Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

• ClinicalTrials.gov Identifier: NCT00920816
• Recruitment Status: Completed
• First Posted: June 15, 2009
• Results First Posted: February 4, 2014
• Last Update Posted: May 6, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Kidney Neoplasms
• Interventions: Drug: Axitinib (AG-013736); Drug: Sorafenib
• Enrollment: 492

Participant Flow

Recruitment Details	First-line participants included all treatment-naive participants with metastatic renal cell cancer (mRCC) from global and second-line participants included all previously-treated Asian participants with mRCC.
Pre-assignment Details	All China participants were excluded from safety analysis due to inability to obtain timely approval to use data in accordance with Human Genetic Resources Administration of China (HGRAC) regulation.

Arm/Group Title	Axitinib (First-line Participants)	Sorafenib (First-line Participants)	Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)
Arm/Group Description	Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Period Title: Overall Study
Started	192	96	135	69
Treated	189	96	135	69
Participants From China (Excluded From Safety Analysis)	16	8	124	64
Completed	0	0	0	0
Not Completed	192	96	135	69
Reason Not Completed
Death	116	63	8	3
Participant refused continued treatment for reason other than adverse events	11	5	1	0
Global deterioration of health status	2	0	0	0
Objective progression or relapse	6	2	0	0
Other	26	15	1	2
Lost to Follow-up	11	2	0	0
Adverse Event	1	1	1	0
Data not disclosed due to lack of HGRAC filings	16	8	124	64
Randomized but not treated	3	0	0	0

Baseline Characteristics

Arm/Group Title		Axitinib (First-line Participants)	Sorafenib (First-line Participants)	Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)	Total
Arm/Group Description		Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		192	96	135	69	492
Baseline Analysis Population Description		Full analysis set (FAS) included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	192 participants	96 participants	135 participants	69 participants	492 participants
	Less than (<) 65 years	142 74.0%	77 80.2%	110 81.5%	56 81.2%	385 78.3%
	Greater than or equal to (>=) 65 years	50 26.0%	19 19.8%	25 18.5%	13 18.8%	107 21.7%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	192 participants	96 participants	135 participants	69 participants	492 participants
	Female	58 30.2%	22 22.9%	41 30.4%	20 29.0%	141 28.7%
	Male	134 69.8%	74 77.1%	94 69.6%	49 71.0%	351 71.3%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS): First-Line Participants
Description	Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.
Time Frame	Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

Outcome Measure Data

Analysis Population Description

FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Arm/Group Title	Axitinib (First-line Participants)	Sorafenib (First-line Participants)
Arm/Group Description:	Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed	192	96
Median (95% Confidence Interval); Unit of Measure: months
	10.1; (7.2 to 12.1)	6.5; (4.7 to 8.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Axitinib (First-line Participants), Sorafenib (First-line Participants)
	Comments	First-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.767
	Confidence Interval	(2-Sided) 95%; 0.559 to 1.053
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Progression Free Survival (PFS): Second-Line Participants
Description	Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.
Time Frame	Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Outcome Measure Data

Analysis Population Description

FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Arm/Group Title	Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)
Arm/Group Description:	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed	135	69
Median (95% Confidence Interval); Unit of Measure: months
	6.5; (4.7 to 9.1)	4.8; (3.0 to 6.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Axitinib (Second-line Participants), Sorafenib (Second-line Participants)
	Comments	Second-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1) and prior treatment (sunitinib versus cytokine-containing regimen).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.731
	Confidence Interval	(2-Sided) 95%; 0.506 to 1.058
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Percentage of Participants With Objective Response (OR): First-Line Participants
Description	Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Time Frame	Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

Outcome Measure Data

Analysis Population Description

FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Arm/Group Title	Axitinib (First-line Participants)	Sorafenib (First-line Participants)
Arm/Group Description:	Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed	192	96
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	32.3; (25.7 to 39.4)	14.6; (8.2 to 23.3)

4. Secondary Outcome

Title	Percentage of Participants With Objective Response (OR): Second-Line Participants
Description	Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Time Frame	Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Outcome Measure Data

Analysis Population Description

FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Arm/Group Title	Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)
Arm/Group Description:	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed	135	69
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	23.7; (16.8 to 31.8)	10.1; (4.2 to 19.8)

5. Secondary Outcome

Title	Duration of Response (DR): First-Line Participants
Description	Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time Frame	Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

Outcome Measure Data

Analysis Population Description

DR was calculated for the subgroup of participants from the FAS treatment-naive population, with a confirmed objective tumor response (CR or PR).

Arm/Group Title	Axitinib (First-line Participants)	Sorafenib (First-line Participants)
Arm/Group Description:	Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed	62	14
Median (95% Confidence Interval); Unit of Measure: months
	14.7 [1]; (11.0 to NA)	14.3 [1]; (11.3 to NA)

[1]

Upper limit of CI was not estimable because participants were still responding to medication as the study was ongoing at the time of primary completion analysis and this analysis was final.

