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SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00083889
Collaborator
(none)
750
Enrollment
124
Locations
2
Arms
49
Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
750 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Study Start Date :
Aug 1, 2004
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 2

Drug: Interferon-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
Other Names:
  • Roferon

    		•
    Experimental: 1

    Drug: SU011248
    50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
    Other Names:
  • Sunitinib, SUTENT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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 Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    9. 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).

    10. 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.

    11. 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.

    12. 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.

    13. 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.

    14. 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.

    15. 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).

    16. 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).

    17. 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.

    18. 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.

    19. 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.

    20. 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]).

    21. 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]).

    22. 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]).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Jonesboro Arkansas United States 72401
    2 Pfizer Investigational Site La Jolla California United States 92037
    3 Pfizer Investigational Site La Jolla California United States 92093
    4 Pfizer Investigational Site Los Angeles California United States 90095
    5 Pfizer Investigational Site San Diego California United States 92103
    6 Pfizer Investigational Site San Francisco California United States 94115
    7 Pfizer Investigational Site Aurora Colorado United States 80040-0510
    8 Pfizer Investigational Site New Haven Connecticut United States 06504
    9 Pfizer Investigational Site New Haven Connecticut United States 06511
    10 Pfizer Investigational Site New Haven Connecticut United States 06520
    11 Pfizer Investigational Site Miami Florida United States 33136
    12 Pfizer Investigational Site Miami Florida United States 33176
    13 Pfizer Investigational Site Tampa Florida United States 33612
    14 Pfizer Investigational Site Chicago Illinois United States 60611
    15 Pfizer Investigational Site Maywood Illinois United States 60153
    16 Pfizer Investigational Site Kansas City Kansas United States 66112
    17 Pfizer Investigational Site Overland Park Kansas United States 66210
    18 Pfizer Investigational Site Louisville Kentucky United States 40207
    19 Pfizer Investigational Site Covington Louisiana United States 70433
    20 Pfizer Investigational Site Metairie Louisiana United States 70002
    21 Pfizer Investigational Site Metairie Louisiana United States 70006
    22 Pfizer Investigational Site Baltimore Maryland United States 21287
    23 Pfizer Investigational Site Boston Massachusetts United States 02114
    24 Pfizer Investigational Site Boston Massachusetts United States 02115
    25 Pfizer Investigational Site Detoit Michigan United States 48201
    26 Pfizer Investigational Site Detroit Michigan United States 48201
    27 Pfizer Investigational Site Farmington Hills Michigan United States 48334
    28 Pfizer Investigational Site Minneapolis Minnesota United States 55455
    29 Pfizer Investigational Site Columbus Mississippi United States 39705
    30 Pfizer Investigational Site Corinth Mississippi United States 38834
    31 Pfizer Investigational Site Jackson Mississippi United States 39213
    32 Pfizer Investigational Site Jackson Mississippi United States 39216
    33 Pfizer Investigational Site Southaven Mississippi United States 38671
    34 Pfizer Investigational Site Tupelo Mississippi United States 38801
    35 Pfizer Investigational Site Kansas City Missouri United States 64131
    36 Pfizer Investigational Site Omaha Nebraska United States 68198-9200
    37 Pfizer Investigational Site Lebanon New Hampshire United States 03756
    38 Pfizer Investigational Site Bronx New York United States 10466
    39 Pfizer Investigational Site New York New York United States 10021
    40 Pfizer Investigational Site New York New York United States 10022
    41 Pfizer Investigational Site Cleveland Ohio United States 44106-5055
    42 Pfizer Investigational Site Cleveland Ohio United States 44195
    43 Pfizer Investigational Site Tulsa Oklahoma United States 74104
    44 Pfizer Investigational Site Tulsa Oklahoma United States 74133
    45 Pfizer Investigational Site Tulsa Oklahoma United States 74136
    46 Pfizer Investigational Site Portland Oregon United States 97210
    47 Pfizer Investigational Site Portland Oregon United States 97239
    48 Pfizer Investigational Site Philadelphia Pennsylvania United States 19111-2497
    49 Pfizer Investigational Site Memphis Tennessee United States 38104
    50 Pfizer Investigational Site Memphis Tennessee United States 38120
    51 Pfizer Investigational Site Nashville Tennessee United States 37232
    52 Pfizer Investigational Site Dallas Texas United States 75246
    53 Pfizer Investigational Site Houston Texas United States 77030
    54 Pfizer Investigational Site Tyler Texas United States 75702
    55 Pfizer Investigational Site Salt Lake City Utah United States 84112
    56 Pfizer Investigational Site Seattle Washington United States 98101
    57 Pfizer Investigational Site Seattle Washington United States 98109-1023
    58 Pfizer Investigational Site Madison Wisconsin United States 53792-0001
    59 Pfizer Investigational Site Lismore New South Wales Australia 2480
    60 Pfizer Investigational Site St. Leonards New South Wales Australia 2065
    61 Pfizer Investigational Site South Brisbane Queensland Australia 4101
    62 Pfizer Investigational Site Woodville South South Australia Australia 5011
    63 Pfizer Investigational Site East Melbourne Victoria Australia 3002
    64 Pfizer Investigational Site Perth Western Australia Australia 6000
    65 Pfizer Investigational Site Victoria Australia 36184
    66 Pfizer Investigational Site Rio de Janeiro RJ Brazil 20231-050
    67 Pfizer Investigational Site Porto Alegre RS Brazil 90020-090
    68 Pfizer Investigational Site Porto Alegre RS Brazil 90610-000
    69 Pfizer Investigational Site Calgary Alberta Canada T2N 4N2
    70 Pfizer Investigational Site Edmonton Alberta Canada T6G 1Z2
    71 Pfizer Investigational Site Kelowna British Columbia Canada V1Y5L3
    72 Pfizer Investigational Site Vancouver British Columbia Canada V5Z 4E6
    73 Pfizer Investigational Site Victoria British Columbia Canada V5Z 4E6
    74 Pfizer Investigational Site London Ontario Canada N6A 4L6
    75 Pfizer Investigational Site Toronto Ontario Canada M4N 3M5
    76 Pfizer Investigational Site Toronto Ontario Canada M5G 2M9
    77 Pfizer Investigational Site Montreal Quebec Canada H2L 4M1
    78 Pfizer Investigational Site Quebec Canada G1R 2J6
    79 Pfizer Investigational Site Quebec Canada G1S 2L6
    80 Pfizer Investigational Site Paris Cedex 15 France 75908
    81 Pfizer Investigational Site Lyon France 69008
    82 Pfizer Investigational Site Paris Cedex 13 France 75651
    83 Pfizer Investigational Site Rennes France 35042
    84 Pfizer Investigational Site Saint Herblain France
    85 Pfizer Investigational Site Vandoeuvre Les Nancy France 54511
    86 Pfizer Investigational Site Aachen Germany 52074
    87 Pfizer Investigational Site Essen Germany 45122
    88 Pfizer Investigational Site Hannover Germany 30625
    89 Pfizer Investigational Site Ulm Germany 89075
    90 Pfizer Investigational Site Ulm Germany 89081
    91 Pfizer Investigational Site Modena Italy 41100
    92 Pfizer Investigational Site Napoli Italy 80131
    93 Pfizer Investigational Site Pavia Italy
    94 Pfizer Investigational Site Roma Italy 00135
    95 Pfizer Investigational Site Roma Italy 00144
    96 Pfizer Investigational Site Roma Italy 00152
    97 Pfizer Investigational Site Moczowego Warszawa Poland
    98 Pfizer Investigational Site Gdansk Poland 80-210
    99 Pfizer Investigational Site Krakow Poland 31-115
    100 Pfizer Investigational Site Lodz Poland 93-509
    101 Pfizer Investigational Site Lublin Poland 20-090
    102 Pfizer Investigational Site Poznan Poland
    103 Pfizer Investigational Site Warszawa Poland 00-909
    104 Pfizer Investigational Site Wroclaw Poland 50-043
    105 Pfizer Investigational Site Wroclaw Poland 50-556
    106 Pfizer Investigational Site Obninsk Kaluga Region Russian Federation 249036
    107 Pfizer Investigational Site Chelyabinsk Russian Federation 454087
    108 Pfizer Investigational Site Moscow Russian Federation 115478
    109 Pfizer Investigational Site Moscow Russian Federation 117836
    110 Pfizer Investigational Site Moscow Russian Federation
    111 Pfizer Investigational Site Saint-Petersburg Russian Federation 197758
    112 Pfizer Investigational Site St. Petersburg Russian Federation 197758
    113 Pfizer Investigational Site Tomsk Russian Federation 634050
    114 Pfizer Investigational Site Hospitalet de Llobregat Barcelona Spain 08907
    115 Pfizer Investigational Site Pamplona Navarra Spain 31008
    116 Pfizer Investigational Site Madrid Spain 28040
    117 Pfizer Investigational Site Madrid Spain 28041
    118 Pfizer Investigational Site Sevilla Spain 41013
    119 Pfizer Investigational Site Whitchurch Cardiff United Kingdom CF14 2 TL
    120 Pfizer Investigational Site Manchester Lancashire United Kingdom M20 4BX
    121 Pfizer Investigational Site Northwood Middlesex United Kingdom HA6 2RN
    122 Pfizer Investigational Site London United Kingdom SE1 9RT
    123 Pfizer Investigational Site London United Kingdom SW3 6JJ
    124 Pfizer Investigational Site Sutton Surrey United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00083889
    Other Study ID Numbers:
    • A6181034
    • NCT00098657
    First Posted:
    Jun 4, 2004
    Last Update Posted:
    Jan 26, 2010
    Last Verified:
    Jan 1, 2010
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell
    Interferons
    Interferon-alpha
    Sunitinib

    Study Results

    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 Detail Subjects were to be followed until survival data was mature (median duration of follow-up: 123 weeks).
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Period Title: Overall Study
    STARTED 375 375
    Received Treatment 375 360
    COMPLETED 0 0
    NOT COMPLETED 375 375

    Baseline Characteristics

    Arm/Group Title SU011248 IFN-α Total
    Arm/Group Description 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. 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. Total of all reporting groups
    Overall Participants 375 375 750
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    223
    59.5%
    252
    67.2%
    475
    63.3%
    >=65 years
    152
    40.5%
    123
    32.8%
    275
    36.7%
    Sex: Female, Male (Count of Participants)
    Female
    108
    28.8%
    106
    28.3%
    214
    28.5%
    Male
    267
    71.2%
    269
    71.7%
    536
    71.5%

