Trial Outcomes & Findings for SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma (NCT NCT00083889)

Last Updated: 2010-01-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

750 participants

Primary outcome timeframe

Day 28 of each 6-week cycle: duration of treatment phase

Results posted on

2010-01-26

Participant Flow

A total of 101 medical centers took part in the study between 10 August 2004 and 19 September 2008.

Subjects were to be followed until survival data was mature (median duration of follow-up: 123 weeks).

Participant milestones

Participant milestones
Measure	SU011248 50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	IFN-α Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Study STARTED	375	375
Overall Study Received Treatment	375	360
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	375	375

Reasons for withdrawal

Reasons for withdrawal
Measure	SU011248 50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	IFN-α Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Study Adverse Event	76	86
Overall Study Protocol Violation	2	2
Overall Study Withdrawal by Subject	22	24
Overall Study Lack of Efficacy	240	219
Overall Study Decision of sponsor	32	4
Overall Study Randomized: did not take study drug	0	15
Overall Study Completed on marketed sunitinub	3	0
Overall Study Crossover to SU011248	0	25

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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 n=750 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	223 Participants n=5 Participants	252 Participants n=7 Participants	475 Participants n=5 Participants
Age, Categorical >=65 years	152 Participants n=5 Participants	123 Participants n=7 Participants	275 Participants n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	106 Participants n=7 Participants	214 Participants n=5 Participants
Sex: Female, Male Male	267 Participants n=5 Participants	269 Participants n=7 Participants	536 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28 of each 6-week cycle: duration of treatment phase

Population: Intent to treat (ITT) population: all patients who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Progression-Free Survival (PFS), Core Radiology Assessment	48.3 weeks Interval 46.4 to 58.3	22.1 weeks Interval 17.1 to 24.0

PRIMARY outcome

Timeframe: Day 28 of each 6-week cycle: duration of treatment phase

Population: ITT

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.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Progression-Free Survival (PFS), Investigator's Assessment	47.7 weeks Interval 46.3 to 58.1	22.1 weeks Interval 16.7 to 27.4

SECONDARY outcome

Timeframe: Day 28 of each 6-week cycle: duration of treatment phase

Population: ITT

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.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Objective Response, Core Radiology Assessment	145 participants	29 participants

SECONDARY outcome

Timeframe: Day 28 of each 6-week cycle: duration of treatment phase

Population: ITT

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.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Objective Response, Investigator's Assessment	171 participants	45 participants

SECONDARY outcome

Timeframe: Clinic visit or telephone contact every 2 months until death

Population: ITT

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.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Overall Survival (OS)	114.6 weeks Interval 100.1 to 142.9	94.9 weeks Interval 77.7 to 117.0

SECONDARY outcome

Timeframe: Randomization to first documentation of tumor progression: duration of treatment phase

Population: ITT

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.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Time to Tumor Progression (TTP), Core Radiology Assessment	49.1 weeks Interval 46.6 to 59.1	22.4 weeks Interval 21.9 to 31.3

SECONDARY outcome

Timeframe: Randomization to first documentation of tumor progression: duration of treatment phase

Population: ITT

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.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Time to Tumor Progression (TTP), Investigator's Assessment	49.0 weeks Interval 46.4 to 59.1	22.3 weeks Interval 17.3 to 31.6

SECONDARY outcome

Timeframe: Day 28 of each cycle: duraton of treatment phase

Population: ITT

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.

Outcome measures

Outcome measures
Measure	SU011248 n=71 Participants 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.	IFN-α n=9 Participants 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.
Duration of Response (DR), Core Radiology Assessement	52.9 weeks Interval 46.1 to 60.1	64.9 weeks Interval 41.9 to 82.0

SECONDARY outcome

Timeframe: Day 28 of each cycle: duration of treatment phase

Population: ITT

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.

Outcome measures

Outcome measures
Measure	SU011248 n=122 Participants 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.	IFN-α n=23 Participants 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.
Duration of Response (DR), Investigator's Assessment	56.3 weeks Interval 48.4 to 64.9	48.1 weeks Interval 42.1 to 120.1

SECONDARY outcome

Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Population: ITT; summary of FKSI-DRS questionnaire results by treatment; N=number of subjects with evaluable data; n = number of subjects with evaluable data at observation, SU011248 and INF-α treatment groups, respectively.

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.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 8 Day 28 (n=190, 62)	29.76 scores on scale Standard Deviation 4.096	28.67 scores on scale Standard Deviation 4.491
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Baseline (n=368, 351)	29.74 scores on scale Standard Deviation 5.244	29.55 scores on scale Standard Deviation 5.026
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 1 Day 28 (n=348, 317)	27.73 scores on scale Standard Deviation 5.080 • Interval 29.0 to 29.663	26.68 scores on scale Standard Deviation 5.195 • Interval 27.011 to 27.782
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 2 Day 1 (n=327, 246)	29.66 scores on scale Standard Deviation 4.778 • Interval 29.019 to 29.667	27.59 scores on scale Standard Deviation 4.908 • Interval 27.016 to 27.775
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 2 Day 28 (n= 315, 237)	28.49 scores on scale Standard Deviation 4.748 • Interval 29.051 to 29.677	27.22 scores on scale Standard Deviation 4.988 • Interval 27.019 to 27.769
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 3 Day 1 (n=294, 198)	29.93 scores on scale Standard Deviation 4.679 • Interval 29.068 to 29.684	28.20 scores on scale Standard Deviation 4.452 • Interval 27.017 to 27.77
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 3 Day 28 (n=285, 195)	28.72 scores on scale Standard Deviation 4.756 • Interval 29.095 to 29.698	27.81 scores on scale Standard Deviation 5.040 • Interval 27.006 to 27.778
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 4 Day 1 (n=272, 151)	30.25 scores on scale Standard Deviation 4.498	28.85 scores on scale Standard Deviation 4.821
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 4 Day 28 (n=264, 142)	29.43 scores on scale Standard Deviation 4.389	28.30 scores on scale Standard Deviation 5.071
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 5 Day 1 (n=248, 119 )	30.87 scores on scale Standard Deviation 3.948	28.57 scores on scale Standard Deviation 4.925
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 5 Day 28 (n=242, 109)	29.43 scores on scale Standard Deviation 4.280	28.37 scores on scale Standard Deviation 4.726
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 6 Day 1 (n=240, 99)	30.80 scores on scale Standard Deviation 4.214	29.12 scores on scale Standard Deviation 4.428
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 6 Day 28 (n=223, 99)	29.62 scores on scale Standard Deviation 4.288	28.44 scores on scale Standard Deviation 4.957
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 7 Day 1 (n=208, 79)	30.93 scores on scale Standard Deviation 4.002	28.99 scores on scale Standard Deviation 4.974
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 7 Day 28 (n=203, 75 )	29.73 scores on scale Standard Deviation 4.417	28.50 scores on scale Standard Deviation 4.556
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 8 Day 1 (n=192, 68)	31.03 scores on scale Standard Deviation 3.649	28.76 scores on scale Standard Deviation 4.847
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 9 Day 1 (n=172, 51)	31.24 scores on scale Standard Deviation 3.560	29.86 scores on scale Standard Deviation 4.247
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 9 Day 28 (n=166, 46)	29.72 scores on scale Standard Deviation 4.245	29.36 scores on scale Standard Deviation 4.418
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 10 Day 1 (n=161, 50)	30.73 scores on scale Standard Deviation 3.820	29.43 scores on scale Standard Deviation 4.455
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 10 Day 28 (n=155, 46)	29.78 scores on scale Standard Deviation 4.034	29.03 scores on scale Standard Deviation 4.980
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 11 Day 1 (n=138, 35)	30.72 scores on scale Standard Deviation 4.018	29.89 scores on scale Standard Deviation 4.006
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 11 Day 28 (n=141, 33)	29.34 scores on scale Standard Deviation 4.117	29.24 scores on scale Standard Deviation 5.014
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 12 Day 1 (n=132, 31)	30.76 scores on scale Standard Deviation 4.108	29.54 scores on scale Standard Deviation 5.607
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 12 Day 28 (n=128, 31)	29.63 scores on scale Standard Deviation 4.362	29.48 scores on scale Standard Deviation 4.774
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 13 Day 1 (113, 27)	30.58 scores on scale Standard Deviation 4.354	29.81 scores on scale Standard Deviation 4.923
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 13 Day 28 (n=114, 27)	29.30 scores on scale Standard Deviation 4.424	29.63 scores on scale Standard Deviation 4.550
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 20 Day 28 (n=53, 9)	29.44 scores on scale Standard Deviation 4.210	29.22 scores on scale Standard Deviation 7.694
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 14 Day 1 (n=114, 26)	30.58 scores on scale Standard Deviation 4.179	29.35 scores on scale Standard Deviation 4.664
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 14 Day 28 (n=105, 25)	28.94 scores on scale Standard Deviation 4.771	29.23 scores on scale Standard Deviation 5.502
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 15 Day 1 (n=100, 22)	30.87 scores on scale Standard Deviation 4.075	29.18 scores on scale Standard Deviation 5.917
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 15 Day 28 (n=94, 20)	29.26 scores on scale Standard Deviation 4.320	28.89 scores on scale Standard Deviation 5.676
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 16 Day 1 (n=96, 19)	30.63 scores on scale Standard Deviation 3.786	27.79 scores on scale Standard Deviation 5.760
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 16 Day 28 (n=90, 18)	29.51 scores on scale Standard Deviation 4.302	28.28 scores on scale Standard Deviation 6.267
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 17 Day 1 (n=85, 17)	30.69 scores on scale Standard Deviation 4.132	29.26 scores on scale Standard Deviation 5.434
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 17 Day 28 (n=81, 14)	29.73 scores on scale Standard Deviation 4.155	27.94 scores on scale Standard Deviation 7.519
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 18 Day 1 (n=80, 12)	30.24 scores on scale Standard Deviation 4.091	28.83 scores on scale Standard Deviation 7.209
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 18 Day 28 (n=70, 11)	29.15 scores on scale Standard Deviation 4.358	28.73 scores on scale Standard Deviation 6.973
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 19 Day 1 (n=71, 11)	30.11 scores on scale Standard Deviation 4.528	29.64 scores on scale Standard Deviation 7.061
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 19 Day 28 (n=61, 10)	29.48 scores on scale Standard Deviation 4.678	28.65 scores on scale Standard Deviation 8.131
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale Cycle 20 Day 1 (n=65, 9)	31.07 scores on scale Standard Deviation 4.073	28.44 scores on scale Standard Deviation 8.048

SECONDARY outcome

Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.

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).

