement | 64.9 weeks |
Secondary
Duration of Response (DR), Investigator's Assessment
Duration of response (DR) = time from the first documentation of objective tumor response to the first documentaion of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.
Time frame: Day 28 of each cycle: duration of treatment phase
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SU011248 | Duration of Response (DR), Investigator's Assessment | 56.3 weeks |
| IFN-α | Duration of Response (DR), Investigator's Assessment | 48.1 weeks |
Secondary
EuroQoL Five Dimension (EQ-5D) Health State Index
EQ-5D Health State Index: a brief, self-administered generic health status instrument. Respondents were asked to describe their current health state on each of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety or depression) on a three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A maximum score of 1 can be derived from these 5 dimensions by score conversion; range: -0.39 (worst health state)to 1.00 (best health state). This descriptive system classifies respondents into one of 243 possible distinct health states (EQ-5D descriptive system).
Time frame: Day 1 & 28 of each cycle: duration of treatment phase
Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 8 Day 1 (192, 68) | 0.82 scores on scale | Standard Deviation 0.18 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 4 Day 1 (269, 150) | 0.80 scores on scale | Standard Deviation 0.199 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 4 Day 28 (261, 142) | 0.76 scores on scale | Standard Deviation 0.218 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 5 Day 1 (247, 120) | 0.80 scores on scale | Standard Deviation 0.209 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 7 Day 1 (205, 79) | 0.81 scores on scale | Standard Deviation 0.192 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 7 Day 28 (204, 74) | 0.77 scores on scale | Standard Deviation 0.221 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 8 Day 28 (190, 61) | 0.77 scores on scale | Standard Deviation 0.222 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 9 Day 28 (168, 45) | 0.78 scores on scale | Standard Deviation 0.194 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 11 Day 28 (138, 32) | 0.75 scores on scale | Standard Deviation 0.189 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 13 Day 1 (114, 26) | 0.81 scores on scale | Standard Deviation 0.176 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 14 Day 1 (114, 25) | 0.81 scores on scale | Standard Deviation 0.181 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 14 Day 28 (107, 24) | 0.75 scores on scale | Standard Deviation 0.224 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 15 Day 1 (100, 21) | 0.80 scores on scale | Standard Deviation 0.19 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 16 Day 1 (96, 19) | 0.79 scores on scale | Standard Deviation 0.194 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 1 Day 28 (346, 315) | 0.72 scores on scale | Standard Deviation 0.262 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 2 Day 1 (326, 244) | 0.78 scores on scale | Standard Deviation 0.23 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 2 Day 28 (311, 233) | 0.73 scores on scale | Standard Deviation 0.246 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 3 Day 1 (287, 200) | 0.78 scores on scale | Standard Deviation 0.22 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 3 Day 28 (283, 195) | 0.75 scores on scale | Standard Deviation 0.231 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 9 Day 1 (170, 51) | 0.80 scores on scale | Standard Deviation 0.196 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 10 Day 1 (161, 50) | 0.81 scores on scale | Standard Deviation 0.209 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 10 Day 28 (153, 46) | 0.78 scores on scale | Standard Deviation 0.2 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 11 Day 1 (138, 34) | 0.80 scores on scale | Standard Deviation 0.192 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 12 Day 1 (132, 31) | 0.81 scores on scale | Standard Deviation 0.187 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 12 Day 28 (127, 31) | 0.77 scores on scale | Standard Deviation 0.182 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 15 Day 28 (95, 20) | 0.75 scores on scale | Standard Deviation 0.209 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 5 Day 28 (240, 106) | 0.76 scores on scale | Standard Deviation 0.223 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 6 Day 1 (240, 98) | 0.80 scores on scale | Standard Deviation 0.249 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 6 Day 28 (224, 100) | 0.77 scores on scale | Standard Deviation 0.206 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Baseline (n=363, 352) | 0.76 scores on scale | Standard Deviation 0.225 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 16 Day 28 (93, 18) | 0.76 scores on scale | Standard Deviation 0.181 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 17 Day 1 (84, 15) | 0.79 scores on scale | Standard Deviation 0.194 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 17 Day 28 (82, 14) | 0.77 scores on scale | Standard Deviation 0.168 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 18 Day 1 (80, 12) | 0.81 scores on scale | Standard Deviation 0.187 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 18 Day 28 (71, 10) | 0.76 scores on scale | Standard Deviation 0.166 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 19 Day 1 (69, 11) | 0.81 scores on scale | Standard Deviation 0.183 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 19 Day 28 (62, 11) | 0.78 scores on scale | Standard Deviation 0.165 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 20 Day 1 (63, 8) | 0.81 scores on scale | Standard Deviation 0.162 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 20 Day 28 (54, 9) | 0.77 scores on scale | Standard Deviation 0.181 |
| SU011248 | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 13 Day 28 (115, 27) | 0.77 scores on scale | Standard Deviation 0.186 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 16 Day 1 (96, 19) | 0.84 scores on scale | Standard Deviation 0.163 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 2 Day 28 (311, 233) | 0.74 scores on scale | Standard Deviation 0.23 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 10 Day 1 (161, 50) | 0.85 scores on scale | Standard Deviation 0.161 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 4 Day 1 (269, 150) | 0.80 scores on scale | Standard Deviation 0.19 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 18 Day 28 (71, 10) | 0.84 scores on scale | Standard Deviation 0.279 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 4 Day 28 (261, 142) | 0.79 scores on scale | Standard Deviation 0.216 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 10 Day 28 (153, 46) | 0.82 scores on scale | Standard Deviation 0.185 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 5 Day 1 (247, 120) | 0.79 scores on scale | Standard Deviation 0.194 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 5 Day 28 (240, 106) | 0.78 scores on scale | Standard Deviation 0.201 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 7 Day 1 (205, 79) | 0.80 scores on scale | Standard Deviation 0.185 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 16 Day 28 (93, 18) | 0.83 scores on scale | Standard Deviation 0.164 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 11 Day 1 (138, 34) | 0.85 scores on scale | Standard Deviation 0.159 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 8 Day 1 (192, 68) | 0.82 scores on scale | Standard Deviation 0.158 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 11 Day 28 (138, 32) | 0.84 scores on scale | Standard Deviation 0.185 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 20 Day 1 (63, 8) | 0.85 scores on scale | Standard Deviation 0.182 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 9 Day 28 (168, 45) | 0.84 scores on scale | Standard Deviation 0.147 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 12 Day 1 (132, 31) | 0.82 scores on scale | Standard Deviation 0.283 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 12 Day 28 (127, 31) | 0.85 scores on scale | Standard Deviation 0.165 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 17 Day 1 (84, 15) | 0.88 scores on scale | Standard Deviation 0.169 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 13 Day 1 (114, 26) | 0.83 scores on scale | Standard Deviation 0.231 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 13 Day 28 (115, 27) | 0.82 scores on scale | Standard Deviation 0.26 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 14 Day 28 (107, 24) | 0.87 scores on scale | Standard Deviation 0.16 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 14 Day 1 (114, 25) | 0.86 scores on scale | Standard Deviation 0.148 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 15 Day 1 (100, 21) | 0.88 scores on scale | Standard Deviation 0.146 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 15 Day 28 (95, 20) | 0.88 scores on scale | Standard Deviation 0.141 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 17 Day 28 (82, 14) | 0.83 scores on scale | Standard Deviation 0.174 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 19 Day 1 (69, 11) | 0.88 scores on scale | Standard Deviation 0.184 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Baseline (n=363, 352) | 0.76 scores on scale | Standard Deviation 0.234 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 19 Day 28 (62, 11) | 0.72 scores on scale | Standard Deviation 0.436 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 1 Day 28 (346, 315) | 0.70 scores on scale | Standard Deviation 0.274 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 6 Day 1 (240, 98) | 0.80 scores on scale | Standard Deviation 0.178 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 2 Day 1 (326, 244) | 0.75 scores on scale | Standard Deviation 0.231 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 18 Day 1 (80, 12) | 0.86 scores on scale | Standard Deviation 0.274 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 6 Day 28 (224, 100) | 0.80 scores on scale | Standard Deviation 0.187 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 3 Day 1 (287, 200) | 0.76 scores on scale | Standard Deviation 0.222 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 7 Day 28 (204, 74) | 0.81 scores on scale | Standard Deviation 0.156 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 3 Day 28 (283, 195) | 0.75 scores on scale | Standard Deviation 0.218 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 8 Day 28 (190, 61) | 0.81 scores on scale | Standard Deviation 0.163 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 20 Day 28 (54, 9) | 0.86 scores on scale | Standard Deviation 0.215 |
| IFN-α | EuroQoL Five Dimension (EQ-5D) Health State Index | Cycle 9 Day 1 (170, 51) | 0.84 scores on scale | Standard Deviation 0.162 |
Comparison: Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EuroQoL Five Dimension (EQ-5D): Health state index baseline score (intercept and time since randomization are included as random effects).p-value: 0.000495% CI: [0.022, 0.076]Mixed Models Analysis
Comparison: Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.000395% CI: [0.022, 0.075]Mixed Models Analysis
Comparison: Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.000395% CI: [0.022, 0.074]Mixed Models Analysis
Comparison: Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.000395% CI: [0.021, 0.072]Mixed Models Analysis
Comparison: Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.000495% CI: [0.021, 0.072]Mixed Models Analysis
Comparison: Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.000595% CI: [0.02, 0.071]Mixed Models Analysis
Comparison: Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.000795% CI: [0.019, 0.07]Mixed Models Analysis
Comparison: Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.001195% CI: [0.017, 0.07]Mixed Models Analysis
Comparison: Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.001695% CI: [0.016, 0.07]Mixed Models Analysis
Comparison: Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.002995% CI: [0.014, 0.07]Mixed Models Analysis
Comparison: Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.004195% CI: [0.013, 0.07]Mixed Models Analysis
Comparison: Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.007695% CI: [0.011, 0.071]Mixed Models Analysis
Comparison: Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.010595% CI: [0.009, 0.071]Mixed Models Analysis
Comparison: Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.017995% CI: [0.007, 0.072]Mixed Models Analysis
Comparison: Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.023695% CI: [0.005, 0.072]Mixed Models Analysis
Comparison: Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.03795% CI: [0.002, 0.073]Mixed Models Analysis
Comparison: Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.046495% CI: [0.001, 0.074]Mixed Models Analysis
Comparison: Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.066795% CI: [-0.002, 0.075]Mixed Models Analysis
Comparison: Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.0895% CI: [-0.004, 0.076]Mixed Models Analysis
Comparison: Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.10795% CI: [-0.007, 0.077]Mixed Models Analysis
Comparison: Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.123795% CI: [-0.009, 0.078]Mixed Models Analysis
Comparison: Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.156195% CI: [-0.013, 0.079]Mixed Models Analysis
Comparison: Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.175295% CI: [-0.015, 0.08]Mixed Models Analysis
Comparison: Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.211295% CI: [-0.018, 0.081]Mixed Models Analysis
Comparison: Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.231995% CI: [-0.02, 0.082]Mixed Models Analysis
Comparison: Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.269895% CI: [-0.023, 0.084]Mixed Models Analysis
Comparison: Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.29195% CI: [-0.025, 0.085]Mixed Models Analysis
Comparison: Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.329395% CI: [-0.029, 0.086]Mixed Models Analysis
Comparison: Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.350495% CI: [-0.031, 0.087]Mixed Models Analysis
Comparison: Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.388195% CI: [-0.034, 0.089]Mixed Models Analysis
Comparison: Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.408695% CI: [-0.036, 0.09]Mixed Models Analysis
Comparison: Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.444995% CI: [-0.04, 0.091]Mixed Models Analysis
Comparison: Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.464695% CI: [-0.042, 0.092]Mixed Models Analysis
Comparison: Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.49995% CI: [-0.046, 0.094]Mixed Models Analysis
Comparison: Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.517695% CI: [-0.048, 0.095]Mixed Models Analysis
Comparison: Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.550195% CI: [-0.051, 0.097]Mixed Models Analysis
Comparison: Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.567595% CI: [-0.054, 0.098]Mixed Models Analysis
Comparison: Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.597995% CI: [-0.057, 0.099]Mixed Models Analysis
Comparison: Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.614195% CI: [-0.059, 0.1]Mixed Models Analysis
Comparison: Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)p-value: 0.642495% CI: [-0.063, 0.102]Mixed Models Analysis
Secondary
Euro-QoL Visual Analog Scale (EQ-VAS)
EQ-VAS: overall self-rating rating of the patient's current health state using a 20 cm Visual Analog Scale (EQ-VAS), also called the health state thermometer) is a metric measurement (in 2 mm interval) from the visual analog scale which ranges between 0 (worse imaginable health state) and 100 (best imaginable health state).