    Outcome Measures

    1. Primary Outcome
    Title Progression-Free Survival (PFS), Core Radiology Assessment
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Median (95% Confidence Interval) [weeks]
    48.3
    22.1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α). Progression-free survival (PFS) was assessed in each treatment arm using the Kaplan-Meier method.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments p-value from 2-sided, unstratified test.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.5268
    Confidence Interval (2-Sided) 95%
    0.4316 to 0.6430
    Parameter Dispersion Type:
    Value:
    Estimation Comments Assuming proportional hazards, a hazard ratio les than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments Stratified analysis: Hazard Ratio (SU011248 vs IFN-a).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.00001
    Comments p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.5136
    Confidence Interval (2-Sided) 95%
    0.4196 to 0.6288
    Parameter Dispersion Type:
    Value:
    Estimation Comments Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.
    2. Secondary Outcome
    Title Objective Response, Core Radiology Assessment
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Number [participants]
    145
    38.7%
    29
    7.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Chi-squared
    Comments
    Method of Estimation Estimation Parameter treatment difference
    Estimated Value 30.93
    Confidence Interval (2-Sided) 95%
    25.31 to 36.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% confidence interval was calculated based on a normal distribution.
    3. Secondary Outcome
    Title Objective Response, Investigator's Assessment
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Number [participants]
    171
    45.6%
    45
    12%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Chi-squared
    Comments
    Method of Estimation Estimation Parameter treatment difference
    Estimated Value 33.66
    Confidence Interval (2-Sided) 95%
    27.62 to 39.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% confidence interval was calculated based on a normal distribution.
    4. Secondary Outcome
    Title Overall Survival (OS)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Median (95% Confidence Interval) [weeks]
    114.6
    94.9
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0510
    Comments p-value is from 2-sided, unstratified tests.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.8209
    Confidence Interval (2-Sided) 95%
    0.6730 to 1.0013
    Parameter Dispersion Type:
    Value:
    Estimation Comments Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0128
    Comments p-value is from 2-sided, unstratified tests.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.8209
    Confidence Interval (2-Sided) 95%
    0.6730 to 1.0013
    Parameter Dispersion Type:
    Value:
    Estimation Comments Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0490
    Comments p-value is from 2-sided, stratified tests. Stratification factors were: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.8179
    Confidence Interval (2-Sided) 95%
    0.6692 to 0.9995
    Parameter Dispersion Type:
    Value:
    Estimation Comments Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.
    5. Secondary Outcome
    Title Time to Tumor Progression (TTP), Core Radiology Assessment
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Median (95% Confidence Interval) [weeks]
    49.1
    22.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-a)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments p-value is from 2-sided, unstratified test.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.5332
    Confidence Interval (2-Sided) 95%
    0.4345 to 0.6544
    Parameter Dispersion Type:
    Value:
    Estimation Comments Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments Stratified Analysis: Hazard Ratio (SU011248 vs IFN-a)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.00001
    Comments p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.5160
    Confidence Interval (2-Sided) 95%
    0.4191 to 0.6352
    Parameter Dispersion Type:
    Value:
    Estimation Comments Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.
    6. Secondary Outcome
    Title Time to Tumor Progression (TTP), Investigator's Assessment
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Median (95% Confidence Interval) [weeks]
    49.0
    22.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-α)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments p-value is from 2-sided, unstratified test.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.5454
    Confidence Interval (2-Sided) 95%
    0.4558 to 0.6526
    Parameter Dispersion Type:
    Value:
    Estimation Comments Assuming proportional hazards, a hazard ratio < 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio > 1 indicates a reduction in hazard rate in favor of IFN-a.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments Stratified Analysis: Hazard Ratio (SU011248 vs IFN-α)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.00001
    Comments p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.5417
    Confidence Interval (2-Sided) 95%
    0.4519 to 0.6492
    Parameter Dispersion Type:
    Value:
    Estimation Comments Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.
    7. Secondary Outcome
    Title Duration of Response (DR), Core Radiology Assessement
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 71 9
    Median (95% Confidence Interval) [weeks]
    52.9
    64.9
    8. Secondary Outcome
    Title Duration of Response (DR), Investigator's Assessment
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 122 23
    Median (95% Confidence Interval) [weeks]
    56.3
    48.1
    9. Secondary Outcome
    Title FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Baseline (n=368, 351)
    29.74
    (5.244)
    29.55
    (5.026)
    Cycle 1 Day 28 (n=348, 317)
    27.73
    (5.080)
    26.68
    (5.195)
    Cycle 2 Day 1 (n=327, 246)
    29.66
    (4.778)
    27.59
    (4.908)
    Cycle 2 Day 28 (n= 315, 237)
    28.49
    (4.748)
    27.22
    (4.988)
    Cycle 3 Day 1 (n=294, 198)
    29.93
    (4.679)
    28.20
    (4.452)
    Cycle 3 Day 28 (n=285, 195)
    28.72
    (4.756)
    27.81
    (5.040)
    Cycle 4 Day 1 (n=272, 151)
    30.25
    (4.498)
    28.85
    (4.821)
    Cycle 4 Day 28 (n=264, 142)
    29.43
    (4.389)
    28.30
    (5.071)
    Cycle 5 Day 1 (n=248, 119 )
    30.87
    (3.948)
    28.57
    (4.925)
    Cycle 5 Day 28 (n=242, 109)
    29.43
    (4.280)
    28.37
    (4.726)
    Cycle 6 Day 1 (n=240, 99)
    30.80
    (4.214)
    29.12
    (4.428)
    Cycle 6 Day 28 (n=223, 99)
    29.62
    (4.288)
    28.44
    (4.957)
    Cycle 7 Day 1 (n=208, 79)
    30.93
    (4.002)
    28.99
    (4.974)
    Cycle 7 Day 28 (n=203, 75 )
    29.73
    (4.417)
    28.50
    (4.556)
    Cycle 8 Day 1 (n=192, 68)
    31.03
    (3.649)
    28.76
    (4.847)
    Cycle 8 Day 28 (n=190, 62)
    29.76
    (4.096)
    28.67
    (4.491)
    Cycle 9 Day 1 (n=172, 51)
    31.24
    (3.560)
    29.86
    (4.247)
    Cycle 9 Day 28 (n=166, 46)
    29.72
    (4.245)
    29.36
    (4.418)
    Cycle 10 Day 1 (n=161, 50)
    30.73
    (3.820)
    29.43
    (4.455)
    Cycle 10 Day 28 (n=155, 46)
    29.78
    (4.034)
    29.03
    (4.980)
    Cycle 11 Day 1 (n=138, 35)
    30.72
    (4.018)
    29.89
    (4.006)
    Cycle 11 Day 28 (n=141, 33)
    29.34
    (4.117)
    29.24
    (5.014)
    Cycle 12 Day 1 (n=132, 31)
    30.76
    (4.108)
    29.54
    (5.607)
    Cycle 12 Day 28 (n=128, 31)
    29.63
    (4.362)
    29.48
    (4.774)
    Cycle 13 Day 1 (113, 27)
    30.58
    (4.354)
    29.81
    (4.923)
    Cycle 13 Day 28 (n=114, 27)
    29.30
    (4.424)
    29.63
    (4.550)
    Cycle 14 Day 1 (n=114, 26)
    30.58
    (4.179)
    29.35
    (4.664)
    Cycle 14 Day 28 (n=105, 25)
    28.94
    (4.771)
    29.23
    (5.502)
    Cycle 15 Day 1 (n=100, 22)
    30.87
    (4.075)
    29.18
    (5.917)
    Cycle 15 Day 28 (n=94, 20)
    29.26
    (4.320)
    28.89
    (5.676)
    Cycle 16 Day 1 (n=96, 19)
    30.63
    (3.786)
    27.79
    (5.760)
    Cycle 16 Day 28 (n=90, 18)
    29.51
    (4.302)
    28.28
    (6.267)
    Cycle 17 Day 1 (n=85, 17)
    30.69
    (4.132)
    29.26
    (5.434)
    Cycle 17 Day 28 (n=81, 14)
    29.73
    (4.155)
    27.94
    (7.519)
    Cycle 18 Day 1 (n=80, 12)
    30.24
    (4.091)
    28.83
    (7.209)
    Cycle 18 Day 28 (n=70, 11)
    29.15
    (4.358)
    28.73
    (6.973)
    Cycle 19 Day 1 (n=71, 11)
    30.11
    (4.528)
    29.64
    (7.061)
    Cycle 19 Day 28 (n=61, 10)
    29.48
    (4.678)
    28.65
    (8.131)
    Cycle 20 Day 1 (n=65, 9)
    31.07
    (4.073)
    28.44
    (8.048)
    Cycle 20 Day 28 (n=53, 9)
    29.44
    (4.210)
    29.22
    (7.694)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.913
    Confidence Interval (2-Sided) 95%
    1.376 to 2.450
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.935
    Confidence Interval (2-Sided) 95%
    1.421 to 2.449
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.948
    Confidence Interval (2-Sided) 95%
    1.443 to 2.452
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.970
    Confidence Interval (2-Sided) 95%
    1.476 to 2.464
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.983
    Confidence Interval (2-Sided) 95%
    1.491 to 2.475
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.005
    Confidence Interval (2-Sided) 95%
    1.510 to 2.501
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.018
    Confidence Interval (2-Sided) 95%
    1.517 to 2.519
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.040
    Confidence Interval (2-Sided) 95%
    1.522 to 2.559
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.053
    Confidence Interval (2-Sided) 95%
    1.522 to 2.584
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.075
    Confidence Interval (2-Sided) 95%
    1.515 to 2.635
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.088
    Confidence Interval (2-Sided) 95%
    1.509 to 2.667
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.110
    Confidence Interval (2-Sided) 95%
    1.494 to 2.727
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.123
    Confidence Interval (2-Sided) 95%
    1.483 to 2.763
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.146
    Confidence Interval (2-Sided) 95%
    1.461 to 2.830
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Median Difference (Final Values)
    Estimated Value 2.158
    Confidence Interval (2-Sided) 95%
    1.447 to 2.869
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.181
    Confidence Interval (2-Sided) 95%
    1.420 to 2.941
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.193
    Confidence Interval (2-Sided) 95%
    1.404 to 2.983
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.216
    Confidence Interval (2-Sided) 95%
    1.373 to 3.059
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.228
    Confidence Interval (2-Sided) 95%
    1.355 to 3.102
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.251
    Confidence Interval (2-Sided) 95%
    1.321 to 3.180
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.263
    Confidence Interval (2-Sided) 95%
    1.302 to 3.225
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.286
    Confidence Interval (2-Sided) 95%
    1.266 to 3.305
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.298
    Confidence Interval (2-Sided) 95%
    1.246 to 3.351
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.321
    Confidence Interval (2-Sided) 95%
    1.209 to 3.433
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.333
    Confidence Interval (2-Sided) 95%
    1.188 to 3.479
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.356
    Confidence Interval (2-Sided) 95%
    1.150 to 3.562
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.369
    Confidence Interval (2-Sided) 95%
    1.128 to 3.609
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.391
    Confidence Interval (2-Sided) 95%
    1.089 to 3.693
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.404
    Confidence Interval (2-Sided) 95%
    1.067 to 3.740
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.426
    Confidence Interval (2-Sided) 95%
    1.027 to 3.825
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.439
    Confidence Interval () 95%
    1.005 to 3.872
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.461
    Confidence Interval (2-Sided) 95%
    0.964 to 3.958
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0016
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.474
    Confidence Interval (2-Sided) 95%
    0.942 to 4.006
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0022
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.496
    Confidence Interval (2-Sided) 95%
    0.901 to 4.092
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0026
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.509
    Confidence Interval (2-Sided) 95%
    0.878 to 4.140
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0034
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.531
    Confidence Interval (2-Sided) 95%
    0.836 to 4.226
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0040
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.544
    Confidence Interval (2-Sided) 95%
    0.813 to 4.274
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0051
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.566
    Confidence Interval (2-Sided) 95%
    0.772 to 4.361
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0058
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.579
    Confidence Interval (2-Sided) 95%
    0.748 to 4.410
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0071
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.602
    Confidence Interval (2-Sided) 95%
    0.706 to 4.497
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title FACT-Kidney Symptom Index (FKSI) Subscale
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Baseline (n=369, 351)
    46.45
    (8.464)
    46.09
    (8.701)
    Cycle 1 Day 28 (n=348, 317)
    42.71
    (8.959)
    40.93
    (9.292)
    Cycle 2 Day 1 (n=327, 246)
    45.98
    (8.401)
    42.33
    (8.733)
    Cycle 2 Day 28 (n=315, 238)
    43.75
    (8.607)
    42.01
    (8.659)
    Cycle 3 Day 1 (n=294, 198)
    46.60
    (8.263)
    43.64
    (7.983)
    Cycle 3 Day 28 (n=285, 195)
    44.01
    (8.529)
    43.13
    (8.925)
    Cycle 4 Day 1 (n=272, 151)
    46.99
    (8.041)
    44.78
    (8.328)
    Cycle 4 Day 28 (n=264, 142)
    45.08
    (8.017)
    44.03
    (8.913)
    Cycle 5 Day 1 (n=248, 119)
    47.99
    (7.313)
    44.82
    (8.293)
    Cycle 5 Day 28 (n=242, 109)
    44.99
    (7.768)
    44.41
    (8.318)
    Cycle 6 Day 1 (n=240, 99)
    47.61
    (7.860)
    45.38
    (7.995)
    Cycle 6 Day 28 (n=223, 99)
    45.40
    (7.840)
    44.07
    (9.003)
    Cycle 7 Day 1 (n=208, 79)
    47.84
    (7.303)