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 17 Day 28 (n=81, 14)	46.27 scores on scale Standard Deviation 8.016	43.64 scores on scale Standard Deviation 11.693
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 18 Day 1 (n=80, 12)	47.47 scores on scale Standard Deviation 7.598	44.92 scores on scale Standard Deviation 12.391
FACT-Kidney Symptom Index (FKSI) Subscale Baseline (n=369, 351)	46.45 scores on scale Standard Deviation 8.464	46.09 scores on scale Standard Deviation 8.701
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 1 Day 28 (n=348, 317)	42.71 scores on scale Standard Deviation 8.959	40.93 scores on scale Standard Deviation 9.292
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 2 Day 1 (n=327, 246)	45.98 scores on scale Standard Deviation 8.401	42.33 scores on scale Standard Deviation 8.733
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 2 Day 28 (n=315, 238)	43.75 scores on scale Standard Deviation 8.607	42.01 scores on scale Standard Deviation 8.659
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 3 Day 1 (n=294, 198)	46.60 scores on scale Standard Deviation 8.263	43.64 scores on scale Standard Deviation 7.983
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 3 Day 28 (n=285, 195)	44.01 scores on scale Standard Deviation 8.529	43.13 scores on scale Standard Deviation 8.925
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 4 Day 1 (n=272, 151)	46.99 scores on scale Standard Deviation 8.041	44.78 scores on scale Standard Deviation 8.328
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 4 Day 28 (n=264, 142)	45.08 scores on scale Standard Deviation 8.017	44.03 scores on scale Standard Deviation 8.913
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 5 Day 1 (n=248, 119)	47.99 scores on scale Standard Deviation 7.313	44.82 scores on scale Standard Deviation 8.293
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 5 Day 28 (n=242, 109)	44.99 scores on scale Standard Deviation 7.768	44.41 scores on scale Standard Deviation 8.318
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 6 Day 1 (n=240, 99)	47.61 scores on scale Standard Deviation 7.860	45.38 scores on scale Standard Deviation 7.995
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 6 Day 28 (n=223, 99)	45.40 scores on scale Standard Deviation 7.840	44.07 scores on scale Standard Deviation 9.003
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 7 Day 1 (n=208, 79)	47.84 scores on scale Standard Deviation 7.303	45.09 scores on scale Standard Deviation 9.061
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 7 Day 28 (n=203, 75)	45.39 scores on scale Standard Deviation 8.013	44.65 scores on scale Standard Deviation 8.082
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 8 Day 1 (n=192, 68)	48.24 scores on scale Standard Deviation 6.818	45.38 scores on scale Standard Deviation 8.597
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 8 Day 28 (n=190, 62)	45.83 scores on scale Standard Deviation 7.589	45.10 scores on scale Standard Deviation 8.197
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 9 Day 1 (n=172, 51)	48.31 scores on scale Standard Deviation 6.971	46.88 scores on scale Standard Deviation 7.901
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 9 Day 28 (n=166, 46)	45.79 scores on scale Standard Deviation 7.969	46.16 scores on scale Standard Deviation 8.133
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 10 Day 1 (n=161, 50)	47.90 scores on scale Standard Deviation 6.993	46.22 scores on scale Standard Deviation 7.778
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 10 Day 28 (n=155, 46)	45.70 scores on scale Standard Deviation 7.372	45.16 scores on scale Standard Deviation 8.961
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 11 Day 1 (n=138, 35)	47.90 scores on scale Standard Deviation 6.988	46.26 scores on scale Standard Deviation 7.398
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 11 Day 28 (n=141, 33)	45.28 scores on scale Standard Deviation 7.330	45.46 scores on scale Standard Deviation 8.920
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 12 Day 1 (n=132, 31)	47.90 scores on scale Standard Deviation 7.458	46.08 scores on scale Standard Deviation 9.456
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 12 Day 28 (n=128, 31)	45.67 scores on scale Standard Deviation 7.696	46.00 scores on scale Standard Deviation 8.802
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 13 Day 1 (n=113, 27)	48.02 scores on scale Standard Deviation 7.723	46.25 scores on scale Standard Deviation 8.833
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 13 Day 28 (n=114, 27)	45.65 scores on scale Standard Deviation 7.659	45.84 scores on scale Standard Deviation 9.095
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 14 Day 1 (n=114, 26)	47.90 scores on scale Standard Deviation 7.370	46.08 scores on scale Standard Deviation 8.621
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 14 Day 28 (n=105, 25)	45.10 scores on scale Standard Deviation 8.641	46.10 scores on scale Standard Deviation 9.650
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 15 Day 1 (n=100, 22)	48.26 scores on scale Standard Deviation 7.663	45.62 scores on scale Standard Deviation 9.715
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 15 Day 28 (n=94, 20)	45.37 scores on scale Standard Deviation 8.040	45.30 scores on scale Standard Deviation 9.776
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 16 Day 1 (n=96, 19)	47.75 scores on scale Standard Deviation 7.063	43.64 scores on scale Standard Deviation 10.688
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 16 Day 28 (n=90, 18)	45.95 scores on scale Standard Deviation 7.625	43.46 scores on scale Standard Deviation 10.549
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 17 Day 1 (n=85, 17)	48.07 scores on scale Standard Deviation 7.641	45.59 scores on scale Standard Deviation 10.302
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 18 Day 28 (n=70, 11)	45.36 scores on scale Standard Deviation 7.585	45.27 scores on scale Standard Deviation 11.909
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 19 Day 1 (n=71, 11)	47.70 scores on scale Standard Deviation 7.671	46.64 scores on scale Standard Deviation 12.808
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 19 Day 28 (n=61, 10)	46.07 scores on scale Standard Deviation 8.442	44.47 scores on scale Standard Deviation 14.476
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 20 Day 1 (n=65, 9)	48.88 scores on scale Standard Deviation 7.133	45.00 scores on scale Standard Deviation 13.811
FACT-Kidney Symptom Index (FKSI) Subscale Cycle 20 Day 28 (n=53, 9)	46.26 scores on scale Standard Deviation 8.065	46.00 scores on scale Standard Deviation 13.266

SECONDARY outcome

Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.

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.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 9 Day 28 (n=166, 46)	82.71 scores on scale Standard Deviation 15.276	83.14 scores on scale Standard Deviation 17.067
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 10 Day 1 (n=158, 49)	85.32 scores on scale Standard Deviation 14.500	84.03 scores on scale Standard Deviation 16.559
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 10 Day 28 (n=150, 45)	82.14 scores on scale Standard Deviation 15.193	81.79 scores on scale Standard Deviation 17.994
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 11 Day 1 (n=134, 35)	84.75 scores on scale Standard Deviation 14.791	81.60 scores on scale Standard Deviation 16.729
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 11 Day 28 (n=139, 32)	81.91 scores on scale Standard Deviation 14.865	80.20 scores on scale Standard Deviation 19.213
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 12 Day 1 (n=130, 29)	85.31 scores on scale Standard Deviation 15.181	80.99 scores on scale Standard Deviation 20.219
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 12 Day 28 (n=126, 31)	82.43 scores on scale Standard Deviation 15.152	81.73 scores on scale Standard Deviation 18.745
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 13 Day 1 (n=113, 27)	85.50 scores on scale Standard Deviation 15.209	81.18 scores on scale Standard Deviation 20.198
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 13 Day 28 (n=114, 27)	83.61 scores on scale Standard Deviation 14.445	80.67 scores on scale Standard Deviation 18.678
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 14 Day 1 (n=112, 26)	85.24 scores on scale Standard Deviation 14.398	81.22 scores on scale Standard Deviation 17.506
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 14 Day 28 (n=107, 24)	82.34 scores on scale Standard Deviation 16.300	81.57 scores on scale Standard Deviation 20.188
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 15 Day 1 (n=101, 20)	86.24 scores on scale Standard Deviation 14.742	81.66 scores on scale Standard Deviation 18.326
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 15 Day 28 (n=96, 20)	82.64 scores on scale Standard Deviation 15.722	80.88 scores on scale Standard Deviation 18.913
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 16 Day 1 (n=94, 19)	84.77 scores on scale Standard Deviation 14.741	78.20 scores on scale Standard Deviation 18.994
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 16 Day 28 (n=89, 18)	83.38 scores on scale Standard Deviation 15.481	78.38 scores on scale Standard Deviation 19.749
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 17 Day 1 (n=84, 16)	86.78 scores on scale Standard Deviation 14.800	81.80 scores on scale Standard Deviation 20.161
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 17 Day 28 (n=80, 14)	84.42 scores on scale Standard Deviation 15.106	78.96 scores on scale Standard Deviation 21.571
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 18 Day 1 (n=79, 12)	85.74 scores on scale Standard Deviation 14.987	82.24 scores on scale Standard Deviation 23.763
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 18 Day 28 (n=70, 11)	83.51 scores on scale Standard Deviation 14.831	82.27 scores on scale Standard Deviation 21.950
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 19 Day 1 (n=71, 11)	87.16 scores on scale Standard Deviation 14.245	82.48 scores on scale Standard Deviation 24.198
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 19 Day 28 (n=61, 10)	84.54 scores on scale Standard Deviation 16.679	79.63 scores on scale Standard Deviation 27.938
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 20 Day 1 (n=63, 9)	87.96 scores on scale Standard Deviation 14.441	81.70 scores on scale Standard Deviation 27.018
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 20 Day 28 (n=52, 8)	84.62 scores on scale Standard Deviation 16.257	79.54 scores on scale Standard Deviation 26.109
Functional Assessment of Cancer Therapy-General (FACT-G) Baseline (n=368, 346)	82.30 scores on scale Standard Deviation 15.213	81.22 scores on scale Standard Deviation 16.030
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 1 Day 28 (n=345, 316)	78.75 scores on scale Standard Deviation 15.702	74.91 scores on scale Standard Deviation 18.374
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 2 Day 1 (n=328, 247)	82.88 scores on scale Standard Deviation 15.733	77.02 scores on scale Standard Deviation 16.670
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 2 Day 28 (n=314, 237)	80.51 scores on scale Standard Deviation 16.229	77.05 scores on scale Standard Deviation 17.468
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 3 Day 1 (n=293, 199)	84.24 scores on scale Standard Deviation 16.121	79.35 scores on scale Standard Deviation 16.862
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 3 Day 28 (n=285, 193)	80.59 scores on scale Standard Deviation 16.144	78.42 scores on scale Standard Deviation 17.836
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 4 Day 1 (n=269, 149)	85.32 scores on scale Standard Deviation 14.723	80.86 scores on scale Standard Deviation 16.477
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 4 Day 28 (n=263, 142)	82.08 scores on scale Standard Deviation 15.147	80.46 scores on scale Standard Deviation 17.136
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 5 Day 1 (n=247, 119)	86.40 scores on scale Standard Deviation 14.019	81.96 scores on scale Standard Deviation 15.286
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 5 Day 28 (n=240, 106)	82.23 scores on scale Standard Deviation 15.124	80.60 scores on scale Standard Deviation 15.527
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 6 Day 1 (n=238, 98)	84.90 scores on scale Standard Deviation 15.189	81.97 scores on scale Standard Deviation 15.918
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 6 Day 28 (n=222, 97)	82.54 scores on scale Standard Deviation 15.338	79.70 scores on scale Standard Deviation 16.686
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 7 Day 1 (n=206, 78)	85.01 scores on scale Standard Deviation 15.118	80.39 scores on scale Standard Deviation 17.811
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 7 Day 28 (n=200, 75)	82.16 scores on scale Standard Deviation 16.207	81.06 scores on scale Standard Deviation 16.701
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 8 Day 1 (n=192, 66)	86.83 scores on scale Standard Deviation 13.456	81.25 scores on scale Standard Deviation 17.179
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 8 Day 28 (n=189, 61)	83.05 scores on scale Standard Deviation 14.699	81.31 scores on scale Standard Deviation 16.700
Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 9 Day 1 (n=170, 51)	85.81 scores on scale Standard Deviation 14.865	84.50 scores on scale Standard Deviation 16.174

SECONDARY outcome

Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.