6. Secondary Outcome

Title	Duration of Response (DR): Second-Line Participants
Description	Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time Frame	Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Outcome Measure Data

Analysis Population Description

DR was calculated for the subgroup of participants from the FAS previously-treated population, with a confirmed objective tumor response (CR or PR).

Arm/Group Title	Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)
Arm/Group Description:	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed	32	7
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (12.5 to NA)	8.7 [2]; (4.1 to NA)

[1]

Median and upper limit of CI was not estimable because participants were still responding to medication as the study was ongoing at the time of primary completion analysis and this analysis was final.

[2]

Upper limit of CI was not estimable because participants were still responding to medication as the study was ongoing at the time of primary completion analysis and this analysis was final.

7. Secondary Outcome

Title	Overall Survival (OS): First-Line Participants
Description	Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time Frame	Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

Outcome Measure Data

Analysis Population Description

FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Arm/Group Title	Axitinib (First-line Participants)	Sorafenib (First-line Participants)
Arm/Group Description:	Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed	192	96
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (18.1 to NA)	NA [1]; (18.1 to NA)

[1]

Median and upper limit of CI was not reachable as data was not matured at the time of the analysis as the study was ongoing at the time of primary completion analysis and this analysis was final.

8. Secondary Outcome

Title	Overall Survival (OS): Second-Line Participants
Description	Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time Frame	Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Outcome Measure Data

Analysis Population Description

FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Arm/Group Title	Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)
Arm/Group Description:	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed	135	69
Median (95% Confidence Interval); Unit of Measure: months
	17.2 [1]; (14.8 to NA)	18.1 [1]; (12.1 to NA)

[1]

Upper limit of the CI was not reachable as data was not matured at the time of the analysis as the study was ongoing at the time of primary completion analysis and this analysis was final.

9. Other Pre-specified Outcome

Title	Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants
Description	FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).
Time Frame	Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)

Outcome Measure Data

Analysis Population Description

FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

Arm/Group Title		Axitinib (First-line Participants)	Sorafenib (First-line Participants)
Arm/Group Description:		Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed		183	95
Mean (Standard Deviation); Unit of Measure: units on a scale
C1 D1	Number Analyzed	183 participants	95 participants
		43.869 (8.117)	43.865 (6.723)
C2 D1	Number Analyzed	176 participants	90 participants
		43.328 (7.630)	43.969 (6.286)
C3 D1	Number Analyzed	164 participants	84 participants
		43.366 (7.192)	43.345 (6.878)
C4 D1	Number Analyzed	156 participants	81 participants
		42.932 (7.566)	42.926 (7.324)
C5 D1	Number Analyzed	153 participants	77 participants
		43.211 (7.578)	44.022 (6.714)
C6 D1	Number Analyzed	141 participants	72 participants
		42.787 (8.098)	42.344 (6.685)
C7 D1	Number Analyzed	139 participants	65 participants
		42.474 (7.926)	43.446 (6.931)
C8 D1	Number Analyzed	131 participants	60 participants
		42.534 (7.510)	44.077 (6.986)
C9 D1	Number Analyzed	126 participants	59 participants
		42.778 (8.229)	44.051 (7.234)
C10 D1	Number Analyzed	122 participants	55 participants
		43.120 (7.966)	44.018 (6.751)
C11 D1	Number Analyzed	114 participants	48 participants
		43.264 (7.837)	45.000 (6.130)
C12 D1	Number Analyzed	105 participants	44 participants
		43.962 (7.243)	45.318 (6.440)
C13 D1	Number Analyzed	99 participants	44 participants
		44.141 (7.289)	45.787 (6.526)
C14 D1	Number Analyzed	95 participants	37 participants
		43.789 (7.985)	45.459 (6.535)
C15 D1	Number Analyzed	85 participants	37 participants
		44.176 (8.055)	45.514 (5.914)
C16 D1	Number Analyzed	82 participants	33 participants
		44.232 (7.515)	46.000 (5.651)
C17 D1	Number Analyzed	78 participants	30 participants
		43.897 (8.456)	46.400 (6.262)
C18 D1	Number Analyzed	71 participants	28 participants
		43.761 (8.019)	45.357 (6.983)
C19 D1	Number Analyzed	57 participants	24 participants
		43.737 (7.413)	45.583 (7.366)
C20 D1	Number Analyzed	45 participants	21 participants
		43.733 (7.605)	44.333 (7.066)
C21 D1	Number Analyzed	36 participants	18 participants
		45.417 (6.240)	43.500 (7.687)
C22 D1	Number Analyzed	23 participants	12 participants
		47.000 (5.985)	45.833 (5.937)
C23 D1	Number Analyzed	14 participants	7 participants
		47.571 (6.357)	45.714 (6.651)
End of treatment	Number Analyzed	72 participants	42 participants
		39.052 (9.109)	39.524 (8.896)
Follow-up	Number Analyzed	41 participants	26 participants
		39.683 (11.132)	40.038 (9.897)