    45.09
    (9.061)
    Cycle 7 Day 28 (n=203, 75)
    45.39
    (8.013)
    44.65
    (8.082)
    Cycle 8 Day 1 (n=192, 68)
    48.24
    (6.818)
    45.38
    (8.597)
    Cycle 8 Day 28 (n=190, 62)
    45.83
    (7.589)
    45.10
    (8.197)
    Cycle 9 Day 1 (n=172, 51)
    48.31
    (6.971)
    46.88
    (7.901)
    Cycle 9 Day 28 (n=166, 46)
    45.79
    (7.969)
    46.16
    (8.133)
    Cycle 10 Day 1 (n=161, 50)
    47.90
    (6.993)
    46.22
    (7.778)
    Cycle 10 Day 28 (n=155, 46)
    45.70
    (7.372)
    45.16
    (8.961)
    Cycle 11 Day 1 (n=138, 35)
    47.90
    (6.988)
    46.26
    (7.398)
    Cycle 11 Day 28 (n=141, 33)
    45.28
    (7.330)
    45.46
    (8.920)
    Cycle 12 Day 1 (n=132, 31)
    47.90
    (7.458)
    46.08
    (9.456)
    Cycle 12 Day 28 (n=128, 31)
    45.67
    (7.696)
    46.00
    (8.802)
    Cycle 13 Day 1 (n=113, 27)
    48.02
    (7.723)
    46.25
    (8.833)
    Cycle 13 Day 28 (n=114, 27)
    45.65
    (7.659)
    45.84
    (9.095)
    Cycle 14 Day 1 (n=114, 26)
    47.90
    (7.370)
    46.08
    (8.621)
    Cycle 14 Day 28 (n=105, 25)
    45.10
    (8.641)
    46.10
    (9.650)
    Cycle 15 Day 1 (n=100, 22)
    48.26
    (7.663)
    45.62
    (9.715)
    Cycle 15 Day 28 (n=94, 20)
    45.37
    (8.040)
    45.30
    (9.776)
    Cycle 16 Day 1 (n=96, 19)
    47.75
    (7.063)
    43.64
    (10.688)
    Cycle 16 Day 28 (n=90, 18)
    45.95
    (7.625)
    43.46
    (10.549)
    Cycle 17 Day 1 (n=85, 17)
    48.07
    (7.641)
    45.59
    (10.302)
    Cycle 17 Day 28 (n=81, 14)
    46.27
    (8.016)
    43.64
    (11.693)
    Cycle 18 Day 1 (n=80, 12)
    47.47
    (7.598)
    44.92
    (12.391)
    Cycle 18 Day 28 (n=70, 11)
    45.36
    (7.585)
    45.27
    (11.909)
    Cycle 19 Day 1 (n=71, 11)
    47.70
    (7.671)
    46.64
    (12.808)
    Cycle 19 Day 28 (n=61, 10)
    46.07
    (8.442)
    44.47
    (14.476)
    Cycle 20 Day 1 (n=65, 9)
    48.88
    (7.133)
    45.00
    (13.811)
    Cycle 20 Day 28 (n=53, 9)
    46.26
    (8.065)
    46.00
    (13.266)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.165
    Confidence Interval (2-Sided) 95%
    2.234 to 4.095
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.205
    Confidence Interval (2-Sided) 95%
    2.318 to 4.092
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.228
    Confidence Interval (2-Sided) 95%
    2.358 to 4.097
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.268
    Confidence Interval (2-Sided) 95%
    2.418 to 4.119
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.291
    Confidence Interval (2-Sided) 95%
    2.443 to 4.139
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.331
    Confidence Interval (2-Sided) 95%
    2.474 to 4.189
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.354
    Confidence Interval () 95%
    2.484 to 4.224
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.395
    Confidence Interval (2-Sided) 95%
    2.489 to 4.300
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.417
    Confidence Interval (2-Sided) 95%
    2.486 to 4.348
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.458
    Confidence Interval (2-Sided) 95%
    2.469 to 4.446
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.480
    Confidence Interval (2-Sided) 95%
    2.455 to 4.505
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.521
    Confidence Interval (2-Sided) 95%
    2.422 to 4.620
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.543
    Confidence Interval (2-Sided) 95%
    2.399 to 4.687
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.584
    Confidence Interval () 95%
    2.354 to 4.814
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.606
    Confidence Interval (2-Sided) 95%
    2.326 to 4.887
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.647
    Confidence Interval (2-Sided) 95%
    2.272 to 5.022
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.669
    Confidence Interval (2-Sided) 95%
    2.240 to 5.099
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.710
    Confidence Interval (2-Sided) 95%
    2.180 to 5.240
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.733
    Confidence Interval (2-Sided) 95%
    2.145 to 5.320
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.773
    Confidence Interval (2-Sided) 95%
    2.080 to 5.466
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.796
    Confidence Interval (2-Sided) 95%
    2.043 to 5.548
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.836
    Confidence Interval (2-Sided) 95%
    1.975 to 5.698
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.859
    Confidence Interval (2-Sided) 95%
    1.936 to 5.781
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.899
    Confidence Interval (2-Sided) 95%
    1.866 to 5.933
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.922
    Confidence Interval (2-Sided) 95%
    1.826 to 6.018
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.962
    Confidence Interval (2-Sided) 95%
    1.753 to 6.172
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.985
    Confidence Interval () 95%
    1.712 to 6.258
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.026
    Confidence Interval (2-Sided) 95%
    1.638 to 6.413
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.048
    Confidence Interval (2-Sided) 95%
    1.597 to 6.500
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.089
    Confidence Interval (2-Sided) 95%
    1.521 to 6.656
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0022
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.111
    Confidence Interval (2-Sided) 95%
    1.479 to 6.743
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.152
    Confidence Interval (2-Sided) 95%
    1.403 to 6.901
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0037
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.174
    Confidence Interval () 95%
    1.360 to 6.988
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0048
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.215
    Confidence Interval (2-Sided) 95%
    1.283 to 7.147
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0056
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.237
    Confidence Interval (2-Sided) 95%
    1.240 to 7.235
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0071
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.278
    Confidence Interval (2-Sided) 95%
    1.162 to 7.394
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0081
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.300
    Confidence Interval (2-Sided) 95%
    1.119 to 7.482
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0099
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.341
    Confidence Interval (2-Sided) 95%
    1.041 to 7.642
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0111
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.364
    Confidence Interval (2-Sided) 95%
    0.997 to 7.730
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0133
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.404
    Confidence Interval (2-Sided) 95%
    0.918 to 7.890
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Primary Outcome
    Title Progression-Free Survival (PFS), Investigator's Assessment
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Median (95% Confidence Interval) [weeks]
    47.7
    22.1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments p-value is from 2-sided, unstratified test.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.5404
    Confidence Interval (2-Sided) 95%
    0.4532 to 0.6444
    Parameter Dispersion Type:
    Value:
    Estimation Comments Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.00001
    Comments p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.5418
    Confidence Interval (2-Sided) 95%
    0.4536 to 0.6473
    Parameter Dispersion Type:
    Value:
    Estimation Comments Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.
    12. Secondary Outcome
    Title Functional Assessment of Cancer Therapy-General (FACT-G)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Baseline (n=368, 346)
    82.30
    (15.213)
    81.22
    (16.030)
    Cycle 1 Day 28 (n=345, 316)
    78.75
    (15.702)
    74.91
    (18.374)
    Cycle 2 Day 1 (n=328, 247)
    82.88
    (15.733)
    77.02
    (16.670)
    Cycle 2 Day 28 (n=314, 237)
    80.51
    (16.229)
    77.05
    (17.468)
    Cycle 3 Day 1 (n=293, 199)
    84.24
    (16.121)
    79.35
    (16.862)
    Cycle 3 Day 28 (n=285, 193)
    80.59
    (16.144)
    78.42
    (17.836)
    Cycle 4 Day 1 (n=269, 149)
    85.32
    (14.723)
    80.86
    (16.477)
    Cycle 4 Day 28 (n=263, 142)
    82.08
    (15.147)
    80.46
    (17.136)
    Cycle 5 Day 1 (n=247, 119)
    86.40
    (14.019)
    81.96
    (15.286)
    Cycle 5 Day 28 (n=240, 106)
    82.23
    (15.124)
    80.60
    (15.527)
    Cycle 6 Day 1 (n=238, 98)
    84.90
    (15.189)
    81.97
    (15.918)
    Cycle 6 Day 28 (n=222, 97)
    82.54
    (15.338)
    79.70
    (16.686)
    Cycle 7 Day 1 (n=206, 78)
    85.01
    (15.118)
    80.39
    (17.811)
    Cycle 7 Day 28 (n=200, 75)
    82.16
    (16.207)
    81.06
    (16.701)
    Cycle 8 Day 1 (n=192, 66)
    86.83
    (13.456)
    81.25
    (17.179)
    Cycle 8 Day 28 (n=189, 61)
    83.05
    (14.699)
    81.31
    (16.700)
    Cycle 9 Day 1 (n=170, 51)
    85.81
    (14.865)
    84.50
    (16.174)
    Cycle 9 Day 28 (n=166, 46)
    82.71
    (15.276)
    83.14
    (17.067)
    Cycle 10 Day 1 (n=158, 49)
    85.32
    (14.500)
    84.03
    (16.559)
    Cycle 10 Day 28 (n=150, 45)
    82.14
    (15.193)
    81.79
    (17.994)
    Cycle 11 Day 1 (n=134, 35)
    84.75
    (14.791)
    81.60
    (16.729)
    Cycle 11 Day 28 (n=139, 32)
    81.91
    (14.865)
    80.20
    (19.213)
    Cycle 12 Day 1 (n=130, 29)
    85.31
    (15.181)
    80.99
    (20.219)
    Cycle 12 Day 28 (n=126, 31)
    82.43
    (15.152)
    81.73
    (18.745)
    Cycle 13 Day 1 (n=113, 27)
    85.50
    (15.209)
    81.18
    (20.198)
    Cycle 13 Day 28 (n=114, 27)
    83.61
    (14.445)
    80.67
    (18.678)
    Cycle 14 Day 1 (n=112, 26)
    85.24
    (14.398)
    81.22
    (17.506)
    Cycle 14 Day 28 (n=107, 24)
    82.34
    (16.300)
    81.57
    (20.188)
    Cycle 15 Day 1 (n=101, 20)
    86.24
    (14.742)
    81.66
    (18.326)
    Cycle 15 Day 28 (n=96, 20)
    82.64
    (15.722)
    80.88
    (18.913)
    Cycle 16 Day 1 (n=94, 19)
    84.77
    (14.741)
    78.20
    (18.994)
    Cycle 16 Day 28 (n=89, 18)
    83.38
    (15.481)
    78.38
    (19.749)
    Cycle 17 Day 1 (n=84, 16)
    86.78
    (14.800)
    81.80
    (20.161)
    Cycle 17 Day 28 (n=80, 14)
    84.42
    (15.106)
    78.96
    (21.571)
    Cycle 18 Day 1 (n=79, 12)
    85.74
    (14.987)
    82.24
    (23.763)
    Cycle 18 Day 28 (n=70, 11)
    83.51
    (14.831)
    82.27
    (21.950)
    Cycle 19 Day 1 (n=71, 11)
    87.16
    (14.245)
    82.48
    (24.198)
    Cycle 19 Day 28 (n=61, 10)
    84.54
    (16.679)
    79.63
    (27.938)
    Cycle 20 Day 1 (n=63, 9)
    87.96
    (14.441)
    81.70
    (27.018)
    Cycle 20 Day 28 (n=52, 8)
    84.62
    (16.257)
    79.54
    (26.109)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.486
    Confidence Interval (2-Sided) 95%
    3.852 to 7.119
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.535
    Confidence Interval (2-Sided) 95%
    3.955 to 7.115
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.562
    Confidence Interval (2-Sided) 95%
    4.000 to 7.124
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.611
    Confidence Interval (2-Sided) 95%
    4.061 to 7.162
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.639
    Confidence Interval (2-Sided) 95%
    4.083 to 7.195
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.688
    Confidence Interval (2-Sided) 95%
    4.100 to 7.276
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.715
    Confidence Interval (2-Sided) 95%
    4.098 to 7.333
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.764
    Confidence Interval (2-Sided) 95%
    4.075 to 7.454
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.792
    Confidence Interval (2-Sided) 95%
    4.053 to 7.531
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.841
    Confidence Interval (2-Sided) 95%
    3.998 to 7.684
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.868
    Confidence Interval (2-Sided) 95%
    3.960 to 7.777
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.917
    Confidence Interval (2-Sided) 95%
    3.880 to 7.955
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.945
    Confidence Interval (2-Sided) 95%
    3.830 to 8.060
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.994
    Confidence Interval (2-Sided) 95%
    3.731 to 8.257
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.021
    Confidence Interval (2-Sided) 95%
    3.672 to 8.370
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.071
    Confidence Interval (2-Sided) 95%
    3.560 to 8.581
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.098
    Confidence Interval (2-Sided) 95%
    3.495 to 8.701
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.147
    Confidence Interval (2-Sided) 95%
    3.373 to 8.921
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.174
    Confidence Interval (2-Sided) 95%
    3.303 to 9.045
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.224
    Confidence Interval (2-Sided) 95%
    3.174 to 9.273
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.251
    Confidence Interval (2-Sided) 95%
    3.101 to 9.401
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.300
    Confidence Interval (2-Sided) 95%
    2.966 to 9.634
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.327
    Confidence Interval (2-Sided) 95%
    2.890 to 9.765
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.377
    Confidence Interval (2-Sided) 95%
    2.751 to 10.002
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.404
    Confidence Interval (2-Sided) 95%
    2.673 to 10.135
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.453
    Confidence Interval (2-Sided) 95%
    2.530 to 10.376
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0016
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.480
    Confidence Interval (2-Sided) 95%
    2.451 to 10.510
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.530
    Confidence Interval (2-Sided) 95%
    2.306 to 10.754
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0030
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.557
    Confidence Interval (2-Sided) 95%
    2.224 to 10.889
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0043
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.606
    Confidence Interval (2-Sided) 95%
    2.077 to 11.135
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0051
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.634
    Confidence Interval (2-Sided) 95%
    1.995 to 11.272
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0068
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.683
    Confidence Interval (2-Sided) 95%
