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

• ClinicalTrials.gov Identifier: NCT00083889
• Recruitment Status: Completed
• First Posted: June 4, 2004
• Results First Posted: December 10, 2009
• Last Update Posted: January 26, 2010
• Sponsor: Pfizer
• Information provided by: Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Carcinoma, Renal Cell
• Interventions: Drug: Interferon-alfa; Drug: SU011248
• Enrollment: 750

Participant Flow

Recruitment Details	A total of 101 medical centers took part in the study between 10 August 2004 and 19 September 2008.
Pre-assignment Details	Subjects were to be followed until survival data was mature (median duration of follow-up: 123 weeks).

Arm/Group Title	SU011248	IFN-α
Arm/Group Description	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Period Title: Overall Study
Started	375	375
Received Treatment	375	360 [1]
Completed	0	0 [2]
Not Completed	375	375
Reason Not Completed
Adverse Event	76	86
Protocol Violation	2	2
Withdrawal by Subject	22	24
Lack of Efficacy	240	219
Decision of sponsor	32	4
Randomized: did not take study drug	0	15
Completed on marketed sunitinub	3	0
Crossover to SU011248	0	25
[1] 15 subjects randomized to IFN-α discontinued before receiving their first dose of study medication.; [2] Discontinuation crossover subjects: AEs 5,consent withdrawn 2, lack efficacy 13, sponsor decision 5.

Baseline Characteristics

Arm/Group Title		SU011248	IFN-α	Total
Arm/Group Description		50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.	Total of all reporting groups
Overall Number of Baseline Participants		375	375	750
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	375 participants	375 participants	750 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	223 59.5%	252 67.2%	475 63.3%
	>=65 years	152 40.5%	123 32.8%	275 36.7%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	375 participants	375 participants	750 participants
	Female	108 28.8%	106 28.3%	214 28.5%
	Male	267 71.2%	269 71.7%	536 71.5%

Outcome Measures

1. Primary Outcome

Title	Progression-Free Survival (PFS), Core Radiology Assessment
Description	Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods.
Time Frame	Day 28 of each 6-week cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Median (95% Confidence Interval); Unit of Measure: weeks
	48.3; (46.4 to 58.3)	22.1; (17.1 to 24.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α). Progression-free survival (PFS) was assessed in each treatment arm using the Kaplan-Meier method.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	p-value from 2-sided, unstratified test.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.5268
	Confidence Interval	(2-Sided) 95%; 0.4316 to 0.6430
	Estimation Comments	Assuming proportional hazards, a hazard ratio les than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Stratified analysis: Hazard Ratio (SU011248 vs IFN-a).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.00001
	Comments	p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.5136
	Confidence Interval	(2-Sided) 95%; 0.4196 to 0.6288
	Estimation Comments	Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.

2. Primary Outcome

Title	Progression-Free Survival (PFS), Investigator's Assessment
Description	Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods.
Time Frame	Day 28 of each 6-week cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Median (95% Confidence Interval); Unit of Measure: weeks
	47.7; (46.3 to 58.1)	22.1; (16.7 to 27.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	p-value is from 2-sided, unstratified test.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.5404
	Confidence Interval	(2-Sided) 95%; 0.4532 to 0.6444
	Estimation Comments	Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.00001
	Comments	p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.5418
	Confidence Interval	(2-Sided) 95%; 0.4536 to 0.6473
	Estimation Comments	Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.

3. Secondary Outcome

Title	Objective Response, Core Radiology Assessment
Description	Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR or PR) = those that persisted on repeat imaging study >= 4 weeks after initial documentation of response.
Time Frame	Day 28 of each 6-week cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Measure Type: Number; Unit of Measure: participants
	145	29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	treatment difference
	Estimated Value	30.93
	Confidence Interval	(2-Sided) 95%; 25.31 to 36.56
	Estimation Comments	95% confidence interval was calculated based on a normal distribution.

4. Secondary Outcome

Title	Objective Response, Investigator's Assessment
Description	Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses = those that persist on repeat imaging study >= 4 weeks after initial documentation of response.
Time Frame	Day 28 of each 6-week cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Measure Type: Number; Unit of Measure: participants
	171	45

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	treatment difference
	Estimated Value	33.66
	Confidence Interval	(2-Sided) 95%; 27.62 to 39.69
	Estimation Comments	95% confidence interval was calculated based on a normal distribution.

5. Secondary Outcome

Title	Overall Survival (OS)
Description	Overall survival (OS) = time from date of randomization to date of death due to any cause. For patients not expiring, survival time was censored at the last date they were known to be alive. Patients lacking data beyond randomization had their survival times censored at the date of randomization with a duration of 1 day.
Time Frame	Clinic visit or telephone contact every 2 months until death

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Median (95% Confidence Interval); Unit of Measure: weeks
	114.6; (100.1 to 142.9)	94.9; (77.7 to 117.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0510
	Comments	p-value is from 2-sided, unstratified tests.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.8209
	Confidence Interval	(2-Sided) 95%; 0.6730 to 1.0013
	Estimation Comments	Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0128
	Comments	p-value is from 2-sided, unstratified tests.
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.8209
	Confidence Interval	(2-Sided) 95%; 0.6730 to 1.0013
	Estimation Comments	Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0490
	Comments	p-value is from 2-sided, stratified tests. Stratification factors were: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.8179
	Confidence Interval	(2-Sided) 95%; 0.6692 to 0.9995
	Estimation Comments	Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.

6. Secondary Outcome

Title	Time to Tumor Progression (TTP), Core Radiology Assessment
Description	TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.
Time Frame	Randomization to first documentation of tumor progression: duration of treatment phase

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Median (95% Confidence Interval); Unit of Measure: weeks
	49.1; (46.6 to 59.1)	22.4; (21.9 to 31.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-a)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	p-value is from 2-sided, unstratified test.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.5332
	Confidence Interval	(2-Sided) 95%; 0.4345 to 0.6544
	Estimation Comments	Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Stratified Analysis: Hazard Ratio (SU011248 vs IFN-a)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.00001
	Comments	p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.5160
	Confidence Interval	(2-Sided) 95%; 0.4191 to 0.6352
	Estimation Comments	Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.

7. Secondary Outcome

Title	Time to Tumor Progression (TTP), Investigator's Assessment
Description	TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than the study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.
Time Frame	Randomization to first documentation of tumor progression: duration of treatment phase

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Median (95% Confidence Interval); Unit of Measure: weeks
	49.0; (46.4 to 59.1)	22.3; (17.3 to 31.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-α)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	p-value is from 2-sided, unstratified test.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.5454
	Confidence Interval	(2-Sided) 95%; 0.4558 to 0.6526
	Estimation Comments	Assuming proportional hazards, a hazard ratio < 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio > 1 indicates a reduction in hazard rate in favor of IFN-a.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Stratified Analysis: Hazard Ratio (SU011248 vs IFN-α)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.00001
	Comments	p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.5417
	Confidence Interval	(2-Sided) 95%; 0.4519 to 0.6492
	Estimation Comments	Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.

8. Secondary Outcome

Title	Duration of Response (DR), Core Radiology Assessement
Description	Duration of response (DR) = time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.
Time Frame	Day 28 of each cycle: duraton of treatment phase

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	71	9
Median (95% Confidence Interval); Unit of Measure: weeks
	52.9; (46.1 to 60.1)	64.9; (41.9 to 82.0)

9. Secondary Outcome

Title	Duration of Response (DR), Investigator's Assessment
Description	Duration of response (DR) = time from the first documentation of objective tumor response to the first documentaion of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.
Time Frame	Day 28 of each cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	122	23
Median (95% Confidence Interval); Unit of Measure: weeks
	56.3; (48.4 to 64.9)	48.1; (42.1 to 120.1)

10. Secondary Outcome

Title	FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale
Description	FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) subscale of the FKSI to measure advanced kidney cancer disease related symptoms. Includes 9 items: lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria. Each question was answered on a five-point Likert-type scale ranging from 0 (not at all) to 4 (very much). Score = the sum score of the item scores in the subscale; total range: 0 to 36. A score greater than 0 indicates the difference favored sunitinib.
Time Frame	Day 1 & 28 of each cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Mean (Standard Deviation); Unit of Measure: scores on scale
Baseline (n=368, 351)	29.74 (5.244)	29.55 (5.026)
Cycle 1 Day 28 (n=348, 317)	27.73 (5.080)	26.68 (5.195)
Cycle 2 Day 1 (n=327, 246)	29.66 (4.778)	27.59 (4.908)
Cycle 2 Day 28 (n= 315, 237)	28.49 (4.748)	27.22 (4.988)
Cycle 3 Day 1 (n=294, 198)	29.93 (4.679)	28.20 (4.452)
Cycle 3 Day 28 (n=285, 195)	28.72 (4.756)	27.81 (5.040)
Cycle 4 Day 1 (n=272, 151)	30.25 (4.498)	28.85 (4.821)
Cycle 4 Day 28 (n=264, 142)	29.43 (4.389)	28.30 (5.071)
Cycle 5 Day 1 (n=248, 119 )	30.87 (3.948)	28.57 (4.925)
Cycle 5 Day 28 (n=242, 109)	29.43 (4.280)	28.37 (4.726)
Cycle 6 Day 1 (n=240, 99)	30.80 (4.214)	29.12 (4.428)
Cycle 6 Day 28 (n=223, 99)	29.62 (4.288)	28.44 (4.957)
Cycle 7 Day 1 (n=208, 79)	30.93 (4.002)	28.99 (4.974)
Cycle 7 Day 28 (n=203, 75 )	29.73 (4.417)	28.50 (4.556)
Cycle 8 Day 1 (n=192, 68)	31.03 (3.649)	28.76 (4.847)
Cycle 8 Day 28 (n=190, 62)	29.76 (4.096)	28.67 (4.491)
Cycle 9 Day 1 (n=172, 51)	31.24 (3.560)	29.86 (4.247)
Cycle 9 Day 28 (n=166, 46)	29.72 (4.245)	29.36 (4.418)
Cycle 10 Day 1 (n=161, 50)	30.73 (3.820)	29.43 (4.455)
Cycle 10 Day 28 (n=155, 46)	29.78 (4.034)	29.03 (4.980)
Cycle 11 Day 1 (n=138, 35)	30.72 (4.018)	29.89 (4.006)
Cycle 11 Day 28 (n=141, 33)	29.34 (4.117)	29.24 (5.014)
Cycle 12 Day 1 (n=132, 31)	30.76 (4.108)	29.54 (5.607)
Cycle 12 Day 28 (n=128, 31)	29.63 (4.362)	29.48 (4.774)
Cycle 13 Day 1 (113, 27)	30.58 (4.354)	29.81 (4.923)
Cycle 13 Day 28 (n=114, 27)	29.30 (4.424)	29.63 (4.550)
Cycle 14 Day 1 (n=114, 26)	30.58 (4.179)	29.35 (4.664)
Cycle 14 Day 28 (n=105, 25)	28.94 (4.771)	29.23 (5.502)
Cycle 15 Day 1 (n=100, 22)	30.87 (4.075)	29.18 (5.917)
Cycle 15 Day 28 (n=94, 20)	29.26 (4.320)	28.89 (5.676)
Cycle 16 Day 1 (n=96, 19)	30.63 (3.786)	27.79 (5.760)
Cycle 16 Day 28 (n=90, 18)	29.51 (4.302)	28.28 (6.267)
Cycle 17 Day 1 (n=85, 17)	30.69 (4.132)	29.26 (5.434)
Cycle 17 Day 28 (n=81, 14)	29.73 (4.155)	27.94 (7.519)
Cycle 18 Day 1 (n=80, 12)	30.24 (4.091)	28.83 (7.209)
Cycle 18 Day 28 (n=70, 11)	29.15 (4.358)	28.73 (6.973)
Cycle 19 Day 1 (n=71, 11)	30.11 (4.528)	29.64 (7.061)
Cycle 19 Day 28 (n=61, 10)	29.48 (4.678)	28.65 (8.131)
Cycle 20 Day 1 (n=65, 9)	31.07 (4.073)	28.44 (8.048)
Cycle 20 Day 28 (n=53, 9)	29.44 (4.210)	29.22 (7.694)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.913
	Confidence Interval	(2-Sided) 95%; 1.376 to 2.450
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 28: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.935
	Confidence Interval	(2-Sided) 95%; 1.421 to 2.449
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 1: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.948
	Confidence Interval	(2-Sided) 95%; 1.443 to 2.452
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.970
	Confidence Interval	(2-Sided) 95%; 1.476 to 2.464
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.983
	Confidence Interval	(2-Sided) 95%; 1.491 to 2.475
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.005
	Confidence Interval	(2-Sided) 95%; 1.510 to 2.501
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.018
	Confidence Interval	(2-Sided) 95%; 1.517 to 2.519
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.040
	Confidence Interval	(2-Sided) 95%; 1.522 to 2.559
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.053
	Confidence Interval	(2-Sided) 95%; 1.522 to 2.584
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.075
	Confidence Interval	(2-Sided) 95%; 1.515 to 2.635
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.088
	Confidence Interval	(2-Sided) 95%; 1.509 to 2.667
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.110
	Confidence Interval	(2-Sided) 95%; 1.494 to 2.727
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.123
	Confidence Interval	(2-Sided) 95%; 1.483 to 2.763
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.146
	Confidence Interval	(2-Sided) 95%; 1.461 to 2.830
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	2.158
	Confidence Interval	(2-Sided) 95%; 1.447 to 2.869
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.181
	Confidence Interval	(2-Sided) 95%; 1.420 to 2.941
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.193
	Confidence Interval	(2-Sided) 95%; 1.404 to 2.983
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.216
	Confidence Interval	(2-Sided) 95%; 1.373 to 3.059
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.228
	Confidence Interval	(2-Sided) 95%; 1.355 to 3.102
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.251
	Confidence Interval	(2-Sided) 95%; 1.321 to 3.180
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.263
	Confidence Interval	(2-Sided) 95%; 1.302 to 3.225
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.286
	Confidence Interval	(2-Sided) 95%; 1.266 to 3.305
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.298
	Confidence Interval	(2-Sided) 95%; 1.246 to 3.351
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.321
	Confidence Interval	(2-Sided) 95%; 1.209 to 3.433
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.333
	Confidence Interval	(2-Sided) 95%; 1.188 to 3.479
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.356
	Confidence Interval	(2-Sided) 95%; 1.150 to 3.562
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.369
	Confidence Interval	(2-Sided) 95%; 1.128 to 3.609
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.391
	Confidence Interval	(2-Sided) 95%; 1.089 to 3.693
	Estimation Comments	[Not Specified]