Time frame: Day 1 & 28 of each cycle: duration of treatment phase
Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 6 Day 1 (n=237, 99) | 78.83 scores on scale | Standard Deviation 15.359 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 11 Day 1 (n=138, 34) | 79.72 scores on scale | Standard Deviation 15.685 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 3 Day 28 (n=287, 193) | 72.33 scores on scale | Standard Deviation 18.472 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 11 Day 28 (n=141, 33) | 76.81 scores on scale | Standard Deviation 15.128 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 12 Day 1 (n=130, 31) | 80.84 scores on scale | Standard Deviation 14.15 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 6 Day 28 (n=223, 98) | 76.81 scores on scale | Standard Deviation 15.204 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 12 Day 28 (n=128, 31) | 76.71 scores on scale | Standard Deviation 14.986 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 1 Day 28 (n=347, 315) | 69.35 scores on scale | Standard Deviation 18.992 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 13 Day 1 (n=114, 27) | 80.59 scores on scale | Standard Deviation 14.875 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 7 Day 1 (n=209, 77) | 79.39 scores on scale | Standard Deviation 14.601 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 13 Day 28 (n=115, 27) | 77.22 scores on scale | Standard Deviation 14.715 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 4 Day 1 (n=270, 152) | 77.46 scores on scale | Standard Deviation 16.024 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 14 Day 1 (n=114, 26) | 80.39 scores on scale | Standard Deviation 14.477 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 7 Day 28 (n=201, 74) | 76.09 scores on scale | Standard Deviation 16.693 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 14 Day 28 (n=107, 25) | 76.53 scores on scale | Standard Deviation 15.933 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 2 Day 28 (n=314, 237) | 72.06 scores on scale | Standard Deviation 18.297 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 15 Day 1 (n=101, 21) | 80.50 scores on scale | Standard Deviation 14.361 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 8 Day 1 (n=192, 67) | 81.34 scores on scale | Standard Deviation 13.02 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 15 Day 28 (n=96, 20) | 76.51 scores on scale | Standard Deviation 15.141 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Baseline (n=365, 352) | 73.80 scores on scale | Standard Deviation 18.498 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 16 Day 1 (n=96, 19) | 79.85 scores on scale | Standard Deviation 15.632 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 8 Day 28 (n=191, 60) | 77.53 scores on scale | Standard Deviation 14.374 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 16 Day 28 (n=92, 18) | 75.51 scores on scale | Standard Deviation 17.687 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 5 Day 1 (n=248, 118) | 79.83 scores on scale | Standard Deviation 13.554 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 17 Day 1 (n=84, 17) | 80.74 scores on scale | Standard Deviation 15.706 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 9 Day 1 (n=172, 50) | 80.08 scores on scale | Standard Deviation 13.812 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 17 Day 28 (n=82, 14) | 77.10 scores on scale | Standard Deviation 16.612 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 3 Day 1 (n=293, 198) | 76.23 scores on scale | Standard Deviation 17.171 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 18 Day 1 (n=78, 12) | 80.40 scores on scale | Standard Deviation 14.658 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 9 Day 28 (n=168, 46) | 76.24 scores on scale | Standard Deviation 15.74 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 18 Day 28 (n=70, 11) | 77.76 scores on scale | Standard Deviation 16.142 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 5 Day 28 (n=240, 104) | 75.13 scores on scale | Standard Deviation 16.771 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 19 Day 1 (n=70, 11) | 81.47 scores on scale | Standard Deviation 15.33 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 10 Day 1 (n=160, 50) | 79.18 scores on scale | Standard Deviation 14.912 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 19 Day 28 (n=62, 11) | 77.05 scores on scale | Standard Deviation 18.676 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 2 Day 1 (n=323, 247) | 75.05 scores on scale | Standard Deviation 17.964 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 20 Day 1 (n=65, 9) | 81.10 scores on scale | Standard Deviation 15.404 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 10 Day 28 (n=154, 45) | 76.44 scores on scale | Standard Deviation 16.106 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 20 Day 28 (n=54, 9) | 76.85 scores on scale | Standard Deviation 16.863 |
| SU011248 | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 4 Day 28 (n=264, 139) | 75.15 scores on scale | Standard Deviation 16.406 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 20 Day 28 (n=54, 9) | 75.44 scores on scale | Standard Deviation 25.06 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 11 Day 28 (n=141, 33) | 72.21 scores on scale | Standard Deviation 23.202 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Baseline (n=365, 352) | 71.43 scores on scale | Standard Deviation 19.507 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 1 Day 28 (n=347, 315) | 67.66 scores on scale | Standard Deviation 20.058 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 2 Day 1 (n=323, 247) | 70.45 scores on scale | Standard Deviation 17.653 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 2 Day 28 (n=314, 237) | 70.70 scores on scale | Standard Deviation 18.271 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 3 Day 1 (n=293, 198) | 72.68 scores on scale | Standard Deviation 17.162 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 3 Day 28 (n=287, 193) | 71.45 scores on scale | Standard Deviation 18.315 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 4 Day 1 (n=270, 152) | 72.74 scores on scale | Standard Deviation 17.678 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 4 Day 28 (n=264, 139) | 72.20 scores on scale | Standard Deviation 18.098 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 5 Day 1 (n=248, 118) | 73.44 scores on scale | Standard Deviation 16.204 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 5 Day 28 (n=240, 104) | 72.57 scores on scale | Standard Deviation 16.007 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 6 Day 1 (n=237, 99) | 73.68 scores on scale | Standard Deviation 16.537 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 6 Day 28 (n=223, 98) | 72.26 scores on scale | Standard Deviation 18.452 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 7 Day 1 (n=209, 77) | 73.80 scores on scale | Standard Deviation 18.868 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 7 Day 28 (n=201, 74) | 73.46 scores on scale | Standard Deviation 17.38 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 8 Day 1 (n=192, 67) | 74.27 scores on scale | Standard Deviation 18.067 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 8 Day 28 (n=191, 60) | 74.33 scores on scale | Standard Deviation 18.407 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 9 Day 1 (n=172, 50) | 77.66 scores on scale | Standard Deviation 15.987 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 9 Day 28 (n=168, 46) | 76.57 scores on scale | Standard Deviation 17.924 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 10 Day 1 (n=160, 50) | 76.64 scores on scale | Standard Deviation 17.886 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 10 Day 28 (n=154, 45) | 76.69 scores on scale | Standard Deviation 19.123 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 11 Day 1 (n=138, 34) | 75.06 scores on scale | Standard Deviation 20.179 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 12 Day 1 (n=130, 31) | 75.19 scores on scale | Standard Deviation 22.02 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 12 Day 28 (n=128, 31) | 73.84 scores on scale | Standard Deviation 20.775 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 13 Day 1 (n=114, 27) | 77.52 scores on scale | Standard Deviation 17.738 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 13 Day 28 (n=115, 27) | 73.56 scores on scale | Standard Deviation 23.523 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 14 Day 1 (n=114, 26) | 76.69 scores on scale | Standard Deviation 16.601 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 14 Day 28 (n=107, 25) | 76.44 scores on scale | Standard Deviation 18.89 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 15 Day 1 (n=101, 21) | 76.62 scores on scale | Standard Deviation 19.075 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 15 Day 28 (n=96, 20) | 76.50 scores on scale | Standard Deviation 18.841 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 16 Day 1 (n=96, 19) | 74.84 scores on scale | Standard Deviation 21.68 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 16 Day 28 (n=92, 18) | 73.11 scores on scale | Standard Deviation 21.202 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 17 Day 1 (n=84, 17) | 76.94 scores on scale | Standard Deviation 21.256 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 17 Day 28 (n=82, 14) | 72.86 scores on scale | Standard Deviation 22.593 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 18 Day 1 (n=78, 12) | 74.42 scores on scale | Standard Deviation 25.065 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 18 Day 28 (n=70, 11) | 73.82 scores on scale | Standard Deviation 24.14 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 19 Day 1 (n=70, 11) | 79.27 scores on scale | Standard Deviation 20.283 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 19 Day 28 (n=62, 11) | 68.55 scores on scale | Standard Deviation 29.717 |
| IFN-α | Euro-QoL Visual Analog Scale (EQ-VAS) | Cycle 20 Day 1 (n=65, 9) | 76.00 scores on scale | Standard Deviation 21.494 |
Comparison: Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Euro-QoL Visual Analog Scale (EQ-VAS) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.088, 5.965]Mixed Models Analysis
Comparison: Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.269, 6.061]Mixed Models Analysis
Comparison: Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.358, 6.128]Mixed Models Analysis
Comparison: Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.494, 6.269]Mixed Models Analysis
Comparison: Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.558, 6.361]Mixed Models Analysis
Comparison: Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.65, 6.547]Mixed Models Analysis
Comparison: Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.689, 6.662]Mixed Models Analysis
Comparison: Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.741, 6.889]Mixed Models Analysis
Comparison: Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.76, 7.024]Mixed Models Analysis
Comparison: Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.78, 7.283]Mixed Models Analysis
Comparison: Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.783, 7.435]Mixed Models Analysis
Comparison: Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.776, 7.72]Mixed Models Analysis
Comparison: Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.767, 7.884]Mixed Models Analysis
Comparison: Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.741, 8.188]Mixed Models Analysis
Comparison: Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.000195% CI: [2.723, 8.361]Mixed Models Analysis
Comparison: Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.000295% CI: [2.683, 8.679]Mixed Models Analysis
Comparison: Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.000395% CI: [2.657, 8.859]Mixed Models Analysis
Comparison: Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.000495% CI: [2.607, 9.188]Mixed Models Analysis
Comparison: Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.000695% CI: [2.576, 9.374]Mixed Models Analysis
Comparison: Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.000995% CI: [2.517, 9.711]Mixed Models Analysis
Comparison: Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.001195% CI: [2.482, 9.9]Mixed Models Analysis
Comparison: Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.001595% CI: [2.417, 10.244]Mixed Models Analysis
Comparison: Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.001895% CI: [2.379, 10.436]Mixed Models Analysis
Comparison: Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.002595% CI: [2.309, 10.785]Mixed Models Analysis
Comparison: Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.002995% CI: [2.269, 10.98]Mixed Models Analysis
Comparison: Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.003795% CI: [2.195, 11.332]Mixed Models Analysis
Comparison: Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.004295% CI: [2.153, 11.529]Mixed Models Analysis
Comparison: Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.005395% CI: [2.076, 11.884]Mixed Models Analysis
Comparison: Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.005995% CI: [2.032, 12.083]Mixed Models Analysis
Comparison: Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.007295% CI: [1.953, 12.441]Mixed Models Analysis
Comparison: Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.007995% CI: [1.908, 12.64]Mixed Models Analysis
Comparison: Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.009395% CI: [1.826, 13]Mixed Models Analysis
Comparison: Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.010195% CI: [1.78, 13.201]Mixed Models Analysis
Comparison: Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.011795% CI: [1.697, 13.562]Mixed Models Analysis
Comparison: Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.012695% CI: [1.65, 13.764]Mixed Models Analysis
Comparison: Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.014495% CI: [1.565, 14.127]Mixed Models Analysis
Comparison: Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.015395% CI: [1.518, 14.329]Mixed Models Analysis
Comparison: Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.017295% CI: [1.432, 14.693]Mixed Models Analysis
Comparison: Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.018295% CI: [1.384, 14.896]Mixed Models Analysis
Comparison: Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)p-value: 0.020195% CI: [1.297, 15.261]Mixed Models Analysis
Secondary
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) subscale of the FKSI to measure advanced kidney cancer disease related symptoms. Includes 9 items: lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria. Each question was answered on a five-point Likert-type scale ranging from 0 (not at all) to 4 (very much). Score = the sum score of the item scores in the subscale; total range: 0 to 36. A score greater than 0 indicates the difference favored sunitinib.
Time frame: Day 1 & 28 of each cycle: duration of treatment phase
Population: ITT; summary of FKSI-DRS questionnaire results by treatment; N=number of subjects with evaluable data; n = number of subjects with evaluable data at observation, SU011248 and INF-α treatment groups, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 6 Day 1 (n=240, 99) | 30.80 scores on scale | Standard Deviation 4.214 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 1 Day 28 (n=348, 317) | 27.73 scores on scale | Standard Deviation 5.08 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 2 Day 1 (n=327, 246) | 29.66 scores on scale | Standard Deviation 4.778 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 2 Day 28 (n= 315, 237) | 28.49 scores on scale | Standard Deviation 4.748 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 3 Day 1 (n=294, 198) | 29.93 scores on scale | Standard Deviation 4.679 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 3 Day 28 (n=285, 195) | 28.72 scores on scale | Standard Deviation 4.756 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 4 Day 1 (n=272, 151) | 30.25 scores on scale | Standard Deviation 4.498 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 4 Day 28 (n=264, 142) | 29.43 scores on scale | Standard Deviation 4.389 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 5 Day 1 (n=248, 119 ) | 30.87 scores on scale | Standard Deviation 3.948 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 5 Day 28 (n=242, 109) | 29.43 scores on scale | Standard Deviation 4.28 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Baseline (n=368, 351) | 29.74 scores on scale | Standard Deviation 5.244 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 6 Day 28 (n=223, 99) | 29.62 scores on scale | Standard Deviation 4.288 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 7 Day 1 (n=208, 79) | 30.93 scores on scale | Standard Deviation 4.002 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 7 Day 28 (n=203, 75 ) | 29.73 scores on scale | Standard Deviation 4.417 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 8 Day 1 (n=192, 68) | 31.03 scores on scale | Standard Deviation 3.649 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 8 Day 28 (n=190, 62) | 29.76 scores on scale | Standard Deviation 4.096 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 9 Day 1 (n=172, 51) | 31.24 scores on scale | Standard Deviation 3.56 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 9 Day 28 (n=166, 46) | 29.72 scores on scale | Standard Deviation 4.245 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 10 Day 1 (n=161, 50) | 30.73 scores on scale | Standard Deviation 3.82 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 10 Day 28 (n=155, 46) | 29.78 scores on scale | Standard Deviation 4.034 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 11 Day 1 (n=138, 35) | 30.72 scores on scale | Standard Deviation 4.018 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 11 Day 28 (n=141, 33) | 29.34 scores on scale | Standard Deviation 4.117 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 12 Day 1 (n=132, 31) | 30.76 scores on scale | Standard Deviation 4.108 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 12 Day 28 (n=128, 31) | 29.63 scores on scale | Standard Deviation 4.362 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 13 Day 1 (113, 27) | 30.58 scores on scale | Standard Deviation 4.354 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 13 Day 28 (n=114, 27) | 29.30 scores on scale | Standard Deviation 4.424 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 14 Day 1 (n=114, 26) | 30.58 scores on scale | Standard Deviation 4.179 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 14 Day 28 (n=105, 25) | 28.94 scores on scale | Standard Deviation 4.771 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 15 Day 1 (n=100, 22) | 30.87 scores on scale | Standard Deviation 4.075 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 15 Day 28 (n=94, 20) | 29.26 scores on scale | Standard Deviation 4.32 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 16 Day 1 (n=96, 19) | 30.63 scores on scale | Standard Deviation 3.786 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 16 Day 28 (n=90, 18) | 29.51 scores on scale | Standard Deviation 4.302 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 17 Day 1 (n=85, 17) | 30.69 scores on scale | Standard Deviation 4.132 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 17 Day 28 (n=81, 14) | 29.73 scores on scale | Standard Deviation 4.155 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 18 Day 1 (n=80, 12) | 30.24 scores on scale | Standard Deviation 4.091 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 18 Day 28 (n=70, 11) | 29.15 scores on scale | Standard Deviation 4.358 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 19 Day 1 (n=71, 11) | 30.11 scores on scale | Standard Deviation 4.528 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 19 Day 28 (n=61, 10) | 29.48 scores on scale | Standard Deviation 4.678 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 20 Day 1 (n=65, 9) | 31.07 scores on scale | Standard Deviation 4.073 |