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.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 14 Day 28 (n=107, 24)	20.80 scores on scale Standard Deviation 5.310	22.75 scores on scale Standard Deviation 4.875
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Baseline (n=369, 348)	23.14 scores on scale Standard Deviation 5.209	22.70 scores on scale Standard Deviation 5.224
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 1 Day 28 (n=348, 318)	19.43 scores on scale Standard Deviation 6.052	18.85 scores on scale Standard Deviation 6.168
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 2 Day 1 (n=329, 247)	22.22 scores on scale Standard Deviation 5.161	20.05 scores on scale Standard Deviation 5.499
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 2 Day 28 (n=316, 239)	20.34 scores on scale Standard Deviation 5.654	19.84 scores on scale Standard Deviation 5.706
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 3 Day 1 (n=294, 200)	22.45 scores on scale Standard Deviation 5.123	20.87 scores on scale Standard Deviation 5.281
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 3 Day 28 (n=286, 195)	20.18 scores on scale Standard Deviation 5.650	20.63 scores on scale Standard Deviation 5.395
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 4 Day 1 (n=270, 150)	22.72 scores on scale Standard Deviation 4.641	21.56 scores on scale Standard Deviation 4.581
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 4 Day 28 (n=264, 142)	21.00 scores on scale Standard Deviation 5.120	21.31 scores on scale Standard Deviation 5.110
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 5 Day 1 (n=248, 120)	23.24 scores on scale Standard Deviation 4.143	21.84 scores on scale Standard Deviation 4.567
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 5 Day 28 (n=241, 106)	20.91 scores on scale Standard Deviation 5.062	21.23 scores on scale Standard Deviation 4.867
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 6 Day 1 (n=239, 99)	22.99 scores on scale Standard Deviation 4.385	21.70 scores on scale Standard Deviation 4.761
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 6 Day 28 (n=224, 97)	21.22 scores on scale Standard Deviation 5.070	20.96 scores on scale Standard Deviation 5.384
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 7 Day 1 (n=207, 79)	23.05 scores on scale Standard Deviation 4.414	21.67 scores on scale Standard Deviation 4.964
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 7 Day 28 (n=201, 75)	21.22 scores on scale Standard Deviation 5.250	21.66 scores on scale Standard Deviation 4.595
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 8 Day 1 (n=193, 67)	23.58 scores on scale Standard Deviation 3.715	21.94 scores on scale Standard Deviation 4.870
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 8 Day 28 (n=189, 61)	21.51 scores on scale Standard Deviation 4.666	21.40 scores on scale Standard Deviation 4.910
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 9 Day 1 (n=172, 51)	23.41 scores on scale Standard Deviation 4.071	22.58 scores on scale Standard Deviation 4.367
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 9 Day 28 (n=166, 46)	21.29 scores on scale Standard Deviation 5.068	22.38 scores on scale Standard Deviation 4.400
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 10 Day 1 (n=159, 49)	22.94 scores on scale Standard Deviation 4.053	22.60 scores on scale Standard Deviation 4.124
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 10 Day 28 (n=151, 46)	21.21 scores on scale Standard Deviation 4.848	21.83 scores on scale Standard Deviation 5.165
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 11 Day 1 (n=135, 35)	23.16 scores on scale Standard Deviation 4.069	22.23 scores on scale Standard Deviation 4.194
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 11 Day 28 (n=140, 32)	20.98 scores on scale Standard Deviation 4.597	21.88 scores on scale Standard Deviation 5.173
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 12 Day 1 (n=131, 30)	23.03 scores on scale Standard Deviation 4.291	22.60 scores on scale Standard Deviation 5.236
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 12 Day 28 (n=127, 31)	20.87 scores on scale Standard Deviation 4.721	21.90 scores on scale Standard Deviation 4.867
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 13 Day 1 (n=114, 27)	23.05 scores on scale Standard Deviation 4.281	21.99 scores on scale Standard Deviation 5.187
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 13 Day 28 (n=114, 27)	21.26 scores on scale Standard Deviation 4.623	21.80 scores on scale Standard Deviation 5.369
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 14 Day 1 (n=112, 26)	23.02 scores on scale Standard Deviation 4.401	22.05 scores on scale Standard Deviation 4.906
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 15 Day 1 (n=101, 21)	23.26 scores on scale Standard Deviation 4.475	22.33 scores on scale Standard Deviation 5.173
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 15 Day 28 (n=96, 20)	20.95 scores on scale Standard Deviation 4.978	22.07 scores on scale Standard Deviation 4.908
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 16 Day 1 (n=94, 19)	22.60 scores on scale Standard Deviation 4.337	20.63 scores on scale Standard Deviation 6.125
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 16 Day 28 (n=90, 18)	21.31 scores on scale Standard Deviation 4.939	21.42 scores on scale Standard Deviation 6.194
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 17 Day 1 (n=85, 16)	22.99 scores on scale Standard Deviation 4.513	21.81 scores on scale Standard Deviation 5.776
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 17 Day 28 (n=80, 14)	21.68 scores on scale Standard Deviation 4.653	20.50 scores on scale Standard Deviation 6.757
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 18 Day 1 (n=79, 12)	22.85 scores on scale Standard Deviation 4.388	21.83 scores on scale Standard Deviation 6.672
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 18 Day 28 (n=70, 11)	20.89 scores on scale Standard Deviation 5.006	22.45 scores on scale Standard Deviation 5.610
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 19 Day 1 (n=71, 11)	23.20 scores on scale Standard Deviation 4.426	22.45 scores on scale Standard Deviation 6.773
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 19 Day 28 (n=61, 10)	21.82 scores on scale Standard Deviation 4.696	21.60 scores on scale Standard Deviation 7.457
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 20 Day 1 (n=63, 9)	23.68 scores on scale Standard Deviation 4.204	21.78 scores on scale Standard Deviation 7.311
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale Cycle 20 Day 28 (n=52, 9)	21.81 scores on scale Standard Deviation 4.835	22.33 scores on scale Standard Deviation 6.423

SECONDARY outcome

Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.

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.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 19 Day 1 (n=71, 11)	23.85 scores on scale Standard Deviation 4.270	21.30 scores on scale Standard Deviation 5.894
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Baseline (n=370, 349)	23.14 scores on scale Standard Deviation 4.641	22.94 scores on scale Standard Deviation 4.735
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 1 Day 28 (n=348, 319)	23.60 scores on scale Standard Deviation 4.088	22.20 scores on scale Standard Deviation 5.076
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 2 Day 1 (n=328, 247)	23.50 scores on scale Standard Deviation 4.344	22.31 scores on scale Standard Deviation 5.190
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 2 Day 28 (n=315, 238)	23.40 scores on scale Standard Deviation 4.471	22.22 scores on scale Standard Deviation 5.203
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 3 Day 1 (n=292, 200)	23.51 scores on scale Standard Deviation 4.375	22.42 scores on scale Standard Deviation 5.011
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 3 Day 28 (n=284, 194)	23.44 scores on scale Standard Deviation 4.369	22.12 scores on scale Standard Deviation 5.289
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 4 Day 1 (n=269, 150)	23.73 scores on scale Standard Deviation 4.072	22.26 scores on scale Standard Deviation 5.275
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 4 Day 28 (n=263, 142)	23.36 scores on scale Standard Deviation 4.451	22.38 scores on scale Standard Deviation 5.198
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 5 Day 1 (n=247, 120)	23.53 scores on scale Standard Deviation 4.334	22.35 scores on scale Standard Deviation 5.486
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 5 Day 28 (n=241, 107)	23.68 scores on scale Standard Deviation 4.137	22.36 scores on scale Standard Deviation 4.956
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 6 Day 1 (n=238, 98)	23.35 scores on scale Standard Deviation 4.428	22.56 scores on scale Standard Deviation 4.678
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 6 Day 28 (n=224, 97)	23.40 scores on scale Standard Deviation 4.393	22.33 scores on scale Standard Deviation 4.641
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 7 Day 1 (n=207, 79)	23.29 scores on scale Standard Deviation 4.532	22.46 scores on scale Standard Deviation 4.722
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 7 Day 28 (n=200, 75)	23.13 scores on scale Standard Deviation 4.585	22.10 scores on scale Standard Deviation 5.286
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 8 Day 1 (n=193, 67)	23.67 scores on scale Standard Deviation 4.225	21.95 scores on scale Standard Deviation 5.112
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 8 Day 28 (n=189, 61)	23.26 scores on scale Standard Deviation 4.402	22.17 scores on scale Standard Deviation 5.236
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 9 Day 1 (n=172, 51)	23.26 scores on scale Standard Deviation 4.376	22.74 scores on scale Standard Deviation 4.826
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 9 Day 28 (n=166, 46)	23.26 scores on scale Standard Deviation 4.395	21.96 scores on scale Standard Deviation 5.418
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 10 Day 1 (n=158, 49)	23.08 scores on scale Standard Deviation 4.348	22.45 scores on scale Standard Deviation 5.279
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 10 Day 28 (n=151, 46)	23.03 scores on scale Standard Deviation 4.417	22.06 scores on scale Standard Deviation 5.065
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 11 Day 1 (n=135, 35)	23.05 scores on scale Standard Deviation 4.521	21.51 scores on scale Standard Deviation 5.267
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 11 Day 28 (n=140, 32)	22.71 scores on scale Standard Deviation 4.624	21.09 scores on scale Standard Deviation 5.957
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 12 Day 1 (n=131, 30)	23.23 scores on scale Standard Deviation 4.563	20.79 scores on scale Standard Deviation 6.007
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 12 Day 28 (n=127, 31)	23.07 scores on scale Standard Deviation 4.586	21.25 scores on scale Standard Deviation 5.627
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 13 Day 1 (n=114, 27)	23.15 scores on scale Standard Deviation 4.498	20.93 scores on scale Standard Deviation 6.142
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 13 Day 28 (n=114, 27)	23.31 scores on scale Standard Deviation 4.255	21.30 scores on scale Standard Deviation 5.491
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 14 Day 1 (n=112, 26)	22.82 scores on scale Standard Deviation 4.647	21.51 scores on scale Standard Deviation 5.510
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 14 Day 28 (n=107, 24)	23.24 scores on scale Standard Deviation 4.503	20.32 scores on scale Standard Deviation 6.628
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 15 Day 1 (n=101, 21)	23.28 scores on scale Standard Deviation 4.178	20.35 scores on scale Standard Deviation 5.986
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 15 Day 28 (n=96, 20)	23.04 scores on scale Standard Deviation 4.312	20.23 scores on scale Standard Deviation 6.162
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 16 Day 1 (n=94, 19)	23.11 scores on scale Standard Deviation 4.335	21.41 scores on scale Standard Deviation 5.196
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 16 Day 28 (n=89, 18)	23.41 scores on scale Standard Deviation 4.322	21.52 scores on scale Standard Deviation 5.821
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 17 Day 1 (n=85, 16)	23.42 scores on scale Standard Deviation 4.603	22.25 scores on scale Standard Deviation 5.037
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 17 Day 28 (n=80, 14)	23.50 scores on scale Standard Deviation 4.424	21.75 scores on scale Standard Deviation 5.680
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 18 Day 1 (n=79, 12)	23.53 scores on scale Standard Deviation 4.428	21.71 scores on scale Standard Deviation 6.276
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 18 Day 28 (n=70, 11)	23.70 scores on scale Standard Deviation 4.410	21.27 scores on scale Standard Deviation 6.051
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 19 Day 28 (n=61, 10)	23.53 scores on scale Standard Deviation 4.641	20.73 scores on scale Standard Deviation 6.816
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 20 Day 1 (n=63, 9)	23.60 scores on scale Standard Deviation 4.045	21.26 scores on scale Standard Deviation 7.201
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale Cycle 20 Day 28 (n=52, 8)	22.93 scores on scale Standard Deviation 4.898	20.67 scores on scale Standard Deviation 6.251

SECONDARY outcome

Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.