    1.847 to 11.519
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0079
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.710
    Confidence Interval (2-Sided) 95%
    1.764 to 11.657
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0100
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.759
    Confidence Interval (2-Sided) 95%
    1.613 to 11.905
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0114
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.787
    Confidence Interval (2-Sided) 95%
    1.530 to 12.043
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0141
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.836
    Confidence Interval (2-Sided) 95%
    1.378 to 12.293
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0157
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.863
    Confidence Interval (2-Sided) 95%
    1.294 to 12.432
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0189
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.912
    Confidence Interval (2-Sided) 95%
    1.142 to 12.683
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0208
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.940
    Confidence Interval (2-Sided) 95%
    1.057 to 12.822
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0244
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.989
    Confidence Interval (2-Sided) 95%
    0.904 to 13.074
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Baseline (n=369, 348)
    23.14
    (5.209)
    22.70
    (5.224)
    Cycle 1 Day 28 (n=348, 318)
    19.43
    (6.052)
    18.85
    (6.168)
    Cycle 2 Day 1 (n=329, 247)
    22.22
    (5.161)
    20.05
    (5.499)
    Cycle 2 Day 28 (n=316, 239)
    20.34
    (5.654)
    19.84
    (5.706)
    Cycle 3 Day 1 (n=294, 200)
    22.45
    (5.123)
    20.87
    (5.281)
    Cycle 3 Day 28 (n=286, 195)
    20.18
    (5.650)
    20.63
    (5.395)
    Cycle 4 Day 1 (n=270, 150)
    22.72
    (4.641)
    21.56
    (4.581)
    Cycle 4 Day 28 (n=264, 142)
    21.00
    (5.120)
    21.31
    (5.110)
    Cycle 5 Day 1 (n=248, 120)
    23.24
    (4.143)
    21.84
    (4.567)
    Cycle 5 Day 28 (n=241, 106)
    20.91
    (5.062)
    21.23
    (4.867)
    Cycle 6 Day 1 (n=239, 99)
    22.99
    (4.385)
    21.70
    (4.761)
    Cycle 6 Day 28 (n=224, 97)
    21.22
    (5.070)
    20.96
    (5.384)
    Cycle 7 Day 1 (n=207, 79)
    23.05
    (4.414)
    21.67
    (4.964)
    Cycle 7 Day 28 (n=201, 75)
    21.22
    (5.250)
    21.66
    (4.595)
    Cycle 8 Day 1 (n=193, 67)
    23.58
    (3.715)
    21.94
    (4.870)
    Cycle 8 Day 28 (n=189, 61)
    21.51
    (4.666)
    21.40
    (4.910)
    Cycle 9 Day 1 (n=172, 51)
    23.41
    (4.071)
    22.58
    (4.367)
    Cycle 9 Day 28 (n=166, 46)
    21.29
    (5.068)
    22.38
    (4.400)
    Cycle 10 Day 1 (n=159, 49)
    22.94
    (4.053)
    22.60
    (4.124)
    Cycle 10 Day 28 (n=151, 46)
    21.21
    (4.848)
    21.83
    (5.165)
    Cycle 11 Day 1 (n=135, 35)
    23.16
    (4.069)
    22.23
    (4.194)
    Cycle 11 Day 28 (n=140, 32)
    20.98
    (4.597)
    21.88
    (5.173)
    Cycle 12 Day 1 (n=131, 30)
    23.03
    (4.291)
    22.60
    (5.236)
    Cycle 12 Day 28 (n=127, 31)
    20.87
    (4.721)
    21.90
    (4.867)
    Cycle 13 Day 1 (n=114, 27)
    23.05
    (4.281)
    21.99
    (5.187)
    Cycle 13 Day 28 (n=114, 27)
    21.26
    (4.623)
    21.80
    (5.369)
    Cycle 14 Day 1 (n=112, 26)
    23.02
    (4.401)
    22.05
    (4.906)
    Cycle 14 Day 28 (n=107, 24)
    20.80
    (5.310)
    22.75
    (4.875)
    Cycle 15 Day 1 (n=101, 21)
    23.26
    (4.475)
    22.33
    (5.173)
    Cycle 15 Day 28 (n=96, 20)
    20.95
    (4.978)
    22.07
    (4.908)
    Cycle 16 Day 1 (n=94, 19)
    22.60
    (4.337)
    20.63
    (6.125)
    Cycle 16 Day 28 (n=90, 18)
    21.31
    (4.939)
    21.42
    (6.194)
    Cycle 17 Day 1 (n=85, 16)
    22.99
    (4.513)
    21.81
    (5.776)
    Cycle 17 Day 28 (n=80, 14)
    21.68
    (4.653)
    20.50
    (6.757)
    Cycle 18 Day 1 (n=79, 12)
    22.85
    (4.388)
    21.83
    (6.672)
    Cycle 18 Day 28 (n=70, 11)
    20.89
    (5.006)
    22.45
    (5.610)
    Cycle 19 Day 1 (n=71, 11)
    23.20
    (4.426)
    22.45
    (6.773)
    Cycle 19 Day 28 (n=61, 10)
    21.82
    (4.696)
    21.60
    (7.457)
    Cycle 20 Day 1 (n=63, 9)
    23.68
    (4.204)
    21.78
    (7.311)
    Cycle 20 Day 28 (n=52, 9)
    21.81
    (4.835)
    22.33
    (6.423)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.459
    Confidence Interval (2-Sided) 95%
    0.805 to 2.114
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.453
    Confidence Interval (2-Sided) 95%
    0.827 to 2.079
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.450
    Confidence Interval (2-Sided) 95%
    0.837 to 2.063
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.444
    Confidence Interval (2-Sided) 95%
    0.847 to 2.041
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.440
    Confidence Interval (2-Sided) 95%
    0.848 to 2.032
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.434
    Confidence Interval (2-Sided) 95%
    0.844 to 2.024
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.431
    Confidence Interval (2-Sided) 95%
    0.838 to 2.023
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.424
    Confidence Interval (2-Sided) 95%
    0.819 to 2.029
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.421
    Confidence Interval (2-Sided) 95%
    0.805 to 2.037
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.415
    Confidence Interval (2-Sided) 95%
    0.774 to 2.056
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.411
    Confidence Interval (2-Sided) 95%
    0.753 to 2.069
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.405
    Confidence Interval (2-Sided) 95%
    0.711 to 2.099
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.402
    Confidence Interval (2-Sided) 95%
    0.685 to 2.119
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.396
    Confidence Interval (2-Sided) 95%
    0.634 to 2.157
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.392
    Confidence Interval (2-Sided) 95%
    0.604 to 2.180
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.386
    Confidence Interval (2-Sided) 95%
    0.547 to 2.225
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.383
    Confidence Interval (2-Sided) 95%
    0.514 to 2.252
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0035
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.376
    Confidence Interval (2-Sided) 95%
    0.451 to 2.301
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0049
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.373
    Confidence Interval (2-Sided) 95%
    0.416 to 2.330
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0084
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.367
    Confidence Interval (2-Sided) 95%
    0.350 to 2.383
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0110
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.363
    Confidence Interval (2-Sided) 95%
    0.313 to 2.414
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0168
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.357
    Confidence Interval (2-Sided) 95%
    0.245 to 2.470
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0208
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.354
    Confidence Interval (2-Sided) 95%
    0.206 to 2.501
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0293
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.348
    Confidence Interval (2-Sided) 95%
    0.136 to 2.559
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0348
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.344
    Confidence Interval (2-Sided) 95%
    0.096 to 2.592
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0459
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.338
    Confidence Interval (2-Sided) 95%
    0.024 to 2.652
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0528
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.335
    Confidence Interval (2-Sided) 95%
    -0.016 to 2.685
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0663
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.328
    Confidence Interval (2-Sided) 95%
    -0.090 to 2.746
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0744
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.325
    Confidence Interval (2-Sided) 95%
    -0.131 to 2.780
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0898
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.319
    Confidence Interval (2-Sided) 95%
    -0.205 to 2.842
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0988
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.315
    Confidence Interval (2-Sided) 95%
    -0.246 to 2.877
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1156
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.309
    Confidence Interval (2-Sided) 95%
    -0.321 to 2.940
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1252
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.306
    Confidence Interval (2-Sided) 95%
    -0.363 to 2.975
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1429
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.300
    Confidence Interval (2-Sided) 95%
    -0.439 to 3.038
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1529
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.296
    Confidence Interval (2-Sided) 95%
    -0.481 to 3.074
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1711
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.290
    Confidence Interval (2-Sided) 95%
    -0.558 to 3.138
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1813
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.287
    Confidence Interval (2-Sided) 95%
    -0.600 to 3.173
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1998
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.280
    Confidence Interval (2-Sided) 95%
    -0.677 to 3.238
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2100
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.277
    Confidence Interval (2-Sided) 95%
    -0.720 to 3.273
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2283
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.271
    Confidence Interval (2-Sided) 95%
    -0.797 to 3.338
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. Secondary Outcome
    Title Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Baseline (n=370, 349)
    23.14
    (4.641)
    22.94
    (4.735)
    Cycle 1 Day 28 (n=348, 319)
    23.60
    (4.088)
    22.20
    (5.076)
    Cycle 2 Day 1 (n=328, 247)
    23.50
    (4.344)
    22.31
    (5.190)
    Cycle 2 Day 28 (n=315, 238)
    23.40
    (4.471)
    22.22
    (5.203)
    Cycle 3 Day 1 (n=292, 200)
    23.51
    (4.375)
    22.42
    (5.011)
    Cycle 3 Day 28 (n=284, 194)
    23.44
    (4.369)
    22.12
    (5.289)
    Cycle 4 Day 1 (n=269, 150)
    23.73
    (4.072)
    22.26
    (5.275)
    Cycle 4 Day 28 (n=263, 142)
    23.36
    (4.451)
    22.38
    (5.198)
    Cycle 5 Day 1 (n=247, 120)
    23.53
    (4.334)
    22.35
    (5.486)
    Cycle 5 Day 28 (n=241, 107)
    23.68
    (4.137)
    22.36
    (4.956)
    Cycle 6 Day 1 (n=238, 98)
    23.35
    (4.428)
    22.56
    (4.678)
    Cycle 6 Day 28 (n=224, 97)
    23.40
    (4.393)
    22.33
    (4.641)
    Cycle 7 Day 1 (n=207, 79)
    23.29
    (4.532)
    22.46
    (4.722)
    Cycle 7 Day 28 (n=200, 75)
    23.13
    (4.585)
    22.10
    (5.286)
    Cycle 8 Day 1 (n=193, 67)
    23.67
    (4.225)
    21.95
    (5.112)
    Cycle 8 Day 28 (n=189, 61)
    23.26
    (4.402)
    22.17
    (5.236)
    Cycle 9 Day 1 (n=172, 51)
    23.26
    (4.376)
    22.74
    (4.826)
    Cycle 9 Day 28 (n=166, 46)
    23.26
    (4.395)
    21.96
    (5.418)
    Cycle 10 Day 1 (n=158, 49)
    23.08
    (4.348)
    22.45
    (5.279)
    Cycle 10 Day 28 (n=151, 46)
    23.03
    (4.417)
    22.06
    (5.065)
    Cycle 11 Day 1 (n=135, 35)
    23.05
    (4.521)
    21.51
    (5.267)
    Cycle 11 Day 28 (n=140, 32)
    22.71
    (4.624)
    21.09
    (5.957)
    Cycle 12 Day 1 (n=131, 30)
    23.23
    (4.563)
    20.79
    (6.007)
    Cycle 12 Day 28 (n=127, 31)
    23.07
    (4.586)
    21.25
    (5.627)
    Cycle 13 Day 1 (n=114, 27)
    23.15
    (4.498)
    20.93
    (6.142)
    Cycle 13 Day 28 (n=114, 27)
    23.31
    (4.255)
    21.30
    (5.491)
    Cycle 14 Day 1 (n=112, 26)
    22.82
    (4.647)
    21.51
    (5.510)
    Cycle 14 Day 28 (n=107, 24)
    23.24
    (4.503)
    20.32
    (6.628)
    Cycle 15 Day 1 (n=101, 21)
    23.28
    (4.178)
    20.35
    (5.986)
    Cycle 15 Day 28 (n=96, 20)
    23.04
    (4.312)
    20.23
    (6.162)
    Cycle 16 Day 1 (n=94, 19)
    23.11
    (4.335)
    21.41
    (5.196)
    Cycle 16 Day 28 (n=89, 18)
    23.41
    (4.322)
    21.52
    (5.821)
    Cycle 17 Day 1 (n=85, 16)
    23.42
    (4.603)
    22.25
    (5.037)
    Cycle 17 Day 28 (n=80, 14)
    23.50
    (4.424)
    21.75
    (5.680)
    Cycle 18 Day 1 (n=79, 12)
    23.53
    (4.428)
    21.71
    (6.276)
    Cycle 18 Day 28 (n=70, 11)
    23.70
    (4.410)
    21.27
    (6.051)
    Cycle 19 Day 1 (n=71, 11)
    23.85
    (4.270)
    21.30
    (5.894)
    Cycle 19 Day 28 (n=61, 10)
    23.53
    (4.641)
    20.73
    (6.816)
    Cycle 20 Day 1 (n=63, 9)
    23.60
    (4.045)
    21.26
    (7.201)
    Cycle 20 Day 28 (n=52, 8)
    22.93
    (4.898)
    20.67
    (6.251)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.214
    Confidence Interval (2-Sided) 95%
    0.719 to 1.708
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.216
    Confidence Interval (2-Sided) 95%
    0.729 to 1.703
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.217
    Confidence Interval (2-Sided) 95%
    0.731 to 1.704
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.220
    Confidence Interval (2-Sided) 95%
    0.730 to 1.710
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.221
    Confidence Interval (2-Sided) 95%
    0.727 to 1.716
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.224
    Confidence Interval (2-Sided) 95%
    0.716 to 1.732
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.225
    Confidence Interval (2-Sided) 95%
    0.707 to 1.744
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.228
    Confidence Interval (2-Sided) 95%
    0.687 to 1.769
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.229
    Confidence Interval (2-Sided) 95%
    0.673 to 1.785
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.232
    Confidence Interval (2-Sided) 95%
    0.646 to 1.818
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.233
    Confidence Interval (2-Sided) 95%
    0.629 to 1.838
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.236
    Confidence Interval (2-Sided) 95%
    0.595 to 1.876
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.237
    Confidence Interval (2-Sided) 95%
    0.575 to 1.899
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.240
    Confidence Interval (2-Sided) 95%
    0.537 to 1.942