| SU011248 | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 20 Day 28 (n=53, 9) | 29.44 scores on scale | Standard Deviation 4.21 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 19 Day 28 (n=61, 10) | 28.65 scores on scale | Standard Deviation 8.131 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Baseline (n=368, 351) | 29.55 scores on scale | Standard Deviation 5.026 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 11 Day 1 (n=138, 35) | 29.89 scores on scale | Standard Deviation 4.006 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 1 Day 28 (n=348, 317) | 26.68 scores on scale | Standard Deviation 5.195 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 16 Day 1 (n=96, 19) | 27.79 scores on scale | Standard Deviation 5.76 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 2 Day 1 (n=327, 246) | 27.59 scores on scale | Standard Deviation 4.908 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 11 Day 28 (n=141, 33) | 29.24 scores on scale | Standard Deviation 5.014 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 2 Day 28 (n= 315, 237) | 27.22 scores on scale | Standard Deviation 4.988 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 18 Day 28 (n=70, 11) | 28.73 scores on scale | Standard Deviation 6.973 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 3 Day 1 (n=294, 198) | 28.20 scores on scale | Standard Deviation 4.452 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 12 Day 1 (n=132, 31) | 29.54 scores on scale | Standard Deviation 5.607 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 3 Day 28 (n=285, 195) | 27.81 scores on scale | Standard Deviation 5.04 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 16 Day 28 (n=90, 18) | 28.28 scores on scale | Standard Deviation 6.267 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 4 Day 1 (n=272, 151) | 28.85 scores on scale | Standard Deviation 4.821 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 12 Day 28 (n=128, 31) | 29.48 scores on scale | Standard Deviation 4.774 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 4 Day 28 (n=264, 142) | 28.30 scores on scale | Standard Deviation 5.071 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 20 Day 28 (n=53, 9) | 29.22 scores on scale | Standard Deviation 7.694 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 5 Day 1 (n=248, 119 ) | 28.57 scores on scale | Standard Deviation 4.925 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 13 Day 1 (113, 27) | 29.81 scores on scale | Standard Deviation 4.923 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 5 Day 28 (n=242, 109) | 28.37 scores on scale | Standard Deviation 4.726 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 17 Day 1 (n=85, 17) | 29.26 scores on scale | Standard Deviation 5.434 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 6 Day 1 (n=240, 99) | 29.12 scores on scale | Standard Deviation 4.428 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 13 Day 28 (n=114, 27) | 29.63 scores on scale | Standard Deviation 4.55 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 6 Day 28 (n=223, 99) | 28.44 scores on scale | Standard Deviation 4.957 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 19 Day 1 (n=71, 11) | 29.64 scores on scale | Standard Deviation 7.061 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 7 Day 1 (n=208, 79) | 28.99 scores on scale | Standard Deviation 4.974 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 14 Day 1 (n=114, 26) | 29.35 scores on scale | Standard Deviation 4.664 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 7 Day 28 (n=203, 75 ) | 28.50 scores on scale | Standard Deviation 4.556 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 17 Day 28 (n=81, 14) | 27.94 scores on scale | Standard Deviation 7.519 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 8 Day 1 (n=192, 68) | 28.76 scores on scale | Standard Deviation 4.847 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 14 Day 28 (n=105, 25) | 29.23 scores on scale | Standard Deviation 5.502 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 8 Day 28 (n=190, 62) | 28.67 scores on scale | Standard Deviation 4.491 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 20 Day 1 (n=65, 9) | 28.44 scores on scale | Standard Deviation 8.048 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 9 Day 1 (n=172, 51) | 29.86 scores on scale | Standard Deviation 4.247 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 15 Day 1 (n=100, 22) | 29.18 scores on scale | Standard Deviation 5.917 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 9 Day 28 (n=166, 46) | 29.36 scores on scale | Standard Deviation 4.418 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 18 Day 1 (n=80, 12) | 28.83 scores on scale | Standard Deviation 7.209 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 10 Day 1 (n=161, 50) | 29.43 scores on scale | Standard Deviation 4.455 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 15 Day 28 (n=94, 20) | 28.89 scores on scale | Standard Deviation 5.676 |
| IFN-α | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Cycle 10 Day 28 (n=155, 46) | 29.03 scores on scale | Standard Deviation 4.98 |
Comparison: Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.376, 2.45]Mixed Models Analysis
Comparison: Cycle 1 Day 28: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.421, 2.449]Mixed Models Analysis
Comparison: Cycle 2 Day 1: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.443, 2.452]Mixed Models Analysis
Comparison: Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.476, 2.464]Mixed Models Analysis
Comparison: Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.491, 2.475]Mixed Models Analysis
Comparison: Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.51, 2.501]Mixed Models Analysis
Comparison: Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.517, 2.519]Mixed Models Analysis
Comparison: Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.522, 2.559]Mixed Models Analysis
Comparison: Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.522, 2.584]Mixed Models Analysis
Comparison: Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.515, 2.635]Mixed Models Analysis
Comparison: Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.509, 2.667]Mixed Models Analysis
Comparison: Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.494, 2.727]Mixed Models Analysis
Comparison: Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.483, 2.763]Mixed Models Analysis
Comparison: Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.461, 2.83]Mixed Models Analysis
Comparison: Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.447, 2.869]Mixed Models Analysis
Comparison: Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.42, 2.941]Mixed Models Analysis
Comparison: Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.404, 2.983]Mixed Models Analysis
Comparison: Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.373, 3.059]Mixed Models Analysis
Comparison: Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.355, 3.102]Mixed Models Analysis
Comparison: Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.321, 3.18]Mixed Models Analysis
Comparison: Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.302, 3.225]Mixed Models Analysis
Comparison: Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.266, 3.305]Mixed Models Analysis
Comparison: Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.246, 3.351]Mixed Models Analysis
Comparison: Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.209, 3.433]Mixed Models Analysis
Comparison: Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.188, 3.479]Mixed Models Analysis
Comparison: Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.000195% CI: [1.15, 3.562]Mixed Models Analysis
Comparison: Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.000295% CI: [1.128, 3.609]Mixed Models Analysis
Comparison: Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.000395% CI: [1.089, 3.693]Mixed Models Analysis
Comparison: Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.000495% CI: [1.067, 3.74]Mixed Models Analysis
Comparison: Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.000795% CI: [1.027, 3.825]Mixed Models Analysis
Comparison: Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.000995% CI: [1.005, 3.872]Mixed Models Analysis
Comparison: Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.001395% CI: [0.964, 3.958]Mixed Models Analysis
Comparison: Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.001695% CI: [0.942, 4.006]Mixed Models Analysis
Comparison: Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.002295% CI: [0.901, 4.092]Mixed Models Analysis
Comparison: Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.002695% CI: [0.878, 4.14]Mixed Models Analysis
Comparison: Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.003495% CI: [0.836, 4.226]Mixed Models Analysis
Comparison: Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.00495% CI: [0.813, 4.274]Mixed Models Analysis
Comparison: Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.005195% CI: [0.772, 4.361]Mixed Models Analysis
Comparison: Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.005895% CI: [0.748, 4.41]Mixed Models Analysis
Comparison: Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).p-value: 0.007195% CI: [0.706, 4.497]Mixed Models Analysis
Secondary
FACT-Kidney Symptom Index (FKSI) Subscale
FACT-Kidney Symptom Index (FKSI) subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions; some questions overlap with the FACT-G questions. Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns).
Time frame: Day 1 & 28 of each cycle: duration of treatment phase
Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 6 Day 1 (n=240, 99) | 47.61 scores on scale | Standard Deviation 7.86 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 1 Day 28 (n=348, 317) | 42.71 scores on scale | Standard Deviation 8.959 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 2 Day 1 (n=327, 246) | 45.98 scores on scale | Standard Deviation 8.401 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 2 Day 28 (n=315, 238) | 43.75 scores on scale | Standard Deviation 8.607 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 3 Day 1 (n=294, 198) | 46.60 scores on scale | Standard Deviation 8.263 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 3 Day 28 (n=285, 195) | 44.01 scores on scale | Standard Deviation 8.529 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 4 Day 1 (n=272, 151) | 46.99 scores on scale | Standard Deviation 8.041 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 4 Day 28 (n=264, 142) | 45.08 scores on scale | Standard Deviation 8.017 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 5 Day 1 (n=248, 119) | 47.99 scores on scale | Standard Deviation 7.313 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 5 Day 28 (n=242, 109) | 44.99 scores on scale | Standard Deviation 7.768 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Baseline (n=369, 351) | 46.45 scores on scale | Standard Deviation 8.464 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 6 Day 28 (n=223, 99) | 45.40 scores on scale | Standard Deviation 7.84 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 7 Day 1 (n=208, 79) | 47.84 scores on scale | Standard Deviation 7.303 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 7 Day 28 (n=203, 75) | 45.39 scores on scale | Standard Deviation 8.013 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 8 Day 1 (n=192, 68) | 48.24 scores on scale | Standard Deviation 6.818 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 8 Day 28 (n=190, 62) | 45.83 scores on scale | Standard Deviation 7.589 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 9 Day 1 (n=172, 51) | 48.31 scores on scale | Standard Deviation 6.971 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 9 Day 28 (n=166, 46) | 45.79 scores on scale | Standard Deviation 7.969 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 10 Day 1 (n=161, 50) | 47.90 scores on scale | Standard Deviation 6.993 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 10 Day 28 (n=155, 46) | 45.70 scores on scale | Standard Deviation 7.372 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 11 Day 1 (n=138, 35) | 47.90 scores on scale | Standard Deviation 6.988 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 11 Day 28 (n=141, 33) | 45.28 scores on scale | Standard Deviation 7.33 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 12 Day 1 (n=132, 31) | 47.90 scores on scale | Standard Deviation 7.458 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 12 Day 28 (n=128, 31) | 45.67 scores on scale | Standard Deviation 7.696 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 13 Day 1 (n=113, 27) | 48.02 scores on scale | Standard Deviation 7.723 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 17 Day 1 (n=85, 17) | 48.07 scores on scale | Standard Deviation 7.641 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 13 Day 28 (n=114, 27) | 45.65 scores on scale | Standard Deviation 7.659 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 14 Day 1 (n=114, 26) | 47.90 scores on scale | Standard Deviation 7.37 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 14 Day 28 (n=105, 25) | 45.10 scores on scale | Standard Deviation 8.641 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 15 Day 1 (n=100, 22) | 48.26 scores on scale | Standard Deviation 7.663 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 15 Day 28 (n=94, 20) | 45.37 scores on scale | Standard Deviation 8.04 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 16 Day 1 (n=96, 19) | 47.75 scores on scale | Standard Deviation 7.063 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 16 Day 28 (n=90, 18) | 45.95 scores on scale | Standard Deviation 7.625 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 17 Day 28 (n=81, 14) | 46.27 scores on scale | Standard Deviation 8.016 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 18 Day 1 (n=80, 12) | 47.47 scores on scale | Standard Deviation 7.598 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 18 Day 28 (n=70, 11) | 45.36 scores on scale | Standard Deviation 7.585 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 19 Day 1 (n=71, 11) | 47.70 scores on scale | Standard Deviation 7.671 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 19 Day 28 (n=61, 10) | 46.07 scores on scale | Standard Deviation 8.442 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 20 Day 1 (n=65, 9) | 48.88 scores on scale | Standard Deviation 7.133 |
| SU011248 | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 20 Day 28 (n=53, 9) | 46.26 scores on scale | Standard Deviation 8.065 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 15 Day 28 (n=94, 20) | 45.30 scores on scale | Standard Deviation 9.776 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Baseline (n=369, 351) | 46.09 scores on scale | Standard Deviation 8.701 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 11 Day 1 (n=138, 35) | 46.26 scores on scale | Standard Deviation 7.398 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 1 Day 28 (n=348, 317) | 40.93 scores on scale | Standard Deviation 9.292 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 18 Day 28 (n=70, 11) | 45.27 scores on scale | Standard Deviation 11.909 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 2 Day 1 (n=327, 246) | 42.33 scores on scale | Standard Deviation 8.733 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 11 Day 28 (n=141, 33) | 45.46 scores on scale | Standard Deviation 8.92 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 2 Day 28 (n=315, 238) | 42.01 scores on scale | Standard Deviation 8.659 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 16 Day 1 (n=96, 19) | 43.64 scores on scale | Standard Deviation 10.688 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 3 Day 1 (n=294, 198) | 43.64 scores on scale | Standard Deviation 7.983 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 12 Day 1 (n=132, 31) | 46.08 scores on scale | Standard Deviation 9.456 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 3 Day 28 (n=285, 195) | 43.13 scores on scale | Standard Deviation 8.925 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 20 Day 28 (n=53, 9) | 46.00 scores on scale | Standard Deviation 13.266 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 4 Day 1 (n=272, 151) | 44.78 scores on scale | Standard Deviation 8.328 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 12 Day 28 (n=128, 31) | 46.00 scores on scale | Standard Deviation 8.802 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 4 Day 28 (n=264, 142) | 44.03 scores on scale | Standard Deviation 8.913 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 16 Day 28 (n=90, 18) | 43.46 scores on scale | Standard Deviation 10.549 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 5 Day 1 (n=248, 119) | 44.82 scores on scale | Standard Deviation 8.293 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 17 Day 1 (n=85, 17) | 45.59 scores on scale | Standard Deviation 10.302 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 5 Day 28 (n=242, 109) | 44.41 scores on scale | Standard Deviation 8.318 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 13 Day 1 (n=113, 27) | 46.25 scores on scale | Standard Deviation 8.833 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 6 Day 1 (n=240, 99) | 45.38 scores on scale | Standard Deviation 7.995 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 19 Day 1 (n=71, 11) | 46.64 scores on scale | Standard Deviation 12.808 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 6 Day 28 (n=223, 99) | 44.07 scores on scale | Standard Deviation 9.003 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 13 Day 28 (n=114, 27) | 45.84 scores on scale | Standard Deviation 9.095 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 7 Day 1 (n=208, 79) | 45.09 scores on scale | Standard Deviation 9.061 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 17 Day 28 (n=81, 14) | 43.64 scores on scale | Standard Deviation 11.693 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 7 Day 28 (n=203, 75) | 44.65 scores on scale | Standard Deviation 8.082 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 14 Day 1 (n=114, 26) | 46.08 scores on scale | Standard Deviation 8.621 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 8 Day 1 (n=192, 68) | 45.38 scores on scale | Standard Deviation 8.597 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 20 Day 1 (n=65, 9) | 45.00 scores on scale | Standard Deviation 13.811 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 8 Day 28 (n=190, 62) | 45.10 scores on scale | Standard Deviation 8.197 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 14 Day 28 (n=105, 25) | 46.10 scores on scale | Standard Deviation 9.65 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 9 Day 1 (n=172, 51) | 46.88 scores on scale | Standard Deviation 7.901 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 18 Day 1 (n=80, 12) | 44.92 scores on scale | Standard Deviation 12.391 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 9 Day 28 (n=166, 46) | 46.16 scores on scale | Standard Deviation 8.133 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 15 Day 1 (n=100, 22) | 45.62 scores on scale | Standard Deviation 9.715 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 10 Day 1 (n=161, 50) | 46.22 scores on scale | Standard Deviation 7.778 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 19 Day 28 (n=61, 10) | 44.47 scores on scale | Standard Deviation 14.476 |
| IFN-α | FACT-Kidney Symptom Index (FKSI) Subscale | Cycle 10 Day 28 (n=155, 46) | 45.16 scores on scale | Standard Deviation 8.961 |
Comparison: Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.234, 4.095]Mixed Models Analysis
Comparison: Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.318, 4.092]Mixed Models Analysis
Comparison: Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.358, 4.097]Mixed Models Analysis
Comparison: Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.418, 4.119]Mixed Models Analysis
Comparison: Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.443, 4.139]Mixed Models Analysis
Comparison: Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.474, 4.189]Mixed Models Analysis
Comparison: Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.484, 4.224]Mixed Models Analysis
Comparison: Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.489, 4.3]Mixed Models Analysis
Comparison: Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.486, 4.348]Mixed Models Analysis
Comparison: Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.469, 4.446]Mixed Models Analysis
Comparison: Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.455, 4.505]Mixed Models Analysis
Comparison: Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.422, 4.62]Mixed Models Analysis
Comparison: Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.399, 4.687]Mixed Models Analysis
Comparison: Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [2.354, 4.814]Mixed Models Analysis
Comparison: Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.326, 4.887]Mixed Models Analysis
Comparison: Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.272, 5.022]Mixed Models Analysis
Comparison: Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.24, 5.099]Mixed Models Analysis
Comparison: Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.18, 5.24]Mixed Models Analysis
Comparison: Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.145, 5.32]Mixed Models Analysis
Comparison: Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.08, 5.466]Mixed Models Analysis
Comparison: Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [2.043, 5.548]Mixed Models Analysis
Comparison: Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.975, 5.698]Mixed Models Analysis
Comparison: Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.936, 5.781]Mixed Models Analysis
Comparison: Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.000295% CI: [1.866, 5.933]Mixed Models Analysis
Comparison: Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.000295% CI: [1.826, 6.018]Mixed Models Analysis
Comparison: Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.000495% CI: [1.753, 6.172]Mixed Models Analysis
Comparison: Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.000695% CI: [1.712, 6.258]Mixed Models Analysis
Comparison: Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.00195% CI: [1.638, 6.413]Mixed Models Analysis
Comparison: Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.001295% CI: [1.597, 6.5]Mixed Models Analysis
Comparison: Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.001895% CI: [1.521, 6.656]Mixed Models Analysis
Comparison: Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.002295% CI: [1.479, 6.743]Mixed Models Analysis
Comparison: Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.003195% CI: [1.403, 6.901]Mixed Models Analysis
Comparison: Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.003795% CI: [1.36, 6.988]Mixed Models Analysis
Comparison: Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.004895% CI: [1.283, 7.147]Mixed Models Analysis
Comparison: Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.005695% CI: [1.24, 7.235]Mixed Models Analysis
Comparison: Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.007195% CI: [1.162, 7.394]Mixed Models Analysis
Comparison: Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.008195% CI: [1.119, 7.482]Mixed Models Analysis
Comparison: Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.009995% CI: [1.041, 7.642]Mixed Models Analysis
Comparison: Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.011195% CI: [0.997, 7.73]Mixed Models Analysis
Comparison: Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).p-value: 0.013395% CI: [0.918, 7.89]Mixed Models Analysis
Secondary
Functional Assessment of Cancer Therapy-General (FACT-G)
Functional Assessment of Cancer Therapy-General (FACT-G): core questionnaire of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system that has been validated in a variety of cancer populations. 27 questions grouped into 4 domains that measure a patient's physical, functional, social and family, and emotional well-being. Five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = sum score of item scores in the subscale; total range: 0 to 108 with higher score indicating better quality of life.