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.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 12 Day 1 (n=132, 30)	19.14 scores on scale Standard Deviation 4.547	18.87 scores on scale Standard Deviation 4.547
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 19 Day 28 (n=61, 10)	19.61 scores on scale Standard Deviation 4.469	18.20 scores on scale Standard Deviation 6.630
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Baseline (370, 352)	17.15 scores on scale Standard Deviation 4.548	17.06 scores on scale Standard Deviation 4.609
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 1 Day 28 (n=347, 318)	17.76 scores on scale Standard Deviation 4.347	17.40 scores on scale Standard Deviation 5.123
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 2 Day 1 (n=328, 249)	18.46 scores on scale Standard Deviation 4.218	17.52 scores on scale Standard Deviation 4.560
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 2 Day 28 (n=316, 237)	18.46 scores on scale Standard Deviation 4.342	17.73 scores on scale Standard Deviation 4.637
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 3 Day 1 (n=294, 200)	18.82 scores on scale Standard Deviation 4.236	18.13 scores on scale Standard Deviation 4.603
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 3 Day 28 (n=287, 196)	18.53 scores on scale Standard Deviation 4.494	18.17 scores on scale Standard Deviation 4.704
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 4 Day 1 (n=272, 152)	19.04 scores on scale Standard Deviation 4.182	18.80 scores on scale Standard Deviation 4.246
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 4 Day 28 (n=265, 142)	18.76 scores on scale Standard Deviation 4.343	18.39 scores on scale Standard Deviation 4.378
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 5 Day 1 (n=249, 120)	19.18 scores on scale Standard Deviation 3.903	19.00 scores on scale Standard Deviation 4.062
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 5 Day 28 (n=241, 109)	18.63 scores on scale Standard Deviation 4.298	18.70 scores on scale Standard Deviation 4.144
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 6 Day 1 (n=240, 99)	18.99 scores on scale Standard Deviation 4.154	18.60 scores on scale Standard Deviation 4.338
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 6 Day 28 (n=222, 99)	18.73 scores on scale Standard Deviation 4.311	18.14 scores on scale Standard Deviation 4.747
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 7 Day 1 (n=208, 77)	19.08 scores on scale Standard Deviation 4.324	18.08 scores on scale Standard Deviation 5.010
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 7 Day 28 (n=204, 75)	18.69 scores on scale Standard Deviation 4.595	18.55 scores on scale Standard Deviation 4.691
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 8 Day 1 (n=192, 67)	19.33 scores on scale Standard Deviation 4.104	18.54 scores on scale Standard Deviation 4.613
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 8 Day 28 (n=189, 62)	18.98 scores on scale Standard Deviation 4.026	18.55 scores on scale Standard Deviation 4.734
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 9 Day 1 (n=171, 51)	19.25 scores on scale Standard Deviation 4.341	18.98 scores on scale Standard Deviation 4.654
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 9 Day 28 (n=167, 46)	18.93 scores on scale Standard Deviation 4.376	18.76 scores on scale Standard Deviation 4.831
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 10 Day 1 (n=161, 50)	19.32 scores on scale Standard Deviation 4.191	18.92 scores on scale Standard Deviation 4.548
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 10 Day 28 (n=154, 45)	18.71 scores on scale Standard Deviation 4.557	18.36 scores on scale Standard Deviation 4.778
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 11 Day 1 (n=138, 35)	18.92 scores on scale Standard Deviation 4.514	18.97 scores on scale Standard Deviation 4.225
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 11 Day 28 (n=141, 33)	19.10 scores on scale Standard Deviation 4.209	18.52 scores on scale Standard Deviation 5.316
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 12 Day 28 (n=128, 31)	19.06 scores on scale Standard Deviation 4.456	19.45 scores on scale Standard Deviation 4.178
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 13 Day 1 (n=114, 27)	19.38 scores on scale Standard Deviation 4.170	18.63 scores on scale Standard Deviation 4.853
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 13 Day 28 (n=114, 27)	19.39 scores on scale Standard Deviation 4.034	18.97 scores on scale Standard Deviation 3.993
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 14 Day 1 (n=114, 26)	19.55 scores on scale Standard Deviation 3.951	18.05 scores on scale Standard Deviation 4.814
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 14 Day 28 (n=107, 25)	19.23 scores on scale Standard Deviation 4.522	18.76 scores on scale Standard Deviation 4.085
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 15 Day 1 (n=101, 21)	19.57 scores on scale Standard Deviation 4.171	18.24 scores on scale Standard Deviation 4.795
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 15 Day 28 (n=96, 20)	19.41 scores on scale Standard Deviation 4.459	18.75 scores on scale Standard Deviation 4.447
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 16 Day 1 (n=96, 19)	19.54 scores on scale Standard Deviation 4.258	17.26 scores on scale Standard Deviation 5.675
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 16 Day 28 (n=91, 18)	19.33 scores on scale Standard Deviation 4.287	16.83 scores on scale Standard Deviation 5.113
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 17 Day 1 (n=84, 17)	19.95 scores on scale Standard Deviation 3.997	18.28 scores on scale Standard Deviation 5.151
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 17 Day 28 (n=81, 14)	19.66 scores on scale Standard Deviation 4.420	18.00 scores on scale Standard Deviation 5.218
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 18 Day 1 (n=80, 12)	19.64 scores on scale Standard Deviation 4.132	19.62 scores on scale Standard Deviation 4.971
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 18 Day 28 (n=71, 11)	19.34 scores on scale Standard Deviation 4.125	19.55 scores on scale Standard Deviation 4.677
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 19 Day 1 (n=71, 11)	19.94 scores on scale Standard Deviation 4.052	19.09 scores on scale Standard Deviation 5.224
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 20 Day 1 (n=65, 9)	20.00 scores on scale Standard Deviation 4.138	18.67 scores on scale Standard Deviation 5.788
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale Cycle 20 Day 28 (n=53, 9)	19.75 scores on scale Standard Deviation 4.206	18.67 scores on scale Standard Deviation 6.384

SECONDARY outcome

Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Population: ITT

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.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Baseline (n=371, 353)	18.93 scores on scale Standard Deviation 6.107	18.51 scores on scale Standard Deviation 6.389
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 3 Day 1 (n=294, 200)	19.51 scores on scale Standard Deviation 6.073	17.92 scores on scale Standard Deviation 6.251
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 4 Day 1 (n=272, 152)	19.93 scores on scale Standard Deviation 5.625	18.40 scores on scale Standard Deviation 6.382
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 1 Day 28 (n=347, 318)	17.92 scores on scale Standard Deviation 6.083	16.37 scores on scale Standard Deviation 6.694
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 2 Day 1 (n=328, 249)	18.78 scores on scale Standard Deviation 6.001	17.08 scores on scale Standard Deviation 6.279
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 2 Day 28 (n=315, 238)	18.37 scores on scale Standard Deviation 6.210	17.18 scores on scale Standard Deviation 6.673
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 3 Day 28 (n=287, 195)	18.58 scores on scale Standard Deviation 5.994	17.56 scores on scale Standard Deviation 6.762
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 4 Day 28 (n=265, 142)	18.86 scores on scale Standard Deviation 5.694	18.37 scores on scale Standard Deviation 6.430
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 5 Day 1 (n=249, 120)	20.27 scores on scale Standard Deviation 5.593	18.81 scores on scale Standard Deviation 5.697
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 5 Day 28 (n=241, 109)	19.02 scores on scale Standard Deviation 5.829	18.47 scores on scale Standard Deviation 6.065
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 6 Day 1 (n=239, 99)	19.74 scores on scale Standard Deviation 5.608	19.02 scores on scale Standard Deviation 6.114
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 6 Day 28 (n=222, 99)	19.21 scores on scale Standard Deviation 5.678	18.24 scores on scale Standard Deviation 6.273
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 7 Day 1 (n=208, 79)	19.69 scores on scale Standard Deviation 5.645	18.45 scores on scale Standard Deviation 6.761
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 7 Day 28 (n=204, 75)	19.12 scores on scale Standard Deviation 5.798	18.76 scores on scale Standard Deviation 6.036
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 8 Day 1 (n=192, 67)	20.29 scores on scale Standard Deviation 5.285	19.22 scores on scale Standard Deviation 5.828
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 8 Day 28 (n=190, 62)	19.33 scores on scale Standard Deviation 5.627	19.10 scores on scale Standard Deviation 6.098
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 9 Day 1 (n=170, 51)	19.87 scores on scale Standard Deviation 5.635	20.20 scores on scale Standard Deviation 5.455
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 9 Day 28 (n=167, 46)	19.27 scores on scale Standard Deviation 5.701	20.04 scores on scale Standard Deviation 5.929
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 10 Day 1 (n=161, 50)	19.95 scores on scale Standard Deviation 5.420	19.88 scores on scale Standard Deviation 5.903
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 10 Day 28 (n=154, 46)	19.22 scores on scale Standard Deviation 5.494	19.40 scores on scale Standard Deviation 6.126
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 11 Day 1 (n=137, 35)	19.81 scores on scale Standard Deviation 5.368	18.89 scores on scale Standard Deviation 6.014
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 11 Day 28 (n=140, 33)	19.12 scores on scale Standard Deviation 5.749	18.81 scores on scale Standard Deviation 6.441
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 12 Day 1 (n=132, 30)	19.98 scores on scale Standard Deviation 5.618	18.80 scores on scale Standard Deviation 6.599
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 12 Day 28 (n=128, 31)	19.42 scores on scale Standard Deviation 5.755	19.13 scores on scale Standard Deviation 6.270
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 13 Day 1 (n=114, 27)	20.02 scores on scale Standard Deviation 5.703	19.63 scores on scale Standard Deviation 6.918
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 13 Day 28 (n=114, 27)	19.65 scores on scale Standard Deviation 5.216	18.59 scores on scale Standard Deviation 6.795
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 14 Day 1 (n=114, 26)	20.04 scores on scale Standard Deviation 5.556	19.62 scores on scale Standard Deviation 6.020
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 14 Day 28 (n=107, 25)	19.07 scores on scale Standard Deviation 6.025	19.72 scores on scale Standard Deviation 6.662
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 15 Day 1 (n=101, 21)	20.13 scores on scale Standard Deviation 5.654	19.86 scores on scale Standard Deviation 6.327
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 15 Day 28 (n=96, 20)	19.24 scores on scale Standard Deviation 5.589	19.83 scores on scale Standard Deviation 5.736
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 16 Day 1 (n=96, 19)	19.80 scores on scale Standard Deviation 5.469	18.89 scores on scale Standard Deviation 6.154
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 16 Day 28 (n=91, 18)	19.53 scores on scale Standard Deviation 5.313	18.61 scores on scale Standard Deviation 6.464
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 17 Day 1 (n=85, 17)	20.20 scores on scale Standard Deviation 5.606	19.35 scores on scale Standard Deviation 6.103
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 17 Day 28 (n=81, 14)	19.67 scores on scale Standard Deviation 5.662	18.71 scores on scale Standard Deviation 6.557
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 18 Day 1 (n=80, 12)	19.76 scores on scale Standard Deviation 5.862	19.08 scores on scale Standard Deviation 7.317
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 18 Day 28 (n=71, 11)	19.47 scores on scale Standard Deviation 5.526	19.00 scores on scale Standard Deviation 7.155
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 19 Day 1 (n=71, 11)	20.18 scores on scale Standard Deviation 5.563	19.64 scores on scale Standard Deviation 7.500
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 19 Day 28 (n=61, 10)	19.59 scores on scale Standard Deviation 6.326	19.10 scores on scale Standard Deviation 8.048
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 20 Day 1 (n=65, 9)	20.50 scores on scale Standard Deviation 5.425	20.00 scores on scale Standard Deviation 7.826
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale Cycle 20 Day 28 (n=53, 9)	20.15 scores on scale Standard Deviation 5.819	20.22 scores on scale Standard Deviation 7.694