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0004
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.404
	Confidence Interval	(2-Sided) 95%; 1.067 to 3.740
	Estimation Comments	[Not Specified]

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0007
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.426
	Confidence Interval	(2-Sided) 95%; 1.027 to 3.825
	Estimation Comments	[Not Specified]

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0009
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.439
	Confidence Interval	95%; 1.005 to 3.872
	Estimation Comments	[Not Specified]

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0013
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.461
	Confidence Interval	(2-Sided) 95%; 0.964 to 3.958
	Estimation Comments	[Not Specified]

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0016
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.474
	Confidence Interval	(2-Sided) 95%; 0.942 to 4.006
	Estimation Comments	[Not Specified]

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0022
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.496
	Confidence Interval	(2-Sided) 95%; 0.901 to 4.092
	Estimation Comments	[Not Specified]

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0026
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.509
	Confidence Interval	(2-Sided) 95%; 0.878 to 4.140
	Estimation Comments	[Not Specified]

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0034
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.531
	Confidence Interval	(2-Sided) 95%; 0.836 to 4.226
	Estimation Comments	[Not Specified]

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0040
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.544
	Confidence Interval	(2-Sided) 95%; 0.813 to 4.274
	Estimation Comments	[Not Specified]

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0051
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.566
	Confidence Interval	(2-Sided) 95%; 0.772 to 4.361
	Estimation Comments	[Not Specified]

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0058
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.579
	Confidence Interval	(2-Sided) 95%; 0.748 to 4.410
	Estimation Comments	[Not Specified]

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0071
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.602
	Confidence Interval	(2-Sided) 95%; 0.706 to 4.497
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	FACT-Kidney Symptom Index (FKSI) Subscale
Description	FACT-Kidney Symptom Index (FKSI) subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions; some questions overlap with the FACT-G questions. Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns).
Time Frame	Day 1 & 28 of each cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Mean (Standard Deviation); Unit of Measure: scores on scale
Baseline (n=369, 351)	46.45 (8.464)	46.09 (8.701)
Cycle 1 Day 28 (n=348, 317)	42.71 (8.959)	40.93 (9.292)
Cycle 2 Day 1 (n=327, 246)	45.98 (8.401)	42.33 (8.733)
Cycle 2 Day 28 (n=315, 238)	43.75 (8.607)	42.01 (8.659)
Cycle 3 Day 1 (n=294, 198)	46.60 (8.263)	43.64 (7.983)
Cycle 3 Day 28 (n=285, 195)	44.01 (8.529)	43.13 (8.925)
Cycle 4 Day 1 (n=272, 151)	46.99 (8.041)	44.78 (8.328)
Cycle 4 Day 28 (n=264, 142)	45.08 (8.017)	44.03 (8.913)
Cycle 5 Day 1 (n=248, 119)	47.99 (7.313)	44.82 (8.293)
Cycle 5 Day 28 (n=242, 109)	44.99 (7.768)	44.41 (8.318)
Cycle 6 Day 1 (n=240, 99)	47.61 (7.860)	45.38 (7.995)
Cycle 6 Day 28 (n=223, 99)	45.40 (7.840)	44.07 (9.003)
Cycle 7 Day 1 (n=208, 79)	47.84 (7.303)	45.09 (9.061)
Cycle 7 Day 28 (n=203, 75)	45.39 (8.013)	44.65 (8.082)
Cycle 8 Day 1 (n=192, 68)	48.24 (6.818)	45.38 (8.597)
Cycle 8 Day 28 (n=190, 62)	45.83 (7.589)	45.10 (8.197)
Cycle 9 Day 1 (n=172, 51)	48.31 (6.971)	46.88 (7.901)
Cycle 9 Day 28 (n=166, 46)	45.79 (7.969)	46.16 (8.133)
Cycle 10 Day 1 (n=161, 50)	47.90 (6.993)	46.22 (7.778)
Cycle 10 Day 28 (n=155, 46)	45.70 (7.372)	45.16 (8.961)
Cycle 11 Day 1 (n=138, 35)	47.90 (6.988)	46.26 (7.398)
Cycle 11 Day 28 (n=141, 33)	45.28 (7.330)	45.46 (8.920)
Cycle 12 Day 1 (n=132, 31)	47.90 (7.458)	46.08 (9.456)
Cycle 12 Day 28 (n=128, 31)	45.67 (7.696)	46.00 (8.802)
Cycle 13 Day 1 (n=113, 27)	48.02 (7.723)	46.25 (8.833)
Cycle 13 Day 28 (n=114, 27)	45.65 (7.659)	45.84 (9.095)
Cycle 14 Day 1 (n=114, 26)	47.90 (7.370)	46.08 (8.621)
Cycle 14 Day 28 (n=105, 25)	45.10 (8.641)	46.10 (9.650)
Cycle 15 Day 1 (n=100, 22)	48.26 (7.663)	45.62 (9.715)
Cycle 15 Day 28 (n=94, 20)	45.37 (8.040)	45.30 (9.776)
Cycle 16 Day 1 (n=96, 19)	47.75 (7.063)	43.64 (10.688)
Cycle 16 Day 28 (n=90, 18)	45.95 (7.625)	43.46 (10.549)
Cycle 17 Day 1 (n=85, 17)	48.07 (7.641)	45.59 (10.302)
Cycle 17 Day 28 (n=81, 14)	46.27 (8.016)	43.64 (11.693)
Cycle 18 Day 1 (n=80, 12)	47.47 (7.598)	44.92 (12.391)
Cycle 18 Day 28 (n=70, 11)	45.36 (7.585)	45.27 (11.909)
Cycle 19 Day 1 (n=71, 11)	47.70 (7.671)	46.64 (12.808)
Cycle 19 Day 28 (n=61, 10)	46.07 (8.442)	44.47 (14.476)
Cycle 20 Day 1 (n=65, 9)	48.88 (7.133)	45.00 (13.811)
Cycle 20 Day 28 (n=53, 9)	46.26 (8.065)	46.00 (13.266)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.165
	Confidence Interval	(2-Sided) 95%; 2.234 to 4.095
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.205
	Confidence Interval	(2-Sided) 95%; 2.318 to 4.092
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.228
	Confidence Interval	(2-Sided) 95%; 2.358 to 4.097
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.268
	Confidence Interval	(2-Sided) 95%; 2.418 to 4.119
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.291
	Confidence Interval	(2-Sided) 95%; 2.443 to 4.139
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.331
	Confidence Interval	(2-Sided) 95%; 2.474 to 4.189
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.354
	Confidence Interval	95%; 2.484 to 4.224
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.395
	Confidence Interval	(2-Sided) 95%; 2.489 to 4.300
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.417
	Confidence Interval	(2-Sided) 95%; 2.486 to 4.348
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.458
	Confidence Interval	(2-Sided) 95%; 2.469 to 4.446
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.480
	Confidence Interval	(2-Sided) 95%; 2.455 to 4.505
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.521
	Confidence Interval	(2-Sided) 95%; 2.422 to 4.620
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.543
	Confidence Interval	(2-Sided) 95%; 2.399 to 4.687
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.584
	Confidence Interval	95%; 2.354 to 4.814
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.606
	Confidence Interval	(2-Sided) 95%; 2.326 to 4.887
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.647
	Confidence Interval	(2-Sided) 95%; 2.272 to 5.022
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.669
	Confidence Interval	(2-Sided) 95%; 2.240 to 5.099
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.710
	Confidence Interval	(2-Sided) 95%; 2.180 to 5.240
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.733
	Confidence Interval	(2-Sided) 95%; 2.145 to 5.320
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.773
	Confidence Interval	(2-Sided) 95%; 2.080 to 5.466
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.796
	Confidence Interval	(2-Sided) 95%; 2.043 to 5.548
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.836
	Confidence Interval	(2-Sided) 95%; 1.975 to 5.698
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.859
	Confidence Interval	(2-Sided) 95%; 1.936 to 5.781
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.899
	Confidence Interval	(2-Sided) 95%; 1.866 to 5.933
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.922
	Confidence Interval	(2-Sided) 95%; 1.826 to 6.018
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0004
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.962
	Confidence Interval	(2-Sided) 95%; 1.753 to 6.172
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0006
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.985
	Confidence Interval	95%; 1.712 to 6.258
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0010
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.026
	Confidence Interval	(2-Sided) 95%; 1.638 to 6.413
	Estimation Comments	[Not Specified]

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0012
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.048
	Confidence Interval	(2-Sided) 95%; 1.597 to 6.500
	Estimation Comments	[Not Specified]

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0018
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.089
	Confidence Interval	(2-Sided) 95%; 1.521 to 6.656
	Estimation Comments	[Not Specified]

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0022
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.111
	Confidence Interval	(2-Sided) 95%; 1.479 to 6.743
	Estimation Comments	[Not Specified]

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0031
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.152
	Confidence Interval	(2-Sided) 95%; 1.403 to 6.901
	Estimation Comments	[Not Specified]

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0037
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.174
	Confidence Interval	95%; 1.360 to 6.988
	Estimation Comments	[Not Specified]

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0048
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.215
	Confidence Interval	(2-Sided) 95%; 1.283 to 7.147
	Estimation Comments	[Not Specified]

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0056
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.237
	Confidence Interval	(2-Sided) 95%; 1.240 to 7.235
	Estimation Comments	[Not Specified]

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0071
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.278
	Confidence Interval	(2-Sided) 95%; 1.162 to 7.394
	Estimation Comments	[Not Specified]

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0081
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.300
	Confidence Interval	(2-Sided) 95%; 1.119 to 7.482
	Estimation Comments	[Not Specified]

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0099
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.341
	Confidence Interval	(2-Sided) 95%; 1.041 to 7.642
	Estimation Comments	[Not Specified]

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0111
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.364
	Confidence Interval	(2-Sided) 95%; 0.997 to 7.730
	Estimation Comments	[Not Specified]

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0133
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.404
	Confidence Interval	(2-Sided) 95%; 0.918 to 7.890
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	Functional Assessment of Cancer Therapy-General (FACT-G)
Description	Functional Assessment of Cancer Therapy-General (FACT-G): core questionnaire of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system that has been validated in a variety of cancer populations. 27 questions grouped into 4 domains that measure a patient's physical, functional, social and family, and emotional well-being. Five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = sum score of item scores in the subscale; total range: 0 to 108 with higher score indicating better quality of life.
Time Frame	Day 1 & 28 of each cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Mean (Standard Deviation); Unit of Measure: scores on scale
Baseline (n=368, 346)	82.30 (15.213)	81.22 (16.030)
Cycle 1 Day 28 (n=345, 316)	78.75 (15.702)	74.91 (18.374)
Cycle 2 Day 1 (n=328, 247)	82.88 (15.733)	77.02 (16.670)
Cycle 2 Day 28 (n=314, 237)	80.51 (16.229)	77.05 (17.468)
Cycle 3 Day 1 (n=293, 199)	84.24 (16.121)	79.35 (16.862)
Cycle 3 Day 28 (n=285, 193)	80.59 (16.144)	78.42 (17.836)
Cycle 4 Day 1 (n=269, 149)	85.32 (14.723)	80.86 (16.477)
Cycle 4 Day 28 (n=263, 142)	82.08 (15.147)	80.46 (17.136)
Cycle 5 Day 1 (n=247, 119)	86.40 (14.019)	81.96 (15.286)
Cycle 5 Day 28 (n=240, 106)	82.23 (15.124)	80.60 (15.527)
Cycle 6 Day 1 (n=238, 98)	84.90 (15.189)	81.97 (15.918)
Cycle 6 Day 28 (n=222, 97)	82.54 (15.338)	79.70 (16.686)
Cycle 7 Day 1 (n=206, 78)	85.01 (15.118)	80.39 (17.811)
Cycle 7 Day 28 (n=200, 75)	82.16 (16.207)	81.06 (16.701)
Cycle 8 Day 1 (n=192, 66)	86.83 (13.456)	81.25 (17.179)
Cycle 8 Day 28 (n=189, 61)	83.05 (14.699)	81.31 (16.700)
Cycle 9 Day 1 (n=170, 51)	85.81 (14.865)	84.50 (16.174)
Cycle 9 Day 28 (n=166, 46)	82.71 (15.276)	83.14 (17.067)
Cycle 10 Day 1 (n=158, 49)	85.32 (14.500)	84.03 (16.559)
Cycle 10 Day 28 (n=150, 45)	82.14 (15.193)	81.79 (17.994)
Cycle 11 Day 1 (n=134, 35)	84.75 (14.791)	81.60 (16.729)
Cycle 11 Day 28 (n=139, 32)	81.91 (14.865)	80.20 (19.213)
Cycle 12 Day 1 (n=130, 29)	85.31 (15.181)	80.99 (20.219)
Cycle 12 Day 28 (n=126, 31)	82.43 (15.152)	81.73 (18.745)
Cycle 13 Day 1 (n=113, 27)	85.50 (15.209)	81.18 (20.198)
Cycle 13 Day 28 (n=114, 27)	83.61 (14.445)	80.67 (18.678)
Cycle 14 Day 1 (n=112, 26)	85.24 (14.398)	81.22 (17.506)
Cycle 14 Day 28 (n=107, 24)	82.34 (16.300)	81.57 (20.188)
Cycle 15 Day 1 (n=101, 20)	86.24 (14.742)	81.66 (18.326)
Cycle 15 Day 28 (n=96, 20)	82.64 (15.722)	80.88 (18.913)
Cycle 16 Day 1 (n=94, 19)	84.77 (14.741)	78.20 (18.994)
Cycle 16 Day 28 (n=89, 18)	83.38 (15.481)	78.38 (19.749)
Cycle 17 Day 1 (n=84, 16)	86.78 (14.800)	81.80 (20.161)
Cycle 17 Day 28 (n=80, 14)	84.42 (15.106)	78.96 (21.571)
Cycle 18 Day 1 (n=79, 12)	85.74 (14.987)	82.24 (23.763)
Cycle 18 Day 28 (n=70, 11)	83.51 (14.831)	82.27 (21.950)
Cycle 19 Day 1 (n=71, 11)	87.16 (14.245)	82.48 (24.198)
Cycle 19 Day 28 (n=61, 10)	84.54 (16.679)	79.63 (27.938)
Cycle 20 Day 1 (n=63, 9)	87.96 (14.441)	81.70 (27.018)
Cycle 20 Day 28 (n=52, 8)	84.62 (16.257)	79.54 (26.109)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.486
	Confidence Interval	(2-Sided) 95%; 3.852 to 7.119
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.535
	Confidence Interval	(2-Sided) 95%; 3.955 to 7.115
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.562
	Confidence Interval	(2-Sided) 95%; 4.000 to 7.124
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.611
	Confidence Interval	(2-Sided) 95%; 4.061 to 7.162
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.639
	Confidence Interval	(2-Sided) 95%; 4.083 to 7.195
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.688
	Confidence Interval	(2-Sided) 95%; 4.100 to 7.276
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.715
	Confidence Interval	(2-Sided) 95%; 4.098 to 7.333
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.764
	Confidence Interval	(2-Sided) 95%; 4.075 to 7.454
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.792
	Confidence Interval	(2-Sided) 95%; 4.053 to 7.531
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.841
	Confidence Interval	(2-Sided) 95%; 3.998 to 7.684
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.868
	Confidence Interval	(2-Sided) 95%; 3.960 to 7.777
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.917
	Confidence Interval	(2-Sided) 95%; 3.880 to 7.955
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.945
	Confidence Interval	(2-Sided) 95%; 3.830 to 8.060
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.994
	Confidence Interval	(2-Sided) 95%; 3.731 to 8.257
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.021
	Confidence Interval	(2-Sided) 95%; 3.672 to 8.370
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.071
	Confidence Interval	(2-Sided) 95%; 3.560 to 8.581
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.098
	Confidence Interval	(2-Sided) 95%; 3.495 to 8.701
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.147
	Confidence Interval	(2-Sided) 95%; 3.373 to 8.921
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.174
	Confidence Interval	(2-Sided) 95%; 3.303 to 9.045
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.224
	Confidence Interval	(2-Sided) 95%; 3.174 to 9.273
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.251
	Confidence Interval	(2-Sided) 95%; 3.101 to 9.401
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.300
	Confidence Interval	(2-Sided) 95%; 2.966 to 9.634
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.327
	Confidence Interval	(2-Sided) 95%; 2.890 to 9.765
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0006
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.377
	Confidence Interval	(2-Sided) 95%; 2.751 to 10.002
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0008
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.404
	Confidence Interval	(2-Sided) 95%; 2.673 to 10.135
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0013
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.453
	Confidence Interval	(2-Sided) 95%; 2.530 to 10.376
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0016
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.480
	Confidence Interval	(2-Sided) 95%; 2.451 to 10.510
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0025
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.530
	Confidence Interval	(2-Sided) 95%; 2.306 to 10.754
	Estimation Comments	[Not Specified]