Time frame: Day 1 & 28 of each cycle: duration of treatment phase
Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 12 Day 28 (n=126, 31) | 82.43 scores on scale | Standard Deviation 15.152 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 3 Day 28 (n=285, 193) | 80.59 scores on scale | Standard Deviation 16.144 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 4 Day 1 (n=269, 149) | 85.32 scores on scale | Standard Deviation 14.723 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 4 Day 28 (n=263, 142) | 82.08 scores on scale | Standard Deviation 15.147 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 5 Day 1 (n=247, 119) | 86.40 scores on scale | Standard Deviation 14.019 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 5 Day 28 (n=240, 106) | 82.23 scores on scale | Standard Deviation 15.124 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 6 Day 1 (n=238, 98) | 84.90 scores on scale | Standard Deviation 15.189 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 6 Day 28 (n=222, 97) | 82.54 scores on scale | Standard Deviation 15.338 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 7 Day 1 (n=206, 78) | 85.01 scores on scale | Standard Deviation 15.118 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 7 Day 28 (n=200, 75) | 82.16 scores on scale | Standard Deviation 16.207 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 13 Day 1 (n=113, 27) | 85.50 scores on scale | Standard Deviation 15.209 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Baseline (n=368, 346) | 82.30 scores on scale | Standard Deviation 15.213 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 8 Day 1 (n=192, 66) | 86.83 scores on scale | Standard Deviation 13.456 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 1 Day 28 (n=345, 316) | 78.75 scores on scale | Standard Deviation 15.702 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 2 Day 1 (n=328, 247) | 82.88 scores on scale | Standard Deviation 15.733 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 2 Day 28 (n=314, 237) | 80.51 scores on scale | Standard Deviation 16.229 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 8 Day 28 (n=189, 61) | 83.05 scores on scale | Standard Deviation 14.699 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 13 Day 28 (n=114, 27) | 83.61 scores on scale | Standard Deviation 14.445 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 14 Day 1 (n=112, 26) | 85.24 scores on scale | Standard Deviation 14.398 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 14 Day 28 (n=107, 24) | 82.34 scores on scale | Standard Deviation 16.3 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 15 Day 1 (n=101, 20) | 86.24 scores on scale | Standard Deviation 14.742 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 15 Day 28 (n=96, 20) | 82.64 scores on scale | Standard Deviation 15.722 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 16 Day 1 (n=94, 19) | 84.77 scores on scale | Standard Deviation 14.741 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 16 Day 28 (n=89, 18) | 83.38 scores on scale | Standard Deviation 15.481 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 17 Day 1 (n=84, 16) | 86.78 scores on scale | Standard Deviation 14.8 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 17 Day 28 (n=80, 14) | 84.42 scores on scale | Standard Deviation 15.106 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 18 Day 1 (n=79, 12) | 85.74 scores on scale | Standard Deviation 14.987 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 18 Day 28 (n=70, 11) | 83.51 scores on scale | Standard Deviation 14.831 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 19 Day 1 (n=71, 11) | 87.16 scores on scale | Standard Deviation 14.245 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 19 Day 28 (n=61, 10) | 84.54 scores on scale | Standard Deviation 16.679 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 20 Day 1 (n=63, 9) | 87.96 scores on scale | Standard Deviation 14.441 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 20 Day 28 (n=52, 8) | 84.62 scores on scale | Standard Deviation 16.257 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 9 Day 1 (n=170, 51) | 85.81 scores on scale | Standard Deviation 14.865 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 9 Day 28 (n=166, 46) | 82.71 scores on scale | Standard Deviation 15.276 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 10 Day 1 (n=158, 49) | 85.32 scores on scale | Standard Deviation 14.5 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 10 Day 28 (n=150, 45) | 82.14 scores on scale | Standard Deviation 15.193 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 11 Day 1 (n=134, 35) | 84.75 scores on scale | Standard Deviation 14.791 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 11 Day 28 (n=139, 32) | 81.91 scores on scale | Standard Deviation 14.865 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 12 Day 1 (n=130, 29) | 85.31 scores on scale | Standard Deviation 15.181 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 3 Day 1 (n=293, 199) | 84.24 scores on scale | Standard Deviation 16.121 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 19 Day 1 (n=71, 11) | 82.48 scores on scale | Standard Deviation 24.198 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 3 Day 1 (n=293, 199) | 79.35 scores on scale | Standard Deviation 16.862 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 14 Day 28 (n=107, 24) | 81.57 scores on scale | Standard Deviation 20.188 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 3 Day 28 (n=285, 193) | 78.42 scores on scale | Standard Deviation 17.836 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 11 Day 1 (n=134, 35) | 81.60 scores on scale | Standard Deviation 16.729 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 4 Day 1 (n=269, 149) | 80.86 scores on scale | Standard Deviation 16.477 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 15 Day 1 (n=101, 20) | 81.66 scores on scale | Standard Deviation 18.326 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 4 Day 28 (n=263, 142) | 80.46 scores on scale | Standard Deviation 17.136 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 19 Day 28 (n=61, 10) | 79.63 scores on scale | Standard Deviation 27.938 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 5 Day 1 (n=247, 119) | 81.96 scores on scale | Standard Deviation 15.286 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 15 Day 28 (n=96, 20) | 80.88 scores on scale | Standard Deviation 18.913 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 5 Day 28 (n=240, 106) | 80.60 scores on scale | Standard Deviation 15.527 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 10 Day 1 (n=158, 49) | 84.03 scores on scale | Standard Deviation 16.559 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 6 Day 1 (n=238, 98) | 81.97 scores on scale | Standard Deviation 15.918 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 16 Day 1 (n=94, 19) | 78.20 scores on scale | Standard Deviation 18.994 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 6 Day 28 (n=222, 97) | 79.70 scores on scale | Standard Deviation 16.686 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 20 Day 1 (n=63, 9) | 81.70 scores on scale | Standard Deviation 27.018 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 7 Day 1 (n=206, 78) | 80.39 scores on scale | Standard Deviation 17.811 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 16 Day 28 (n=89, 18) | 78.38 scores on scale | Standard Deviation 19.749 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 8 Day 1 (n=192, 66) | 81.25 scores on scale | Standard Deviation 17.179 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 9 Day 1 (n=170, 51) | 84.50 scores on scale | Standard Deviation 16.174 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 12 Day 28 (n=126, 31) | 81.73 scores on scale | Standard Deviation 18.745 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 12 Day 1 (n=130, 29) | 80.99 scores on scale | Standard Deviation 20.219 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 17 Day 1 (n=84, 16) | 81.80 scores on scale | Standard Deviation 20.161 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Baseline (n=368, 346) | 81.22 scores on scale | Standard Deviation 16.03 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 20 Day 28 (n=52, 8) | 79.54 scores on scale | Standard Deviation 26.109 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 17 Day 28 (n=80, 14) | 78.96 scores on scale | Standard Deviation 21.571 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 1 Day 28 (n=345, 316) | 74.91 scores on scale | Standard Deviation 18.374 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 10 Day 28 (n=150, 45) | 81.79 scores on scale | Standard Deviation 17.994 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 2 Day 1 (n=328, 247) | 77.02 scores on scale | Standard Deviation 16.67 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 18 Day 1 (n=79, 12) | 82.24 scores on scale | Standard Deviation 23.763 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 2 Day 28 (n=314, 237) | 77.05 scores on scale | Standard Deviation 17.468 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 11 Day 28 (n=139, 32) | 80.20 scores on scale | Standard Deviation 19.213 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 8 Day 28 (n=189, 61) | 81.31 scores on scale | Standard Deviation 16.7 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 7 Day 28 (n=200, 75) | 81.06 scores on scale | Standard Deviation 16.701 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 13 Day 1 (n=113, 27) | 81.18 scores on scale | Standard Deviation 20.198 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 18 Day 28 (n=70, 11) | 82.27 scores on scale | Standard Deviation 21.95 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 13 Day 28 (n=114, 27) | 80.67 scores on scale | Standard Deviation 18.678 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 9 Day 28 (n=166, 46) | 83.14 scores on scale | Standard Deviation 17.067 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G) | Cycle 14 Day 1 (n=112, 26) | 81.22 scores on scale | Standard Deviation 17.506 |
Comparison: Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [3.852, 7.119]Mixed Models Analysis
Comparison: Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [3.955, 7.115]Mixed Models Analysis
Comparison: Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [4, 7.124]Mixed Models Analysis
Comparison: Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [4.061, 7.162]Mixed Models Analysis
Comparison: Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [4.083, 7.195]Mixed Models Analysis
Comparison: Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [4.1, 7.276]Mixed Models Analysis
Comparison: Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [4.098, 7.333]Mixed Models Analysis
Comparison: Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [4.075, 7.454]Mixed Models Analysis
Comparison: Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [4.053, 7.531]Mixed Models Analysis
Comparison: Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [3.998, 7.684]Mixed Models Analysis
Comparison: Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [3.96, 7.777]Mixed Models Analysis
Comparison: Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [3.88, 7.955]Mixed Models Analysis
Comparison: Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [3.83, 8.06]Mixed Models Analysis
Comparison: Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [3.731, 8.257]Mixed Models Analysis
Comparison: Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [3.672, 8.37]Mixed Models Analysis
Comparison: Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [3.56, 8.581]Mixed Models Analysis
Comparison: Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [3.495, 8.701]Mixed Models Analysis
Comparison: Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [3.373, 8.921]Mixed Models Analysis
Comparison: Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [3.303, 9.045]Mixed Models Analysis
Comparison: Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [3.174, 9.273]Mixed Models Analysis
Comparison: Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.000195% CI: [3.101, 9.401]Mixed Models Analysis
Comparison: Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.000295% CI: [2.966, 9.634]Mixed Models Analysis
Comparison: Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.000395% CI: [2.89, 9.765]Mixed Models Analysis
Comparison: Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.000695% CI: [2.751, 10.002]Mixed Models Analysis
Comparison: Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.000895% CI: [2.673, 10.135]Mixed Models Analysis
Comparison: Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.001395% CI: [2.53, 10.376]Mixed Models Analysis
Comparison: Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.001695% CI: [2.451, 10.51]Mixed Models Analysis
Comparison: Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.002595% CI: [2.306, 10.754]Mixed Models Analysis
Comparison: Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.00395% CI: [2.224, 10.889]Mixed Models Analysis
Comparison: Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.004395% CI: [2.077, 11.135]Mixed Models Analysis
Comparison: Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.005195% CI: [1.995, 11.272]Mixed Models Analysis
Comparison: Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.006895% CI: [1.847, 11.519]Mixed Models Analysis
Comparison: Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.007995% CI: [1.764, 11.657]Mixed Models Analysis
Comparison: Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.0195% CI: [1.613, 11.905]Mixed Models Analysis
Comparison: Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.011495% CI: [1.53, 12.043]Mixed Models Analysis
Comparison: Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.014195% CI: [1.378, 12.293]Mixed Models Analysis
Comparison: Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.015795% CI: [1.294, 12.432]Mixed Models Analysis
Comparison: Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.018995% CI: [1.142, 12.683]Mixed Models Analysis
Comparison: Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.020895% CI: [1.057, 12.822]Mixed Models Analysis
Comparison: Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).p-value: 0.024495% CI: [0.904, 13.074]Mixed Models Analysis
Secondary
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale
Emotional well-being (EWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 24; lower score indicates better emotional well-being.