SECONDARY outcome

Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.

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).

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 2 Day 28 (311, 233)	0.73 scores on scale Standard Deviation 0.246	0.74 scores on scale Standard Deviation 0.230
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 2 Day 1 (326, 244)	0.78 scores on scale Standard Deviation 0.230	0.75 scores on scale Standard Deviation 0.231
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 3 Day 1 (287, 200)	0.78 scores on scale Standard Deviation 0.220	0.76 scores on scale Standard Deviation 0.222
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 20 Day 28 (54, 9)	0.77 scores on scale Standard Deviation 0.181	0.86 scores on scale Standard Deviation 0.215
EuroQoL Five Dimension (EQ-5D) Health State Index Baseline (n=363, 352)	0.76 scores on scale Standard Deviation 0.225	0.76 scores on scale Standard Deviation 0.234
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 1 Day 28 (346, 315)	0.72 scores on scale Standard Deviation 0.262	0.70 scores on scale Standard Deviation 0.274
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 3 Day 28 (283, 195)	0.75 scores on scale Standard Deviation 0.231	0.75 scores on scale Standard Deviation 0.218
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 4 Day 1 (269, 150)	0.80 scores on scale Standard Deviation 0.199	0.80 scores on scale Standard Deviation 0.190
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 4 Day 28 (261, 142)	0.76 scores on scale Standard Deviation 0.218	0.79 scores on scale Standard Deviation 0.216
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 5 Day 1 (247, 120)	0.80 scores on scale Standard Deviation 0.209	0.79 scores on scale Standard Deviation 0.194
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 5 Day 28 (240, 106)	0.76 scores on scale Standard Deviation 0.223	0.78 scores on scale Standard Deviation 0.201
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 6 Day 1 (240, 98)	0.80 scores on scale Standard Deviation 0.249	0.80 scores on scale Standard Deviation 0.178
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 6 Day 28 (224, 100)	0.77 scores on scale Standard Deviation 0.206	0.80 scores on scale Standard Deviation 0.187
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 7 Day 1 (205, 79)	0.81 scores on scale Standard Deviation 0.192	0.80 scores on scale Standard Deviation 0.185
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 7 Day 28 (204, 74)	0.77 scores on scale Standard Deviation 0.221	0.81 scores on scale Standard Deviation 0.156
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 8 Day 1 (192, 68)	0.82 scores on scale Standard Deviation 0.180	0.82 scores on scale Standard Deviation 0.158
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 8 Day 28 (190, 61)	0.77 scores on scale Standard Deviation 0.222	0.81 scores on scale Standard Deviation 0.163
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 9 Day 1 (170, 51)	0.80 scores on scale Standard Deviation 0.196	0.84 scores on scale Standard Deviation 0.162
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 9 Day 28 (168, 45)	0.78 scores on scale Standard Deviation 0.194	0.84 scores on scale Standard Deviation 0.147
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 10 Day 1 (161, 50)	0.81 scores on scale Standard Deviation 0.209	0.85 scores on scale Standard Deviation 0.161
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 10 Day 28 (153, 46)	0.78 scores on scale Standard Deviation 0.200	0.82 scores on scale Standard Deviation 0.185
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 11 Day 1 (138, 34)	0.80 scores on scale Standard Deviation 0.192	0.85 scores on scale Standard Deviation 0.159
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 11 Day 28 (138, 32)	0.75 scores on scale Standard Deviation 0.189	0.84 scores on scale Standard Deviation 0.185
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 12 Day 1 (132, 31)	0.81 scores on scale Standard Deviation 0.187	0.82 scores on scale Standard Deviation 0.283
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 12 Day 28 (127, 31)	0.77 scores on scale Standard Deviation 0.182	0.85 scores on scale Standard Deviation 0.165
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 13 Day 1 (114, 26)	0.81 scores on scale Standard Deviation 0.176	0.83 scores on scale Standard Deviation 0.231
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 13 Day 28 (115, 27)	0.77 scores on scale Standard Deviation 0.186	0.82 scores on scale Standard Deviation 0.260
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 14 Day 1 (114, 25)	0.81 scores on scale Standard Deviation 0.181	0.86 scores on scale Standard Deviation 0.148
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 14 Day 28 (107, 24)	0.75 scores on scale Standard Deviation 0.224	0.87 scores on scale Standard Deviation 0.160
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 15 Day 1 (100, 21)	0.80 scores on scale Standard Deviation 0.190	0.88 scores on scale Standard Deviation 0.146
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 15 Day 28 (95, 20)	0.75 scores on scale Standard Deviation 0.209	0.88 scores on scale Standard Deviation 0.141
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 16 Day 1 (96, 19)	0.79 scores on scale Standard Deviation 0.194	0.84 scores on scale Standard Deviation 0.163
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 16 Day 28 (93, 18)	0.76 scores on scale Standard Deviation 0.181	0.83 scores on scale Standard Deviation 0.164
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 17 Day 1 (84, 15)	0.79 scores on scale Standard Deviation 0.194	0.88 scores on scale Standard Deviation 0.169
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 17 Day 28 (82, 14)	0.77 scores on scale Standard Deviation 0.168	0.83 scores on scale Standard Deviation 0.174
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 18 Day 1 (80, 12)	0.81 scores on scale Standard Deviation 0.187	0.86 scores on scale Standard Deviation 0.274
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 18 Day 28 (71, 10)	0.76 scores on scale Standard Deviation 0.166	0.84 scores on scale Standard Deviation 0.279
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 19 Day 1 (69, 11)	0.81 scores on scale Standard Deviation 0.183	0.88 scores on scale Standard Deviation 0.184
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 19 Day 28 (62, 11)	0.78 scores on scale Standard Deviation 0.165	0.72 scores on scale Standard Deviation 0.436
EuroQoL Five Dimension (EQ-5D) Health State Index Cycle 20 Day 1 (63, 8)	0.81 scores on scale Standard Deviation 0.162	0.85 scores on scale Standard Deviation 0.182

SECONDARY outcome

Timeframe: Day 1 & 28 of each cycle: duration of treatment phase

Population: ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.

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).