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0030
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.557
	Confidence Interval	(2-Sided) 95%; 2.224 to 10.889
	Estimation Comments	[Not Specified]

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0043
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.606
	Confidence Interval	(2-Sided) 95%; 2.077 to 11.135
	Estimation Comments	[Not Specified]

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0051
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.634
	Confidence Interval	(2-Sided) 95%; 1.995 to 11.272
	Estimation Comments	[Not Specified]

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0068
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.683
	Confidence Interval	(2-Sided) 95%; 1.847 to 11.519
	Estimation Comments	[Not Specified]

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0079
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.710
	Confidence Interval	(2-Sided) 95%; 1.764 to 11.657
	Estimation Comments	[Not Specified]

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0100
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.759
	Confidence Interval	(2-Sided) 95%; 1.613 to 11.905
	Estimation Comments	[Not Specified]

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0114
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.787
	Confidence Interval	(2-Sided) 95%; 1.530 to 12.043
	Estimation Comments	[Not Specified]

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0141
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.836
	Confidence Interval	(2-Sided) 95%; 1.378 to 12.293
	Estimation Comments	[Not Specified]

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0157
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.863
	Confidence Interval	(2-Sided) 95%; 1.294 to 12.432
	Estimation Comments	[Not Specified]

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0189
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.912
	Confidence Interval	(2-Sided) 95%; 1.142 to 12.683
	Estimation Comments	[Not Specified]

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0208
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.940
	Confidence Interval	(2-Sided) 95%; 1.057 to 12.822
	Estimation Comments	[Not Specified]

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0244
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.989
	Confidence Interval	(2-Sided) 95%; 0.904 to 13.074
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale
Description	Physical well-being (PWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates better physical well-being.
Time Frame	Day 1 & 28 of each cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Mean (Standard Deviation); Unit of Measure: scores on scale
Baseline (n=369, 348)	23.14 (5.209)	22.70 (5.224)
Cycle 1 Day 28 (n=348, 318)	19.43 (6.052)	18.85 (6.168)
Cycle 2 Day 1 (n=329, 247)	22.22 (5.161)	20.05 (5.499)
Cycle 2 Day 28 (n=316, 239)	20.34 (5.654)	19.84 (5.706)
Cycle 3 Day 1 (n=294, 200)	22.45 (5.123)	20.87 (5.281)
Cycle 3 Day 28 (n=286, 195)	20.18 (5.650)	20.63 (5.395)
Cycle 4 Day 1 (n=270, 150)	22.72 (4.641)	21.56 (4.581)
Cycle 4 Day 28 (n=264, 142)	21.00 (5.120)	21.31 (5.110)
Cycle 5 Day 1 (n=248, 120)	23.24 (4.143)	21.84 (4.567)
Cycle 5 Day 28 (n=241, 106)	20.91 (5.062)	21.23 (4.867)
Cycle 6 Day 1 (n=239, 99)	22.99 (4.385)	21.70 (4.761)
Cycle 6 Day 28 (n=224, 97)	21.22 (5.070)	20.96 (5.384)
Cycle 7 Day 1 (n=207, 79)	23.05 (4.414)	21.67 (4.964)
Cycle 7 Day 28 (n=201, 75)	21.22 (5.250)	21.66 (4.595)
Cycle 8 Day 1 (n=193, 67)	23.58 (3.715)	21.94 (4.870)
Cycle 8 Day 28 (n=189, 61)	21.51 (4.666)	21.40 (4.910)
Cycle 9 Day 1 (n=172, 51)	23.41 (4.071)	22.58 (4.367)
Cycle 9 Day 28 (n=166, 46)	21.29 (5.068)	22.38 (4.400)
Cycle 10 Day 1 (n=159, 49)	22.94 (4.053)	22.60 (4.124)
Cycle 10 Day 28 (n=151, 46)	21.21 (4.848)	21.83 (5.165)
Cycle 11 Day 1 (n=135, 35)	23.16 (4.069)	22.23 (4.194)
Cycle 11 Day 28 (n=140, 32)	20.98 (4.597)	21.88 (5.173)
Cycle 12 Day 1 (n=131, 30)	23.03 (4.291)	22.60 (5.236)
Cycle 12 Day 28 (n=127, 31)	20.87 (4.721)	21.90 (4.867)
Cycle 13 Day 1 (n=114, 27)	23.05 (4.281)	21.99 (5.187)
Cycle 13 Day 28 (n=114, 27)	21.26 (4.623)	21.80 (5.369)
Cycle 14 Day 1 (n=112, 26)	23.02 (4.401)	22.05 (4.906)
Cycle 14 Day 28 (n=107, 24)	20.80 (5.310)	22.75 (4.875)
Cycle 15 Day 1 (n=101, 21)	23.26 (4.475)	22.33 (5.173)
Cycle 15 Day 28 (n=96, 20)	20.95 (4.978)	22.07 (4.908)
Cycle 16 Day 1 (n=94, 19)	22.60 (4.337)	20.63 (6.125)
Cycle 16 Day 28 (n=90, 18)	21.31 (4.939)	21.42 (6.194)
Cycle 17 Day 1 (n=85, 16)	22.99 (4.513)	21.81 (5.776)
Cycle 17 Day 28 (n=80, 14)	21.68 (4.653)	20.50 (6.757)
Cycle 18 Day 1 (n=79, 12)	22.85 (4.388)	21.83 (6.672)
Cycle 18 Day 28 (n=70, 11)	20.89 (5.006)	22.45 (5.610)
Cycle 19 Day 1 (n=71, 11)	23.20 (4.426)	22.45 (6.773)
Cycle 19 Day 28 (n=61, 10)	21.82 (4.696)	21.60 (7.457)
Cycle 20 Day 1 (n=63, 9)	23.68 (4.204)	21.78 (7.311)
Cycle 20 Day 28 (n=52, 9)	21.81 (4.835)	22.33 (6.423)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Physical Well Being (PWB) subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.459
	Confidence Interval	(2-Sided) 95%; 0.805 to 2.114
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.453
	Confidence Interval	(2-Sided) 95%; 0.827 to 2.079
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.450
	Confidence Interval	(2-Sided) 95%; 0.837 to 2.063
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.444
	Confidence Interval	(2-Sided) 95%; 0.847 to 2.041
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.440
	Confidence Interval	(2-Sided) 95%; 0.848 to 2.032
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.434
	Confidence Interval	(2-Sided) 95%; 0.844 to 2.024
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.431
	Confidence Interval	(2-Sided) 95%; 0.838 to 2.023
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.424
	Confidence Interval	(2-Sided) 95%; 0.819 to 2.029
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.421
	Confidence Interval	(2-Sided) 95%; 0.805 to 2.037
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.415
	Confidence Interval	(2-Sided) 95%; 0.774 to 2.056
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.411
	Confidence Interval	(2-Sided) 95%; 0.753 to 2.069
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.405
	Confidence Interval	(2-Sided) 95%; 0.711 to 2.099
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.402
	Confidence Interval	(2-Sided) 95%; 0.685 to 2.119
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.396
	Confidence Interval	(2-Sided) 95%; 0.634 to 2.157
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0005
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.392
	Confidence Interval	(2-Sided) 95%; 0.604 to 2.180
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0012
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.386
	Confidence Interval	(2-Sided) 95%; 0.547 to 2.225
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0018
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.383
	Confidence Interval	(2-Sided) 95%; 0.514 to 2.252
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0035
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.376
	Confidence Interval	(2-Sided) 95%; 0.451 to 2.301
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0049
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.373
	Confidence Interval	(2-Sided) 95%; 0.416 to 2.330
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0084
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.367
	Confidence Interval	(2-Sided) 95%; 0.350 to 2.383
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0110
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.363
	Confidence Interval	(2-Sided) 95%; 0.313 to 2.414
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0168
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.357
	Confidence Interval	(2-Sided) 95%; 0.245 to 2.470
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0208
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.354
	Confidence Interval	(2-Sided) 95%; 0.206 to 2.501
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0293
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.348
	Confidence Interval	(2-Sided) 95%; 0.136 to 2.559
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0348
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.344
	Confidence Interval	(2-Sided) 95%; 0.096 to 2.592
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0459
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.338
	Confidence Interval	(2-Sided) 95%; 0.024 to 2.652
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0528
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.335
	Confidence Interval	(2-Sided) 95%; -0.016 to 2.685
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0663
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.328
	Confidence Interval	(2-Sided) 95%; -0.090 to 2.746
	Estimation Comments	[Not Specified]

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0744
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.325
	Confidence Interval	(2-Sided) 95%; -0.131 to 2.780
	Estimation Comments	[Not Specified]

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0898
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.319
	Confidence Interval	(2-Sided) 95%; -0.205 to 2.842
	Estimation Comments	[Not Specified]

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0988
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.315
	Confidence Interval	(2-Sided) 95%; -0.246 to 2.877
	Estimation Comments	[Not Specified]

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1156
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.309
	Confidence Interval	(2-Sided) 95%; -0.321 to 2.940
	Estimation Comments	[Not Specified]

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1252
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.306
	Confidence Interval	(2-Sided) 95%; -0.363 to 2.975
	Estimation Comments	[Not Specified]

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1429
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.300
	Confidence Interval	(2-Sided) 95%; -0.439 to 3.038
	Estimation Comments	[Not Specified]

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1529
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.296
	Confidence Interval	(2-Sided) 95%; -0.481 to 3.074
	Estimation Comments	[Not Specified]

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1711
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.290
	Confidence Interval	(2-Sided) 95%; -0.558 to 3.138
	Estimation Comments	[Not Specified]

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1813
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.287
	Confidence Interval	(2-Sided) 95%; -0.600 to 3.173
	Estimation Comments	[Not Specified]

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1998
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.280
	Confidence Interval	(2-Sided) 95%; -0.677 to 3.238
	Estimation Comments	[Not Specified]

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2100
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.277
	Confidence Interval	(2-Sided) 95%; -0.720 to 3.273
	Estimation Comments	[Not Specified]

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2283
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.271
	Confidence Interval	(2-Sided) 95%; -0.797 to 3.338
	Estimation Comments	[Not Specified]