Time frame: Day 1 & 28 of each cycle: duration of treatment phase
Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 6 Day 1 (n=240, 99) | 18.99 scores on scale | Standard Deviation 4.154 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 1 Day 28 (n=347, 318) | 17.76 scores on scale | Standard Deviation 4.347 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 2 Day 1 (n=328, 249) | 18.46 scores on scale | Standard Deviation 4.218 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 2 Day 28 (n=316, 237) | 18.46 scores on scale | Standard Deviation 4.342 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 3 Day 1 (n=294, 200) | 18.82 scores on scale | Standard Deviation 4.236 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 3 Day 28 (n=287, 196) | 18.53 scores on scale | Standard Deviation 4.494 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 4 Day 1 (n=272, 152) | 19.04 scores on scale | Standard Deviation 4.182 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 4 Day 28 (n=265, 142) | 18.76 scores on scale | Standard Deviation 4.343 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 5 Day 1 (n=249, 120) | 19.18 scores on scale | Standard Deviation 3.903 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 5 Day 28 (n=241, 109) | 18.63 scores on scale | Standard Deviation 4.298 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Baseline (370, 352) | 17.15 scores on scale | Standard Deviation 4.548 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 6 Day 28 (n=222, 99) | 18.73 scores on scale | Standard Deviation 4.311 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 7 Day 1 (n=208, 77) | 19.08 scores on scale | Standard Deviation 4.324 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 7 Day 28 (n=204, 75) | 18.69 scores on scale | Standard Deviation 4.595 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 8 Day 1 (n=192, 67) | 19.33 scores on scale | Standard Deviation 4.104 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 8 Day 28 (n=189, 62) | 18.98 scores on scale | Standard Deviation 4.026 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 9 Day 1 (n=171, 51) | 19.25 scores on scale | Standard Deviation 4.341 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 9 Day 28 (n=167, 46) | 18.93 scores on scale | Standard Deviation 4.376 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 10 Day 1 (n=161, 50) | 19.32 scores on scale | Standard Deviation 4.191 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 10 Day 28 (n=154, 45) | 18.71 scores on scale | Standard Deviation 4.557 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 11 Day 1 (n=138, 35) | 18.92 scores on scale | Standard Deviation 4.514 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 11 Day 28 (n=141, 33) | 19.10 scores on scale | Standard Deviation 4.209 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 12 Day 1 (n=132, 30) | 19.14 scores on scale | Standard Deviation 4.547 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 12 Day 28 (n=128, 31) | 19.06 scores on scale | Standard Deviation 4.456 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 13 Day 1 (n=114, 27) | 19.38 scores on scale | Standard Deviation 4.17 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 13 Day 28 (n=114, 27) | 19.39 scores on scale | Standard Deviation 4.034 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 14 Day 1 (n=114, 26) | 19.55 scores on scale | Standard Deviation 3.951 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 14 Day 28 (n=107, 25) | 19.23 scores on scale | Standard Deviation 4.522 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 15 Day 1 (n=101, 21) | 19.57 scores on scale | Standard Deviation 4.171 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 15 Day 28 (n=96, 20) | 19.41 scores on scale | Standard Deviation 4.459 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 16 Day 1 (n=96, 19) | 19.54 scores on scale | Standard Deviation 4.258 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 16 Day 28 (n=91, 18) | 19.33 scores on scale | Standard Deviation 4.287 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 17 Day 1 (n=84, 17) | 19.95 scores on scale | Standard Deviation 3.997 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 17 Day 28 (n=81, 14) | 19.66 scores on scale | Standard Deviation 4.42 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 18 Day 1 (n=80, 12) | 19.64 scores on scale | Standard Deviation 4.132 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 18 Day 28 (n=71, 11) | 19.34 scores on scale | Standard Deviation 4.125 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 19 Day 1 (n=71, 11) | 19.94 scores on scale | Standard Deviation 4.052 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 19 Day 28 (n=61, 10) | 19.61 scores on scale | Standard Deviation 4.469 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 20 Day 1 (n=65, 9) | 20.00 scores on scale | Standard Deviation 4.138 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 20 Day 28 (n=53, 9) | 19.75 scores on scale | Standard Deviation 4.206 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 19 Day 28 (n=61, 10) | 18.20 scores on scale | Standard Deviation 6.63 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Baseline (370, 352) | 17.06 scores on scale | Standard Deviation 4.609 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 11 Day 1 (n=138, 35) | 18.97 scores on scale | Standard Deviation 4.225 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 1 Day 28 (n=347, 318) | 17.40 scores on scale | Standard Deviation 5.123 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 16 Day 1 (n=96, 19) | 17.26 scores on scale | Standard Deviation 5.675 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 2 Day 1 (n=328, 249) | 17.52 scores on scale | Standard Deviation 4.56 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 11 Day 28 (n=141, 33) | 18.52 scores on scale | Standard Deviation 5.316 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 2 Day 28 (n=316, 237) | 17.73 scores on scale | Standard Deviation 4.637 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 18 Day 28 (n=71, 11) | 19.55 scores on scale | Standard Deviation 4.677 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 3 Day 1 (n=294, 200) | 18.13 scores on scale | Standard Deviation 4.603 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 12 Day 1 (n=132, 30) | 18.87 scores on scale | Standard Deviation 4.547 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 3 Day 28 (n=287, 196) | 18.17 scores on scale | Standard Deviation 4.704 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 16 Day 28 (n=91, 18) | 16.83 scores on scale | Standard Deviation 5.113 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 4 Day 1 (n=272, 152) | 18.80 scores on scale | Standard Deviation 4.246 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 12 Day 28 (n=128, 31) | 19.45 scores on scale | Standard Deviation 4.178 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 4 Day 28 (n=265, 142) | 18.39 scores on scale | Standard Deviation 4.378 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 20 Day 28 (n=53, 9) | 18.67 scores on scale | Standard Deviation 6.384 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 5 Day 1 (n=249, 120) | 19.00 scores on scale | Standard Deviation 4.062 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 13 Day 1 (n=114, 27) | 18.63 scores on scale | Standard Deviation 4.853 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 5 Day 28 (n=241, 109) | 18.70 scores on scale | Standard Deviation 4.144 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 17 Day 1 (n=84, 17) | 18.28 scores on scale | Standard Deviation 5.151 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 6 Day 1 (n=240, 99) | 18.60 scores on scale | Standard Deviation 4.338 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 13 Day 28 (n=114, 27) | 18.97 scores on scale | Standard Deviation 3.993 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 6 Day 28 (n=222, 99) | 18.14 scores on scale | Standard Deviation 4.747 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 19 Day 1 (n=71, 11) | 19.09 scores on scale | Standard Deviation 5.224 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 7 Day 1 (n=208, 77) | 18.08 scores on scale | Standard Deviation 5.01 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 14 Day 1 (n=114, 26) | 18.05 scores on scale | Standard Deviation 4.814 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 7 Day 28 (n=204, 75) | 18.55 scores on scale | Standard Deviation 4.691 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 17 Day 28 (n=81, 14) | 18.00 scores on scale | Standard Deviation 5.218 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 8 Day 1 (n=192, 67) | 18.54 scores on scale | Standard Deviation 4.613 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 14 Day 28 (n=107, 25) | 18.76 scores on scale | Standard Deviation 4.085 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 8 Day 28 (n=189, 62) | 18.55 scores on scale | Standard Deviation 4.734 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 20 Day 1 (n=65, 9) | 18.67 scores on scale | Standard Deviation 5.788 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 9 Day 1 (n=171, 51) | 18.98 scores on scale | Standard Deviation 4.654 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 15 Day 1 (n=101, 21) | 18.24 scores on scale | Standard Deviation 4.795 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 9 Day 28 (n=167, 46) | 18.76 scores on scale | Standard Deviation 4.831 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 18 Day 1 (n=80, 12) | 19.62 scores on scale | Standard Deviation 4.971 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 10 Day 1 (n=161, 50) | 18.92 scores on scale | Standard Deviation 4.548 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 15 Day 28 (n=96, 20) | 18.75 scores on scale | Standard Deviation 4.447 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Cycle 10 Day 28 (n=154, 45) | 18.36 scores on scale | Standard Deviation 4.778 |
Comparison: Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Emotional Well Being (EWB) subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.000195% CI: [0.46, 1.398]Mixed Models Analysis
Comparison: Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [0.469, 1.375]Mixed Models Analysis
Comparison: Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [0.471, 1.365]Mixed Models Analysis
Comparison: Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [0.469, 1.352]Mixed Models Analysis
Comparison: Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [0.466, 1.348]Mixed Models Analysis
Comparison: Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [0.453, 1.345]Mixed Models Analysis
Comparison: Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.000195% CI: [0.444, 1.347]Mixed Models Analysis
Comparison: Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.000295% CI: [0.421, 1.355]Mixed Models Analysis
Comparison: Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.000395% CI: [0.406, 1.362]Mixed Models Analysis
Comparison: Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.000695% CI: [0.375, 1.379]Mixed Models Analysis
Comparison: Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.000995% CI: [0.356, 1.39]Mixed Models Analysis
Comparison: Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.00295% CI: [0.318, 1.414]Mixed Models Analysis
Comparison: Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.002995% CI: [0.295, 1.428]Mixed Models Analysis
Comparison: Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.005595% CI: [0.251, 1.457]Mixed Models Analysis
Comparison: Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.007695% CI: [0.226, 1.475]Mixed Models Analysis
Comparison: Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.012995% CI: [0.179, 1.508]Mixed Models Analysis
Comparison: Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.016895% CI: [0.151, 1.527]Mixed Models Analysis
Comparison: Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.025795% CI: [0.101, 1.563]Mixed Models Analysis
Comparison: Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.031895% CI: [0.072, 1.583]Mixed Models Analysis
Comparison: Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.044795% CI: [0.019, 1.622]Mixed Models Analysis
Comparison: Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.052995% CI: [-0.01, 1.643]Mixed Models Analysis
Comparison: Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.069695% CI: [-0.065, 1.683]Mixed Models Analysis
Comparison: Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.079795% CI: [-0.095, 1.706]Mixed Models Analysis
Comparison: Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.099495% CI: [-0.151, 1.747]Mixed Models Analysis
Comparison: Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.11195% CI: [-0.182, 1.77]Mixed Models Analysis
Comparison: Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.132895% CI: [-0.239, 1.813]Mixed Models Analysis
Comparison: Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.145495% CI: [-0.271, 1.836]Mixed Models Analysis
Comparison: Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.168695% CI: [-0.329, 1.88]Mixed Models Analysis
Comparison: Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.181795% CI: [-0.361, 1.904]Mixed Models Analysis
Comparison: Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.205595% CI: [-0.419, 1.948]Mixed Models Analysis
Comparison: Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.218895% CI: [-0.452, 1.972]Mixed Models Analysis
Comparison: Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.242795% CI: [-0.51, 2.016]Mixed Models Analysis
Comparison: Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.255995% CI: [-0.543, 2.041]Mixed Models Analysis
Comparison: Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.279495% CI: [-0.602, 2.086]Mixed Models Analysis
Comparison: Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.292395% CI: [-0.635, 2.111]Mixed Models Analysis
Comparison: Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.315295% CI: [-0.695, 2.156]Mixed Models Analysis
Comparison: Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.327695% CI: [-0.728, 2.181]Mixed Models Analysis
Comparison: Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.349795% CI: [-0.788, 2.227]Mixed Models Analysis
Comparison: Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.361695% CI: [-0.822, 2.252]Mixed Models Analysis
Comparison: Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.382795% CI: [-0.882, 2.298]Mixed Models Analysis
Secondary
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale
Functional well-being (FWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; higher score indicates greater functional well-being.