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 8 Day 1 (n=192, 67)	81.34 scores on scale Standard Deviation 13.020	74.27 scores on scale Standard Deviation 18.067
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 16 Day 28 (n=92, 18)	75.51 scores on scale Standard Deviation 17.687	73.11 scores on scale Standard Deviation 21.202
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 17 Day 1 (n=84, 17)	80.74 scores on scale Standard Deviation 15.706	76.94 scores on scale Standard Deviation 21.256
Euro-QoL Visual Analog Scale (EQ-VAS) Baseline (n=365, 352)	73.80 scores on scale Standard Deviation 18.498	71.43 scores on scale Standard Deviation 19.507
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 1 Day 28 (n=347, 315)	69.35 scores on scale Standard Deviation 18.992	67.66 scores on scale Standard Deviation 20.058
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 2 Day 1 (n=323, 247)	75.05 scores on scale Standard Deviation 17.964	70.45 scores on scale Standard Deviation 17.653
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 2 Day 28 (n=314, 237)	72.06 scores on scale Standard Deviation 18.297	70.70 scores on scale Standard Deviation 18.271
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 3 Day 1 (n=293, 198)	76.23 scores on scale Standard Deviation 17.171	72.68 scores on scale Standard Deviation 17.162
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 3 Day 28 (n=287, 193)	72.33 scores on scale Standard Deviation 18.472	71.45 scores on scale Standard Deviation 18.315
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 4 Day 1 (n=270, 152)	77.46 scores on scale Standard Deviation 16.024	72.74 scores on scale Standard Deviation 17.678
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 4 Day 28 (n=264, 139)	75.15 scores on scale Standard Deviation 16.406	72.20 scores on scale Standard Deviation 18.098
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 5 Day 1 (n=248, 118)	79.83 scores on scale Standard Deviation 13.554	73.44 scores on scale Standard Deviation 16.204
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 5 Day 28 (n=240, 104)	75.13 scores on scale Standard Deviation 16.771	72.57 scores on scale Standard Deviation 16.007
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 6 Day 1 (n=237, 99)	78.83 scores on scale Standard Deviation 15.359	73.68 scores on scale Standard Deviation 16.537
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 6 Day 28 (n=223, 98)	76.81 scores on scale Standard Deviation 15.204	72.26 scores on scale Standard Deviation 18.452
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 7 Day 1 (n=209, 77)	79.39 scores on scale Standard Deviation 14.601	73.80 scores on scale Standard Deviation 18.868
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 7 Day 28 (n=201, 74)	76.09 scores on scale Standard Deviation 16.693	73.46 scores on scale Standard Deviation 17.380
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 8 Day 28 (n=191, 60)	77.53 scores on scale Standard Deviation 14.374	74.33 scores on scale Standard Deviation 18.407
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 9 Day 1 (n=172, 50)	80.08 scores on scale Standard Deviation 13.812	77.66 scores on scale Standard Deviation 15.987
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 9 Day 28 (n=168, 46)	76.24 scores on scale Standard Deviation 15.740	76.57 scores on scale Standard Deviation 17.924
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 10 Day 1 (n=160, 50)	79.18 scores on scale Standard Deviation 14.912	76.64 scores on scale Standard Deviation 17.886
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 10 Day 28 (n=154, 45)	76.44 scores on scale Standard Deviation 16.106	76.69 scores on scale Standard Deviation 19.123
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 11 Day 1 (n=138, 34)	79.72 scores on scale Standard Deviation 15.685	75.06 scores on scale Standard Deviation 20.179
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 11 Day 28 (n=141, 33)	76.81 scores on scale Standard Deviation 15.128	72.21 scores on scale Standard Deviation 23.202
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 12 Day 1 (n=130, 31)	80.84 scores on scale Standard Deviation 14.150	75.19 scores on scale Standard Deviation 22.020
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 12 Day 28 (n=128, 31)	76.71 scores on scale Standard Deviation 14.986	73.84 scores on scale Standard Deviation 20.775
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 13 Day 1 (n=114, 27)	80.59 scores on scale Standard Deviation 14.875	77.52 scores on scale Standard Deviation 17.738
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 13 Day 28 (n=115, 27)	77.22 scores on scale Standard Deviation 14.715	73.56 scores on scale Standard Deviation 23.523
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 14 Day 1 (n=114, 26)	80.39 scores on scale Standard Deviation 14.477	76.69 scores on scale Standard Deviation 16.601
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 14 Day 28 (n=107, 25)	76.53 scores on scale Standard Deviation 15.933	76.44 scores on scale Standard Deviation 18.890
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 15 Day 1 (n=101, 21)	80.50 scores on scale Standard Deviation 14.361	76.62 scores on scale Standard Deviation 19.075
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 15 Day 28 (n=96, 20)	76.51 scores on scale Standard Deviation 15.141	76.50 scores on scale Standard Deviation 18.841
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 16 Day 1 (n=96, 19)	79.85 scores on scale Standard Deviation 15.632	74.84 scores on scale Standard Deviation 21.680
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 17 Day 28 (n=82, 14)	77.10 scores on scale Standard Deviation 16.612	72.86 scores on scale Standard Deviation 22.593
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 18 Day 1 (n=78, 12)	80.40 scores on scale Standard Deviation 14.658	74.42 scores on scale Standard Deviation 25.065
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 18 Day 28 (n=70, 11)	77.76 scores on scale Standard Deviation 16.142	73.82 scores on scale Standard Deviation 24.140
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 19 Day 1 (n=70, 11)	81.47 scores on scale Standard Deviation 15.330	79.27 scores on scale Standard Deviation 20.283
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 19 Day 28 (n=62, 11)	77.05 scores on scale Standard Deviation 18.676	68.55 scores on scale Standard Deviation 29.717
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 20 Day 1 (n=65, 9)	81.10 scores on scale Standard Deviation 15.404	76.00 scores on scale Standard Deviation 21.494
Euro-QoL Visual Analog Scale (EQ-VAS) Cycle 20 Day 28 (n=54, 9)	76.85 scores on scale Standard Deviation 16.863	75.44 scores on scale Standard Deviation 25.060

SECONDARY outcome

Timeframe: Day 1 & Day 28, Cycle 1 to Cycle 4

Population: Pharmacodynamic analyses performed at selected sites on AT population who had at least one pharmacokinetic sample; n= SU011248, INF-α; Abbreviations: C: Cycle, D: Day, VEGF: vascular endothelial growth factor, sVEGFR-3: soluble vascular endothelial growth factor Receptor-3, IL-8: interleukin-8, bFGF: basic fibroblast growth factor. .

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.

Outcome measures

SECONDARY outcome

Timeframe: Day 1 & Day 28, Cycle 1 to Cycle 4

Population: Pharmacodynamic analyses performed at selected sites on AT population who had at least one PK (pharmacokinetic) sample; n = subjects with evaluable data at observation, SU011248 and INF-α treatment groups, respectively. Abbreviations: C = Cycle, D = Day, bFGF: basic fibroblast growth factor.

Outcome measures

Outcome measures
Measure	SU011248 n=14 Participants 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.	IFN-α Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis PLASMA bFGF: C2D28:C1D1 (n=14, 0)	0.760 pg/ml and ratio to Baseline Standard Deviation 0.604	—
Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis PLASMA bFGF: C3D1:C1D1 (n=12, 0)	1.582 pg/ml and ratio to Baseline Standard Deviation 2.622	—
Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis PLASMA bFGF: C3D28:C1D1 (n=12, 0)	1.671 pg/ml and ratio to Baseline Standard Deviation 2.109	—
Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis PLASMA bFGF: C4D1:C1D1 (n=14, 0)	2.895 pg/ml and ratio to Baseline Standard Deviation 4.252	—
Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis PLASMA bFGF: C4:D28:C1D1 (n=10, 0)	0.803 pg/ml and ratio to Baseline Standard Deviation 0.799	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SU011248 n=375 Participants 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.	IFN-α n=375 Participants 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.
Incremental Cost Effectiveness Ratio (ICER)	0 ratio	0 ratio

SECONDARY outcome

Timeframe: Day 28 of Cycle 1 to Cycle 4

Population: As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples.

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 \[ng/mL\]).

Outcome measures

Outcome measures
Measure	SU011248 n=45 Participants 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.	IFN-α Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Ctrough Concentrations of SU011248 Dose-Corrected: Cycle 2, Day 28 (n=28)	59.90 ng/mL Standard Deviation 26.42	—
Ctrough Concentrations of SU011248 Dose-Corrected: Cycle 3, Day 28 (n=27)	58.45 ng/mL Standard Deviation 29.39	—
Ctrough Concentrations of SU011248 Cycle 1, Day 28 (n=31)	57.26 ng/mL Standard Deviation 31.37	—
Ctrough Concentrations of SU011248 Cycle 2, Day 28 (n=36)	57.59 ng/mL Standard Deviation 28.59	—
Ctrough Concentrations of SU011248 Cycle 3, Day 28 (n=36)	50.26 ng/mL Standard Deviation 24.89	—
Ctrough Concentrations of SU011248 Cycle 4, Day 28 (n=32)	45.05 ng/mL Standard Deviation 23.76	—
Ctrough Concentrations of SU011248 Dose-Corrected: Cycle 1, Day 28 (n=24)	64.22 ng/mL Standard Deviation 31.40	—
Ctrough Concentrations of SU011248 Dose-Corrected: Cycle 4, Day 28 (n=26)	54.31 ng/mL Standard Deviation 30.70	—

SECONDARY outcome

Timeframe: 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 \[ng/mL\]).

Outcome measures

Outcome measures
Measure	SU011248 n=45 Participants 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.	IFN-α Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Ctrough Concentrations of Metabolite SU012662 Cycle 1, Day 28 (n=31)	27.10 ng/mL Standard Deviation 17.28	—
Ctrough Concentrations of Metabolite SU012662 Cycle 2, Day 28 (n=36)	27.35 ng/mL Standard Deviation 15.42	—
Ctrough Concentrations of Metabolite SU012662 Cycle 3, Day 28 (n=36)	26.11 ng/mL Standard Deviation 16.15	—
Ctrough Concentrations of Metabolite SU012662 Cycle 4, Day 28 (n=32)	22.11 ng/mL Standard Deviation 12.67	—
Ctrough Concentrations of Metabolite SU012662 Dose-Corrected: Cycle 1, Day 28 (n=24)	28.21 ng/mL Standard Deviation 19.01	—
Ctrough Concentrations of Metabolite SU012662 Dose-Corrected: Cycle 2, Day 28 (n=28)	28.32 ng/mL Standard Deviation 13.74	—
Ctrough Concentrations of Metabolite SU012662 Dose-Corrected: Cycle 3, Day 28 (n=27)	29.04 ng/mL Standard Deviation 19.07	—
Ctrough Concentrations of Metabolite SU012662 Dose-Corrected: Cycle 4, Day 28 (n=26)	25.99 ng/mL Standard Deviation 16.25	—

SECONDARY outcome

Timeframe: 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 \[ng/mL\]).

Outcome measures

Outcome measures
Measure	SU011248 n=45 Participants 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.	IFN-α Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Ctrough Concentrations of SU011248 and Active Metabolite SU012662 Cycle 1, Day 28 (n=31)	84.36 ng/mL Standard Deviation 46.06	—
Ctrough Concentrations of SU011248 and Active Metabolite SU012662 Cycle 2, Day 28 (n=36)	84.94 ng/mL Standard Deviation 41.18	—
Ctrough Concentrations of SU011248 and Active Metabolite SU012662 Cycle 3, Day 28 (n=36)	76.37 ng/mL Standard Deviation 38.86	—
Ctrough Concentrations of SU011248 and Active Metabolite SU012662 Cycle 4, Day 28 (n=32)	67.15 ng/mL Standard Deviation 34.13	—
Ctrough Concentrations of SU011248 and Active Metabolite SU012662 Dose-Corrected: Cycle 1, Day 28 (n=24)	92.43 ng/mL Standard Deviation 48.08	—
Ctrough Concentrations of SU011248 and Active Metabolite SU012662 Dose-Corrected: Cycle 2, Day 28 (n=28)	88.22 ng/mL Standard Deviation 36.34	—
Ctrough Concentrations of SU011248 and Active Metabolite SU012662 Dose-Corrected: Cycle 3, Day 28 (n=27)	87.49 ng/mL Standard Deviation 45.85	—
Ctrough Concentrations of SU011248 and Active Metabolite SU012662 Dose-Corrected: Cycle 4, Day 28 (n=27)	80.30 ng/mL Standard Deviation 44.76	—