14. Secondary Outcome

Title	Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale
Description	Social/family well-being (SWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates less social/family well-being.
Time Frame	Day 1 & 28 of each cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Mean (Standard Deviation); Unit of Measure: scores on scale
Baseline (n=370, 349)	23.14 (4.641)	22.94 (4.735)
Cycle 1 Day 28 (n=348, 319)	23.60 (4.088)	22.20 (5.076)
Cycle 2 Day 1 (n=328, 247)	23.50 (4.344)	22.31 (5.190)
Cycle 2 Day 28 (n=315, 238)	23.40 (4.471)	22.22 (5.203)
Cycle 3 Day 1 (n=292, 200)	23.51 (4.375)	22.42 (5.011)
Cycle 3 Day 28 (n=284, 194)	23.44 (4.369)	22.12 (5.289)
Cycle 4 Day 1 (n=269, 150)	23.73 (4.072)	22.26 (5.275)
Cycle 4 Day 28 (n=263, 142)	23.36 (4.451)	22.38 (5.198)
Cycle 5 Day 1 (n=247, 120)	23.53 (4.334)	22.35 (5.486)
Cycle 5 Day 28 (n=241, 107)	23.68 (4.137)	22.36 (4.956)
Cycle 6 Day 1 (n=238, 98)	23.35 (4.428)	22.56 (4.678)
Cycle 6 Day 28 (n=224, 97)	23.40 (4.393)	22.33 (4.641)
Cycle 7 Day 1 (n=207, 79)	23.29 (4.532)	22.46 (4.722)
Cycle 7 Day 28 (n=200, 75)	23.13 (4.585)	22.10 (5.286)
Cycle 8 Day 1 (n=193, 67)	23.67 (4.225)	21.95 (5.112)
Cycle 8 Day 28 (n=189, 61)	23.26 (4.402)	22.17 (5.236)
Cycle 9 Day 1 (n=172, 51)	23.26 (4.376)	22.74 (4.826)
Cycle 9 Day 28 (n=166, 46)	23.26 (4.395)	21.96 (5.418)
Cycle 10 Day 1 (n=158, 49)	23.08 (4.348)	22.45 (5.279)
Cycle 10 Day 28 (n=151, 46)	23.03 (4.417)	22.06 (5.065)
Cycle 11 Day 1 (n=135, 35)	23.05 (4.521)	21.51 (5.267)
Cycle 11 Day 28 (n=140, 32)	22.71 (4.624)	21.09 (5.957)
Cycle 12 Day 1 (n=131, 30)	23.23 (4.563)	20.79 (6.007)
Cycle 12 Day 28 (n=127, 31)	23.07 (4.586)	21.25 (5.627)
Cycle 13 Day 1 (n=114, 27)	23.15 (4.498)	20.93 (6.142)
Cycle 13 Day 28 (n=114, 27)	23.31 (4.255)	21.30 (5.491)
Cycle 14 Day 1 (n=112, 26)	22.82 (4.647)	21.51 (5.510)
Cycle 14 Day 28 (n=107, 24)	23.24 (4.503)	20.32 (6.628)
Cycle 15 Day 1 (n=101, 21)	23.28 (4.178)	20.35 (5.986)
Cycle 15 Day 28 (n=96, 20)	23.04 (4.312)	20.23 (6.162)
Cycle 16 Day 1 (n=94, 19)	23.11 (4.335)	21.41 (5.196)
Cycle 16 Day 28 (n=89, 18)	23.41 (4.322)	21.52 (5.821)
Cycle 17 Day 1 (n=85, 16)	23.42 (4.603)	22.25 (5.037)
Cycle 17 Day 28 (n=80, 14)	23.50 (4.424)	21.75 (5.680)
Cycle 18 Day 1 (n=79, 12)	23.53 (4.428)	21.71 (6.276)
Cycle 18 Day 28 (n=70, 11)	23.70 (4.410)	21.27 (6.051)
Cycle 19 Day 1 (n=71, 11)	23.85 (4.270)	21.30 (5.894)
Cycle 19 Day 28 (n=61, 10)	23.53 (4.641)	20.73 (6.816)
Cycle 20 Day 1 (n=63, 9)	23.60 (4.045)	21.26 (7.201)
Cycle 20 Day 28 (n=52, 8)	22.93 (4.898)	20.67 (6.251)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Social/Family Well Being (SWB) subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.214
	Confidence Interval	(2-Sided) 95%; 0.719 to 1.708
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.216
	Confidence Interval	(2-Sided) 95%; 0.729 to 1.703
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.217
	Confidence Interval	(2-Sided) 95%; 0.731 to 1.704
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.220
	Confidence Interval	(2-Sided) 95%; 0.730 to 1.710
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.221
	Confidence Interval	(2-Sided) 95%; 0.727 to 1.716
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.224
	Confidence Interval	(2-Sided) 95%; 0.716 to 1.732
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.225
	Confidence Interval	(2-Sided) 95%; 0.707 to 1.744
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.228
	Confidence Interval	(2-Sided) 95%; 0.687 to 1.769
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.229
	Confidence Interval	(2-Sided) 95%; 0.673 to 1.785
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.232
	Confidence Interval	(2-Sided) 95%; 0.646 to 1.818
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.233
	Confidence Interval	(2-Sided) 95%; 0.629 to 1.838
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.236
	Confidence Interval	(2-Sided) 95%; 0.595 to 1.876
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.237
	Confidence Interval	(2-Sided) 95%; 0.575 to 1.899
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0005
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.240
	Confidence Interval	(2-Sided) 95%; 0.537 to 1.942
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0008
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.241
	Confidence Interval	(2-Sided) 95%; 0.515 to 1.967
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0015
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.244
	Confidence Interval	(2-Sided) 95%; 0.474 to 2.013
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0021
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.245
	Confidence Interval	(2-Sided) 95%; 0.450 to 2.040
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0037
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.248
	Confidence Interval	(2-Sided) 95%; 0.406 to 2.089
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0048
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.249
	Confidence Interval	(2-Sided) 95%; 0.382 to 2.116
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0074
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.251
	Confidence Interval	(2-Sided) 95%; 0.336 to 2.167
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0092
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.253
	Confidence Interval	(2-Sided) 95%; 0.310 to 2.196
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0132
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.255
	Confidence Interval	(2-Sided) 95%; 0.262 to 2.248
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0159
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.257
	Confidence Interval	(2-Sided) 95%; 0.236 to 2.278
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0213
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.259
	Confidence Interval	(2-Sided) 95%; 0.187 to 2.332
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0248
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.261
	Confidence Interval	(2-Sided) 95%; 0.160 to 2.362
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0318
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.263
	Confidence Interval	(2-Sided) 95%; 0.110 to 2.416
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0360
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.265
	Confidence Interval	(2-Sided) 95%; 0.083 to 2.447
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0443
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.267
	Confidence Interval	(2-Sided) 95%; 0.032 to 2.502
	Estimation Comments	[Not Specified]

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0493
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.269
	Confidence Interval	(2-Sided) 95%; 0.004 to 2.533
	Estimation Comments	[Not Specified]

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0587
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.271
	Confidence Interval	(2-Sided) 95%; -0.047 to 2.589
	Estimation Comments	[Not Specified]

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0642
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.273
	Confidence Interval	(2-Sided) 95%; -0.075 to 2.620
	Estimation Comments	[Not Specified]

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0746
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.275
	Confidence Interval	(2-Sided) 95%; -0.127 to 2.677
	Estimation Comments	[Not Specified]

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0806
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.276
	Confidence Interval	(2-Sided) 95%; -0.155 to 2.708
	Estimation Comments	[Not Specified]

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0917
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.279
	Confidence Interval	(2-Sided) 95%; -0.207 to 2.765
	Estimation Comments	[Not Specified]

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0980
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.280
	Confidence Interval	(2-Sided) 95%; -0.236 to 2.797
	Estimation Comments	[Not Specified]

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1095
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.283
	Confidence Interval	(2-Sided) 95%; -0.288 to 2.854
	Estimation Comments	[Not Specified]

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1161
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.284
	Confidence Interval	(2-Sided) 95%; -0.318 to 2.886
	Estimation Comments	[Not Specified]

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1280
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.287
	Confidence Interval	(2-Sided) 95%; -0.370 to 2.944
	Estimation Comments	[Not Specified]

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1346
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.288
	Confidence Interval	(2-Sided) 95%; -0.399 to 2.976
	Estimation Comments	[Not Specified]

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1466
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.291
	Confidence Interval	(2-Sided) 95%; -0.452 to 3.034
	Estimation Comments	[Not Specified]

15. Secondary Outcome

Title	Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale
Description	Emotional well-being (EWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 24; lower score indicates better emotional well-being.
Time Frame	Day 1 & 28 of each cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Mean (Standard Deviation); Unit of Measure: scores on scale
Baseline (370, 352)	17.15 (4.548)	17.06 (4.609)
Cycle 1 Day 28 (n=347, 318)	17.76 (4.347)	17.40 (5.123)
Cycle 2 Day 1 (n=328, 249)	18.46 (4.218)	17.52 (4.560)
Cycle 2 Day 28 (n=316, 237)	18.46 (4.342)	17.73 (4.637)
Cycle 3 Day 1 (n=294, 200)	18.82 (4.236)	18.13 (4.603)
Cycle 3 Day 28 (n=287, 196)	18.53 (4.494)	18.17 (4.704)
Cycle 4 Day 1 (n=272, 152)	19.04 (4.182)	18.80 (4.246)
Cycle 4 Day 28 (n=265, 142)	18.76 (4.343)	18.39 (4.378)
Cycle 5 Day 1 (n=249, 120)	19.18 (3.903)	19.00 (4.062)
Cycle 5 Day 28 (n=241, 109)	18.63 (4.298)	18.70 (4.144)
Cycle 6 Day 1 (n=240, 99)	18.99 (4.154)	18.60 (4.338)
Cycle 6 Day 28 (n=222, 99)	18.73 (4.311)	18.14 (4.747)
Cycle 7 Day 1 (n=208, 77)	19.08 (4.324)	18.08 (5.010)
Cycle 7 Day 28 (n=204, 75)	18.69 (4.595)	18.55 (4.691)
Cycle 8 Day 1 (n=192, 67)	19.33 (4.104)	18.54 (4.613)
Cycle 8 Day 28 (n=189, 62)	18.98 (4.026)	18.55 (4.734)
Cycle 9 Day 1 (n=171, 51)	19.25 (4.341)	18.98 (4.654)
Cycle 9 Day 28 (n=167, 46)	18.93 (4.376)	18.76 (4.831)
Cycle 10 Day 1 (n=161, 50)	19.32 (4.191)	18.92 (4.548)
Cycle 10 Day 28 (n=154, 45)	18.71 (4.557)	18.36 (4.778)
Cycle 11 Day 1 (n=138, 35)	18.92 (4.514)	18.97 (4.225)
Cycle 11 Day 28 (n=141, 33)	19.10 (4.209)	18.52 (5.316)
Cycle 12 Day 1 (n=132, 30)	19.14 (4.547)	18.87 (4.547)
Cycle 12 Day 28 (n=128, 31)	19.06 (4.456)	19.45 (4.178)
Cycle 13 Day 1 (n=114, 27)	19.38 (4.170)	18.63 (4.853)
Cycle 13 Day 28 (n=114, 27)	19.39 (4.034)	18.97 (3.993)
Cycle 14 Day 1 (n=114, 26)	19.55 (3.951)	18.05 (4.814)
Cycle 14 Day 28 (n=107, 25)	19.23 (4.522)	18.76 (4.085)
Cycle 15 Day 1 (n=101, 21)	19.57 (4.171)	18.24 (4.795)
Cycle 15 Day 28 (n=96, 20)	19.41 (4.459)	18.75 (4.447)
Cycle 16 Day 1 (n=96, 19)	19.54 (4.258)	17.26 (5.675)
Cycle 16 Day 28 (n=91, 18)	19.33 (4.287)	16.83 (5.113)
Cycle 17 Day 1 (n=84, 17)	19.95 (3.997)	18.28 (5.151)
Cycle 17 Day 28 (n=81, 14)	19.66 (4.420)	18.00 (5.218)
Cycle 18 Day 1 (n=80, 12)	19.64 (4.132)	19.62 (4.971)
Cycle 18 Day 28 (n=71, 11)	19.34 (4.125)	19.55 (4.677)
Cycle 19 Day 1 (n=71, 11)	19.94 (4.052)	19.09 (5.224)
Cycle 19 Day 28 (n=61, 10)	19.61 (4.469)	18.20 (6.630)
Cycle 20 Day 1 (n=65, 9)	20.00 (4.138)	18.67 (5.788)
Cycle 20 Day 28 (n=53, 9)	19.75 (4.206)	18.67 (6.384)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Emotional Well Being (EWB) subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.929
	Confidence Interval	(2-Sided) 95%; 0.460 to 1.398
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.922
	Confidence Interval	95%; 0.469 to 1.375
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.918
	Confidence Interval	95%; 0.471 to 1.365
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.911
	Confidence Interval	95%; 0.469 to 1.352
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.907
	Confidence Interval	95%; 0.466 to 1.348
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.899
	Confidence Interval	95%; 0.453 to 1.345
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.895
	Confidence Interval	95%; 0.444 to 1.347
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.888
	Confidence Interval	95%; 0.421 to 1.355
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.884
	Confidence Interval	95%; 0.406 to 1.362
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0006
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.877
	Confidence Interval	95%; 0.375 to 1.379
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0009
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.873
	Confidence Interval	95%; 0.356 to 1.390
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0020
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.866
	Confidence Interval	95%; 0.318 to 1.414
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0029
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.862
	Confidence Interval	95%; 0.295 to 1.428
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0055
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.854
	Confidence Interval	95%; 0.251 to 1.457
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0076
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.850
	Confidence Interval	95%; 0.226 to 1.475
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0129
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.843
	Confidence Interval	95%; 0.179 to 1.508
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0168
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.839
	Confidence Interval	95%; 0.151 to 1.527
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0257
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.832
	Confidence Interval	95%; 0.101 to 1.563
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0318
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.828
	Confidence Interval	95%; 0.072 to 1.583
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0447
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.821
	Confidence Interval	95%; 0.019 to 1.622
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0529
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.817
	Confidence Interval	95%; -0.010 to 1.643
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0696
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.809
	Confidence Interval	95%; -0.065 to 1.683
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0797
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.805
	Confidence Interval	95%; -0.095 to 1.706
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0994
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.798
	Confidence Interval	95%; -0.151 to 1.747
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1110
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.794
	Confidence Interval	95%; -0.182 to 1.770
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1328
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.787
	Confidence Interval	95%; -0.239 to 1.813
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1454
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.783
	Confidence Interval	95%; -0.271 to 1.836
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1686
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.776
	Confidence Interval	95%; -0.329 to 1.880
	Estimation Comments	[Not Specified]

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1817
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.771
	Confidence Interval	95%; -0.361 to 1.904
	Estimation Comments	[Not Specified]

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2055
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.764
	Confidence Interval	95%; -0.419 to 1.948
	Estimation Comments	[Not Specified]

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2188
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.760
	Confidence Interval	95%; -0.452 to 1.972
	Estimation Comments	[Not Specified]

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2427
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.753
	Confidence Interval	95%; -0.510 to 2.016
	Estimation Comments	[Not Specified]