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.241
    Confidence Interval (2-Sided) 95%
    0.515 to 1.967
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.244
    Confidence Interval (2-Sided) 95%
    0.474 to 2.013
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.245
    Confidence Interval (2-Sided) 95%
    0.450 to 2.040
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0037
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.248
    Confidence Interval (2-Sided) 95%
    0.406 to 2.089
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0048
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.249
    Confidence Interval (2-Sided) 95%
    0.382 to 2.116
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0074
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.251
    Confidence Interval (2-Sided) 95%
    0.336 to 2.167
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0092
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.253
    Confidence Interval (2-Sided) 95%
    0.310 to 2.196
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0132
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.255
    Confidence Interval (2-Sided) 95%
    0.262 to 2.248
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0159
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.257
    Confidence Interval (2-Sided) 95%
    0.236 to 2.278
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0213
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.259
    Confidence Interval (2-Sided) 95%
    0.187 to 2.332
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0248
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.261
    Confidence Interval (2-Sided) 95%
    0.160 to 2.362
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0318
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.263
    Confidence Interval (2-Sided) 95%
    0.110 to 2.416
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0360
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.265
    Confidence Interval (2-Sided) 95%
    0.083 to 2.447
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0443
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.267
    Confidence Interval (2-Sided) 95%
    0.032 to 2.502
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0493
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.269
    Confidence Interval (2-Sided) 95%
    0.004 to 2.533
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0587
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.271
    Confidence Interval (2-Sided) 95%
    -0.047 to 2.589
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0642
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.273
    Confidence Interval (2-Sided) 95%
    -0.075 to 2.620
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0746
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.275
    Confidence Interval (2-Sided) 95%
    -0.127 to 2.677
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0806
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.276
    Confidence Interval (2-Sided) 95%
    -0.155 to 2.708
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0917
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.279
    Confidence Interval (2-Sided) 95%
    -0.207 to 2.765
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0980
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.280
    Confidence Interval (2-Sided) 95%
    -0.236 to 2.797
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1095
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.283
    Confidence Interval (2-Sided) 95%
    -0.288 to 2.854
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1161
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.284
    Confidence Interval (2-Sided) 95%
    -0.318 to 2.886
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1280
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.287
    Confidence Interval (2-Sided) 95%
    -0.370 to 2.944
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1346
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.288
    Confidence Interval (2-Sided) 95%
    -0.399 to 2.976
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1466
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.291
    Confidence Interval (2-Sided) 95%
    -0.452 to 3.034
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. Secondary Outcome
    Title Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Baseline (370, 352)
    17.15
    (4.548)
    17.06
    (4.609)
    Cycle 1 Day 28 (n=347, 318)
    17.76
    (4.347)
    17.40
    (5.123)
    Cycle 2 Day 1 (n=328, 249)
    18.46
    (4.218)
    17.52
    (4.560)
    Cycle 2 Day 28 (n=316, 237)
    18.46
    (4.342)
    17.73
    (4.637)
    Cycle 3 Day 1 (n=294, 200)
    18.82
    (4.236)
    18.13
    (4.603)
    Cycle 3 Day 28 (n=287, 196)
    18.53
    (4.494)
    18.17
    (4.704)
    Cycle 4 Day 1 (n=272, 152)
    19.04
    (4.182)
    18.80
    (4.246)
    Cycle 4 Day 28 (n=265, 142)
    18.76
    (4.343)
    18.39
    (4.378)
    Cycle 5 Day 1 (n=249, 120)
    19.18
    (3.903)
    19.00
    (4.062)
    Cycle 5 Day 28 (n=241, 109)
    18.63
    (4.298)
    18.70
    (4.144)
    Cycle 6 Day 1 (n=240, 99)
    18.99
    (4.154)
    18.60
    (4.338)
    Cycle 6 Day 28 (n=222, 99)
    18.73
    (4.311)
    18.14
    (4.747)
    Cycle 7 Day 1 (n=208, 77)
    19.08
    (4.324)
    18.08
    (5.010)
    Cycle 7 Day 28 (n=204, 75)
    18.69
    (4.595)
    18.55
    (4.691)
    Cycle 8 Day 1 (n=192, 67)
    19.33
    (4.104)
    18.54
    (4.613)
    Cycle 8 Day 28 (n=189, 62)
    18.98
    (4.026)
    18.55
    (4.734)
    Cycle 9 Day 1 (n=171, 51)
    19.25
    (4.341)
    18.98
    (4.654)
    Cycle 9 Day 28 (n=167, 46)
    18.93
    (4.376)
    18.76
    (4.831)
    Cycle 10 Day 1 (n=161, 50)
    19.32
    (4.191)
    18.92
    (4.548)
    Cycle 10 Day 28 (n=154, 45)
    18.71
    (4.557)
    18.36
    (4.778)
    Cycle 11 Day 1 (n=138, 35)
    18.92
    (4.514)
    18.97
    (4.225)
    Cycle 11 Day 28 (n=141, 33)
    19.10
    (4.209)
    18.52
    (5.316)
    Cycle 12 Day 1 (n=132, 30)
    19.14
    (4.547)
    18.87
    (4.547)
    Cycle 12 Day 28 (n=128, 31)
    19.06
    (4.456)
    19.45
    (4.178)
    Cycle 13 Day 1 (n=114, 27)
    19.38
    (4.170)
    18.63
    (4.853)
    Cycle 13 Day 28 (n=114, 27)
    19.39
    (4.034)
    18.97
    (3.993)
    Cycle 14 Day 1 (n=114, 26)
    19.55
    (3.951)
    18.05
    (4.814)
    Cycle 14 Day 28 (n=107, 25)
    19.23
    (4.522)
    18.76
    (4.085)
    Cycle 15 Day 1 (n=101, 21)
    19.57
    (4.171)
    18.24
    (4.795)
    Cycle 15 Day 28 (n=96, 20)
    19.41
    (4.459)
    18.75
    (4.447)
    Cycle 16 Day 1 (n=96, 19)
    19.54
    (4.258)
    17.26
    (5.675)
    Cycle 16 Day 28 (n=91, 18)
    19.33
    (4.287)
    16.83
    (5.113)
    Cycle 17 Day 1 (n=84, 17)
    19.95
    (3.997)
    18.28
    (5.151)
    Cycle 17 Day 28 (n=81, 14)
    19.66
    (4.420)
    18.00
    (5.218)
    Cycle 18 Day 1 (n=80, 12)
    19.64
    (4.132)
    19.62
    (4.971)
    Cycle 18 Day 28 (n=71, 11)
    19.34
    (4.125)
    19.55
    (4.677)
    Cycle 19 Day 1 (n=71, 11)
    19.94
    (4.052)
    19.09
    (5.224)
    Cycle 19 Day 28 (n=61, 10)
    19.61
    (4.469)
    18.20
    (6.630)
    Cycle 20 Day 1 (n=65, 9)
    20.00
    (4.138)
    18.67
    (5.788)
    Cycle 20 Day 28 (n=53, 9)
    19.75
    (4.206)
    18.67
    (6.384)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.929
    Confidence Interval (2-Sided) 95%
    0.460 to 1.398
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.922
    Confidence Interval () 95%
    0.469 to 1.375
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.918
    Confidence Interval () 95%
    0.471 to 1.365
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.911
    Confidence Interval () 95%
    0.469 to 1.352
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.907
    Confidence Interval () 95%
    0.466 to 1.348
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.899
    Confidence Interval () 95%
    0.453 to 1.345
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.895
    Confidence Interval () 95%
    0.444 to 1.347
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.888
    Confidence Interval () 95%
    0.421 to 1.355
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.884
    Confidence Interval () 95%
    0.406 to 1.362
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.877
    Confidence Interval () 95%
    0.375 to 1.379
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.873
    Confidence Interval () 95%
    0.356 to 1.390
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.866
    Confidence Interval () 95%
    0.318 to 1.414
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0029
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.862
    Confidence Interval () 95%
    0.295 to 1.428
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0055
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.854
    Confidence Interval () 95%
    0.251 to 1.457
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0076
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.850
    Confidence Interval () 95%
    0.226 to 1.475
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0129
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.843
    Confidence Interval () 95%
    0.179 to 1.508
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0168
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.839
    Confidence Interval () 95%
    0.151 to 1.527
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0257
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.832
    Confidence Interval () 95%
    0.101 to 1.563
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0318
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.828
    Confidence Interval () 95%
    0.072 to 1.583
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0447
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.821
    Confidence Interval () 95%
    0.019 to 1.622
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0529
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.817
    Confidence Interval () 95%
    -0.010 to 1.643
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0696
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.809
    Confidence Interval () 95%
    -0.065 to 1.683
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0797
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.805
    Confidence Interval () 95%
    -0.095 to 1.706
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0994
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.798
    Confidence Interval () 95%
    -0.151 to 1.747
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1110
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.794
    Confidence Interval () 95%
    -0.182 to 1.770
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1328
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.787
    Confidence Interval () 95%
    -0.239 to 1.813
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1454
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.783
    Confidence Interval () 95%
    -0.271 to 1.836
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1686
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.776
    Confidence Interval () 95%
    -0.329 to 1.880
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1817
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.771
    Confidence Interval () 95%
    -0.361 to 1.904
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2055
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.764
    Confidence Interval () 95%
    -0.419 to 1.948
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2188
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.760
    Confidence Interval () 95%
    -0.452 to 1.972
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2427
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.753
    Confidence Interval () 95%
    -0.510 to 2.016
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2559
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.749
    Confidence Interval () 95%
    -0.543 to 2.041
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2794
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.742
    Confidence Interval () 95%
    -0.602 to 2.086
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2923
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.738
    Confidence Interval () 95%
    -0.635 to 2.111
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3152
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.730
    Confidence Interval () 95%
    -0.695 to 2.156
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3276
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.726
    Confidence Interval () 95%
    -0.728 to 2.181
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3497
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.719
    Confidence Interval () 95%
    -0.788 to 2.227
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3616
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.715
    Confidence Interval () 95%
    -0.822 to 2.252
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3827
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.708
    Confidence Interval () 95%
    -0.882 to 2.298
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Baseline (n=371, 353)
    18.93
    (6.107)
    18.51
    (6.389)
    Cycle 1 Day 28 (n=347, 318)
    17.92
    (6.083)
    16.37
    (6.694)
    Cycle 2 Day 1 (n=328, 249)
    18.78
    (6.001)
    17.08
    (6.279)
    Cycle 2 Day 28 (n=315, 238)
    18.37
    (6.210)
    17.18
    (6.673)
    Cycle 3 Day 1 (n=294, 200)
    19.51
    (6.073)
    17.92
    (6.251)
    Cycle 3 Day 28 (n=287, 195)
    18.58
    (5.994)
    17.56
    (6.762)
    Cycle 4 Day 1 (n=272, 152)
    19.93
    (5.625)
    18.40
    (6.382)
    Cycle 4 Day 28 (n=265, 142)
    18.86
    (5.694)
    18.37
    (6.430)
    Cycle 5 Day 1 (n=249, 120)
    20.27
    (5.593)
    18.81
    (5.697)
    Cycle 5 Day 28 (n=241, 109)
    19.02
    (5.829)
    18.47
    (6.065)
    Cycle 6 Day 1 (n=239, 99)
    19.74
    (5.608)
    19.02
    (6.114)
    Cycle 6 Day 28 (n=222, 99)
    19.21
    (5.678)
    18.24
    (6.273)
    Cycle 7 Day 1 (n=208, 79)
    19.69
    (5.645)
    18.45
    (6.761)
    Cycle 7 Day 28 (n=204, 75)
    19.12
    (5.798)
    18.76
    (6.036)
    Cycle 8 Day 1 (n=192, 67)
    20.29
    (5.285)
    19.22
    (5.828)
    Cycle 8 Day 28 (n=190, 62)
    19.33
    (5.627)
    19.10
    (6.098)
    Cycle 9 Day 1 (n=170, 51)
    19.87
    (5.635)
    20.20
    (5.455)
    Cycle 9 Day 28 (n=167, 46)
    19.27
    (5.701)
    20.04
    (5.929)
    Cycle 10 Day 1 (n=161, 50)
    19.95
    (5.420)
    19.88
    (5.903)
    Cycle 10 Day 28 (n=154, 46)
    19.22
    (5.494)
    19.40
    (6.126)
    Cycle 11 Day 1 (n=137, 35)
    19.81
    (5.368)
    18.89
    (6.014)
    Cycle 11 Day 28 (n=140, 33)
    19.12
    (5.749)
    18.81
    (6.441)
    Cycle 12 Day 1 (n=132, 30)
    19.98
    (5.618)
    18.80