Time frame: Day 1 & 28 of each cycle: duration of treatment phase
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 20 Day 28 (n=53, 9) | 20.15 scores on scale | Standard Deviation 5.819 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 11 Day 28 (n=140, 33) | 19.12 scores on scale | Standard Deviation 5.749 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 17 Day 28 (n=81, 14) | 19.67 scores on scale | Standard Deviation 5.662 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 19 Day 28 (n=61, 10) | 19.59 scores on scale | Standard Deviation 6.326 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Baseline (n=371, 353) | 18.93 scores on scale | Standard Deviation 6.107 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 1 Day 28 (n=347, 318) | 17.92 scores on scale | Standard Deviation 6.083 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 2 Day 1 (n=328, 249) | 18.78 scores on scale | Standard Deviation 6.001 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 2 Day 28 (n=315, 238) | 18.37 scores on scale | Standard Deviation 6.21 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 3 Day 1 (n=294, 200) | 19.51 scores on scale | Standard Deviation 6.073 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 3 Day 28 (n=287, 195) | 18.58 scores on scale | Standard Deviation 5.994 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 4 Day 1 (n=272, 152) | 19.93 scores on scale | Standard Deviation 5.625 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 4 Day 28 (n=265, 142) | 18.86 scores on scale | Standard Deviation 5.694 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 5 Day 1 (n=249, 120) | 20.27 scores on scale | Standard Deviation 5.593 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 5 Day 28 (n=241, 109) | 19.02 scores on scale | Standard Deviation 5.829 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 6 Day 1 (n=239, 99) | 19.74 scores on scale | Standard Deviation 5.608 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 6 Day 28 (n=222, 99) | 19.21 scores on scale | Standard Deviation 5.678 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 7 Day 1 (n=208, 79) | 19.69 scores on scale | Standard Deviation 5.645 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 7 Day 28 (n=204, 75) | 19.12 scores on scale | Standard Deviation 5.798 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 8 Day 1 (n=192, 67) | 20.29 scores on scale | Standard Deviation 5.285 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 8 Day 28 (n=190, 62) | 19.33 scores on scale | Standard Deviation 5.627 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 9 Day 1 (n=170, 51) | 19.87 scores on scale | Standard Deviation 5.635 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 9 Day 28 (n=167, 46) | 19.27 scores on scale | Standard Deviation 5.701 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 10 Day 1 (n=161, 50) | 19.95 scores on scale | Standard Deviation 5.42 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 11 Day 1 (n=137, 35) | 19.81 scores on scale | Standard Deviation 5.368 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 12 Day 1 (n=132, 30) | 19.98 scores on scale | Standard Deviation 5.618 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 12 Day 28 (n=128, 31) | 19.42 scores on scale | Standard Deviation 5.755 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 13 Day 1 (n=114, 27) | 20.02 scores on scale | Standard Deviation 5.703 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 13 Day 28 (n=114, 27) | 19.65 scores on scale | Standard Deviation 5.216 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 14 Day 1 (n=114, 26) | 20.04 scores on scale | Standard Deviation 5.556 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 14 Day 28 (n=107, 25) | 19.07 scores on scale | Standard Deviation 6.025 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 15 Day 1 (n=101, 21) | 20.13 scores on scale | Standard Deviation 5.654 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 15 Day 28 (n=96, 20) | 19.24 scores on scale | Standard Deviation 5.589 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 16 Day 1 (n=96, 19) | 19.80 scores on scale | Standard Deviation 5.469 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 16 Day 28 (n=91, 18) | 19.53 scores on scale | Standard Deviation 5.313 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 17 Day 1 (n=85, 17) | 20.20 scores on scale | Standard Deviation 5.606 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 18 Day 1 (n=80, 12) | 19.76 scores on scale | Standard Deviation 5.862 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 18 Day 28 (n=71, 11) | 19.47 scores on scale | Standard Deviation 5.526 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 19 Day 1 (n=71, 11) | 20.18 scores on scale | Standard Deviation 5.563 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 20 Day 1 (n=65, 9) | 20.50 scores on scale | Standard Deviation 5.425 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 10 Day 28 (n=154, 46) | 19.22 scores on scale | Standard Deviation 5.494 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 14 Day 1 (n=114, 26) | 19.62 scores on scale | Standard Deviation 6.02 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 10 Day 28 (n=154, 46) | 19.40 scores on scale | Standard Deviation 6.126 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 11 Day 1 (n=137, 35) | 18.89 scores on scale | Standard Deviation 6.014 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 8 Day 28 (n=190, 62) | 19.10 scores on scale | Standard Deviation 6.098 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 15 Day 28 (n=96, 20) | 19.83 scores on scale | Standard Deviation 5.736 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 17 Day 1 (n=85, 17) | 19.35 scores on scale | Standard Deviation 6.103 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 18 Day 28 (n=71, 11) | 19.00 scores on scale | Standard Deviation 7.155 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 19 Day 1 (n=71, 11) | 19.64 scores on scale | Standard Deviation 7.5 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 9 Day 1 (n=170, 51) | 20.20 scores on scale | Standard Deviation 5.455 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 20 Day 28 (n=53, 9) | 20.22 scores on scale | Standard Deviation 7.694 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 14 Day 28 (n=107, 25) | 19.72 scores on scale | Standard Deviation 6.662 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Baseline (n=371, 353) | 18.51 scores on scale | Standard Deviation 6.389 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 9 Day 28 (n=167, 46) | 20.04 scores on scale | Standard Deviation 5.929 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 1 Day 28 (n=347, 318) | 16.37 scores on scale | Standard Deviation 6.694 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 17 Day 28 (n=81, 14) | 18.71 scores on scale | Standard Deviation 6.557 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 2 Day 1 (n=328, 249) | 17.08 scores on scale | Standard Deviation 6.279 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 10 Day 1 (n=161, 50) | 19.88 scores on scale | Standard Deviation 5.903 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 2 Day 28 (n=315, 238) | 17.18 scores on scale | Standard Deviation 6.673 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 15 Day 1 (n=101, 21) | 19.86 scores on scale | Standard Deviation 6.327 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 3 Day 1 (n=294, 200) | 17.92 scores on scale | Standard Deviation 6.251 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 11 Day 28 (n=140, 33) | 18.81 scores on scale | Standard Deviation 6.441 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 3 Day 28 (n=287, 195) | 17.56 scores on scale | Standard Deviation 6.762 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 20 Day 1 (n=65, 9) | 20.00 scores on scale | Standard Deviation 7.826 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 4 Day 1 (n=272, 152) | 18.40 scores on scale | Standard Deviation 6.382 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 12 Day 1 (n=132, 30) | 18.80 scores on scale | Standard Deviation 6.599 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 4 Day 28 (n=265, 142) | 18.37 scores on scale | Standard Deviation 6.43 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 18 Day 1 (n=80, 12) | 19.08 scores on scale | Standard Deviation 7.317 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 5 Day 1 (n=249, 120) | 18.81 scores on scale | Standard Deviation 5.697 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 5 Day 28 (n=241, 109) | 18.47 scores on scale | Standard Deviation 6.065 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 12 Day 28 (n=128, 31) | 19.13 scores on scale | Standard Deviation 6.27 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 16 Day 1 (n=96, 19) | 18.89 scores on scale | Standard Deviation 6.154 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 6 Day 1 (n=239, 99) | 19.02 scores on scale | Standard Deviation 6.114 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 13 Day 1 (n=114, 27) | 19.63 scores on scale | Standard Deviation 6.918 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 6 Day 28 (n=222, 99) | 18.24 scores on scale | Standard Deviation 6.273 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 19 Day 28 (n=61, 10) | 19.10 scores on scale | Standard Deviation 8.048 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 7 Day 1 (n=208, 79) | 18.45 scores on scale | Standard Deviation 6.761 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 13 Day 28 (n=114, 27) | 18.59 scores on scale | Standard Deviation 6.795 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 7 Day 28 (n=204, 75) | 18.76 scores on scale | Standard Deviation 6.036 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 16 Day 28 (n=91, 18) | 18.61 scores on scale | Standard Deviation 6.464 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Cycle 8 Day 1 (n=192, 67) | 19.22 scores on scale | Standard Deviation 5.828 |
Comparison: Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Functional Well Being (FWB) subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [1.261, 2.533]Mixed Models Analysis
Comparison: Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.309, 2.539]Mixed Models Analysis
Comparison: Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.331, 2.546]Mixed Models Analysis
Comparison: Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.363, 2.568]Mixed Models Analysis
Comparison: Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.376, 2.584]Mixed Models Analysis
Comparison: Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.392, 2.622]Mixed Models Analysis
Comparison: Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.396, 2.647]Mixed Models Analysis
Comparison: Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.397, 2.7]Mixed Models Analysis
Comparison: Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.394, 2.732]Mixed Models Analysis
Comparison: Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.383, 2.797]Mixed Models Analysis
Comparison: Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.374, 2.836]Mixed Models Analysis
Comparison: Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.353, 2.91]Mixed Models Analysis
Comparison: Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.339, 2.954]Mixed Models Analysis
Comparison: Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.311, 3.036]Mixed Models Analysis
Comparison: Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.294, 3.082]Mixed Models Analysis
Comparison: Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.26, 3.169]Mixed Models Analysis
Comparison: Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.241, 3.219]Mixed Models Analysis
Comparison: Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.203, 3.309]Mixed Models Analysis
Comparison: Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.182, 3.361]Mixed Models Analysis
Comparison: Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: <0.000195% CI: [1.142, 3.454]Mixed Models Analysis
Comparison: Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.000195% CI: [1.119, 3.507]Mixed Models Analysis
Comparison: Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.000395% CI: [1.076, 3.603]Mixed Models Analysis
Comparison: Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.000495% CI: [1.052, 3.657]Mixed Models Analysis
Comparison: Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.000795% CI: [1.008, 3.754]Mixed Models Analysis
Comparison: Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.000995% CI: [0.983, 3.809]Mixed Models Analysis
Comparison: Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.001495% CI: [0.938, 3.908]Mixed Models Analysis
Comparison: Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.001795% CI: [0.912, 3.963]Mixed Models Analysis
Comparison: Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.002595% CI: [0.866, 4.063]Mixed Models Analysis
Comparison: Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.00395% CI: [0.84, 4.119]Mixed Models Analysis
Comparison: Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.004295% CI: [0.792, 4.219]Mixed Models Analysis
Comparison: Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.004995% CI: [0.766, 4.275]Mixed Models Analysis
Comparison: Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.006495% CI: [0.718, 4.377]Mixed Models Analysis
Comparison: Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.007395% CI: [0.691, 4.433]Mixed Models Analysis
Comparison: Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.009195% CI: [0.643, 4.535]Mixed Models Analysis
Comparison: Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.010395% CI: [0.616, 4.592]Mixed Models Analysis
Comparison: Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.012595% CI: [0.567, 4.695]Mixed Models Analysis
Comparison: Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.013895% CI: [0.539, 4.752]Mixed Models Analysis
Comparison: Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.016495% CI: [0.49, 4.855]Mixed Models Analysis
Comparison: Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.017995% CI: [0.462, 4.912]Mixed Models Analysis
Comparison: Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)p-value: 0.020895% CI: [0.413, 5.015]Mixed Models Analysis
Secondary
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale
Physical well-being (PWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates better physical well-being.
Time frame: Day 1 & 28 of each cycle: duration of treatment phase
Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Baseline (n=369, 348) | 23.14 scores on scale | Standard Deviation 5.209 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 10 Day 28 (n=151, 46) | 21.21 scores on scale | Standard Deviation 4.848 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 5 Day 28 (n=241, 106) | 20.91 scores on scale | Standard Deviation 5.062 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 11 Day 1 (n=135, 35) | 23.16 scores on scale | Standard Deviation 4.069 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 3 Day 1 (n=294, 200) | 22.45 scores on scale | Standard Deviation 5.123 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 11 Day 28 (n=140, 32) | 20.98 scores on scale | Standard Deviation 4.597 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 6 Day 1 (n=239, 99) | 22.99 scores on scale | Standard Deviation 4.385 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 12 Day 28 (n=127, 31) | 20.87 scores on scale | Standard Deviation 4.721 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 2 Day 1 (n=329, 247) | 22.22 scores on scale | Standard Deviation 5.161 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 13 Day 1 (n=114, 27) | 23.05 scores on scale | Standard Deviation 4.281 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 6 Day 28 (n=224, 97) | 21.22 scores on scale | Standard Deviation 5.07 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 13 Day 28 (n=114, 27) | 21.26 scores on scale | Standard Deviation 4.623 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 3 Day 28 (n=286, 195) | 20.18 scores on scale | Standard Deviation 5.65 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 14 Day 1 (n=112, 26) | 23.02 scores on scale | Standard Deviation 4.401 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 7 Day 1 (n=207, 79) | 23.05 scores on scale | Standard Deviation 4.414 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 14 Day 28 (n=107, 24) | 20.80 scores on scale | Standard Deviation 5.31 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 1 Day 28 (n=348, 318) | 19.43 scores on scale | Standard Deviation 6.052 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 15 Day 1 (n=101, 21) | 23.26 scores on scale | Standard Deviation 4.475 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 7 Day 28 (n=201, 75) | 21.22 scores on scale | Standard Deviation 5.25 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 15 Day 28 (n=96, 20) | 20.95 scores on scale | Standard Deviation 4.978 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 16 Day 1 (n=94, 19) | 22.60 scores on scale | Standard Deviation 4.337 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 4 Day 1 (n=270, 150) | 22.72 scores on scale | Standard Deviation 4.641 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 16 Day 28 (n=90, 18) | 21.31 scores on scale | Standard Deviation 4.939 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 8 Day 1 (n=193, 67) | 23.58 scores on scale | Standard Deviation 3.715 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 17 Day 1 (n=85, 16) | 22.99 scores on scale | Standard Deviation 4.513 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 12 Day 1 (n=131, 30) | 23.03 scores on scale | Standard Deviation 4.291 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 17 Day 28 (n=80, 14) | 21.68 scores on scale | Standard Deviation 4.653 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 8 Day 28 (n=189, 61) | 21.51 scores on scale | Standard Deviation 4.666 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 18 Day 1 (n=79, 12) | 22.85 scores on scale | Standard Deviation 4.388 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 4 Day 28 (n=264, 142) | 21.00 scores on scale | Standard Deviation 5.12 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 18 Day 28 (n=70, 11) | 20.89 scores on scale | Standard Deviation 5.006 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 9 Day 1 (n=172, 51) | 23.41 scores on scale | Standard Deviation 4.071 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 19 Day 1 (n=71, 11) | 23.20 scores on scale | Standard Deviation 4.426 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 2 Day 28 (n=316, 239) | 20.34 scores on scale | Standard Deviation 5.654 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 19 Day 28 (n=61, 10) | 21.82 scores on scale | Standard Deviation 4.696 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 9 Day 28 (n=166, 46) | 21.29 scores on scale | Standard Deviation 5.068 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 20 Day 1 (n=63, 9) | 23.68 scores on scale | Standard Deviation 4.204 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 5 Day 1 (n=248, 120) | 23.24 scores on scale | Standard Deviation 4.143 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 20 Day 28 (n=52, 9) | 21.81 scores on scale | Standard Deviation 4.835 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 10 Day 1 (n=159, 49) | 22.94 scores on scale | Standard Deviation 4.053 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 20 Day 28 (n=52, 9) | 22.33 scores on scale | Standard Deviation 6.423 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 12 Day 1 (n=131, 30) | 22.60 scores on scale | Standard Deviation 5.236 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 15 Day 28 (n=96, 20) | 22.07 scores on scale | Standard Deviation 4.908 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Baseline (n=369, 348) | 22.70 scores on scale | Standard Deviation 5.224 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 2 Day 1 (n=329, 247) | 20.05 scores on scale | Standard Deviation 5.499 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 2 Day 28 (n=316, 239) | 19.84 scores on scale | Standard Deviation 5.706 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 3 Day 1 (n=294, 200) | 20.87 scores on scale | Standard Deviation 5.281 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 3 Day 28 (n=286, 195) | 20.63 scores on scale | Standard Deviation 5.395 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 4 Day 1 (n=270, 150) | 21.56 scores on scale | Standard Deviation 4.581 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 4 Day 28 (n=264, 142) | 21.31 scores on scale | Standard Deviation 5.11 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 5 Day 1 (n=248, 120) | 21.84 scores on scale | Standard Deviation 4.567 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 5 Day 28 (n=241, 106) | 21.23 scores on scale | Standard Deviation 4.867 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 6 Day 1 (n=239, 99) | 21.70 scores on scale | Standard Deviation 4.761 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 6 Day 28 (n=224, 97) | 20.96 scores on scale | Standard Deviation 5.384 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 7 Day 1 (n=207, 79) | 21.67 scores on scale | Standard Deviation 4.964 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 7 Day 28 (n=201, 75) | 21.66 scores on scale | Standard Deviation 4.595 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 8 Day 1 (n=193, 67) | 21.94 scores on scale | Standard Deviation 4.87 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 8 Day 28 (n=189, 61) | 21.40 scores on scale | Standard Deviation 4.91 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 9 Day 1 (n=172, 51) | 22.58 scores on scale | Standard Deviation 4.367 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 9 Day 28 (n=166, 46) | 22.38 scores on scale | Standard Deviation 4.4 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 10 Day 1 (n=159, 49) | 22.60 scores on scale | Standard Deviation 4.124 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 10 Day 28 (n=151, 46) | 21.83 scores on scale | Standard Deviation 5.165 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 11 Day 1 (n=135, 35) | 22.23 scores on scale | Standard Deviation 4.194 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 11 Day 28 (n=140, 32) | 21.88 scores on scale | Standard Deviation 5.173 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 12 Day 28 (n=127, 31) | 21.90 scores on scale | Standard Deviation 4.867 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 13 Day 1 (n=114, 27) | 21.99 scores on scale | Standard Deviation 5.187 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 13 Day 28 (n=114, 27) | 21.80 scores on scale | Standard Deviation 5.369 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 14 Day 1 (n=112, 26) | 22.05 scores on scale | Standard Deviation 4.906 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 14 Day 28 (n=107, 24) | 22.75 scores on scale | Standard Deviation 4.875 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 15 Day 1 (n=101, 21) | 22.33 scores on scale | Standard Deviation 5.173 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 16 Day 1 (n=94, 19) | 20.63 scores on scale | Standard Deviation 6.125 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 16 Day 28 (n=90, 18) | 21.42 scores on scale | Standard Deviation 6.194 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 17 Day 1 (n=85, 16) | 21.81 scores on scale | Standard Deviation 5.776 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 17 Day 28 (n=80, 14) | 20.50 scores on scale | Standard Deviation 6.757 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 18 Day 1 (n=79, 12) | 21.83 scores on scale | Standard Deviation 6.672 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 18 Day 28 (n=70, 11) | 22.45 scores on scale | Standard Deviation 5.61 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 19 Day 1 (n=71, 11) | 22.45 scores on scale | Standard Deviation 6.773 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 19 Day 28 (n=61, 10) | 21.60 scores on scale | Standard Deviation 7.457 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 20 Day 1 (n=63, 9) | 21.78 scores on scale | Standard Deviation 7.311 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Cycle 1 Day 28 (n=348, 318) | 18.85 scores on scale | Standard Deviation 6.168 |
Comparison: Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Physical Well Being (PWB) subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.805, 2.114]Mixed Models Analysis
Comparison: Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.827, 2.079]Mixed Models Analysis
Comparison: Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.837, 2.063]Mixed Models Analysis
Comparison: Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.847, 2.041]Mixed Models Analysis
Comparison: Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.848, 2.032]Mixed Models Analysis
Comparison: Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.844, 2.024]Mixed Models Analysis
Comparison: Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.838, 2.023]Mixed Models Analysis
Comparison: Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.819, 2.029]Mixed Models Analysis
Comparison: Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.805, 2.037]Mixed Models Analysis
Comparison: Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.774, 2.056]Mixed Models Analysis
Comparison: Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.753, 2.069]Mixed Models Analysis
Comparison: Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.711, 2.099]Mixed Models Analysis
Comparison: Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.000195% CI: [0.685, 2.119]Mixed Models Analysis
Comparison: Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.000395% CI: [0.634, 2.157]Mixed Models Analysis
Comparison: Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.000595% CI: [0.604, 2.18]Mixed Models Analysis
Comparison: Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.001295% CI: [0.547, 2.225]Mixed Models Analysis
Comparison: Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.001895% CI: [0.514, 2.252]Mixed Models Analysis
Comparison: Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.003595% CI: [0.451, 2.301]Mixed Models Analysis
Comparison: Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.004995% CI: [0.416, 2.33]Mixed Models Analysis
Comparison: Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.008495% CI: [0.35, 2.383]Mixed Models Analysis
Comparison: Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.01195% CI: [0.313, 2.414]Mixed Models Analysis
Comparison: Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.016895% CI: [0.245, 2.47]Mixed Models Analysis
Comparison: Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.020895% CI: [0.206, 2.501]Mixed Models Analysis
Comparison: Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.029395% CI: [0.136, 2.559]Mixed Models Analysis
Comparison: Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.034895% CI: [0.096, 2.592]Mixed Models Analysis
Comparison: Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.045995% CI: [0.024, 2.652]Mixed Models Analysis
Comparison: Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.052895% CI: [-0.016, 2.685]Mixed Models Analysis
Comparison: Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.066395% CI: [-0.09, 2.746]Mixed Models Analysis
Comparison: Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.074495% CI: [-0.131, 2.78]Mixed Models Analysis
Comparison: Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.089895% CI: [-0.205, 2.842]Mixed Models Analysis
Comparison: Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.098895% CI: [-0.246, 2.877]Mixed Models Analysis
Comparison: Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.115695% CI: [-0.321, 2.94]Mixed Models Analysis
Comparison: Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.125295% CI: [-0.363, 2.975]Mixed Models Analysis
Comparison: Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.142995% CI: [-0.439, 3.038]Mixed Models Analysis
Comparison: Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.152995% CI: [-0.481, 3.074]Mixed Models Analysis
Comparison: Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.171195% CI: [-0.558, 3.138]Mixed Models Analysis
Comparison: Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.181395% CI: [-0.6, 3.173]Mixed Models Analysis
Comparison: Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.199895% CI: [-0.677, 3.238]Mixed Models Analysis
Comparison: Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.2195% CI: [-0.72, 3.273]Mixed Models Analysis
Comparison: Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.228395% CI: [-0.797, 3.338]Mixed Models Analysis
Secondary
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale
Social/family well-being (SWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates less social/family well-being.