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2559
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.749
	Confidence Interval	95%; -0.543 to 2.041
	Estimation Comments	[Not Specified]

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2794
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.742
	Confidence Interval	95%; -0.602 to 2.086
	Estimation Comments	[Not Specified]

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2923
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.738
	Confidence Interval	95%; -0.635 to 2.111
	Estimation Comments	[Not Specified]

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3152
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.730
	Confidence Interval	95%; -0.695 to 2.156
	Estimation Comments	[Not Specified]

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3276
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.726
	Confidence Interval	95%; -0.728 to 2.181
	Estimation Comments	[Not Specified]

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3497
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.719
	Confidence Interval	95%; -0.788 to 2.227
	Estimation Comments	[Not Specified]

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3616
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.715
	Confidence Interval	95%; -0.822 to 2.252
	Estimation Comments	[Not Specified]

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3827
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.708
	Confidence Interval	95%; -0.882 to 2.298
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale
Description	Functional well-being (FWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; higher score indicates greater functional well-being.
Time Frame	Day 1 & 28 of each cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Mean (Standard Deviation); Unit of Measure: scores on scale
Baseline (n=371, 353)	18.93 (6.107)	18.51 (6.389)
Cycle 1 Day 28 (n=347, 318)	17.92 (6.083)	16.37 (6.694)
Cycle 2 Day 1 (n=328, 249)	18.78 (6.001)	17.08 (6.279)
Cycle 2 Day 28 (n=315, 238)	18.37 (6.210)	17.18 (6.673)
Cycle 3 Day 1 (n=294, 200)	19.51 (6.073)	17.92 (6.251)
Cycle 3 Day 28 (n=287, 195)	18.58 (5.994)	17.56 (6.762)
Cycle 4 Day 1 (n=272, 152)	19.93 (5.625)	18.40 (6.382)
Cycle 4 Day 28 (n=265, 142)	18.86 (5.694)	18.37 (6.430)
Cycle 5 Day 1 (n=249, 120)	20.27 (5.593)	18.81 (5.697)
Cycle 5 Day 28 (n=241, 109)	19.02 (5.829)	18.47 (6.065)
Cycle 6 Day 1 (n=239, 99)	19.74 (5.608)	19.02 (6.114)
Cycle 6 Day 28 (n=222, 99)	19.21 (5.678)	18.24 (6.273)
Cycle 7 Day 1 (n=208, 79)	19.69 (5.645)	18.45 (6.761)
Cycle 7 Day 28 (n=204, 75)	19.12 (5.798)	18.76 (6.036)
Cycle 8 Day 1 (n=192, 67)	20.29 (5.285)	19.22 (5.828)
Cycle 8 Day 28 (n=190, 62)	19.33 (5.627)	19.10 (6.098)
Cycle 9 Day 1 (n=170, 51)	19.87 (5.635)	20.20 (5.455)
Cycle 9 Day 28 (n=167, 46)	19.27 (5.701)	20.04 (5.929)
Cycle 10 Day 1 (n=161, 50)	19.95 (5.420)	19.88 (5.903)
Cycle 10 Day 28 (n=154, 46)	19.22 (5.494)	19.40 (6.126)
Cycle 11 Day 1 (n=137, 35)	19.81 (5.368)	18.89 (6.014)
Cycle 11 Day 28 (n=140, 33)	19.12 (5.749)	18.81 (6.441)
Cycle 12 Day 1 (n=132, 30)	19.98 (5.618)	18.80 (6.599)
Cycle 12 Day 28 (n=128, 31)	19.42 (5.755)	19.13 (6.270)
Cycle 13 Day 1 (n=114, 27)	20.02 (5.703)	19.63 (6.918)
Cycle 13 Day 28 (n=114, 27)	19.65 (5.216)	18.59 (6.795)
Cycle 14 Day 1 (n=114, 26)	20.04 (5.556)	19.62 (6.020)
Cycle 14 Day 28 (n=107, 25)	19.07 (6.025)	19.72 (6.662)
Cycle 15 Day 1 (n=101, 21)	20.13 (5.654)	19.86 (6.327)
Cycle 15 Day 28 (n=96, 20)	19.24 (5.589)	19.83 (5.736)
Cycle 16 Day 1 (n=96, 19)	19.80 (5.469)	18.89 (6.154)
Cycle 16 Day 28 (n=91, 18)	19.53 (5.313)	18.61 (6.464)
Cycle 17 Day 1 (n=85, 17)	20.20 (5.606)	19.35 (6.103)
Cycle 17 Day 28 (n=81, 14)	19.67 (5.662)	18.71 (6.557)
Cycle 18 Day 1 (n=80, 12)	19.76 (5.862)	19.08 (7.317)
Cycle 18 Day 28 (n=71, 11)	19.47 (5.526)	19.00 (7.155)
Cycle 19 Day 1 (n=71, 11)	20.18 (5.563)	19.64 (7.500)
Cycle 19 Day 28 (n=61, 10)	19.59 (6.326)	19.10 (8.048)
Cycle 20 Day 1 (n=65, 9)	20.50 (5.425)	20.00 (7.826)
Cycle 20 Day 28 (n=53, 9)	20.15 (5.819)	20.22 (7.694)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Functional Well Being (FWB) subscale baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.897
	Confidence Interval	(2-Sided) 95%; 1.261 to 2.533
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.924
	Confidence Interval	95%; 1.309 to 2.539
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.939
	Confidence Interval	95%; 1.331 to 2.546
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.965
	Confidence Interval	95%; 1.363 to 2.568
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.980
	Confidence Interval	95%; 1.376 to 2.584
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.007
	Confidence Interval	95%; 1.392 to 2.622
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.022
	Confidence Interval	95%; 1.396 to 2.647
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.048
	Confidence Interval	95%; 1.397 to 2.700
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.063
	Confidence Interval	95%; 1.394 to 2.732
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.090
	Confidence Interval	95%; 1.383 to 2.797
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.105
	Confidence Interval	95%; 1.374 to 2.836
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.132
	Confidence Interval	95%; 1.353 to 2.910
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.146
	Confidence Interval	95%; 1.339 to 2.954
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.173
	Confidence Interval	95%; 1.311 to 3.036
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.188
	Confidence Interval	95%; 1.294 to 3.082
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.215
	Confidence Interval	95%; 1.260 to 3.169
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.230
	Confidence Interval	95%; 1.241 to 3.219
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.256
	Confidence Interval	95%; 1.203 to 3.309
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.271
	Confidence Interval	95%; 1.182 to 3.361
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.298
	Confidence Interval	95%; 1.142 to 3.454
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.313
	Confidence Interval	95%; 1.119 to 3.507
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.340
	Confidence Interval	95%; 1.076 to 3.603
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0004
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.354
	Confidence Interval	95%; 1.052 to 3.657
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0007
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.381
	Confidence Interval	95%; 1.008 to 3.754
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0009
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.396
	Confidence Interval	95%; 0.983 to 3.809
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0014
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.423
	Confidence Interval	95%; 0.938 to 3.908
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0017
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.438
	Confidence Interval	95%; 0.912 to 3.963
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0025
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.464
	Confidence Interval	95%; 0.866 to 4.063
	Estimation Comments	[Not Specified]

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0030
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.479
	Confidence Interval	95%; 0.840 to 4.119
	Estimation Comments	[Not Specified]

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0042
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.506
	Confidence Interval	95%; 0.792 to 4.219
	Estimation Comments	[Not Specified]

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0049
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.521
	Confidence Interval	95%; 0.766 to 4.275
	Estimation Comments	[Not Specified]

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0064
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.547
	Confidence Interval	95%; 0.718 to 4.377
	Estimation Comments	[Not Specified]

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0073
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.562
	Confidence Interval	95%; 0.691 to 4.433
	Estimation Comments	[Not Specified]

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0091
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.589
	Confidence Interval	95%; 0.643 to 4.535
	Estimation Comments	[Not Specified]

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0103
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.604
	Confidence Interval	95%; 0.616 to 4.592
	Estimation Comments	[Not Specified]

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0125
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.631
	Confidence Interval	95%; 0.567 to 4.695
	Estimation Comments	[Not Specified]

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0138
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.645
	Confidence Interval	95%; 0.539 to 4.752
	Estimation Comments	[Not Specified]

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0164
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.672
	Confidence Interval	95%; 0.490 to 4.855
	Estimation Comments	[Not Specified]

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0179
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.687
	Confidence Interval	95%; 0.462 to 4.912
	Estimation Comments	[Not Specified]

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0208
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.714
	Confidence Interval	95%; 0.413 to 5.015
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	EuroQoL Five Dimension (EQ-5D) Health State Index
Description	EQ-5D Health State Index: a brief, self-administered generic health status instrument. Respondents were asked to describe their current health state on each of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety or depression) on a three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A maximum score of 1 can be derived from these 5 dimensions by score conversion; range: -0.39 (worst health state)to 1.00 (best health state). This descriptive system classifies respondents into one of 243 possible distinct health states (EQ-5D descriptive system).
Time Frame	Day 1 & 28 of each cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Mean (Standard Deviation); Unit of Measure: scores on scale
Baseline (n=363, 352)	0.76 (0.225)	0.76 (0.234)
Cycle 1 Day 28 (346, 315)	0.72 (0.262)	0.70 (0.274)
Cycle 2 Day 1 (326, 244)	0.78 (0.230)	0.75 (0.231)
Cycle 2 Day 28 (311, 233)	0.73 (0.246)	0.74 (0.230)
Cycle 3 Day 1 (287, 200)	0.78 (0.220)	0.76 (0.222)
Cycle 3 Day 28 (283, 195)	0.75 (0.231)	0.75 (0.218)
Cycle 4 Day 1 (269, 150)	0.80 (0.199)	0.80 (0.190)
Cycle 4 Day 28 (261, 142)	0.76 (0.218)	0.79 (0.216)
Cycle 5 Day 1 (247, 120)	0.80 (0.209)	0.79 (0.194)
Cycle 5 Day 28 (240, 106)	0.76 (0.223)	0.78 (0.201)
Cycle 6 Day 1 (240, 98)	0.80 (0.249)	0.80 (0.178)
Cycle 6 Day 28 (224, 100)	0.77 (0.206)	0.80 (0.187)
Cycle 7 Day 1 (205, 79)	0.81 (0.192)	0.80 (0.185)
Cycle 7 Day 28 (204, 74)	0.77 (0.221)	0.81 (0.156)
Cycle 8 Day 1 (192, 68)	0.82 (0.180)	0.82 (0.158)
Cycle 8 Day 28 (190, 61)	0.77 (0.222)	0.81 (0.163)
Cycle 9 Day 1 (170, 51)	0.80 (0.196)	0.84 (0.162)
Cycle 9 Day 28 (168, 45)	0.78 (0.194)	0.84 (0.147)
Cycle 10 Day 1 (161, 50)	0.81 (0.209)	0.85 (0.161)
Cycle 10 Day 28 (153, 46)	0.78 (0.200)	0.82 (0.185)
Cycle 11 Day 1 (138, 34)	0.80 (0.192)	0.85 (0.159)
Cycle 11 Day 28 (138, 32)	0.75 (0.189)	0.84 (0.185)
Cycle 12 Day 1 (132, 31)	0.81 (0.187)	0.82 (0.283)
Cycle 12 Day 28 (127, 31)	0.77 (0.182)	0.85 (0.165)
Cycle 13 Day 1 (114, 26)	0.81 (0.176)	0.83 (0.231)
Cycle 13 Day 28 (115, 27)	0.77 (0.186)	0.82 (0.260)
Cycle 14 Day 1 (114, 25)	0.81 (0.181)	0.86 (0.148)
Cycle 14 Day 28 (107, 24)	0.75 (0.224)	0.87 (0.160)
Cycle 15 Day 1 (100, 21)	0.80 (0.190)	0.88 (0.146)
Cycle 15 Day 28 (95, 20)	0.75 (0.209)	0.88 (0.141)
Cycle 16 Day 1 (96, 19)	0.79 (0.194)	0.84 (0.163)
Cycle 16 Day 28 (93, 18)	0.76 (0.181)	0.83 (0.164)
Cycle 17 Day 1 (84, 15)	0.79 (0.194)	0.88 (0.169)
Cycle 17 Day 28 (82, 14)	0.77 (0.168)	0.83 (0.174)
Cycle 18 Day 1 (80, 12)	0.81 (0.187)	0.86 (0.274)
Cycle 18 Day 28 (71, 10)	0.76 (0.166)	0.84 (0.279)
Cycle 19 Day 1 (69, 11)	0.81 (0.183)	0.88 (0.184)
Cycle 19 Day 28 (62, 11)	0.78 (0.165)	0.72 (0.436)
Cycle 20 Day 1 (63, 8)	0.81 (0.162)	0.85 (0.182)
Cycle 20 Day 28 (54, 9)	0.77 (0.181)	0.86 (0.215)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EuroQoL Five Dimension (EQ-5D): Health state index baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0004
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.049
	Confidence Interval	(2-Sided) 95%; 0.022 to 0.076
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.048
	Confidence Interval	95%; 0.022 to 0.075
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.048
	Confidence Interval	95%; 0.022 to 0.074
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.047
	Confidence Interval	95%; 0.021 to 0.072
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0004
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.046
	Confidence Interval	95%; 0.021 to 0.072
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0005
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.045
	Confidence Interval	95%; 0.020 to 0.071
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0007
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.045
	Confidence Interval	95%; 0.019 to 0.070
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0011
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.044
	Confidence Interval	95%; 0.017 to 0.070
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0016
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.043
	Confidence Interval	95%; 0.016 to 0.070
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0029
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.042
	Confidence Interval	95%; 0.014 to 0.070
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0041
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.042
	Confidence Interval	95%; 0.013 to 0.070
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0076
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.041
	Confidence Interval	95%; 0.011 to 0.071
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0105
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.040
	Confidence Interval	95%; 0.009 to 0.071
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0179
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.039
	Confidence Interval	95%; 0.007 to 0.072
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0236
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.039
	Confidence Interval	95%; 0.005 to 0.072
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0370
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.038
	Confidence Interval	95%; 0.002 to 0.073
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0464
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.037
	Confidence Interval	95%; 0.001 to 0.074
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0667
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.036
	Confidence Interval	95%; -0.002 to 0.075
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0800
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.036
	Confidence Interval	95%; -0.004 to 0.076
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1070
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.035
	Confidence Interval	95%; -0.007 to 0.077
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1237
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.034
	Confidence Interval	95%; -0.009 to 0.078
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1561
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.033
	Confidence Interval	95%; -0.013 to 0.079
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1752
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.033
	Confidence Interval	95%; -0.015 to 0.080
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2112
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.032
	Confidence Interval	95%; -0.018 to 0.081
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2319
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.031
	Confidence Interval	95%; -0.020 to 0.082
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2698
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.030
	Confidence Interval	95%; -0.023 to 0.084
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2910
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.030
	Confidence Interval	95%; -0.025 to 0.085
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3293
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.029
	Confidence Interval	95%; -0.029 to 0.086
	Estimation Comments	[Not Specified]