    (6.599)
    Cycle 12 Day 28 (n=128, 31)
    19.42
    (5.755)
    19.13
    (6.270)
    Cycle 13 Day 1 (n=114, 27)
    20.02
    (5.703)
    19.63
    (6.918)
    Cycle 13 Day 28 (n=114, 27)
    19.65
    (5.216)
    18.59
    (6.795)
    Cycle 14 Day 1 (n=114, 26)
    20.04
    (5.556)
    19.62
    (6.020)
    Cycle 14 Day 28 (n=107, 25)
    19.07
    (6.025)
    19.72
    (6.662)
    Cycle 15 Day 1 (n=101, 21)
    20.13
    (5.654)
    19.86
    (6.327)
    Cycle 15 Day 28 (n=96, 20)
    19.24
    (5.589)
    19.83
    (5.736)
    Cycle 16 Day 1 (n=96, 19)
    19.80
    (5.469)
    18.89
    (6.154)
    Cycle 16 Day 28 (n=91, 18)
    19.53
    (5.313)
    18.61
    (6.464)
    Cycle 17 Day 1 (n=85, 17)
    20.20
    (5.606)
    19.35
    (6.103)
    Cycle 17 Day 28 (n=81, 14)
    19.67
    (5.662)
    18.71
    (6.557)
    Cycle 18 Day 1 (n=80, 12)
    19.76
    (5.862)
    19.08
    (7.317)
    Cycle 18 Day 28 (n=71, 11)
    19.47
    (5.526)
    19.00
    (7.155)
    Cycle 19 Day 1 (n=71, 11)
    20.18
    (5.563)
    19.64
    (7.500)
    Cycle 19 Day 28 (n=61, 10)
    19.59
    (6.326)
    19.10
    (8.048)
    Cycle 20 Day 1 (n=65, 9)
    20.50
    (5.425)
    20.00
    (7.826)
    Cycle 20 Day 28 (n=53, 9)
    20.15
    (5.819)
    20.22
    (7.694)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.897
    Confidence Interval (2-Sided) 95%
    1.261 to 2.533
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.924
    Confidence Interval () 95%
    1.309 to 2.539
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.939
    Confidence Interval () 95%
    1.331 to 2.546
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.965
    Confidence Interval () 95%
    1.363 to 2.568
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.980
    Confidence Interval () 95%
    1.376 to 2.584
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.007
    Confidence Interval () 95%
    1.392 to 2.622
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.022
    Confidence Interval () 95%
    1.396 to 2.647
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.048
    Confidence Interval () 95%
    1.397 to 2.700
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.063
    Confidence Interval () 95%
    1.394 to 2.732
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.090
    Confidence Interval () 95%
    1.383 to 2.797
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.105
    Confidence Interval () 95%
    1.374 to 2.836
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.132
    Confidence Interval () 95%
    1.353 to 2.910
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.146
    Confidence Interval () 95%
    1.339 to 2.954
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.173
    Confidence Interval () 95%
    1.311 to 3.036
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.188
    Confidence Interval () 95%
    1.294 to 3.082
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.215
    Confidence Interval () 95%
    1.260 to 3.169
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.230
    Confidence Interval () 95%
    1.241 to 3.219
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.256
    Confidence Interval () 95%
    1.203 to 3.309
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.271
    Confidence Interval () 95%
    1.182 to 3.361
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.298
    Confidence Interval () 95%
    1.142 to 3.454
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.313
    Confidence Interval () 95%
    1.119 to 3.507
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.340
    Confidence Interval () 95%
    1.076 to 3.603
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.354
    Confidence Interval () 95%
    1.052 to 3.657
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.381
    Confidence Interval () 95%
    1.008 to 3.754
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.396
    Confidence Interval () 95%
    0.983 to 3.809
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.423
    Confidence Interval () 95%
    0.938 to 3.908
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0017
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.438
    Confidence Interval () 95%
    0.912 to 3.963
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.464
    Confidence Interval () 95%
    0.866 to 4.063
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0030
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.479
    Confidence Interval () 95%
    0.840 to 4.119
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0042
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.506
    Confidence Interval () 95%
    0.792 to 4.219
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0049
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.521
    Confidence Interval () 95%
    0.766 to 4.275
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0064
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.547
    Confidence Interval () 95%
    0.718 to 4.377
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0073
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.562
    Confidence Interval () 95%
    0.691 to 4.433
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0091
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.589
    Confidence Interval () 95%
    0.643 to 4.535
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0103
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.604
    Confidence Interval () 95%
    0.616 to 4.592
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0125
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.631
    Confidence Interval () 95%
    0.567 to 4.695
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0138
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.645
    Confidence Interval () 95%
    0.539 to 4.752
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0164
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.672
    Confidence Interval () 95%
    0.490 to 4.855
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0179
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.687
    Confidence Interval () 95%
    0.462 to 4.912
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0208
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.714
    Confidence Interval () 95%
    0.413 to 5.015
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    17. Secondary Outcome
    Title EuroQoL Five Dimension (EQ-5D) Health State Index
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Baseline (n=363, 352)
    0.76
    (0.225)
    0.76
    (0.234)
    Cycle 1 Day 28 (346, 315)
    0.72
    (0.262)
    0.70
    (0.274)
    Cycle 2 Day 1 (326, 244)
    0.78
    (0.230)
    0.75
    (0.231)
    Cycle 2 Day 28 (311, 233)
    0.73
    (0.246)
    0.74
    (0.230)
    Cycle 3 Day 1 (287, 200)
    0.78
    (0.220)
    0.76
    (0.222)
    Cycle 3 Day 28 (283, 195)
    0.75
    (0.231)
    0.75
    (0.218)
    Cycle 4 Day 1 (269, 150)
    0.80
    (0.199)
    0.80
    (0.190)
    Cycle 4 Day 28 (261, 142)
    0.76
    (0.218)
    0.79
    (0.216)
    Cycle 5 Day 1 (247, 120)
    0.80
    (0.209)
    0.79
    (0.194)
    Cycle 5 Day 28 (240, 106)
    0.76
    (0.223)
    0.78
    (0.201)
    Cycle 6 Day 1 (240, 98)
    0.80
    (0.249)
    0.80
    (0.178)
    Cycle 6 Day 28 (224, 100)
    0.77
    (0.206)
    0.80
    (0.187)
    Cycle 7 Day 1 (205, 79)
    0.81
    (0.192)
    0.80
    (0.185)
    Cycle 7 Day 28 (204, 74)
    0.77
    (0.221)
    0.81
    (0.156)
    Cycle 8 Day 1 (192, 68)
    0.82
    (0.180)
    0.82
    (0.158)
    Cycle 8 Day 28 (190, 61)
    0.77
    (0.222)
    0.81
    (0.163)
    Cycle 9 Day 1 (170, 51)
    0.80
    (0.196)
    0.84
    (0.162)
    Cycle 9 Day 28 (168, 45)
    0.78
    (0.194)
    0.84
    (0.147)
    Cycle 10 Day 1 (161, 50)
    0.81
    (0.209)
    0.85
    (0.161)
    Cycle 10 Day 28 (153, 46)
    0.78
    (0.200)
    0.82
    (0.185)
    Cycle 11 Day 1 (138, 34)
    0.80
    (0.192)
    0.85
    (0.159)
    Cycle 11 Day 28 (138, 32)
    0.75
    (0.189)
    0.84
    (0.185)
    Cycle 12 Day 1 (132, 31)
    0.81
    (0.187)
    0.82
    (0.283)
    Cycle 12 Day 28 (127, 31)
    0.77
    (0.182)
    0.85
    (0.165)
    Cycle 13 Day 1 (114, 26)
    0.81
    (0.176)
    0.83
    (0.231)
    Cycle 13 Day 28 (115, 27)
    0.77
    (0.186)
    0.82
    (0.260)
    Cycle 14 Day 1 (114, 25)
    0.81
    (0.181)
    0.86
    (0.148)
    Cycle 14 Day 28 (107, 24)
    0.75
    (0.224)
    0.87
    (0.160)
    Cycle 15 Day 1 (100, 21)
    0.80
    (0.190)
    0.88
    (0.146)
    Cycle 15 Day 28 (95, 20)
    0.75
    (0.209)
    0.88
    (0.141)
    Cycle 16 Day 1 (96, 19)
    0.79
    (0.194)
    0.84
    (0.163)
    Cycle 16 Day 28 (93, 18)
    0.76
    (0.181)
    0.83
    (0.164)
    Cycle 17 Day 1 (84, 15)
    0.79
    (0.194)
    0.88
    (0.169)
    Cycle 17 Day 28 (82, 14)
    0.77
    (0.168)
    0.83
    (0.174)
    Cycle 18 Day 1 (80, 12)
    0.81
    (0.187)
    0.86
    (0.274)
    Cycle 18 Day 28 (71, 10)
    0.76
    (0.166)
    0.84
    (0.279)
    Cycle 19 Day 1 (69, 11)
    0.81
    (0.183)
    0.88
    (0.184)
    Cycle 19 Day 28 (62, 11)
    0.78
    (0.165)
    0.72
    (0.436)
    Cycle 20 Day 1 (63, 8)
    0.81
    (0.162)
    0.85
    (0.182)
    Cycle 20 Day 28 (54, 9)
    0.77
    (0.181)
    0.86
    (0.215)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.049
    Confidence Interval (2-Sided) 95%
    0.022 to 0.076
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.048
    Confidence Interval () 95%
    0.022 to 0.075
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.048
    Confidence Interval () 95%
    0.022 to 0.074
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.047
    Confidence Interval () 95%
    0.021 to 0.072
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.046
    Confidence Interval () 95%
    0.021 to 0.072
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.045
    Confidence Interval () 95%
    0.020 to 0.071
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.045
    Confidence Interval () 95%
    0.019 to 0.070
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.044
    Confidence Interval () 95%
    0.017 to 0.070
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0016
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.043
    Confidence Interval () 95%
    0.016 to 0.070
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0029
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.042
    Confidence Interval () 95%
    0.014 to 0.070
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0041
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.042
    Confidence Interval () 95%
    0.013 to 0.070
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0076
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.041
    Confidence Interval () 95%
    0.011 to 0.071
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0105
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.040
    Confidence Interval () 95%
    0.009 to 0.071
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0179
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.039
    Confidence Interval () 95%
    0.007 to 0.072
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0236
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.039
    Confidence Interval () 95%
    0.005 to 0.072
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0370
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.038
    Confidence Interval () 95%
    0.002 to 0.073
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0464
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.037
    Confidence Interval () 95%
    0.001 to 0.074
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0667
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.036
    Confidence Interval () 95%
    -0.002 to 0.075
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0800
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.036
    Confidence Interval () 95%
    -0.004 to 0.076
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1070
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.035
    Confidence Interval () 95%
    -0.007 to 0.077
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1237
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.034
    Confidence Interval () 95%
    -0.009 to 0.078
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1561
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.033
    Confidence Interval () 95%
    -0.013 to 0.079
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1752
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.033
    Confidence Interval () 95%
    -0.015 to 0.080
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2112
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.032
    Confidence Interval () 95%
    -0.018 to 0.081
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2319
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.031
    Confidence Interval () 95%
    -0.020 to 0.082
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2698
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.030
    Confidence Interval () 95%
    -0.023 to 0.084
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2910
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.030
    Confidence Interval () 95%
    -0.025 to 0.085
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3293
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.029
    Confidence Interval () 95%
    -0.029 to 0.086
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3504
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.028
    Confidence Interval () 95%
    -0.031 to 0.087
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3881
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.027
    Confidence Interval () 95%
    -0.034 to 0.089
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4086
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.027
    Confidence Interval () 95%
    -0.036 to 0.090
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4449
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.026
    Confidence Interval () 95%
    -0.040 to 0.091
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4646
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.025
    Confidence Interval () 95%
    -0.042 to 0.092
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4990
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.024
    Confidence Interval () 95%
    -0.046 to 0.094
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5176
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.024
    Confidence Interval () 95%
    -0.048 to 0.095
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5501
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.023
    Confidence Interval () 95%
    -0.051 to 0.097
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5675
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.022
    Confidence Interval () 95%
    -0.054 to 0.098
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5979