Time frame: Day 1 & 28 of each cycle: duration of treatment phase
Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 3 Day 1 (n=292, 200) | 23.51 scores on scale | Standard Deviation 4.375 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 8 Day 1 (n=193, 67) | 23.67 scores on scale | Standard Deviation 4.225 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 18 Day 28 (n=70, 11) | 23.70 scores on scale | Standard Deviation 4.41 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 8 Day 28 (n=189, 61) | 23.26 scores on scale | Standard Deviation 4.402 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 3 Day 28 (n=284, 194) | 23.44 scores on scale | Standard Deviation 4.369 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 9 Day 1 (n=172, 51) | 23.26 scores on scale | Standard Deviation 4.376 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 20 Day 1 (n=63, 9) | 23.60 scores on scale | Standard Deviation 4.045 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 9 Day 28 (n=166, 46) | 23.26 scores on scale | Standard Deviation 4.395 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 4 Day 1 (n=269, 150) | 23.73 scores on scale | Standard Deviation 4.072 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 10 Day 1 (n=158, 49) | 23.08 scores on scale | Standard Deviation 4.348 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Baseline (n=370, 349) | 23.14 scores on scale | Standard Deviation 4.641 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 10 Day 28 (n=151, 46) | 23.03 scores on scale | Standard Deviation 4.417 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 18 Day 1 (n=79, 12) | 23.53 scores on scale | Standard Deviation 4.428 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 11 Day 1 (n=135, 35) | 23.05 scores on scale | Standard Deviation 4.521 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 4 Day 28 (n=263, 142) | 23.36 scores on scale | Standard Deviation 4.451 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 11 Day 28 (n=140, 32) | 22.71 scores on scale | Standard Deviation 4.624 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 20 Day 28 (n=52, 8) | 22.93 scores on scale | Standard Deviation 4.898 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 12 Day 1 (n=131, 30) | 23.23 scores on scale | Standard Deviation 4.563 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 5 Day 1 (n=247, 120) | 23.53 scores on scale | Standard Deviation 4.334 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 12 Day 28 (n=127, 31) | 23.07 scores on scale | Standard Deviation 4.586 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 19 Day 1 (n=71, 11) | 23.85 scores on scale | Standard Deviation 4.27 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 13 Day 1 (n=114, 27) | 23.15 scores on scale | Standard Deviation 4.498 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 5 Day 28 (n=241, 107) | 23.68 scores on scale | Standard Deviation 4.137 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 13 Day 28 (n=114, 27) | 23.31 scores on scale | Standard Deviation 4.255 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 2 Day 1 (n=328, 247) | 23.50 scores on scale | Standard Deviation 4.344 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 14 Day 1 (n=112, 26) | 22.82 scores on scale | Standard Deviation 4.647 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 6 Day 1 (n=238, 98) | 23.35 scores on scale | Standard Deviation 4.428 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 14 Day 28 (n=107, 24) | 23.24 scores on scale | Standard Deviation 4.503 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 1 Day 28 (n=348, 319) | 23.60 scores on scale | Standard Deviation 4.088 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 15 Day 1 (n=101, 21) | 23.28 scores on scale | Standard Deviation 4.178 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 6 Day 28 (n=224, 97) | 23.40 scores on scale | Standard Deviation 4.393 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 15 Day 28 (n=96, 20) | 23.04 scores on scale | Standard Deviation 4.312 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 2 Day 28 (n=315, 238) | 23.40 scores on scale | Standard Deviation 4.471 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 16 Day 1 (n=94, 19) | 23.11 scores on scale | Standard Deviation 4.335 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 7 Day 1 (n=207, 79) | 23.29 scores on scale | Standard Deviation 4.532 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 16 Day 28 (n=89, 18) | 23.41 scores on scale | Standard Deviation 4.322 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 19 Day 28 (n=61, 10) | 23.53 scores on scale | Standard Deviation 4.641 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 17 Day 1 (n=85, 16) | 23.42 scores on scale | Standard Deviation 4.603 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 7 Day 28 (n=200, 75) | 23.13 scores on scale | Standard Deviation 4.585 |
| SU011248 | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 17 Day 28 (n=80, 14) | 23.50 scores on scale | Standard Deviation 4.424 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 10 Day 1 (n=158, 49) | 22.45 scores on scale | Standard Deviation 5.279 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Baseline (n=370, 349) | 22.94 scores on scale | Standard Deviation 4.735 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 1 Day 28 (n=348, 319) | 22.20 scores on scale | Standard Deviation 5.076 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 17 Day 28 (n=80, 14) | 21.75 scores on scale | Standard Deviation 5.68 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 18 Day 1 (n=79, 12) | 21.71 scores on scale | Standard Deviation 6.276 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 18 Day 28 (n=70, 11) | 21.27 scores on scale | Standard Deviation 6.051 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 19 Day 1 (n=71, 11) | 21.30 scores on scale | Standard Deviation 5.894 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 19 Day 28 (n=61, 10) | 20.73 scores on scale | Standard Deviation 6.816 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 20 Day 1 (n=63, 9) | 21.26 scores on scale | Standard Deviation 7.201 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 20 Day 28 (n=52, 8) | 20.67 scores on scale | Standard Deviation 6.251 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 2 Day 1 (n=328, 247) | 22.31 scores on scale | Standard Deviation 5.19 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 2 Day 28 (n=315, 238) | 22.22 scores on scale | Standard Deviation 5.203 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 3 Day 1 (n=292, 200) | 22.42 scores on scale | Standard Deviation 5.011 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 3 Day 28 (n=284, 194) | 22.12 scores on scale | Standard Deviation 5.289 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 4 Day 1 (n=269, 150) | 22.26 scores on scale | Standard Deviation 5.275 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 4 Day 28 (n=263, 142) | 22.38 scores on scale | Standard Deviation 5.198 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 5 Day 1 (n=247, 120) | 22.35 scores on scale | Standard Deviation 5.486 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 5 Day 28 (n=241, 107) | 22.36 scores on scale | Standard Deviation 4.956 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 6 Day 1 (n=238, 98) | 22.56 scores on scale | Standard Deviation 4.678 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 6 Day 28 (n=224, 97) | 22.33 scores on scale | Standard Deviation 4.641 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 7 Day 1 (n=207, 79) | 22.46 scores on scale | Standard Deviation 4.722 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 7 Day 28 (n=200, 75) | 22.10 scores on scale | Standard Deviation 5.286 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 8 Day 1 (n=193, 67) | 21.95 scores on scale | Standard Deviation 5.112 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 8 Day 28 (n=189, 61) | 22.17 scores on scale | Standard Deviation 5.236 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 9 Day 1 (n=172, 51) | 22.74 scores on scale | Standard Deviation 4.826 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 9 Day 28 (n=166, 46) | 21.96 scores on scale | Standard Deviation 5.418 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 10 Day 28 (n=151, 46) | 22.06 scores on scale | Standard Deviation 5.065 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 11 Day 1 (n=135, 35) | 21.51 scores on scale | Standard Deviation 5.267 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 11 Day 28 (n=140, 32) | 21.09 scores on scale | Standard Deviation 5.957 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 12 Day 1 (n=131, 30) | 20.79 scores on scale | Standard Deviation 6.007 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 12 Day 28 (n=127, 31) | 21.25 scores on scale | Standard Deviation 5.627 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 13 Day 1 (n=114, 27) | 20.93 scores on scale | Standard Deviation 6.142 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 13 Day 28 (n=114, 27) | 21.30 scores on scale | Standard Deviation 5.491 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 14 Day 1 (n=112, 26) | 21.51 scores on scale | Standard Deviation 5.51 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 14 Day 28 (n=107, 24) | 20.32 scores on scale | Standard Deviation 6.628 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 15 Day 1 (n=101, 21) | 20.35 scores on scale | Standard Deviation 5.986 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 15 Day 28 (n=96, 20) | 20.23 scores on scale | Standard Deviation 6.162 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 16 Day 1 (n=94, 19) | 21.41 scores on scale | Standard Deviation 5.196 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 16 Day 28 (n=89, 18) | 21.52 scores on scale | Standard Deviation 5.821 |
| IFN-α | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Cycle 17 Day 1 (n=85, 16) | 22.25 scores on scale | Standard Deviation 5.037 |
Comparison: Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Social/Family Well Being (SWB) subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.719, 1.708]Mixed Models Analysis
Comparison: Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.729, 1.703]Mixed Models Analysis
Comparison: Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.731, 1.704]Mixed Models Analysis
Comparison: Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.73, 1.71]Mixed Models Analysis
Comparison: Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.727, 1.716]Mixed Models Analysis
Comparison: Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.716, 1.732]Mixed Models Analysis
Comparison: Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.707, 1.744]Mixed Models Analysis
Comparison: Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.687, 1.769]Mixed Models Analysis
Comparison: Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.673, 1.785]Mixed Models Analysis
Comparison: Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.646, 1.818]Mixed Models Analysis
Comparison: Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: <0.000195% CI: [0.629, 1.838]Mixed Models Analysis
Comparison: Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.000295% CI: [0.595, 1.876]Mixed Models Analysis
Comparison: Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.000395% CI: [0.575, 1.899]Mixed Models Analysis
Comparison: Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.000595% CI: [0.537, 1.942]Mixed Models Analysis
Comparison: Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.000895% CI: [0.515, 1.967]Mixed Models Analysis
Comparison: Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.001595% CI: [0.474, 2.013]Mixed Models Analysis
Comparison: Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.002195% CI: [0.45, 2.04]Mixed Models Analysis
Comparison: Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.003795% CI: [0.406, 2.089]Mixed Models Analysis
Comparison: Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.004895% CI: [0.382, 2.116]Mixed Models Analysis
Comparison: Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.007495% CI: [0.336, 2.167]Mixed Models Analysis
Comparison: Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.009295% CI: [0.31, 2.196]Mixed Models Analysis
Comparison: Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.013295% CI: [0.262, 2.248]Mixed Models Analysis
Comparison: Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.015995% CI: [0.236, 2.278]Mixed Models Analysis
Comparison: Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.021395% CI: [0.187, 2.332]Mixed Models Analysis
Comparison: Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.024895% CI: [0.16, 2.362]Mixed Models Analysis
Comparison: Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.031895% CI: [0.11, 2.416]Mixed Models Analysis
Comparison: Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.03695% CI: [0.083, 2.447]Mixed Models Analysis
Comparison: Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.044395% CI: [0.032, 2.502]Mixed Models Analysis
Comparison: Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.049395% CI: [0.004, 2.533]Mixed Models Analysis
Comparison: Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.058795% CI: [-0.047, 2.589]Mixed Models Analysis
Comparison: Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.064295% CI: [-0.075, 2.62]Mixed Models Analysis
Comparison: Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.074695% CI: [-0.127, 2.677]Mixed Models Analysis
Comparison: Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.080695% CI: [-0.155, 2.708]Mixed Models Analysis
Comparison: Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.091795% CI: [-0.207, 2.765]Mixed Models Analysis
Comparison: Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.09895% CI: [-0.236, 2.797]Mixed Models Analysis
Comparison: Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.109595% CI: [-0.288, 2.854]Mixed Models Analysis
Comparison: Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.116195% CI: [-0.318, 2.886]Mixed Models Analysis
Comparison: Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.12895% CI: [-0.37, 2.944]Mixed Models Analysis
Comparison: Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.134695% CI: [-0.399, 2.976]Mixed Models Analysis
Comparison: Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).p-value: 0.146695% CI: [-0.452, 3.034]Mixed Models Analysis
Secondary
Incremental Cost Effectiveness Ratio (ICER)
Incremental cost effectiveness ratio (ICER) of sunitinib compared to IFN-a as first-line treatment for MRCC, defined as the ratio of the incremental cost of treatment over the incremental effectiveness; effectiveness measured as quality adjusted life year (QALY) gain. This objective was not addressed in the clinical study report, but an interim analysis of cost-effectiveness was presented separately. These results were not available for inclusion at the time of this posting.