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3504
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.028
	Confidence Interval	95%; -0.031 to 0.087
	Estimation Comments	[Not Specified]

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3881
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.027
	Confidence Interval	95%; -0.034 to 0.089
	Estimation Comments	[Not Specified]

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4086
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.027
	Confidence Interval	95%; -0.036 to 0.090
	Estimation Comments	[Not Specified]

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4449
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.026
	Confidence Interval	95%; -0.040 to 0.091
	Estimation Comments	[Not Specified]

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4646
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.025
	Confidence Interval	95%; -0.042 to 0.092
	Estimation Comments	[Not Specified]

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4990
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.024
	Confidence Interval	95%; -0.046 to 0.094
	Estimation Comments	[Not Specified]

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5176
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.024
	Confidence Interval	95%; -0.048 to 0.095
	Estimation Comments	[Not Specified]

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5501
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.023
	Confidence Interval	95%; -0.051 to 0.097
	Estimation Comments	[Not Specified]

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5675
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.022
	Confidence Interval	95%; -0.054 to 0.098
	Estimation Comments	[Not Specified]

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5979
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.021
	Confidence Interval	95%; -0.057 to 0.099
	Estimation Comments	[Not Specified]

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6141
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.021
	Confidence Interval	95%; -0.059 to 0.100
	Estimation Comments	[Not Specified]

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6424
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.020
	Confidence Interval	95%; -0.063 to 0.102
	Estimation Comments	[Not Specified]

18. Secondary Outcome

Title	Euro-QoL Visual Analog Scale (EQ-VAS)
Description	EQ-VAS: overall self-rating rating of the patient's current health state using a 20 cm Visual Analog Scale (EQ-VAS), also called the health state thermometer) is a metric measurement (in 2 mm interval) from the visual analog scale which ranges between 0 (worse imaginable health state) and 100 (best imaginable health state).
Time Frame	Day 1 & 28 of each cycle: duration of treatment phase

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Mean (Standard Deviation); Unit of Measure: scores on scale
Baseline (n=365, 352)	73.80 (18.498)	71.43 (19.507)
Cycle 1 Day 28 (n=347, 315)	69.35 (18.992)	67.66 (20.058)
Cycle 2 Day 1 (n=323, 247)	75.05 (17.964)	70.45 (17.653)
Cycle 2 Day 28 (n=314, 237)	72.06 (18.297)	70.70 (18.271)
Cycle 3 Day 1 (n=293, 198)	76.23 (17.171)	72.68 (17.162)
Cycle 3 Day 28 (n=287, 193)	72.33 (18.472)	71.45 (18.315)
Cycle 4 Day 1 (n=270, 152)	77.46 (16.024)	72.74 (17.678)
Cycle 4 Day 28 (n=264, 139)	75.15 (16.406)	72.20 (18.098)
Cycle 5 Day 1 (n=248, 118)	79.83 (13.554)	73.44 (16.204)
Cycle 5 Day 28 (n=240, 104)	75.13 (16.771)	72.57 (16.007)
Cycle 6 Day 1 (n=237, 99)	78.83 (15.359)	73.68 (16.537)
Cycle 6 Day 28 (n=223, 98)	76.81 (15.204)	72.26 (18.452)
Cycle 7 Day 1 (n=209, 77)	79.39 (14.601)	73.80 (18.868)
Cycle 7 Day 28 (n=201, 74)	76.09 (16.693)	73.46 (17.380)
Cycle 8 Day 1 (n=192, 67)	81.34 (13.020)	74.27 (18.067)
Cycle 8 Day 28 (n=191, 60)	77.53 (14.374)	74.33 (18.407)
Cycle 9 Day 1 (n=172, 50)	80.08 (13.812)	77.66 (15.987)
Cycle 9 Day 28 (n=168, 46)	76.24 (15.740)	76.57 (17.924)
Cycle 10 Day 1 (n=160, 50)	79.18 (14.912)	76.64 (17.886)
Cycle 10 Day 28 (n=154, 45)	76.44 (16.106)	76.69 (19.123)
Cycle 11 Day 1 (n=138, 34)	79.72 (15.685)	75.06 (20.179)
Cycle 11 Day 28 (n=141, 33)	76.81 (15.128)	72.21 (23.202)
Cycle 12 Day 1 (n=130, 31)	80.84 (14.150)	75.19 (22.020)
Cycle 12 Day 28 (n=128, 31)	76.71 (14.986)	73.84 (20.775)
Cycle 13 Day 1 (n=114, 27)	80.59 (14.875)	77.52 (17.738)
Cycle 13 Day 28 (n=115, 27)	77.22 (14.715)	73.56 (23.523)
Cycle 14 Day 1 (n=114, 26)	80.39 (14.477)	76.69 (16.601)
Cycle 14 Day 28 (n=107, 25)	76.53 (15.933)	76.44 (18.890)
Cycle 15 Day 1 (n=101, 21)	80.50 (14.361)	76.62 (19.075)
Cycle 15 Day 28 (n=96, 20)	76.51 (15.141)	76.50 (18.841)
Cycle 16 Day 1 (n=96, 19)	79.85 (15.632)	74.84 (21.680)
Cycle 16 Day 28 (n=92, 18)	75.51 (17.687)	73.11 (21.202)
Cycle 17 Day 1 (n=84, 17)	80.74 (15.706)	76.94 (21.256)
Cycle 17 Day 28 (n=82, 14)	77.10 (16.612)	72.86 (22.593)
Cycle 18 Day 1 (n=78, 12)	80.40 (14.658)	74.42 (25.065)
Cycle 18 Day 28 (n=70, 11)	77.76 (16.142)	73.82 (24.140)
Cycle 19 Day 1 (n=70, 11)	81.47 (15.330)	79.27 (20.283)
Cycle 19 Day 28 (n=62, 11)	77.05 (18.676)	68.55 (29.717)
Cycle 20 Day 1 (n=65, 9)	81.10 (15.404)	76.00 (21.494)
Cycle 20 Day 28 (n=54, 9)	76.85 (16.863)	75.44 (25.060)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Euro-QoL Visual Analog Scale (EQ-VAS) baseline score (intercept and time since randomization are included as random effects).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.026
	Confidence Interval	(2-Sided) 95%; 2.088 to 5.965
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.165
	Confidence Interval	95%; 2.269 to 6.061
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.243
	Confidence Interval	95%; 2.358 to 6.128
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.382
	Confidence Interval	95%; 2.494 to 6.269
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.459
	Confidence Interval	95%; 2.558 to 6.361
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.598
	Confidence Interval	95%; 2.650 to 6.547
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.676
	Confidence Interval	95%; 2.689 to 6.662
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.815
	Confidence Interval	95%; 2.741 to 6.889
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.892
	Confidence Interval	95%; 2.760 to 7.024
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.031
	Confidence Interval	95%; 2.780 to 7.283
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.109
	Confidence Interval	95%; 2.783 to 7.435
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.248
	Confidence Interval	95%; 2.776 to 7.720
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.325
	Confidence Interval	95%; 2.767 to 7.884
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.464
	Confidence Interval	95%; 2.741 to 8.188
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.542
	Confidence Interval	95%; 2.723 to 8.361
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.681
	Confidence Interval	95%; 2.683 to 8.679
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.758
	Confidence Interval	95%; 2.657 to 8.859
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0004
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.898
	Confidence Interval	95%; 2.607 to 9.188
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0006
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.975
	Confidence Interval	95%; 2.576 to 9.374
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0009
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.114
	Confidence Interval	95%; 2.517 to 9.711
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0011
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.191
	Confidence Interval	95%; 2.482 to 9.900
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0015
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.331
	Confidence Interval	95%; 2.417 to 10.244
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0018
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.408
	Confidence Interval	95%; 2.379 to 10.436
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0025
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.547
	Confidence Interval	95%; 2.309 to 10.785
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0029
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.624
	Confidence Interval	95%; 2.269 to 10.980
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0037
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.764
	Confidence Interval	95%; 2.195 to 11.332
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0042
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.841
	Confidence Interval	95%; 2.153 to 11.529
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0053
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.980
	Confidence Interval	95%; 2.076 to 11.884
	Estimation Comments	[Not Specified]

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0059
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.057
	Confidence Interval	95%; 2.032 to 12.083
	Estimation Comments	[Not Specified]

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0072
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.197
	Confidence Interval	95%; 1.953 to 12.441
	Estimation Comments	[Not Specified]

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0079
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.274
	Confidence Interval	95%; 1.908 to 12.640
	Estimation Comments	[Not Specified]

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0093
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.413
	Confidence Interval	95%; 1.826 to 13.000
	Estimation Comments	[Not Specified]

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0101
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.491
	Confidence Interval	95%; 1.780 to 13.201
	Estimation Comments	[Not Specified]

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0117
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.630
	Confidence Interval	95%; 1.697 to 13.562
	Estimation Comments	[Not Specified]

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0126
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.707
	Confidence Interval	95%; 1.650 to 13.764
	Estimation Comments	[Not Specified]

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0144
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.846
	Confidence Interval	95%; 1.565 to 14.127
	Estimation Comments	[Not Specified]

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0153
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.924
	Confidence Interval	95%; 1.518 to 14.329
	Estimation Comments	[Not Specified]

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0172
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.063
	Confidence Interval	95%; 1.432 to 14.693
	Estimation Comments	[Not Specified]

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0182
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.140
	Confidence Interval	95%; 1.384 to 14.896
	Estimation Comments	[Not Specified]

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	SU011248, IFN-α
	Comments	Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0201
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.279
	Confidence Interval	95%; 1.297 to 15.261
	Estimation Comments	[Not Specified]

19. Secondary Outcome

Title	Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis
Description	Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Time Frame	Day 1 & Day 28, Cycle 1 to Cycle 4

Outcome Measure Data

Analysis Population Description

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

.

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	35	31
Mean (Standard Deviation); Unit of Measure: pg/ml and ratio to Baseline
Plasma VEGF-A: Baseline (n=33, 31)	101.9 (184.3)	109.0 (242.4)
Plasma VEGF-A: C1D28: C1D1 (n=31, 26)	4.280 (2.619)	1.134 (0.683)
Plasma VEGF-A: C2D1: C1D1 (n=32, 21)	1.161 (0.624)	1.171 (0.527)
Plasma VEGF-A: C2D28: C1D1 (n=31, 20)	5.851 (4.345)	1.153 (0.517)
Plasma VEGF-A: C3D1: C1D1 (n=27, 15)	1.630 (1.685)	1.253 (0.483)
Plasma VEGF-A: C3D28: C1D1 (n=28, 15)	5.236 (3.333)	1.149 (0.570)
Plasma VEGF-A: C4D1: C1D1 (n=27, 12)	1.486 (1.125)	1.209 (0.654)
Plasma VEGF-A: C4D28: C1D1 (n=25, 11)	4.924 (3.679)	1.008 (0.372)
Plasma VEGF-C: Baseline (n=35, 31)	556.4 (311.7)	651.2 (552.3)
Plasma VEGF-C: C1D28: C1D1 (n=31, 26)	0.945 (0.428)	1.165 (0.606)
Plasma VEGF-C: C2D1:C1D1 (n=30, 21)	1.045 (0.623)	1.177 (0.464)
Plasma VEGF-C: C2D28:C1D1 (n=31, 19)	0.871 (0.511)	1.081 (0.410)
Plasma VEGF-C: C3D1:C1D1 (n=28, 15)	1.159 (0.659)	1.174 (0.588)
Plasma VEGF-C: C3D28:C1D1 (n=28, 15)	1.043 (0.926)	1.054 (0.586)
Plasma VEGF-C: C4D1:C1D1 (n=28, 12)	1.243 (1.304)	1.382 (0.799)
Plasma VEGF-C: C4:D28:C1D1 (n=26, 11)	1.207 (1.269)	1.139 (0.403)
PLASMA sVEGFR-3: Baseline (n=29, 30)	44049.3 (20168.2)	40317.7 (12938.3)
PLASMA sVEGFR-3: C1D28:C1D1 (n=27, 25)	0.473 (0.185)	1.068 (0.292)
PLASMA sVEGFR-3: C2D1:C1D1 (n=28, 20)	0.787 (0.172)	1.075 (0.331)
PLASMA sVEGFR-3: C2D28:C1D1 (n=28, 19)	0.407 (0.173)	1.150 (0.355)
PLASMA sVEGFR-3: C3D1:C1D1 (n=25, 14)	0.800 (0.309)	1.015 (0.210)
PLASMA sVEGFR-3: C3D28:C1D1 (n=25, 14)	0.427 (0.194)	1.042 (0.349)
PLASMA sVEGFR-3: C4D1:C1D1 (n=24, 11)	0.846 (0.380)	1.183 (0.333)
PLASMA sVEGFR-3: C4:D28:C1D1 (n=23, 10)	0.486 (0.265)	1.044 (0.141)
PLASMA IL-8: Baseline (n=31, 29)	10.1 (9.7)	18.6 (32.0)
PLASMA IL-8: C1D28:C1D1 (n=29, 25)	2.815 (1.340)	2.297 (2.036)
PLASMA IL-8: C2D1:C1D1 (n=29, 20)	1.716 (0.630)	1.579 (0.688)
PLASMA IL-8: C2D28:C1D1 (n=29, 19)	2.423 (1.514)	1.858 (0.849)
PLASMA IL-8: C3D1:C1D1 (n=26, 15)	2.788 (2.781)	1.531 (0.693)
PLASMA IL-8: C3D28:C1D1 (n=26, 14)	2.574 (1.726)	1.999 (0.964)
PLASMA IL-8: C4D1:C1D1 (n=26, 12)	1.934 (1.372)	1.662 (0.736)
PLASMA IL-8: C4:D28:C1D1 (n=25, 11)	2.549 (1.489)	2.492 (2.023)
PLASMA bFGF: Baseline (n=21, 2)	13.1 (13.1)	13.6 (16.8)
PLASMA bFGF: C1D28:C1D1 (n=15, 1)	2.762 (5.087)	0.429 (0)
PLASMA bFGF: C2D1:C1D1 (n=13, 1)	1.370 (1.800)	0.157 (0)