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.021
    Confidence Interval () 95%
    -0.057 to 0.099
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6141
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.021
    Confidence Interval () 95%
    -0.059 to 0.100
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6424
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.020
    Confidence Interval () 95%
    -0.063 to 0.102
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    18. Secondary Outcome
    Title Euro-QoL Visual Analog Scale (EQ-VAS)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Baseline (n=365, 352)
    73.80
    (18.498)
    71.43
    (19.507)
    Cycle 1 Day 28 (n=347, 315)
    69.35
    (18.992)
    67.66
    (20.058)
    Cycle 2 Day 1 (n=323, 247)
    75.05
    (17.964)
    70.45
    (17.653)
    Cycle 2 Day 28 (n=314, 237)
    72.06
    (18.297)
    70.70
    (18.271)
    Cycle 3 Day 1 (n=293, 198)
    76.23
    (17.171)
    72.68
    (17.162)
    Cycle 3 Day 28 (n=287, 193)
    72.33
    (18.472)
    71.45
    (18.315)
    Cycle 4 Day 1 (n=270, 152)
    77.46
    (16.024)
    72.74
    (17.678)
    Cycle 4 Day 28 (n=264, 139)
    75.15
    (16.406)
    72.20
    (18.098)
    Cycle 5 Day 1 (n=248, 118)
    79.83
    (13.554)
    73.44
    (16.204)
    Cycle 5 Day 28 (n=240, 104)
    75.13
    (16.771)
    72.57
    (16.007)
    Cycle 6 Day 1 (n=237, 99)
    78.83
    (15.359)
    73.68
    (16.537)
    Cycle 6 Day 28 (n=223, 98)
    76.81
    (15.204)
    72.26
    (18.452)
    Cycle 7 Day 1 (n=209, 77)
    79.39
    (14.601)
    73.80
    (18.868)
    Cycle 7 Day 28 (n=201, 74)
    76.09
    (16.693)
    73.46
    (17.380)
    Cycle 8 Day 1 (n=192, 67)
    81.34
    (13.020)
    74.27
    (18.067)
    Cycle 8 Day 28 (n=191, 60)
    77.53
    (14.374)
    74.33
    (18.407)
    Cycle 9 Day 1 (n=172, 50)
    80.08
    (13.812)
    77.66
    (15.987)
    Cycle 9 Day 28 (n=168, 46)
    76.24
    (15.740)
    76.57
    (17.924)
    Cycle 10 Day 1 (n=160, 50)
    79.18
    (14.912)
    76.64
    (17.886)
    Cycle 10 Day 28 (n=154, 45)
    76.44
    (16.106)
    76.69
    (19.123)
    Cycle 11 Day 1 (n=138, 34)
    79.72
    (15.685)
    75.06
    (20.179)
    Cycle 11 Day 28 (n=141, 33)
    76.81
    (15.128)
    72.21
    (23.202)
    Cycle 12 Day 1 (n=130, 31)
    80.84
    (14.150)
    75.19
    (22.020)
    Cycle 12 Day 28 (n=128, 31)
    76.71
    (14.986)
    73.84
    (20.775)
    Cycle 13 Day 1 (n=114, 27)
    80.59
    (14.875)
    77.52
    (17.738)
    Cycle 13 Day 28 (n=115, 27)
    77.22
    (14.715)
    73.56
    (23.523)
    Cycle 14 Day 1 (n=114, 26)
    80.39
    (14.477)
    76.69
    (16.601)
    Cycle 14 Day 28 (n=107, 25)
    76.53
    (15.933)
    76.44
    (18.890)
    Cycle 15 Day 1 (n=101, 21)
    80.50
    (14.361)
    76.62
    (19.075)
    Cycle 15 Day 28 (n=96, 20)
    76.51
    (15.141)
    76.50
    (18.841)
    Cycle 16 Day 1 (n=96, 19)
    79.85
    (15.632)
    74.84
    (21.680)
    Cycle 16 Day 28 (n=92, 18)
    75.51
    (17.687)
    73.11
    (21.202)
    Cycle 17 Day 1 (n=84, 17)
    80.74
    (15.706)
    76.94
    (21.256)
    Cycle 17 Day 28 (n=82, 14)
    77.10
    (16.612)
    72.86
    (22.593)
    Cycle 18 Day 1 (n=78, 12)
    80.40
    (14.658)
    74.42
    (25.065)
    Cycle 18 Day 28 (n=70, 11)
    77.76
    (16.142)
    73.82
    (24.140)
    Cycle 19 Day 1 (n=70, 11)
    81.47
    (15.330)
    79.27
    (20.283)
    Cycle 19 Day 28 (n=62, 11)
    77.05
    (18.676)
    68.55
    (29.717)
    Cycle 20 Day 1 (n=65, 9)
    81.10
    (15.404)
    76.00
    (21.494)
    Cycle 20 Day 28 (n=54, 9)
    76.85
    (16.863)
    75.44
    (25.060)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.026
    Confidence Interval (2-Sided) 95%
    2.088 to 5.965
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.165
    Confidence Interval () 95%
    2.269 to 6.061
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.243
    Confidence Interval () 95%
    2.358 to 6.128
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.382
    Confidence Interval () 95%
    2.494 to 6.269
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.459
    Confidence Interval () 95%
    2.558 to 6.361
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.598
    Confidence Interval () 95%
    2.650 to 6.547
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.676
    Confidence Interval () 95%
    2.689 to 6.662
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.815
    Confidence Interval () 95%
    2.741 to 6.889
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.892
    Confidence Interval () 95%
    2.760 to 7.024
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.031
    Confidence Interval () 95%
    2.780 to 7.283
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.109
    Confidence Interval () 95%
    2.783 to 7.435
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.248
    Confidence Interval () 95%
    2.776 to 7.720
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.325
    Confidence Interval () 95%
    2.767 to 7.884
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.464
    Confidence Interval () 95%
    2.741 to 8.188
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.542
    Confidence Interval () 95%
    2.723 to 8.361
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.681
    Confidence Interval () 95%
    2.683 to 8.679
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.758
    Confidence Interval () 95%
    2.657 to 8.859
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.898
    Confidence Interval () 95%
    2.607 to 9.188
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.975
    Confidence Interval () 95%
    2.576 to 9.374
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.114
    Confidence Interval () 95%
    2.517 to 9.711
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.191
    Confidence Interval () 95%
    2.482 to 9.900
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.331
    Confidence Interval () 95%
    2.417 to 10.244
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0018
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.408
    Confidence Interval () 95%
    2.379 to 10.436
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.547
    Confidence Interval () 95%
    2.309 to 10.785
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0029
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.624
    Confidence Interval () 95%
    2.269 to 10.980
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0037
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.764
    Confidence Interval () 95%
    2.195 to 11.332
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0042
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.841
    Confidence Interval () 95%
    2.153 to 11.529
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0053
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.980
    Confidence Interval () 95%
    2.076 to 11.884
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0059
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 7.057
    Confidence Interval () 95%
    2.032 to 12.083
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0072
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 7.197
    Confidence Interval () 95%
    1.953 to 12.441
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0079
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 7.274
    Confidence Interval () 95%
    1.908 to 12.640
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0093
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 7.413
    Confidence Interval () 95%
    1.826 to 13.000
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0101
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 7.491
    Confidence Interval () 95%
    1.780 to 13.201
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0117
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 7.630
    Confidence Interval () 95%
    1.697 to 13.562
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0126
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 7.707
    Confidence Interval () 95%
    1.650 to 13.764
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0144
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 7.846
    Confidence Interval () 95%
    1.565 to 14.127
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0153
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 7.924
    Confidence Interval () 95%
    1.518 to 14.329
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0172
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 8.063
    Confidence Interval () 95%
    1.432 to 14.693
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0182
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 8.140
    Confidence Interval () 95%
    1.384 to 14.896
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection SU011248, IFN-α
    Comments 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)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0201
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 8.279
    Confidence Interval () 95%
    1.297 to 15.261
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    19. Secondary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 35 31
    Plasma VEGF-A: Baseline (n=33, 31)
    101.9
    (184.3)
    109.0
    (242.4)
    Plasma VEGF-A: C1D28: C1D1 (n=31, 26)
    4.280
    (2.619)
    1.134
    (0.683)
    Plasma VEGF-A: C2D1: C1D1 (n=32, 21)
    1.161
    (0.624)
    1.171
    (0.527)
    Plasma VEGF-A: C2D28: C1D1 (n=31, 20)
    5.851
    (4.345)
    1.153
    (0.517)
    Plasma VEGF-A: C3D1: C1D1 (n=27, 15)
    1.630
    (1.685)
    1.253
    (0.483)
    Plasma VEGF-A: C3D28: C1D1 (n=28, 15)
    5.236
    (3.333)
    1.149
    (0.570)
    Plasma VEGF-A: C4D1: C1D1 (n=27, 12)
    1.486
    (1.125)
    1.209
    (0.654)
    Plasma VEGF-A: C4D28: C1D1 (n=25, 11)
    4.924
    (3.679)
    1.008
    (0.372)
    Plasma VEGF-C: Baseline (n=35, 31)
    556.4
    (311.7)
    651.2
    (552.3)
    Plasma VEGF-C: C1D28: C1D1 (n=31, 26)
    0.945
    (0.428)
    1.165
    (0.606)
    Plasma VEGF-C: C2D1:C1D1 (n=30, 21)
    1.045
    (0.623)
    1.177
    (0.464)
    Plasma VEGF-C: C2D28:C1D1 (n=31, 19)
    0.871
    (0.511)
    1.081
    (0.410)
    Plasma VEGF-C: C3D1:C1D1 (n=28, 15)
    1.159
    (0.659)
    1.174
    (0.588)
    Plasma VEGF-C: C3D28:C1D1 (n=28, 15)
    1.043
    (0.926)
    1.054
    (0.586)
    Plasma VEGF-C: C4D1:C1D1 (n=28, 12)
    1.243
    (1.304)
    1.382
    (0.799)
    Plasma VEGF-C: C4:D28:C1D1 (n=26, 11)
    1.207
    (1.269)
    1.139
    (0.403)
    PLASMA sVEGFR-3: Baseline (n=29, 30)
    44049.3
    (20168.2)
    40317.7
    (12938.3)
    PLASMA sVEGFR-3: C1D28:C1D1 (n=27, 25)
    0.473
    (0.185)
    1.068
    (0.292)
    PLASMA sVEGFR-3: C2D1:C1D1 (n=28, 20)
    0.787
    (0.172)
    1.075
    (0.331)
    PLASMA sVEGFR-3: C2D28:C1D1 (n=28, 19)
    0.407
    (0.173)
    1.150
    (0.355)
    PLASMA sVEGFR-3: C3D1:C1D1 (n=25, 14)
    0.800
    (0.309)
    1.015
    (0.210)
    PLASMA sVEGFR-3: C3D28:C1D1 (n=25, 14)
    0.427
    (0.194)
    1.042
    (0.349)
    PLASMA sVEGFR-3: C4D1:C1D1 (n=24, 11)
    0.846
    (0.380)
    1.183
    (0.333)
    PLASMA sVEGFR-3: C4:D28:C1D1 (n=23, 10)
    0.486
    (0.265)
    1.044
    (0.141)
    PLASMA IL-8: Baseline (n=31, 29)
    10.1
    (9.7)
    18.6
    (32.0)
    PLASMA IL-8: C1D28:C1D1 (n=29, 25)
    2.815
    (1.340)
    2.297
    (2.036)
    PLASMA IL-8: C2D1:C1D1 (n=29, 20)
    1.716
    (0.630)
    1.579
    (0.688)
    PLASMA IL-8: C2D28:C1D1 (n=29, 19)
    2.423
    (1.514)
    1.858
    (0.849)
    PLASMA IL-8: C3D1:C1D1 (n=26, 15)
    2.788
    (2.781)
    1.531
    (0.693)
    PLASMA IL-8: C3D28:C1D1 (n=26, 14)
    2.574
    (1.726)
    1.999
    (0.964)
    PLASMA IL-8: C4D1:C1D1 (n=26, 12)
    1.934
    (1.372)
    1.662
    (0.736)
    PLASMA IL-8: C4:D28:C1D1 (n=25, 11)
    2.549
    (1.489)
    2.492
    (2.023)
    PLASMA bFGF: Baseline (n=21, 2)
    13.1
    (13.1)
    13.6
    (16.8)
    PLASMA bFGF: C1D28:C1D1 (n=15, 1)
    2.762
    (5.087)
    0.429
    (0)
    PLASMA bFGF: C2D1:C1D1 (n=13, 1)
    1.370
    (1.800)
    0.157
    (0)
    20. Secondary Outcome
    Title Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 14 0
    PLASMA bFGF: C2D28:C1D1 (n=14, 0)
    0.760
    (0.604)
    PLASMA bFGF: C3D1:C1D1 (n=12, 0)
    1.582
    (2.622)
    PLASMA bFGF: C3D28:C1D1 (n=12, 0)
    1.671
    (2.109)
    PLASMA bFGF: C4D1:C1D1 (n=14, 0)
    2.895
    (4.252)
    PLASMA bFGF: C4:D28:C1D1 (n=10, 0)
    0.803
    (0.799)
    21. Secondary Outcome
    Title Incremental Cost Effectiveness Ratio (ICER)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    Measure Participants 375 375
    Number [ratio]
    0
    0
    22. Secondary Outcome
    Title Ctrough Concentrations of SU011248
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title SU011248
    Arm/Group Description 50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle. Intra-subject dose reduction to 35.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
    Measure Participants 45
    Cycle 1, Day 28 (n=31)
    57.26
    (31.37)
    Cycle 2, Day 28 (n=36)
    57.59
    (28.59)
    Cycle 3, Day 28 (n=36)
    50.26
    (24.89)
    Cycle 4, Day 28 (n=32)
    45.05
    (23.76)
    Dose-Corrected: Cycle 1, Day 28 (n=24)
    64.22
    (31.40)
    Dose-Corrected: Cycle 2, Day 28 (n=28)
    59.90
    (26.42)
    Dose-Corrected: Cycle 3, Day 28 (n=27)
    58.45
    (29.39)
    Dose-Corrected: Cycle 4, Day 28 (n=26)
    54.31
    (30.70)
    23. Secondary Outcome
    Title Ctrough Concentrations of Metabolite SU012662
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title SU012662
    Arm/Group Description Active metabolite of SU011248
    Measure Participants 45
    Cycle 1, Day 28 (n=31)
    27.10
    (17.28)
    Cycle 2, Day 28 (n=36)
    27.35
    (15.42)
    Cycle 3, Day 28 (n=36)
    26.11
    (16.15)
    Cycle 4, Day 28 (n=32)
    22.11
    (12.67)
    Dose-Corrected: Cycle 1, Day 28 (n=24)
    28.21
    (19.01)
    Dose-Corrected: Cycle 2, Day 28 (n=28)
    28.32
    (13.74)
    Dose-Corrected: Cycle 3, Day 28 (n=27)
    29.04
    (19.07)
    Dose-Corrected: Cycle 4, Day 28 (n=26)
    25.99
    (16.25)
    24. Secondary Outcome
    Title Ctrough Concentrations of SU011248 and Active Metabolite SU012662
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Total Drug: SU011248 and SU012662
    Arm/Group Description SU011248 and active metabolite SU012662
    Measure Participants 45
    Cycle 1, Day 28 (n=31)
    84.36
    (46.06)
    Cycle 2, Day 28 (n=36)
    84.94
    (41.18)
    Cycle 3, Day 28 (n=36)
    76.37
    (38.86)
    Cycle 4, Day 28 (n=32)
    67.15
    (34.13)
    Dose-Corrected: Cycle 1, Day 28 (n=24)
    92.43
    (48.08)
    Dose-Corrected: Cycle 2, Day 28 (n=28)
    88.22
    (36.34)
    Dose-Corrected: Cycle 3, Day 28 (n=27)
    87.49
    (45.85)
    Dose-Corrected: Cycle 4, Day 28 (n=27)
    80.30
    (44.76)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title SU011248 IFN-α