Time frame: post study measurement
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SU011248 | Incremental Cost Effectiveness Ratio (ICER) | 0 ratio |
| IFN-α | Incremental Cost Effectiveness Ratio (ICER) | 0 ratio |
Secondary
Objective Response, Core Radiology Assessment
Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR or PR) = those that persisted on repeat imaging study \>= 4 weeks after initial documentation of response.
Time frame: Day 28 of each 6-week cycle: duration of treatment phase
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SU011248 | Objective Response, Core Radiology Assessment | 145 participants |
| IFN-α | Objective Response, Core Radiology Assessment | 29 participants |
p-value: <0.00195% CI: [25.31, 36.56]Chi-squared
Secondary
Objective Response, Investigator's Assessment
Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses = those that persist on repeat imaging study \>= 4 weeks after initial documentation of response.
Time frame: Day 28 of each 6-week cycle: duration of treatment phase
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SU011248 | Objective Response, Investigator's Assessment | 171 participants |
| IFN-α | Objective Response, Investigator's Assessment | 45 participants |
p-value: <0.00195% CI: [27.62, 39.69]Chi-squared
Secondary
Overall Survival (OS)
Overall survival (OS) = time from date of randomization to date of death due to any cause. For patients not expiring, survival time was censored at the last date they were known to be alive. Patients lacking data beyond randomization had their survival times censored at the date of randomization with a duration of 1 day.
Time frame: Clinic visit or telephone contact every 2 months until death
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SU011248 | Overall Survival (OS) | 114.6 weeks |
| IFN-α | Overall Survival (OS) | 94.9 weeks |
Comparison: Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).p-value: 0.05195% CI: [0.673, 1.0013]Log Rank
Comparison: Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).p-value: 0.012895% CI: [0.673, 1.0013]Wilcoxon (Mann-Whitney)
Comparison: Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).p-value: 0.04995% CI: [0.6692, 0.9995]Log Rank
Secondary
Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis
Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter \[pg/ml\]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Time frame: Day 1 & Day 28, Cycle 1 to Cycle 4
Population: Pharmacodynamic analyses performed at selected sites on AT population who had at least one PK (pharmacokinetic) sample; n = subjects with evaluable data at observation, SU011248 and INF-α treatment groups, respectively. Abbreviations: C = Cycle, D = Day, bFGF: basic fibroblast growth factor.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA bFGF: C2D28:C1D1 (n=14, 0) | 0.760 pg/ml and ratio to Baseline | Standard Deviation 0.604 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA bFGF: C3D1:C1D1 (n=12, 0) | 1.582 pg/ml and ratio to Baseline | Standard Deviation 2.622 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA bFGF: C3D28:C1D1 (n=12, 0) | 1.671 pg/ml and ratio to Baseline | Standard Deviation 2.109 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA bFGF: C4D1:C1D1 (n=14, 0) | 2.895 pg/ml and ratio to Baseline | Standard Deviation 4.252 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA bFGF: C4:D28:C1D1 (n=10, 0) | 0.803 pg/ml and ratio to Baseline | Standard Deviation 0.799 |
Secondary
Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis
Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter \[pg/ml\]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Time frame: Day 1 & Day 28, Cycle 1 to Cycle 4
Population: Pharmacodynamic analyses performed at selected sites on AT population who had at least one pharmacokinetic sample; n= SU011248, INF-α; Abbreviations: C: Cycle, D: Day, VEGF: vascular endothelial growth factor, sVEGFR-3: soluble vascular endothelial growth factor Receptor-3, IL-8: interleukin-8, bFGF: basic fibroblast growth factor.~.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C2D28: C1D1 (n=31, 20) | 5.851 pg/ml and ratio to Baseline | Standard Deviation 4.345 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C3D28:C1D1 (n=26, 14) | 2.574 pg/ml and ratio to Baseline | Standard Deviation 1.726 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C3D1: C1D1 (n=27, 15) | 1.630 pg/ml and ratio to Baseline | Standard Deviation 1.685 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA bFGF: C2D1:C1D1 (n=13, 1) | 1.370 pg/ml and ratio to Baseline | Standard Deviation 1.8 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C3D28: C1D1 (n=28, 15) | 5.236 pg/ml and ratio to Baseline | Standard Deviation 3.333 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C2D28:C1D1 (n=29, 19) | 2.423 pg/ml and ratio to Baseline | Standard Deviation 1.514 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C4D1: C1D1 (n=27, 12) | 1.486 pg/ml and ratio to Baseline | Standard Deviation 1.125 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C4D1:C1D1 (n=24, 11) | 0.846 pg/ml and ratio to Baseline | Standard Deviation 0.38 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C4D28: C1D1 (n=25, 11) | 4.924 pg/ml and ratio to Baseline | Standard Deviation 3.679 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C4D1:C1D1 (n=26, 12) | 1.934 pg/ml and ratio to Baseline | Standard Deviation 1.372 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: Baseline (n=35, 31) | 556.4 pg/ml and ratio to Baseline | Standard Deviation 311.7 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C4:D28:C1D1 (n=23, 10) | 0.486 pg/ml and ratio to Baseline | Standard Deviation 0.265 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C1D28: C1D1 (n=31, 26) | 0.945 pg/ml and ratio to Baseline | Standard Deviation 0.428 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C2D1:C1D1 (n=29, 20) | 1.716 pg/ml and ratio to Baseline | Standard Deviation 0.63 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C2D1:C1D1 (n=30, 21) | 1.045 pg/ml and ratio to Baseline | Standard Deviation 0.623 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C3D1:C1D1 (n=25, 14) | 0.800 pg/ml and ratio to Baseline | Standard Deviation 0.309 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: Baseline (n=31, 29) | 10.1 pg/ml and ratio to Baseline | Standard Deviation 9.7 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C2D28:C1D1 (n=31, 19) | 0.871 pg/ml and ratio to Baseline | Standard Deviation 0.511 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C4:D28:C1D1 (n=25, 11) | 2.549 pg/ml and ratio to Baseline | Standard Deviation 1.489 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C3D1:C1D1 (n=28, 15) | 1.159 pg/ml and ratio to Baseline | Standard Deviation 0.659 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C3D28:C1D1 (n=25, 14) | 0.427 pg/ml and ratio to Baseline | Standard Deviation 0.194 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C3D28:C1D1 (n=28, 15) | 1.043 pg/ml and ratio to Baseline | Standard Deviation 0.926 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C3D1:C1D1 (n=26, 15) | 2.788 pg/ml and ratio to Baseline | Standard Deviation 2.781 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C4D1:C1D1 (n=28, 12) | 1.243 pg/ml and ratio to Baseline | Standard Deviation 1.304 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: Baseline (n=33, 31) | 101.9 pg/ml and ratio to Baseline | Standard Deviation 184.3 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C4:D28:C1D1 (n=26, 11) | 1.207 pg/ml and ratio to Baseline | Standard Deviation 1.269 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA bFGF: Baseline (n=21, 2) | 13.1 pg/ml and ratio to Baseline | Standard Deviation 13.1 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: Baseline (n=29, 30) | 44049.3 pg/ml and ratio to Baseline | Standard Deviation 20168.2 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C1D28: C1D1 (n=31, 26) | 4.280 pg/ml and ratio to Baseline | Standard Deviation 2.619 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C1D28:C1D1 (n=27, 25) | 0.473 pg/ml and ratio to Baseline | Standard Deviation 0.185 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C1D28:C1D1 (n=29, 25) | 2.815 pg/ml and ratio to Baseline | Standard Deviation 1.34 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C2D1:C1D1 (n=28, 20) | 0.787 pg/ml and ratio to Baseline | Standard Deviation 0.172 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C2D1: C1D1 (n=32, 21) | 1.161 pg/ml and ratio to Baseline | Standard Deviation 0.624 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C2D28:C1D1 (n=28, 19) | 0.407 pg/ml and ratio to Baseline | Standard Deviation 0.173 |
| SU011248 | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA bFGF: C1D28:C1D1 (n=15, 1) | 2.762 pg/ml and ratio to Baseline | Standard Deviation 5.087 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C2D28:C1D1 (n=28, 19) | 1.150 pg/ml and ratio to Baseline | Standard Deviation 0.355 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C1D28:C1D1 (n=29, 25) | 2.297 pg/ml and ratio to Baseline | Standard Deviation 2.036 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C2D1:C1D1 (n=29, 20) | 1.579 pg/ml and ratio to Baseline | Standard Deviation 0.688 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C2D28:C1D1 (n=29, 19) | 1.858 pg/ml and ratio to Baseline | Standard Deviation 0.849 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C3D1:C1D1 (n=26, 15) | 1.531 pg/ml and ratio to Baseline | Standard Deviation 0.693 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C3D28:C1D1 (n=26, 14) | 1.999 pg/ml and ratio to Baseline | Standard Deviation 0.964 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C4D1:C1D1 (n=26, 12) | 1.662 pg/ml and ratio to Baseline | Standard Deviation 0.736 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: C4:D28:C1D1 (n=25, 11) | 2.492 pg/ml and ratio to Baseline | Standard Deviation 2.023 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA bFGF: Baseline (n=21, 2) | 13.6 pg/ml and ratio to Baseline | Standard Deviation 16.8 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA bFGF: C1D28:C1D1 (n=15, 1) | 0.429 pg/ml and ratio to Baseline | Standard Deviation 0 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA bFGF: C2D1:C1D1 (n=13, 1) | 0.157 pg/ml and ratio to Baseline | Standard Deviation 0 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C4D1:C1D1 (n=24, 11) | 1.183 pg/ml and ratio to Baseline | Standard Deviation 0.333 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C4:D28:C1D1 (n=23, 10) | 1.044 pg/ml and ratio to Baseline | Standard Deviation 0.141 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C3D1:C1D1 (n=25, 14) | 1.015 pg/ml and ratio to Baseline | Standard Deviation 0.21 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C3D28:C1D1 (n=25, 14) | 1.042 pg/ml and ratio to Baseline | Standard Deviation 0.349 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: Baseline (n=33, 31) | 109.0 pg/ml and ratio to Baseline | Standard Deviation 242.4 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C1D28: C1D1 (n=31, 26) | 1.134 pg/ml and ratio to Baseline | Standard Deviation 0.683 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C2D1: C1D1 (n=32, 21) | 1.171 pg/ml and ratio to Baseline | Standard Deviation 0.527 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C2D28: C1D1 (n=31, 20) | 1.153 pg/ml and ratio to Baseline | Standard Deviation 0.517 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C3D1: C1D1 (n=27, 15) | 1.253 pg/ml and ratio to Baseline | Standard Deviation 0.483 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C3D28: C1D1 (n=28, 15) | 1.149 pg/ml and ratio to Baseline | Standard Deviation 0.57 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C4D1: C1D1 (n=27, 12) | 1.209 pg/ml and ratio to Baseline | Standard Deviation 0.654 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-A: C4D28: C1D1 (n=25, 11) | 1.008 pg/ml and ratio to Baseline | Standard Deviation 0.372 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: Baseline (n=35, 31) | 651.2 pg/ml and ratio to Baseline | Standard Deviation 552.3 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C1D28: C1D1 (n=31, 26) | 1.165 pg/ml and ratio to Baseline | Standard Deviation 0.606 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C2D1:C1D1 (n=30, 21) | 1.177 pg/ml and ratio to Baseline | Standard Deviation 0.464 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C2D28:C1D1 (n=31, 19) | 1.081 pg/ml and ratio to Baseline | Standard Deviation 0.41 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C3D1:C1D1 (n=28, 15) | 1.174 pg/ml and ratio to Baseline | Standard Deviation 0.588 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C3D28:C1D1 (n=28, 15) | 1.054 pg/ml and ratio to Baseline | Standard Deviation 0.586 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C4D1:C1D1 (n=28, 12) | 1.382 pg/ml and ratio to Baseline | Standard Deviation 0.799 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | Plasma VEGF-C: C4:D28:C1D1 (n=26, 11) | 1.139 pg/ml and ratio to Baseline | Standard Deviation 0.403 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: Baseline (n=29, 30) | 40317.7 pg/ml and ratio to Baseline | Standard Deviation 12938.3 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C1D28:C1D1 (n=27, 25) | 1.068 pg/ml and ratio to Baseline | Standard Deviation 0.292 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA sVEGFR-3: C2D1:C1D1 (n=28, 20) | 1.075 pg/ml and ratio to Baseline | Standard Deviation 0.331 |
| IFN-α | Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis | PLASMA IL-8: Baseline (n=31, 29) | 18.6 pg/ml and ratio to Baseline | Standard Deviation 32 |
Secondary
Time to Tumor Progression (TTP), Core Radiology Assessment
TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.
Time frame: Randomization to first documentation of tumor progression: duration of treatment phase
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SU011248 | Time to Tumor Progression (TTP), Core Radiology Assessment | 49.1 weeks |
| IFN-α | Time to Tumor Progression (TTP), Core Radiology Assessment | 22.4 weeks |
Comparison: Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-a)p-value: <0.000195% CI: [0.4345, 0.6544]Log Rank
Comparison: Stratified Analysis: Hazard Ratio (SU011248 vs IFN-a)p-value: <0.0000195% CI: [0.4191, 0.6352]Log Rank
Secondary
Time to Tumor Progression (TTP), Investigator's Assessment
TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than the study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.
Time frame: Randomization to first documentation of tumor progression: duration of treatment phase
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SU011248 | Time to Tumor Progression (TTP), Investigator's Assessment | 49.0 weeks |
| IFN-α | Time to Tumor Progression (TTP), Investigator's Assessment | 22.3 weeks |
Comparison: Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-α)p-value: <0.000195% CI: [0.4558, 0.6526]Log Rank
Comparison: Stratified Analysis: Hazard Ratio (SU011248 vs IFN-α)p-value: <0.0000195% CI: [0.4519, 0.6492]Log Rank