20. Secondary Outcome

Title	Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis
Description	Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Time Frame	Day 1 & Day 28, Cycle 1 to Cycle 4

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	14	0
Mean (Standard Deviation); Unit of Measure: pg/ml and ratio to Baseline
PLASMA bFGF: C2D28:C1D1 (n=14, 0)	0.760 (0.604)
PLASMA bFGF: C3D1:C1D1 (n=12, 0)	1.582 (2.622)
PLASMA bFGF: C3D28:C1D1 (n=12, 0)	1.671 (2.109)
PLASMA bFGF: C4D1:C1D1 (n=14, 0)	2.895 (4.252)
PLASMA bFGF: C4:D28:C1D1 (n=10, 0)	0.803 (0.799)

21. Secondary Outcome

Title	Incremental Cost Effectiveness Ratio (ICER)
Description	Incremental cost effectiveness ratio (ICER) of sunitinib compared to IFN-a as first-line treatment for MRCC, defined as the ratio of the incremental cost of treatment over the incremental effectiveness; effectiveness measured as quality adjusted life year (QALY) gain. This objective was not addressed in the clinical study report, but an interim analysis of cost-effectiveness was presented separately. These results were not available for inclusion at the time of this posting.
Time Frame	post study measurement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SU011248	IFN-α
Arm/Group Description:	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
Overall Number of Participants Analyzed	375	375
Measure Type: Number; Unit of Measure: ratio
	0	0

22. Secondary Outcome

Title	Ctrough Concentrations of SU011248
Description	Subject observed Ctrough (trough drug) concentrations of SU011248 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).
Time Frame	Day 28 of Cycle 1 to Cycle 4

Outcome Measure Data

Analysis Population Description

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

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

23. Secondary Outcome

Title	Ctrough Concentrations of Metabolite SU012662
Description	Subject observed Ctrough (trough drug) concentrations of active metabolite SU012662 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).
Time Frame	Day 28 of Cycle 1 to Cycle 4

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SU012662
Arm/Group Description:	Active metabolite of SU011248
Overall Number of Participants Analyzed	45
Mean (Standard Deviation); Unit of Measure: ng/mL
Cycle 1, Day 28 (n=31)	27.10 (17.28)
Cycle 2, Day 28 (n=36)	27.35 (15.42)
Cycle 3, Day 28 (n=36)	26.11 (16.15)
Cycle 4, Day 28 (n=32)	22.11 (12.67)
Dose-Corrected: Cycle 1, Day 28 (n=24)	28.21 (19.01)
Dose-Corrected: Cycle 2, Day 28 (n=28)	28.32 (13.74)
Dose-Corrected: Cycle 3, Day 28 (n=27)	29.04 (19.07)
Dose-Corrected: Cycle 4, Day 28 (n=26)	25.99 (16.25)

24. Secondary Outcome

Title	Ctrough Concentrations of SU011248 and Active Metabolite SU012662
Description	Subject observed Ctrough (trough drug) concentrations of total drug (SU011248 and its active metabolite SU012662) per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).
Time Frame	Day 28 of Cycle 1 to Cycle 4