Adverse Events

SU011248

Serious events: 170 serious events

Other events: 368 other events

Deaths: 0 deaths

IFN-α

Serious events: 93 serious events

Other events: 344 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SU011248 n=375 participants at risk 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.	IFN-α n=360 participants at risk 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.
Blood and lymphatic system disorders Anaemia	3.7% 14/375	3.3% 12/360
Blood and lymphatic system disorders Thrombocytopenia	1.3% 5/375	0.00% 0/360
Blood and lymphatic system disorders Febrile neutropenia	0.80% 3/375	0.00% 0/360
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.53% 2/375	0.00% 0/360
Blood and lymphatic system disorders Leukopenia	0.27% 1/375	0.00% 0/360
Blood and lymphatic system disorders Neutropenia	0.27% 1/375	0.00% 0/360
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.27% 1/375	0.00% 0/360
Cardiac disorders Myocardial infarction	1.3% 5/375	0.56% 2/360
Cardiac disorders Atrial fibrillation	0.80% 3/375	0.00% 0/360
Cardiac disorders Coronary artery disease	0.53% 2/375	0.00% 0/360
Cardiac disorders Pericardial effusion	0.53% 2/375	0.28% 1/360
Cardiac disorders Atrial flutter	0.27% 1/375	0.00% 0/360
Cardiac disorders Cardiac arrest	0.27% 1/375	0.00% 0/360
Cardiac disorders Cardiac failure congestive	0.27% 1/375	0.28% 1/360
Cardiac disorders Left ventricular dysfunction	0.27% 1/375	0.00% 0/360
Cardiac disorders Myocardial ischaemia	0.27% 1/375	0.00% 0/360
Cardiac disorders Palpitations	0.27% 1/375	0.00% 0/360
Cardiac disorders Tachycardia	0.27% 1/375	0.00% 0/360
Cardiac disorders Acute myocardial infarction	0.00% 0/375	0.28% 1/360
Cardiac disorders Cardiac disorder	0.00% 0/375	0.28% 1/360
Ear and labyrinth disorders Deafness	0.27% 1/375	0.00% 0/360
Ear and labyrinth disorders Vertigo positional	0.00% 0/375	0.28% 1/360
Endocrine disorders Hypothyroidism	2.1% 8/375	0.00% 0/360
Endocrine disorders Hyperthyroidism	0.00% 0/375	0.28% 1/360
Eye disorders Visual impairment	0.53% 2/375	0.00% 0/360
Eye disorders Retinal artery occlusion	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Vomiting	3.2% 12/375	0.83% 3/360
Gastrointestinal disorders Nausea	2.7% 10/375	0.83% 3/360
Gastrointestinal disorders Abdominal pain	2.1% 8/375	0.83% 3/360
Gastrointestinal disorders Diarrhoea	1.3% 5/375	0.00% 0/360
Gastrointestinal disorders Gastrointestinal haemorrhage	1.1% 4/375	0.00% 0/360
Gastrointestinal disorders Dysphagia	0.53% 2/375	0.00% 0/360
Gastrointestinal disorders Gastric haemorrhage	0.53% 2/375	0.00% 0/360
Gastrointestinal disorders Intestinal obstruction	0.53% 2/375	0.00% 0/360
Gastrointestinal disorders Intestinal perforation	0.53% 2/375	0.28% 1/360
Gastrointestinal disorders Pancreatitis	0.53% 2/375	0.00% 0/360
Gastrointestinal disorders Stomatitis	0.53% 2/375	0.00% 0/360
Gastrointestinal disorders Abdominal pain lower	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Anal fistula	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Ascites	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Constipation	0.27% 1/375	0.28% 1/360
Gastrointestinal disorders Gastric ulcer haemorrhage	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Gastrointestinal obstruction	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Glossodynia	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Haematemesis	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Haematochezia	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Ileus	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Intestinal fistula	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Mouth ulceration	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Rectal haemorrhage	0.27% 1/375	0.28% 1/360
Gastrointestinal disorders Small intestinal obstruction	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Tongue oedema	0.27% 1/375	0.00% 0/360
Gastrointestinal disorders Abdominal pain upper	0.00% 0/375	0.56% 2/360
Gastrointestinal disorders Dry mouth	0.00% 0/375	0.28% 1/360
Gastrointestinal disorders Large intestine perforation	0.00% 0/375	0.28% 1/360
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/375	0.28% 1/360
General disorders Disease progression	4.5% 17/375	4.2% 15/360
General disorders Asthenia	4.3% 16/375	1.4% 5/360
General disorders Chest pain	1.9% 7/375	1.7% 6/360
General disorders General physical health deterioration	1.3% 5/375	0.00% 0/360
General disorders Pyrexia	1.3% 5/375	0.00% 0/360
General disorders Condition aggravated	0.80% 3/375	0.56% 2/360
General disorders Fatigue	0.80% 3/375	1.4% 5/360
General disorders Oedema peripheral	0.53% 2/375	0.00% 0/360
General disorders Pain	0.53% 2/375	0.00% 0/360
General disorders Chills	0.27% 1/375	0.00% 0/360
General disorders Face oedema	0.27% 1/375	0.00% 0/360
General disorders Hypothermia	0.27% 1/375	0.00% 0/360
General disorders Sudden death	0.27% 1/375	0.00% 0/360
General disorders Performance status decreased	0.00% 0/375	0.56% 2/360
Hepatobiliary disorders Biliary tract disorder	0.27% 1/375	0.00% 0/360
Hepatobiliary disorders Cholecystitis	0.27% 1/375	0.00% 0/360
Hepatobiliary disorders Cholecystitis acute	0.27% 1/375	0.00% 0/360
Hepatobiliary disorders Cholelithiasis	0.27% 1/375	0.00% 0/360
Hepatobiliary disorders Hepatitis	0.27% 1/375	0.00% 0/360
Hepatobiliary disorders Bile duct stone	0.00% 0/375	0.28% 1/360
Infections and infestations Cellulitis	0.80% 3/375	0.00% 0/360
Infections and infestations Pneumonia	0.80% 3/375	0.56% 2/360
Infections and infestations Gastroenteritis	0.53% 2/375	0.00% 0/360
Infections and infestations Urosepsis	0.53% 2/375	0.00% 0/360
Infections and infestations Arthritis bacterial	0.27% 1/375	0.00% 0/360
Infections and infestations Arthritis infective	0.27% 1/375	0.00% 0/360
Infections and infestations Fungal infection	0.27% 1/375	0.00% 0/360
Infections and infestations Herpes zoster	0.27% 1/375	0.00% 0/360
Infections and infestations Infected skin ulcer	0.27% 1/375	0.00% 0/360
Infections and infestations Localised infection	0.27% 1/375	0.00% 0/360
Infections and infestations Lung infection	0.27% 1/375	0.00% 0/360
Infections and infestations Oesophageal candidiasis	0.27% 1/375	0.00% 0/360
Infections and infestations Otitis externa	0.27% 1/375	0.00% 0/360
Infections and infestations Perirectal abscess	0.27% 1/375	0.00% 0/360
Infections and infestations Pleural infection	0.27% 1/375	0.00% 0/360
Infections and infestations Pyothorax	0.27% 1/375	0.00% 0/360
Infections and infestations Sepsis	0.27% 1/375	0.56% 2/360
Infections and infestations Sinusitis	0.27% 1/375	0.28% 1/360
Infections and infestations Upper respiratory tract infection	0.27% 1/375	0.00% 0/360
Infections and infestations Urinary tract infection	0.27% 1/375	0.28% 1/360
Infections and infestations Wound infection	0.27% 1/375	0.00% 0/360
Infections and infestations Diverticulitis	0.00% 0/375	0.28% 1/360
Infections and infestations Infection	0.00% 0/375	0.28% 1/360
Infections and infestations Respiratory tract infection	0.00% 0/375	0.28% 1/360
Infections and infestations Staphylococcal infection	0.00% 0/375	0.28% 1/360
Injury, poisoning and procedural complications Cervical vertebral fracture	0.27% 1/375	0.00% 0/360
Injury, poisoning and procedural complications Dislocation of joint prosthesis	0.27% 1/375	0.00% 0/360
Injury, poisoning and procedural complications Head injury	0.27% 1/375	0.00% 0/360
Injury, poisoning and procedural complications Hip fracture	0.27% 1/375	0.00% 0/360
Injury, poisoning and procedural complications Humerus fracture	0.27% 1/375	0.28% 1/360
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.27% 1/375	0.00% 0/360
Injury, poisoning and procedural complications Wound dehiscence	0.27% 1/375	0.00% 0/360
Injury, poisoning and procedural complications Brain herniation	0.00% 0/375	0.28% 1/360
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/375	0.28% 1/360
Investigations Blood bilirubin increased	0.53% 2/375	0.00% 0/360
Investigations Ejection fraction decreased	0.53% 2/375	0.00% 0/360
Investigations Platelet count decreased	0.53% 2/375	0.00% 0/360
Investigations Alanine aminotransferase increased	0.27% 1/375	0.00% 0/360
Investigations Aspartate aminotransferase increased	0.27% 1/375	0.00% 0/360
Investigations Blood creatine phosphokinase increased	0.27% 1/375	0.00% 0/360
Investigations Electrocardiogram change	0.27% 1/375	0.00% 0/360
Investigations Haemoglobin decreased	0.27% 1/375	0.00% 0/360
Investigations Urine output decreased	0.27% 1/375	0.00% 0/360
Investigations Blood creatinine increased	0.00% 0/375	0.28% 1/360
Investigations Weight decreased	0.00% 0/375	0.28% 1/360
Metabolism and nutrition disorders Dehydration	2.9% 11/375	1.7% 6/360
Metabolism and nutrition disorders Hyponatraemia	1.3% 5/375	0.00% 0/360
Metabolism and nutrition disorders Anorexia	0.80% 3/375	0.00% 0/360
Metabolism and nutrition disorders Hypoglycaemia	0.80% 3/375	0.00% 0/360
Metabolism and nutrition disorders Decreased appetite	0.27% 1/375	0.00% 0/360
Metabolism and nutrition disorders Hyperglycaemia	0.27% 1/375	0.00% 0/360
Metabolism and nutrition disorders Hyperkalaemia	0.27% 1/375	0.28% 1/360
Metabolism and nutrition disorders Hypokalaemia	0.27% 1/375	0.00% 0/360
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/375	0.83% 3/360
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/375	0.56% 2/360
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/375	0.28% 1/360
Musculoskeletal and connective tissue disorders Back pain	1.9% 7/375	0.28% 1/360
Musculoskeletal and connective tissue disorders Arthralgia	0.53% 2/375	0.28% 1/360
Musculoskeletal and connective tissue disorders Muscular weakness	0.53% 2/375	0.00% 0/360
Musculoskeletal and connective tissue disorders Pathological fracture	0.53% 2/375	1.4% 5/360
Musculoskeletal and connective tissue disorders Bone pain	0.27% 1/375	0.28% 1/360
Musculoskeletal and connective tissue disorders Groin pain	0.27% 1/375	0.00% 0/360
Musculoskeletal and connective tissue disorders Hypercreatinaemia	0.27% 1/375	0.00% 0/360
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.27% 1/375	0.00% 0/360
Musculoskeletal and connective tissue disorders Pain in extremity	0.27% 1/375	0.28% 1/360
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/375	0.28% 1/360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.27% 1/375	0.00% 0/360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.27% 1/375	0.00% 0/360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.27% 1/375	0.28% 1/360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial tumour haemorrhage	0.00% 0/375	0.28% 1/360
Nervous system disorders Convulsion	0.80% 3/375	0.28% 1/360
Nervous system disorders Spinal cord compression	0.80% 3/375	0.28% 1/360
Nervous system disorders Epilepsy	0.53% 2/375	0.28% 1/360
Nervous system disorders Headache	0.53% 2/375	0.00% 0/360
Nervous system disorders Monoparesis	0.53% 2/375	0.00% 0/360
Nervous system disorders Syncope	0.53% 2/375	0.28% 1/360
Nervous system disorders Aphasia	0.27% 1/375	0.00% 0/360
Nervous system disorders Cerebellar syndrome	0.27% 1/375	0.00% 0/360
Nervous system disorders Cerebral haematoma	0.27% 1/375	0.00% 0/360
Nervous system disorders Cerebral ischaemia	0.27% 1/375	0.00% 0/360
Nervous system disorders Facial palsy	0.27% 1/375	0.00% 0/360
Nervous system disorders Hemiparesis	0.27% 1/375	0.28% 1/360
Nervous system disorders Incoherent	0.27% 1/375	0.00% 0/360
Nervous system disorders Memory impairment	0.27% 1/375	0.00% 0/360
Nervous system disorders Nervous system disorder	0.27% 1/375	0.00% 0/360
Nervous system disorders Paresis	0.27% 1/375	0.00% 0/360
Nervous system disorders Peripheral sensory neuropathy	0.27% 1/375	0.00% 0/360
Nervous system disorders Reversible posterior leukoencephalopathy syndrome	0.27% 1/375	0.00% 0/360
Nervous system disorders Transient ischaemic attack	0.27% 1/375	0.28% 1/360
Nervous system disorders Cerebral haemorrhage	0.00% 0/375	0.28% 1/360
Nervous system disorders Cerebrovascular accident	0.00% 0/375	0.28% 1/360
Nervous system disorders Dizziness	0.00% 0/375	0.28% 1/360
Nervous system disorders Haemorrhage intracranial	0.00% 0/375	0.28% 1/360
Nervous system disorders Motor dysfunction	0.00% 0/375	0.28% 1/360
Psychiatric disorders Confusional state	0.80% 3/375	0.00% 0/360
Psychiatric disorders Mental status changes	0.53% 2/375	0.56% 2/360
Psychiatric disorders Anxiety	0.27% 1/375	0.00% 0/360
Psychiatric disorders Delirium	0.27% 1/375	0.00% 0/360
Psychiatric disorders Insomnia	0.27% 1/375	0.00% 0/360
Psychiatric disorders Depression	0.00% 0/375	0.28% 1/360
Psychiatric disorders Emotional disorder	0.00% 0/375	0.28% 1/360
Renal and urinary disorders Haematuria	1.3% 5/375	0.28% 1/360
Renal and urinary disorders Renal failure	1.1% 4/375	0.28% 1/360
Renal and urinary disorders Renal failure acute	1.1% 4/375	0.28% 1/360
Renal and urinary disorders Urinary retention	0.53% 2/375	0.56% 2/360
Renal and urinary disorders Nephrotic syndrome	0.27% 1/375	0.00% 0/360
Renal and urinary disorders Pollakiuria	0.27% 1/375	0.00% 0/360
Renal and urinary disorders Urinary bladder haemorrhage	0.27% 1/375	0.00% 0/360
Reproductive system and breast disorders Metrorrhagia	0.27% 1/375	0.00% 0/360
Reproductive system and breast disorders Uterine haemorrhage	0.27% 1/375	0.00% 0/360
Reproductive system and breast disorders Vaginal haemorrhage	0.27% 1/375	0.00% 0/360
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.4% 9/375	2.5% 9/360
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.4% 9/375	0.28% 1/360
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.6% 6/375	1.1% 4/360
Respiratory, thoracic and mediastinal disorders Epistaxis	1.1% 4/375	0.00% 0/360
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.53% 2/375	0.00% 0/360
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.27% 1/375	0.00% 0/360
Respiratory, thoracic and mediastinal disorders Hypoxia	0.27% 1/375	0.28% 1/360
Respiratory, thoracic and mediastinal disorders Lung disorder	0.27% 1/375	0.00% 0/360
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.27% 1/375	0.00% 0/360
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.27% 1/375	0.00% 0/360
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.27% 1/375	0.00% 0/360
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.27% 1/375	0.28% 1/360
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/375	0.28% 1/360
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/375	0.56% 2/360
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/375	0.28% 1/360
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/375	0.56% 2/360
Skin and subcutaneous tissue disorders Dermatitis	0.27% 1/375	0.00% 0/360
Skin and subcutaneous tissue disorders Diabetic ulcer	0.27% 1/375	0.00% 0/360
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.27% 1/375	0.00% 0/360
Skin and subcutaneous tissue disorders Rash	0.27% 1/375	0.00% 0/360
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.27% 1/375	0.00% 0/360
Surgical and medical procedures Bone graft	0.27% 1/375	0.00% 0/360
Surgical and medical procedures Hepatectomy	0.27% 1/375	0.00% 0/360
Surgical and medical procedures Hip arthroplasty	0.27% 1/375	0.00% 0/360
Surgical and medical procedures Inguinal hernia repair	0.27% 1/375	0.00% 0/360
Surgical and medical procedures Pleurectomy	0.27% 1/375	0.00% 0/360
Surgical and medical procedures Vertebroplasty	0.27% 1/375	0.00% 0/360
Vascular disorders Hypertension	2.1% 8/375	0.00% 0/360
Vascular disorders Deep vein thrombosis	0.80% 3/375	0.28% 1/360
Vascular disorders Malignant hypertension	0.27% 1/375	0.00% 0/360
Vascular disorders Phlebitis	0.27% 1/375	0.00% 0/360
Vascular disorders Superior vena caval occlusion	0.27% 1/375	0.00% 0/360
Vascular disorders Vasculitis	0.27% 1/375	0.00% 0/360
Vascular disorders Hypotension	0.00% 0/375	0.28% 1/360