    Arm/Group Description 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. 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.
    All Cause Mortality
    SU011248 IFN-α
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    SU011248 IFN-α
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 170/375 (45.3%) 93/360 (25.8%)
    Blood and lymphatic system disorders
    Anaemia 14/375 (3.7%) 12/360 (3.3%)
    Thrombocytopenia 5/375 (1.3%) 0/360 (0%)
    Febrile neutropenia 3/375 (0.8%) 0/360 (0%)
    Idiopathic thrombocytopenic purpura 2/375 (0.5%) 0/360 (0%)
    Leukopenia 1/375 (0.3%) 0/360 (0%)
    Neutropenia 1/375 (0.3%) 0/360 (0%)
    Thrombotic thrombocytopenic purpura 1/375 (0.3%) 0/360 (0%)
    Cardiac disorders
    Myocardial infarction 5/375 (1.3%) 2/360 (0.6%)
    Atrial fibrillation 3/375 (0.8%) 0/360 (0%)
    Coronary artery disease 2/375 (0.5%) 0/360 (0%)
    Pericardial effusion 2/375 (0.5%) 1/360 (0.3%)
    Atrial flutter 1/375 (0.3%) 0/360 (0%)
    Cardiac arrest 1/375 (0.3%) 0/360 (0%)
    Cardiac failure congestive 1/375 (0.3%) 1/360 (0.3%)
    Left ventricular dysfunction 1/375 (0.3%) 0/360 (0%)
    Myocardial ischaemia 1/375 (0.3%) 0/360 (0%)
    Palpitations 1/375 (0.3%) 0/360 (0%)
    Tachycardia 1/375 (0.3%) 0/360 (0%)
    Acute myocardial infarction 0/375 (0%) 1/360 (0.3%)
    Cardiac disorder 0/375 (0%) 1/360 (0.3%)
    Ear and labyrinth disorders
    Deafness 1/375 (0.3%) 0/360 (0%)
    Vertigo positional 0/375 (0%) 1/360 (0.3%)
    Endocrine disorders
    Hypothyroidism 8/375 (2.1%) 0/360 (0%)
    Hyperthyroidism 0/375 (0%) 1/360 (0.3%)
    Eye disorders
    Visual impairment 2/375 (0.5%) 0/360 (0%)
    Retinal artery occlusion 1/375 (0.3%) 0/360 (0%)
    Gastrointestinal disorders
    Vomiting 12/375 (3.2%) 3/360 (0.8%)
    Nausea 10/375 (2.7%) 3/360 (0.8%)
    Abdominal pain 8/375 (2.1%) 3/360 (0.8%)
    Diarrhoea 5/375 (1.3%) 0/360 (0%)
    Gastrointestinal haemorrhage 4/375 (1.1%) 0/360 (0%)
    Dysphagia 2/375 (0.5%) 0/360 (0%)
    Gastric haemorrhage 2/375 (0.5%) 0/360 (0%)
    Intestinal obstruction 2/375 (0.5%) 0/360 (0%)
    Intestinal perforation 2/375 (0.5%) 1/360 (0.3%)
    Pancreatitis 2/375 (0.5%) 0/360 (0%)
    Stomatitis 2/375 (0.5%) 0/360 (0%)
    Abdominal pain lower 1/375 (0.3%) 0/360 (0%)
    Anal fistula 1/375 (0.3%) 0/360 (0%)
    Ascites 1/375 (0.3%) 0/360 (0%)
    Constipation 1/375 (0.3%) 1/360 (0.3%)
    Gastric ulcer haemorrhage 1/375 (0.3%) 0/360 (0%)
    Gastrointestinal obstruction 1/375 (0.3%) 0/360 (0%)
    Glossodynia 1/375 (0.3%) 0/360 (0%)
    Haematemesis 1/375 (0.3%) 0/360 (0%)
    Haematochezia 1/375 (0.3%) 0/360 (0%)
    Haemorrhoidal haemorrhage 1/375 (0.3%) 0/360 (0%)
    Ileus 1/375 (0.3%) 0/360 (0%)
    Intestinal fistula 1/375 (0.3%) 0/360 (0%)
    Mouth ulceration 1/375 (0.3%) 0/360 (0%)
    Rectal haemorrhage 1/375 (0.3%) 1/360 (0.3%)
    Small intestinal obstruction 1/375 (0.3%) 0/360 (0%)
    Tongue oedema 1/375 (0.3%) 0/360 (0%)
    Abdominal pain upper 0/375 (0%) 2/360 (0.6%)
    Dry mouth 0/375 (0%) 1/360 (0.3%)
    Large intestine perforation 0/375 (0%) 1/360 (0.3%)
    Upper gastrointestinal haemorrhage 0/375 (0%) 1/360 (0.3%)
    General disorders
    Disease progression 17/375 (4.5%) 15/360 (4.2%)
    Asthenia 16/375 (4.3%) 5/360 (1.4%)
    Chest pain 7/375 (1.9%) 6/360 (1.7%)
    General physical health deterioration 5/375 (1.3%) 0/360 (0%)
    Pyrexia 5/375 (1.3%) 0/360 (0%)
    Condition aggravated 3/375 (0.8%) 2/360 (0.6%)
    Fatigue 3/375 (0.8%) 5/360 (1.4%)
    Oedema peripheral 2/375 (0.5%) 0/360 (0%)
    Pain 2/375 (0.5%) 0/360 (0%)
    Chills 1/375 (0.3%) 0/360 (0%)
    Face oedema 1/375 (0.3%) 0/360 (0%)
    Hypothermia 1/375 (0.3%) 0/360 (0%)
    Sudden death 1/375 (0.3%) 0/360 (0%)
    Performance status decreased 0/375 (0%) 2/360 (0.6%)
    Hepatobiliary disorders
    Biliary tract disorder 1/375 (0.3%) 0/360 (0%)
    Cholecystitis 1/375 (0.3%) 0/360 (0%)
    Cholecystitis acute 1/375 (0.3%) 0/360 (0%)
    Cholelithiasis 1/375 (0.3%) 0/360 (0%)
    Hepatitis 1/375 (0.3%) 0/360 (0%)
    Bile duct stone 0/375 (0%) 1/360 (0.3%)
    Infections and infestations
    Cellulitis 3/375 (0.8%) 0/360 (0%)
    Pneumonia 3/375 (0.8%) 2/360 (0.6%)
    Gastroenteritis 2/375 (0.5%) 0/360 (0%)
    Urosepsis 2/375 (0.5%) 0/360 (0%)
    Arthritis bacterial 1/375 (0.3%) 0/360 (0%)
    Arthritis infective 1/375 (0.3%) 0/360 (0%)
    Fungal infection 1/375 (0.3%) 0/360 (0%)
    Herpes zoster 1/375 (0.3%) 0/360 (0%)
    Infected skin ulcer 1/375 (0.3%) 0/360 (0%)
    Localised infection 1/375 (0.3%) 0/360 (0%)
    Lung infection 1/375 (0.3%) 0/360 (0%)
    Oesophageal candidiasis 1/375 (0.3%) 0/360 (0%)
    Otitis externa 1/375 (0.3%) 0/360 (0%)
    Perirectal abscess 1/375 (0.3%) 0/360 (0%)
    Pleural infection 1/375 (0.3%) 0/360 (0%)
    Pyothorax 1/375 (0.3%) 0/360 (0%)
    Sepsis 1/375 (0.3%) 2/360 (0.6%)
    Sinusitis 1/375 (0.3%) 1/360 (0.3%)
    Upper respiratory tract infection 1/375 (0.3%) 0/360 (0%)
    Urinary tract infection 1/375 (0.3%) 1/360 (0.3%)
    Wound infection 1/375 (0.3%) 0/360 (0%)
    Diverticulitis 0/375 (0%) 1/360 (0.3%)
    Infection 0/375 (0%) 1/360 (0.3%)
    Respiratory tract infection 0/375 (0%) 1/360 (0.3%)
    Staphylococcal infection 0/375 (0%) 1/360 (0.3%)
    Injury, poisoning and procedural complications
    Cervical vertebral fracture 1/375 (0.3%) 0/360 (0%)
    Dislocation of joint prosthesis 1/375 (0.3%) 0/360 (0%)
    Head injury 1/375 (0.3%) 0/360 (0%)
    Hip fracture 1/375 (0.3%) 0/360 (0%)
    Humerus fracture 1/375 (0.3%) 1/360 (0.3%)
    Lumbar vertebral fracture 1/375 (0.3%) 0/360 (0%)
    Wound dehiscence 1/375 (0.3%) 0/360 (0%)
    Brain herniation 0/375 (0%) 1/360 (0.3%)
    Pelvic fracture 0/375 (0%) 1/360 (0.3%)
    Investigations
    Blood bilirubin increased 2/375 (0.5%) 0/360 (0%)
    Ejection fraction decreased 2/375 (0.5%) 0/360 (0%)
    Platelet count decreased 2/375 (0.5%) 0/360 (0%)
    Alanine aminotransferase increased 1/375 (0.3%) 0/360 (0%)
    Aspartate aminotransferase increased 1/375 (0.3%) 0/360 (0%)
    Blood creatine phosphokinase increased 1/375 (0.3%) 0/360 (0%)
    Electrocardiogram change 1/375 (0.3%) 0/360 (0%)
    Haemoglobin decreased 1/375 (0.3%) 0/360 (0%)
    Urine output decreased 1/375 (0.3%) 0/360 (0%)
    Blood creatinine increased 0/375 (0%) 1/360 (0.3%)
    Weight decreased 0/375 (0%) 1/360 (0.3%)
    Metabolism and nutrition disorders
    Dehydration 11/375 (2.9%) 6/360 (1.7%)
    Hyponatraemia 5/375 (1.3%) 0/360 (0%)
    Anorexia 3/375 (0.8%) 0/360 (0%)
    Hypoglycaemia 3/375 (0.8%) 0/360 (0%)
    Decreased appetite 1/375 (0.3%) 0/360 (0%)
    Hyperglycaemia 1/375 (0.3%) 0/360 (0%)
    Hyperkalaemia 1/375 (0.3%) 1/360 (0.3%)
    Hypokalaemia 1/375 (0.3%) 0/360 (0%)
    Diabetes mellitus 0/375 (0%) 3/360 (0.8%)
    Hypercalcaemia 0/375 (0%) 2/360 (0.6%)
    Hyperuricaemia 0/375 (0%) 1/360 (0.3%)
    Musculoskeletal and connective tissue disorders
    Back pain 7/375 (1.9%) 1/360 (0.3%)
    Arthralgia 2/375 (0.5%) 1/360 (0.3%)
    Muscular weakness 2/375 (0.5%) 0/360 (0%)
    Pathological fracture 2/375 (0.5%) 5/360 (1.4%)
    Bone pain 1/375 (0.3%) 1/360 (0.3%)
    Groin pain 1/375 (0.3%) 0/360 (0%)
    Hypercreatinaemia 1/375 (0.3%) 0/360 (0%)
    Musculoskeletal chest pain 1/375 (0.3%) 0/360 (0%)
    Pain in extremity 1/375 (0.3%) 1/360 (0.3%)
    Fistula 0/375 (0%) 1/360 (0.3%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain 1/375 (0.3%) 0/360 (0%)
    Colon cancer 1/375 (0.3%) 0/360 (0%)
    Prostate cancer 1/375 (0.3%) 1/360 (0.3%)
    Intracranial tumour haemorrhage 0/375 (0%) 1/360 (0.3%)
    Nervous system disorders
    Convulsion 3/375 (0.8%) 1/360 (0.3%)
    Spinal cord compression 3/375 (0.8%) 1/360 (0.3%)
    Epilepsy 2/375 (0.5%) 1/360 (0.3%)
    Headache 2/375 (0.5%) 0/360 (0%)
    Monoparesis 2/375 (0.5%) 0/360 (0%)
    Syncope 2/375 (0.5%) 1/360 (0.3%)
    Aphasia 1/375 (0.3%) 0/360 (0%)
    Cerebellar syndrome 1/375 (0.3%) 0/360 (0%)
    Cerebral haematoma 1/375 (0.3%) 0/360 (0%)
    Cerebral ischaemia 1/375 (0.3%) 0/360 (0%)
    Facial palsy 1/375 (0.3%) 0/360 (0%)
    Hemiparesis 1/375 (0.3%) 1/360 (0.3%)
    Incoherent 1/375 (0.3%) 0/360 (0%)
    Memory impairment 1/375 (0.3%) 0/360 (0%)
    Nervous system disorder 1/375 (0.3%) 0/360 (0%)
    Paresis 1/375 (0.3%) 0/360 (0%)
    Peripheral sensory neuropathy 1/375 (0.3%) 0/360 (0%)
    Reversible posterior leukoencephalopathy syndrome 1/375 (0.3%) 0/360 (0%)
    Transient ischaemic attack 1/375 (0.3%) 1/360 (0.3%)
    Cerebral haemorrhage 0/375 (0%) 1/360 (0.3%)
    Cerebrovascular accident 0/375 (0%) 1/360 (0.3%)
    Dizziness 0/375 (0%) 1/360 (0.3%)
    Haemorrhage intracranial 0/375 (0%) 1/360 (0.3%)
    Motor dysfunction 0/375 (0%) 1/360 (0.3%)
    Psychiatric disorders
    Confusional state 3/375 (0.8%) 0/360 (0%)
    Mental status changes 2/375 (0.5%) 2/360 (0.6%)
    Anxiety 1/375 (0.3%) 0/360 (0%)
    Delirium 1/375 (0.3%) 0/360 (0%)
    Insomnia 1/375 (0.3%) 0/360 (0%)
    Depression 0/375 (0%) 1/360 (0.3%)
    Emotional disorder 0/375 (0%) 1/360 (0.3%)
    Renal and urinary disorders
    Haematuria 5/375 (1.3%) 1/360 (0.3%)
    Renal failure 4/375 (1.1%) 1/360 (0.3%)
    Renal failure acute 4/375 (1.1%) 1/360 (0.3%)
    Urinary retention 2/375 (0.5%) 2/360 (0.6%)
    Nephrotic syndrome 1/375 (0.3%) 0/360 (0%)
    Pollakiuria 1/375 (0.3%) 0/360 (0%)
    Urinary bladder haemorrhage 1/375 (0.3%) 0/360 (0%)
    Reproductive system and breast disorders
    Metrorrhagia 1/375 (0.3%) 0/360 (0%)
    Uterine haemorrhage 1/375 (0.3%) 0/360 (0%)
    Vaginal haemorrhage 1/375 (0.3%) 0/360 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 9/375 (2.4%) 9/360 (2.5%)
    Pleural effusion 9/375 (2.4%) 1/360 (0.3%)
    Pulmonary embolism 6/375 (1.6%) 4/360 (1.1%)
    Epistaxis 4/375 (1.1%) 0/360 (0%)
    Pneumothorax 2/375 (0.5%) 0/360 (0%)
    Dyspnoea exertional 1/375 (0.3%) 0/360 (0%)
    Hypoxia 1/375 (0.3%) 1/360 (0.3%)
    Lung disorder 1/375 (0.3%) 0/360 (0%)
    Oropharyngeal pain 1/375 (0.3%) 0/360 (0%)
    Respiratory arrest 1/375 (0.3%) 0/360 (0%)
    Respiratory distress 1/375 (0.3%) 0/360 (0%)
    Respiratory failure 1/375 (0.3%) 1/360 (0.3%)
    Cough 0/375 (0%) 1/360 (0.3%)
    Haemoptysis 0/375 (0%) 2/360 (0.6%)
    Lung infiltration 0/375 (0%) 1/360 (0.3%)
    Pulmonary oedema 0/375 (0%) 2/360 (0.6%)
    Skin and subcutaneous tissue disorders
    Dermatitis 1/375 (0.3%) 0/360 (0%)
    Diabetic ulcer 1/375 (0.3%) 0/360 (0%)
    Palmar-plantar erythrodysaesthesia syndrome 1/375 (0.3%) 0/360 (0%)
    Rash 1/375 (0.3%) 0/360 (0%)
    Stevens-Johnson syndrome 1/375 (0.3%) 0/360 (0%)
    Surgical and medical procedures
    Bone graft 1/375 (0.3%) 0/360 (0%)
    Hepatectomy 1/375 (0.3%) 0/360 (0%)
    Hip arthroplasty 1/375 (0.3%) 0/360 (0%)
    Inguinal hernia repair 1/375 (0.3%) 0/360 (0%)
    Pleurectomy 1/375 (0.3%) 0/360 (0%)
    Vertebroplasty 1/375 (0.3%) 0/360 (0%)
    Vascular disorders
    Hypertension 8/375 (2.1%) 0/360 (0%)
    Deep vein thrombosis 3/375 (0.8%) 1/360 (0.3%)
    Malignant hypertension 1/375 (0.3%) 0/360 (0%)
    Phlebitis 1/375 (0.3%) 0/360 (0%)
    Superior vena caval occlusion 1/375 (0.3%) 0/360 (0%)
    Vasculitis 1/375 (0.3%) 0/360 (0%)
    Hypotension 0/375 (0%) 1/360 (0.3%)
    Other (Not Including Serious) Adverse Events
    SU011248 IFN-α
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 368/375 (98.1%) 344/360 (95.6%)
    Blood and lymphatic system disorders
    Anaemia 75/375 (20%) 55/360 (15.3%)
    Leukopenia 40/375 (10.7%) 16/360 (4.4%)
    Lymphopenia 19/375 (5.1%) 21/360 (5.8%)
    Neutropenia 69/375 (18.4%) 33/360 (9.2%)
    Thrombocytopenia 69/375 (18.4%) 15/360 (4.2%)
    Endocrine disorders
    Hypothyroidism 57/375 (15.2%) 3/360 (0.8%)
    Gastrointestinal disorders
    Abdominal pain 64/375 (17.1%) 28/360 (7.8%)
    Abdominal pain upper 52/375 (13.9%) 10/360 (2.8%)
    Constipation 85/375 (22.7%) 48/360 (13.3%)
    Diarrhoea 245/375 (65.3%) 76/360 (21.1%)
    Dry mouth 50/375 (13.3%) 27/360 (7.5%)
    Dyspepsia 128/375 (34.1%) 16/360 (4.4%)
    Flatulence 52/375 (13.9%) 8/360 (2.2%)
    Gastrooesophageal reflux disease 47/375 (12.5%) 3/360 (0.8%)
    Glossodynia 39/375 (10.4%) 2/360 (0.6%)
    Haemorrhoids 38/375 (10.1%) 6/360 (1.7%)
    Nausea 215/375 (57.3%) 146/360 (40.6%)
    Oral pain 54/375 (14.4%) 2/360 (0.6%)
    Stomatitis 113/375 (30.1%) 12/360 (3.3%)
    Stomatitis 144/375 (38.4%) 60/360 (16.7%)
    General disorders
    Asthenia 91/375 (24.3%) 79/360 (21.9%)
    Chest pain 45/375 (12%) 21/360 (5.8%)
    Chills 52/375 (13.9%) 111/360 (30.8%)
    Fatigue 230/375 (61.3%) 200/360 (55.6%)
    Influenza like illness 18/375 (4.8%) 54/360 (15%)
    Mucosal inflammation 100/375 (26.7%) 7/360 (1.9%)
    Oedema peripheral 90/375 (24%) 17/360 (4.7%)
    Pain 35/375 (9.3%) 20/360 (5.6%)
    Pyrexia 80/375 (21.3%) 134/360 (37.2%)
    Infections and infestations
    Nasopharyngitis 54/375 (14.4%) 8/360 (2.2%)
    Upper respiratory tract infection 42/375 (11.2%) 9/360 (2.5%)
    Investigations
    Ejection fraction decreased 60/375 (16%) 19/360 (5.3%)
    Weight decreased 60/375 (16%) 59/360 (16.4%)
    Metabolism and nutrition disorders
    Anorexia 154/375 (41.1%) 112/360 (31.1%)
    Decreased appetite 44/375 (11.7%) 44/360 (12.2%)
    Dehydration 27/375 (7.2%) 14/360 (3.9%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 110/375 (29.3%) 68/360 (18.9%)
    Back pain 103/375 (27.5%) 52/360 (14.4%)
    Bone pain 27/375 (7.2%) 14/360 (3.9%)
    Muscle spasms 28/375 (7.5%) 9/360 (2.5%)
    Musculoskeletal chest pain 28/375 (7.5%) 14/360 (3.9%)
    Musculoskeletal pain 50/375 (13.3%) 23/360 (6.4%)
    Myalgia 46/375 (12.3%) 68/360 (18.9%)
    Pain in extremity 100/375 (26.7%) 30/360 (8.3%)
    Nervous system disorders
    Dizziness 43/375 (11.5%) 50/360 (13.9%)
    Dysgeusia 174/375 (46.4%) 53/360 (14.7%)
    Headache 86/375 (22.9%) 69/360 (19.2%)
    Paraesthesia 35/375 (9.3%) 7/360 (1.9%)
    Psychiatric disorders
    Anxiety 24/375 (6.4%) 18/360 (5%)
    Depression 40/375 (10.7%) 51/360 (14.2%)
    Insomnia 56/375 (14.9%) 37/360 (10.3%)
    Respiratory, thoracic and mediastinal disorders
    Cough 100/375 (26.7%) 50/360 (13.9%)
    Dyspnoea 95/375 (25.3%) 67/360 (18.6%)
    Epistaxis 79/375 (21.1%) 9/360 (2.5%)
    Oropharyngeal pain 51/375 (13.6%) 9/360 (2.5%)
    Skin and subcutaneous tissue disorders
    Alopecia 51/375 (13.6%) 34/360 (9.4%)
    Dry skin 85/375 (22.7%) 26/360 (7.2%)
    Erythema 46/375 (12.3%) 5/360 (1.4%)
    Hair colour changes 75/375 (20%) 1/360 (0.3%)
    Palmar-plantar erythrodysaesthesia syndrome 108/375 (28.8%) 3/360 (0.8%)
    Pruritus 44/375 (11.7%) 24/360 (6.7%)
    Rash 109/375 (29.1%) 39/360 (10.8%)
    Skin discolouration 94/375 (25.1%) 0/360 (0%)
    Skin exfoliation 37/375 (9.9%) 5/360 (1.4%)
    Vascular disorders
    Hypertension 125/375 (33.3%) 13/360 (3.6%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.govCallCenter@pfizer.com
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00083889
    Other Study ID Numbers:
    • A6181034
    • NCT00098657
    First Posted:
    Jun 4, 2004
    Last Update Posted:
    Jan 26, 2010
    Last Verified:
    Jan 1, 2010