Outcome Measure Data

Analysis Population Description

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

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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	SU011248	IFN-α
Arm/Group Description	50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.	Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
All-Cause Mortality
	SU011248	IFN-α
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	SU011248	IFN-α
	Affected / at Risk (%)	Affected / at Risk (%)
Total	170/375 (45.33%)	93/360 (25.83%)
Blood and lymphatic system disorders
Anaemia † 1	14/375 (3.73%)	12/360 (3.33%)
Thrombocytopenia † 2	5/375 (1.33%)	0/360 (0.00%)
Febrile neutropenia †	3/375 (0.80%)	0/360 (0.00%)
Idiopathic thrombocytopenic purpura †	2/375 (0.53%)	0/360 (0.00%)
Leukopenia †	1/375 (0.27%)	0/360 (0.00%)
Neutropenia †	1/375 (0.27%)	0/360 (0.00%)
Thrombotic thrombocytopenic purpura †	1/375 (0.27%)	0/360 (0.00%)
Cardiac disorders
Myocardial infarction †	5/375 (1.33%)	2/360 (0.56%)
Atrial fibrillation †	3/375 (0.80%)	0/360 (0.00%)
Coronary artery disease †	2/375 (0.53%)	0/360 (0.00%)
Pericardial effusion †	2/375 (0.53%)	1/360 (0.28%)
Atrial flutter †	1/375 (0.27%)	0/360 (0.00%)
Cardiac arrest †	1/375 (0.27%)	0/360 (0.00%)
Cardiac failure congestive †	1/375 (0.27%)	1/360 (0.28%)
Left ventricular dysfunction †	1/375 (0.27%)	0/360 (0.00%)
Myocardial ischaemia †	1/375 (0.27%)	0/360 (0.00%)
Palpitations †	1/375 (0.27%)	0/360 (0.00%)
Tachycardia †	1/375 (0.27%)	0/360 (0.00%)
Acute myocardial infarction †	0/375 (0.00%)	1/360 (0.28%)
Cardiac disorder †	0/375 (0.00%)	1/360 (0.28%)
Ear and labyrinth disorders
Deafness †	1/375 (0.27%)	0/360 (0.00%)
Vertigo positional †	0/375 (0.00%)	1/360 (0.28%)
Endocrine disorders
Hypothyroidism †	8/375 (2.13%)	0/360 (0.00%)
Hyperthyroidism †	0/375 (0.00%)	1/360 (0.28%)
Eye disorders
Visual impairment †	2/375 (0.53%)	0/360 (0.00%)
Retinal artery occlusion †	1/375 (0.27%)	0/360 (0.00%)
Gastrointestinal disorders
Vomiting †	12/375 (3.20%)	3/360 (0.83%)
Nausea †	10/375 (2.67%)	3/360 (0.83%)
Abdominal pain †	8/375 (2.13%)	3/360 (0.83%)
Diarrhoea †	5/375 (1.33%)	0/360 (0.00%)
Gastrointestinal haemorrhage †	4/375 (1.07%)	0/360 (0.00%)
Dysphagia †	2/375 (0.53%)	0/360 (0.00%)
Gastric haemorrhage †	2/375 (0.53%)	0/360 (0.00%)
Intestinal obstruction †	2/375 (0.53%)	0/360 (0.00%)
Intestinal perforation †	2/375 (0.53%)	1/360 (0.28%)
Pancreatitis †	2/375 (0.53%)	0/360 (0.00%)
Stomatitis †	2/375 (0.53%)	0/360 (0.00%)
Abdominal pain lower †	1/375 (0.27%)	0/360 (0.00%)
Anal fistula †	1/375 (0.27%)	0/360 (0.00%)
Ascites †	1/375 (0.27%)	0/360 (0.00%)
Constipation †	1/375 (0.27%)	1/360 (0.28%)
Gastric ulcer haemorrhage †	1/375 (0.27%)	0/360 (0.00%)
Gastrointestinal obstruction †	1/375 (0.27%)	0/360 (0.00%)
Glossodynia †	1/375 (0.27%)	0/360 (0.00%)
Haematemesis †	1/375 (0.27%)	0/360 (0.00%)
Haematochezia †	1/375 (0.27%)	0/360 (0.00%)
Haemorrhoidal haemorrhage †	1/375 (0.27%)	0/360 (0.00%)
Ileus †	1/375 (0.27%)	0/360 (0.00%)
Intestinal fistula †	1/375 (0.27%)	0/360 (0.00%)
Mouth ulceration †	1/375 (0.27%)	0/360 (0.00%)
Rectal haemorrhage †	1/375 (0.27%)	1/360 (0.28%)
Small intestinal obstruction †	1/375 (0.27%)	0/360 (0.00%)
Tongue oedema †	1/375 (0.27%)	0/360 (0.00%)
Abdominal pain upper †	0/375 (0.00%)	2/360 (0.56%)
Dry mouth †	0/375 (0.00%)	1/360 (0.28%)
Large intestine perforation †	0/375 (0.00%)	1/360 (0.28%)
Upper gastrointestinal haemorrhage †	0/375 (0.00%)	1/360 (0.28%)
General disorders
Disease progression †	17/375 (4.53%)	15/360 (4.17%)
Asthenia †	16/375 (4.27%)	5/360 (1.39%)
Chest pain †	7/375 (1.87%)	6/360 (1.67%)
General physical health deterioration †	5/375 (1.33%)	0/360 (0.00%)
Pyrexia †	5/375 (1.33%)	0/360 (0.00%)
Condition aggravated †	3/375 (0.80%)	2/360 (0.56%)
Fatigue †	3/375 (0.80%)	5/360 (1.39%)
Oedema peripheral †	2/375 (0.53%)	0/360 (0.00%)
Pain †	2/375 (0.53%)	0/360 (0.00%)
Chills †	1/375 (0.27%)	0/360 (0.00%)
Face oedema †	1/375 (0.27%)	0/360 (0.00%)
Hypothermia †	1/375 (0.27%)	0/360 (0.00%)
Sudden death †	1/375 (0.27%)	0/360 (0.00%)
Performance status decreased †	0/375 (0.00%)	2/360 (0.56%)
Hepatobiliary disorders
Biliary tract disorder †	1/375 (0.27%)	0/360 (0.00%)
Cholecystitis †	1/375 (0.27%)	0/360 (0.00%)
Cholecystitis acute †	1/375 (0.27%)	0/360 (0.00%)
Cholelithiasis †	1/375 (0.27%)	0/360 (0.00%)
Hepatitis †	1/375 (0.27%)	0/360 (0.00%)
Bile duct stone †	0/375 (0.00%)	1/360 (0.28%)
Infections and infestations
Cellulitis †	3/375 (0.80%)	0/360 (0.00%)
Pneumonia †	3/375 (0.80%)	2/360 (0.56%)
Gastroenteritis †	2/375 (0.53%)	0/360 (0.00%)
Urosepsis †	2/375 (0.53%)	0/360 (0.00%)
Arthritis bacterial †	1/375 (0.27%)	0/360 (0.00%)
Arthritis infective †	1/375 (0.27%)	0/360 (0.00%)
Fungal infection †	1/375 (0.27%)	0/360 (0.00%)
Herpes zoster †	1/375 (0.27%)	0/360 (0.00%)
Infected skin ulcer †	1/375 (0.27%)	0/360 (0.00%)
Localised infection †	1/375 (0.27%)	0/360 (0.00%)
Lung infection †	1/375 (0.27%)	0/360 (0.00%)
Oesophageal candidiasis †	1/375 (0.27%)	0/360 (0.00%)
Otitis externa †	1/375 (0.27%)	0/360 (0.00%)
Perirectal abscess †	1/375 (0.27%)	0/360 (0.00%)
Pleural infection †	1/375 (0.27%)	0/360 (0.00%)
Pyothorax †	1/375 (0.27%)	0/360 (0.00%)
Sepsis †	1/375 (0.27%)	2/360 (0.56%)
Sinusitis †	1/375 (0.27%)	1/360 (0.28%)
Upper respiratory tract infection †	1/375 (0.27%)	0/360 (0.00%)
Urinary tract infection †	1/375 (0.27%)	1/360 (0.28%)
Wound infection †	1/375 (0.27%)	0/360 (0.00%)
Diverticulitis †	0/375 (0.00%)	1/360 (0.28%)
Infection †	0/375 (0.00%)	1/360 (0.28%)
Respiratory tract infection †	0/375 (0.00%)	1/360 (0.28%)
Staphylococcal infection †	0/375 (0.00%)	1/360 (0.28%)
Injury, poisoning and procedural complications
Cervical vertebral fracture †	1/375 (0.27%)	0/360 (0.00%)
Dislocation of joint prosthesis †	1/375 (0.27%)	0/360 (0.00%)
Head injury †	1/375 (0.27%)	0/360 (0.00%)
Hip fracture †	1/375 (0.27%)	0/360 (0.00%)
Humerus fracture †	1/375 (0.27%)	1/360 (0.28%)
Lumbar vertebral fracture †	1/375 (0.27%)	0/360 (0.00%)
Wound dehiscence †	1/375 (0.27%)	0/360 (0.00%)
Brain herniation †	0/375 (0.00%)	1/360 (0.28%)
Pelvic fracture †	0/375 (0.00%)	1/360 (0.28%)
Investigations
Blood bilirubin increased †	2/375 (0.53%)	0/360 (0.00%)
Ejection fraction decreased †	2/375 (0.53%)	0/360 (0.00%)
Platelet count decreased †	2/375 (0.53%)	0/360 (0.00%)
Alanine aminotransferase increased †	1/375 (0.27%)	0/360 (0.00%)
Aspartate aminotransferase increased †	1/375 (0.27%)	0/360 (0.00%)
Blood creatine phosphokinase increased †	1/375 (0.27%)	0/360 (0.00%)
Electrocardiogram change †	1/375 (0.27%)	0/360 (0.00%)
Haemoglobin decreased †	1/375 (0.27%)	0/360 (0.00%)
Urine output decreased †	1/375 (0.27%)	0/360 (0.00%)
Blood creatinine increased †	0/375 (0.00%)	1/360 (0.28%)
Weight decreased †	0/375 (0.00%)	1/360 (0.28%)
Metabolism and nutrition disorders
Dehydration †	11/375 (2.93%)	6/360 (1.67%)
Hyponatraemia †	5/375 (1.33%)	0/360 (0.00%)
Anorexia †	3/375 (0.80%)	0/360 (0.00%)
Hypoglycaemia †	3/375 (0.80%)	0/360 (0.00%)
Decreased appetite †	1/375 (0.27%)	0/360 (0.00%)
Hyperglycaemia †	1/375 (0.27%)	0/360 (0.00%)
Hyperkalaemia †	1/375 (0.27%)	1/360 (0.28%)
Hypokalaemia †	1/375 (0.27%)	0/360 (0.00%)
Diabetes mellitus †	0/375 (0.00%)	3/360 (0.83%)
Hypercalcaemia †	0/375 (0.00%)	2/360 (0.56%)
Hyperuricaemia †	0/375 (0.00%)	1/360 (0.28%)
Musculoskeletal and connective tissue disorders
Back pain †	7/375 (1.87%)	1/360 (0.28%)
Arthralgia †	2/375 (0.53%)	1/360 (0.28%)
Muscular weakness †	2/375 (0.53%)	0/360 (0.00%)
Pathological fracture †	2/375 (0.53%)	5/360 (1.39%)
Bone pain †	1/375 (0.27%)	1/360 (0.28%)
Groin pain †	1/375 (0.27%)	0/360 (0.00%)
Hypercreatinaemia †	1/375 (0.27%)	0/360 (0.00%)
Musculoskeletal chest pain †	1/375 (0.27%)	0/360 (0.00%)
Pain in extremity †	1/375 (0.27%)	1/360 (0.28%)
Fistula †	0/375 (0.00%)	1/360 (0.28%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain †	1/375 (0.27%)	0/360 (0.00%)
Colon cancer †	1/375 (0.27%)	0/360 (0.00%)
Prostate cancer †	1/375 (0.27%)	1/360 (0.28%)
Intracranial tumour haemorrhage †	0/375 (0.00%)	1/360 (0.28%)
Nervous system disorders
Convulsion †	3/375 (0.80%)	1/360 (0.28%)
Spinal cord compression †	3/375 (0.80%)	1/360 (0.28%)
Epilepsy †	2/375 (0.53%)	1/360 (0.28%)
Headache †	2/375 (0.53%)	0/360 (0.00%)
Monoparesis †	2/375 (0.53%)	0/360 (0.00%)
Syncope †	2/375 (0.53%)	1/360 (0.28%)
Aphasia †	1/375 (0.27%)	0/360 (0.00%)
Cerebellar syndrome †	1/375 (0.27%)	0/360 (0.00%)
Cerebral haematoma †	1/375 (0.27%)	0/360 (0.00%)
Cerebral ischaemia †	1/375 (0.27%)	0/360 (0.00%)
Facial palsy †	1/375 (0.27%)	0/360 (0.00%)
Hemiparesis †	1/375 (0.27%)	1/360 (0.28%)
Incoherent †	1/375 (0.27%)	0/360 (0.00%)
Memory impairment †	1/375 (0.27%)	0/360 (0.00%)
Nervous system disorder †	1/375 (0.27%)	0/360 (0.00%)
Paresis †	1/375 (0.27%)	0/360 (0.00%)
Peripheral sensory neuropathy †	1/375 (0.27%)	0/360 (0.00%)
Reversible posterior leukoencephalopathy syndrome †	1/375 (0.27%)	0/360 (0.00%)
Transient ischaemic attack †	1/375 (0.27%)	1/360 (0.28%)
Cerebral haemorrhage †	0/375 (0.00%)	1/360 (0.28%)
Cerebrovascular accident †	0/375 (0.00%)	1/360 (0.28%)
Dizziness †	0/375 (0.00%)	1/360 (0.28%)
Haemorrhage intracranial †	0/375 (0.00%)	1/360 (0.28%)
Motor dysfunction †	0/375 (0.00%)	1/360 (0.28%)
Psychiatric disorders
Confusional state †	3/375 (0.80%)	0/360 (0.00%)
Mental status changes †	2/375 (0.53%)	2/360 (0.56%)
Anxiety †	1/375 (0.27%)	0/360 (0.00%)
Delirium †	1/375 (0.27%)	0/360 (0.00%)
Insomnia †	1/375 (0.27%)	0/360 (0.00%)
Depression †	0/375 (0.00%)	1/360 (0.28%)
Emotional disorder †	0/375 (0.00%)	1/360 (0.28%)
Renal and urinary disorders
Haematuria †	5/375 (1.33%)	1/360 (0.28%)
Renal failure †	4/375 (1.07%)	1/360 (0.28%)
Renal failure acute †	4/375 (1.07%)	1/360 (0.28%)
Urinary retention †	2/375 (0.53%)	2/360 (0.56%)
Nephrotic syndrome †	1/375 (0.27%)	0/360 (0.00%)
Pollakiuria †	1/375 (0.27%)	0/360 (0.00%)
Urinary bladder haemorrhage †	1/375 (0.27%)	0/360 (0.00%)
Reproductive system and breast disorders
Metrorrhagia †	1/375 (0.27%)	0/360 (0.00%)
Uterine haemorrhage †	1/375 (0.27%)	0/360 (0.00%)
Vaginal haemorrhage †	1/375 (0.27%)	0/360 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea †	9/375 (2.40%)	9/360 (2.50%)
Pleural effusion †	9/375 (2.40%)	1/360 (0.28%)
Pulmonary embolism †	6/375 (1.60%)	4/360 (1.11%)
Epistaxis †	4/375 (1.07%)	0/360 (0.00%)
Pneumothorax †	2/375 (0.53%)	0/360 (0.00%)
Dyspnoea exertional †	1/375 (0.27%)	0/360 (0.00%)
Hypoxia †	1/375 (0.27%)	1/360 (0.28%)
Lung disorder †	1/375 (0.27%)	0/360 (0.00%)
Oropharyngeal pain †	1/375 (0.27%)	0/360 (0.00%)
Respiratory arrest †	1/375 (0.27%)	0/360 (0.00%)
Respiratory distress †	1/375 (0.27%)	0/360 (0.00%)
Respiratory failure †	1/375 (0.27%)	1/360 (0.28%)
Cough †	0/375 (0.00%)	1/360 (0.28%)
Haemoptysis †	0/375 (0.00%)	2/360 (0.56%)
Lung infiltration †	0/375 (0.00%)	1/360 (0.28%)
Pulmonary oedema †	0/375 (0.00%)	2/360 (0.56%)
Skin and subcutaneous tissue disorders
Dermatitis †	1/375 (0.27%)	0/360 (0.00%)
Diabetic ulcer †	1/375 (0.27%)	0/360 (0.00%)
Palmar-plantar erythrodysaesthesia syndrome †	1/375 (0.27%)	0/360 (0.00%)
Rash †	1/375 (0.27%)	0/360 (0.00%)
Stevens-Johnson syndrome †	1/375 (0.27%)	0/360 (0.00%)
Surgical and medical procedures
Bone graft †	1/375 (0.27%)	0/360 (0.00%)
Hepatectomy †	1/375 (0.27%)	0/360 (0.00%)
Hip arthroplasty †	1/375 (0.27%)	0/360 (0.00%)
Inguinal hernia repair †	1/375 (0.27%)	0/360 (0.00%)
Pleurectomy †	1/375 (0.27%)	0/360 (0.00%)
Vertebroplasty †	1/375 (0.27%)	0/360 (0.00%)
Vascular disorders
Hypertension †	8/375 (2.13%)	0/360 (0.00%)
Deep vein thrombosis †	3/375 (0.80%)	1/360 (0.28%)
Malignant hypertension †	1/375 (0.27%)	0/360 (0.00%)
Phlebitis †	1/375 (0.27%)	0/360 (0.00%)
Superior vena caval occlusion †	1/375 (0.27%)	0/360 (0.00%)
Vasculitis †	1/375 (0.27%)	0/360 (0.00%)
Hypotension †	0/375 (0.00%)	1/360 (0.28%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (v11.1); 2 Term from vocabulary, MedDRA
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	SU011248	IFN-α
	Affected / at Risk (%)	Affected / at Risk (%)
Total	368/375 (98.13%)	344/360 (95.56%)
Blood and lymphatic system disorders
Anaemia † 1	75/375 (20.00%)	55/360 (15.28%)
Leukopenia †	40/375 (10.67%)	16/360 (4.44%)
Lymphopenia †	19/375 (5.07%)	21/360 (5.83%)
Neutropenia †	69/375 (18.40%)	33/360 (9.17%)
Thrombocytopenia †	69/375 (18.40%)	15/360 (4.17%)
Endocrine disorders
Hypothyroidism †	57/375 (15.20%)	3/360 (0.83%)
Gastrointestinal disorders
Abdominal pain †	64/375 (17.07%)	28/360 (7.78%)
Abdominal pain upper †	52/375 (13.87%)	10/360 (2.78%)
Constipation †	85/375 (22.67%)	48/360 (13.33%)
Diarrhoea †	245/375 (65.33%)	76/360 (21.11%)
Dry mouth †	50/375 (13.33%)	27/360 (7.50%)
Dyspepsia †	128/375 (34.13%)	16/360 (4.44%)
Flatulence †	52/375 (13.87%)	8/360 (2.22%)
Gastrooesophageal reflux disease †	47/375 (12.53%)	3/360 (0.83%)
Glossodynia †	39/375 (10.40%)	2/360 (0.56%)
Haemorrhoids †	38/375 (10.13%)	6/360 (1.67%)
Nausea †	215/375 (57.33%)	146/360 (40.56%)
Oral pain †	54/375 (14.40%)	2/360 (0.56%)
Stomatitis †	113/375 (30.13%)	12/360 (3.33%)
Stomatitis †	144/375 (38.40%)	60/360 (16.67%)
General disorders
Asthenia †	91/375 (24.27%)	79/360 (21.94%)
Chest pain †	45/375 (12.00%)	21/360 (5.83%)
Chills †	52/375 (13.87%)	111/360 (30.83%)
Fatigue †	230/375 (61.33%)	200/360 (55.56%)
Influenza like illness †	18/375 (4.80%)	54/360 (15.00%)
Mucosal inflammation †	100/375 (26.67%)	7/360 (1.94%)
Oedema peripheral †	90/375 (24.00%)	17/360 (4.72%)
Pain †	35/375 (9.33%)	20/360 (5.56%)
Pyrexia †	80/375 (21.33%)	134/360 (37.22%)
Infections and infestations
Nasopharyngitis †	54/375 (14.40%)	8/360 (2.22%)
Upper respiratory tract infection †	42/375 (11.20%)	9/360 (2.50%)
Investigations
Ejection fraction decreased †	60/375 (16.00%)	19/360 (5.28%)
Weight decreased †	60/375 (16.00%)	59/360 (16.39%)
Metabolism and nutrition disorders
Anorexia †	154/375 (41.07%)	112/360 (31.11%)
Decreased appetite †	44/375 (11.73%)	44/360 (12.22%)
Dehydration †	27/375 (7.20%)	14/360 (3.89%)
Musculoskeletal and connective tissue disorders
Arthralgia †	110/375 (29.33%)	68/360 (18.89%)
Back pain †	103/375 (27.47%)	52/360 (14.44%)
Bone pain †	27/375 (7.20%)	14/360 (3.89%)
Muscle spasms †	28/375 (7.47%)	9/360 (2.50%)
Musculoskeletal chest pain †	28/375 (7.47%)	14/360 (3.89%)
Musculoskeletal pain †	50/375 (13.33%)	23/360 (6.39%)
Myalgia †	46/375 (12.27%)	68/360 (18.89%)
Pain in extremity †	100/375 (26.67%)	30/360 (8.33%)
Nervous system disorders
Dizziness †	43/375 (11.47%)	50/360 (13.89%)
Dysgeusia †	174/375 (46.40%)	53/360 (14.72%)
Headache †	86/375 (22.93%)	69/360 (19.17%)
Paraesthesia †	35/375 (9.33%)	7/360 (1.94%)
Psychiatric disorders
Anxiety †	24/375 (6.40%)	18/360 (5.00%)
Depression †	40/375 (10.67%)	51/360 (14.17%)
Insomnia †	56/375 (14.93%)	37/360 (10.28%)
Respiratory, thoracic and mediastinal disorders
Cough †	100/375 (26.67%)	50/360 (13.89%)
Dyspnoea †	95/375 (25.33%)	67/360 (18.61%)
Epistaxis †	79/375 (21.07%)	9/360 (2.50%)
Oropharyngeal pain †	51/375 (13.60%)	9/360 (2.50%)
Skin and subcutaneous tissue disorders
Alopecia †	51/375 (13.60%)	34/360 (9.44%)
Dry skin †	85/375 (22.67%)	26/360 (7.22%)
Erythema †	46/375 (12.27%)	5/360 (1.39%)
Hair colour changes †	75/375 (20.00%)	1/360 (0.28%)
Palmar-plantar erythrodysaesthesia syndrome †	108/375 (28.80%)	3/360 (0.83%)
Pruritus †	44/375 (11.73%)	24/360 (6.67%)
Rash †	109/375 (29.07%)	39/360 (10.83%)
Skin discolouration †	94/375 (25.07%)	0/360 (0.00%)
Skin exfoliation †	37/375 (9.87%)	5/360 (1.39%)
Vascular disorders
Hypertension †	125/375 (33.33%)	13/360 (3.61%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (v11.1)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.govCallCenter@pfizer.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rini BI, Hutson TE, Figlin RA, Lechuga MJ, Valota O, Serfass L, Rosbrook B, Motzer RJ. Sunitinib in Patients With Metastatic Renal Cell Carcinoma: Clinical Outcome According to International Metastatic Renal Cell Carcinoma Database Consortium Risk Group. Clin Genitourin Cancer. 2018 Aug;16(4):298-304. doi: 10.1016/j.clgc.2018.04.005. Epub 2018 May 4.

de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.

Cella D, Michaelson MD, Bushmakin AG, Cappelleri JC, Charbonneau C, Kim ST, Li JZ, Motzer RJ. Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-alpha in a phase III trial: final results and geographical analysis. Br J Cancer. 2010 Feb 16;102(4):658-64. doi: 10.1038/sj.bjc.6605552. Epub 2010 Jan 26.

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• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
• ClinicalTrials.gov Identifier: NCT00083889
• Obsolete Identifiers: NCT00098657
• Other Study ID Numbers: A6181034
• First Submitted: June 3, 2004
• First Posted: June 4, 2004
• Results First Submitted: September 16, 2009
• Results First Posted: December 10, 2009
• Last Update Posted: January 26, 2010