Other adverse events

Other adverse events
Measure	SU011248 n=375 participants at risk 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.	IFN-α n=360 participants at risk 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.
Blood and lymphatic system disorders Anaemia	20.0% 75/375	15.3% 55/360
Blood and lymphatic system disorders Leukopenia	10.7% 40/375	4.4% 16/360
Blood and lymphatic system disorders Lymphopenia	5.1% 19/375	5.8% 21/360
Blood and lymphatic system disorders Neutropenia	18.4% 69/375	9.2% 33/360
Blood and lymphatic system disorders Thrombocytopenia	18.4% 69/375	4.2% 15/360
Endocrine disorders Hypothyroidism	15.2% 57/375	0.83% 3/360
Gastrointestinal disorders Abdominal pain	17.1% 64/375	7.8% 28/360
Gastrointestinal disorders Abdominal pain upper	13.9% 52/375	2.8% 10/360
Gastrointestinal disorders Constipation	22.7% 85/375	13.3% 48/360
Gastrointestinal disorders Diarrhoea	65.3% 245/375	21.1% 76/360
Gastrointestinal disorders Dry mouth	13.3% 50/375	7.5% 27/360
Gastrointestinal disorders Dyspepsia	34.1% 128/375	4.4% 16/360
Gastrointestinal disorders Flatulence	13.9% 52/375	2.2% 8/360
Gastrointestinal disorders Gastrooesophageal reflux disease	12.5% 47/375	0.83% 3/360
Gastrointestinal disorders Glossodynia	10.4% 39/375	0.56% 2/360
Gastrointestinal disorders Haemorrhoids	10.1% 38/375	1.7% 6/360
Gastrointestinal disorders Nausea	57.3% 215/375	40.6% 146/360
Gastrointestinal disorders Oral pain	14.4% 54/375	0.56% 2/360
Gastrointestinal disorders Stomatitis	38.4% 144/375	16.7% 60/360
General disorders Asthenia	24.3% 91/375	21.9% 79/360
General disorders Chest pain	12.0% 45/375	5.8% 21/360
General disorders Chills	13.9% 52/375	30.8% 111/360
General disorders Fatigue	61.3% 230/375	55.6% 200/360
General disorders Influenza like illness	4.8% 18/375	15.0% 54/360
General disorders Mucosal inflammation	26.7% 100/375	1.9% 7/360
General disorders Oedema peripheral	24.0% 90/375	4.7% 17/360
General disorders Pain	9.3% 35/375	5.6% 20/360
General disorders Pyrexia	21.3% 80/375	37.2% 134/360
Infections and infestations Nasopharyngitis	14.4% 54/375	2.2% 8/360
Infections and infestations Upper respiratory tract infection	11.2% 42/375	2.5% 9/360
Investigations Ejection fraction decreased	16.0% 60/375	5.3% 19/360
Investigations Weight decreased	16.0% 60/375	16.4% 59/360
Metabolism and nutrition disorders Anorexia	41.1% 154/375	31.1% 112/360
Metabolism and nutrition disorders Decreased appetite	11.7% 44/375	12.2% 44/360
Metabolism and nutrition disorders Dehydration	7.2% 27/375	3.9% 14/360
Musculoskeletal and connective tissue disorders Arthralgia	29.3% 110/375	18.9% 68/360
Musculoskeletal and connective tissue disorders Back pain	27.5% 103/375	14.4% 52/360
Musculoskeletal and connective tissue disorders Bone pain	7.2% 27/375	3.9% 14/360
Musculoskeletal and connective tissue disorders Muscle spasms	7.5% 28/375	2.5% 9/360
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	7.5% 28/375	3.9% 14/360
Musculoskeletal and connective tissue disorders Musculoskeletal pain	13.3% 50/375	6.4% 23/360
Musculoskeletal and connective tissue disorders Myalgia	12.3% 46/375	18.9% 68/360
Musculoskeletal and connective tissue disorders Pain in extremity	26.7% 100/375	8.3% 30/360
Nervous system disorders Dizziness	11.5% 43/375	13.9% 50/360
Nervous system disorders Dysgeusia	46.4% 174/375	14.7% 53/360
Nervous system disorders Headache	22.9% 86/375	19.2% 69/360
Nervous system disorders Paraesthesia	9.3% 35/375	1.9% 7/360
Psychiatric disorders Anxiety	6.4% 24/375	5.0% 18/360
Psychiatric disorders Depression	10.7% 40/375	14.2% 51/360
Psychiatric disorders Insomnia	14.9% 56/375	10.3% 37/360
Respiratory, thoracic and mediastinal disorders Cough	26.7% 100/375	13.9% 50/360
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.3% 95/375	18.6% 67/360
Respiratory, thoracic and mediastinal disorders Epistaxis	21.1% 79/375	2.5% 9/360
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	13.6% 51/375	2.5% 9/360
Skin and subcutaneous tissue disorders Alopecia	13.6% 51/375	9.4% 34/360
Skin and subcutaneous tissue disorders Dry skin	22.7% 85/375	7.2% 26/360
Skin and subcutaneous tissue disorders Erythema	12.3% 46/375	1.4% 5/360
Skin and subcutaneous tissue disorders Hair colour changes	20.0% 75/375	0.28% 1/360
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	28.8% 108/375	0.83% 3/360
Skin and subcutaneous tissue disorders Pruritus	11.7% 44/375	6.7% 24/360
Skin and subcutaneous tissue disorders Rash	29.1% 109/375	10.8% 39/360
Skin and subcutaneous tissue disorders Skin discolouration	25.1% 94/375	0.00% 0/360
Skin and subcutaneous tissue disorders Skin exfoliation	9.9% 37/375	1.4% 5/360
Vascular disorders Hypertension	33.3% 125/375	3.6% 13/360

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

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