10. Other Pre-specified Outcome

Title	Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants
Description	FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).
Time Frame	Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)

Outcome Measure Data

Analysis Population Description

FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

Arm/Group Title		Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)
Arm/Group Description:		Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed		134	69
Mean (Standard Deviation); Unit of Measure: units on a scale
C1 D1	Number Analyzed	134 participants	69 participants
		46.753 (6.692)	47.470 (7.450)
C2 D1	Number Analyzed	127 participants	66 participants
		46.217 (7.028)	45.045 (7.478)
C3 D1	Number Analyzed	124 participants	57 participants
		45.968 (7.237)	45.684 (7.756)
C4 D1	Number Analyzed	116 participants	53 participants
		45.060 (8.040)	45.792 (7.762)
C5 D1	Number Analyzed	111 participants	48 participants
		45.775 (7.797)	46.125 (7.491)
C6 D1	Number Analyzed	108 participants	41 participants
		45.407 (7.274)	46.341 (7.213)
C7 D1	Number Analyzed	100 participants	38 participants
		45.709 (8.263)	45.053 (7.843)
C8 D1	Number Analyzed	89 participants	37 participants
		45.169 (7.609)	45.676 (9.357)
C9 D1	Number Analyzed	82 participants	33 participants
		45.829 (7.442)	45.970 (8.487)
C10 D1	Number Analyzed	74 participants	27 participants
		45.608 (8.299)	46.148 (8.156)
C11 D1	Number Analyzed	66 participants	22 participants
		45.833 (7.599)	47.227 (6.611)
C12 D1	Number Analyzed	59 participants	22 participants
		45.797 (6.967)	48.091 (6.414)
C13 D1	Number Analyzed	55 participants	20 participants
		46.727 (7.307)	47.600 (5.762)
C14 D1	Number Analyzed	50 participants	15 participants
		47.740 (7.094)	49.133 (5.235)
C15 D1	Number Analyzed	44 participants	13 participants
		48.023 (6.297)	49.308 (4.111)
C16 D1	Number Analyzed	38 participants	12 participants
		48.184 (6.186)	50.500 (3.989)
C17 D1	Number Analyzed	33 participants	10 participants
		47.909 (6.866)	49.000 (5.869)
C18 D1	Number Analyzed	29 participants	8 participants
		48.138 (6.791)	49.125 (5.139)
C19 D1	Number Analyzed	22 participants	7 participants
		48.636 (5.206)	48.571 (7.458)
C20 D1	Number Analyzed	21 participants	6 participants
		48.810 (6.478)	50.500 (4.637)
C21 D1	Number Analyzed	16 participants	6 participants
		50.188 (5.588)	50.000 (5.177)
End of treatment	Number Analyzed	37 participants	27 participants
		41.432 (9.188)	42.889 (8.846)
Follow-up	Number Analyzed	13 participants	12 participants
		35.385 (7.795)	38.583 (11.556)

11. Other Pre-specified Outcome

Title	Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants
Description	FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).
Time Frame	Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)

Outcome Measure Data

Analysis Population Description

FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

Arm/Group Title		Axitinib (First-line Participants)	Sorafenib (First-line Participants)
Arm/Group Description:		Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed		183	95
Mean (Standard Deviation); Unit of Measure: units on a scale
C1 D1	Number Analyzed	183 participants	95 participants
		28.691 (5.392)	29.653 (4.699)
C2 D1	Number Analyzed	176 participants	90 participants
		28.728 (4.581)	29.963 (3.817)
C3 D1 (	Number Analyzed	164 participants	84 participants
		29.171 (4.093)	29.750 (4.095)
C4 D1	Number Analyzed	156 participants	81 participants
		28.577 (4.305)	29.642 (4.244)
C5 D1	Number Analyzed	153 participants	77 participants
		29.020 (4.257)	30.255 (3.668)
C6 D1	Number Analyzed	141 participants	72 participants
		28.574 (4.674)	29.153 (4.009)
C7 D1	Number Analyzed	139 participants	65 participants
		28.568 (4.548)	29.523 (4.051)
C8 D1	Number Analyzed	131 participants	60 participants
		28.557 (4.308)	30.296 (3.890)
C9 D1	Number Analyzed	126 participants	59 participants
		28.817 (4.665)	30.186 (4.392)
C10 D1	Number Analyzed	122 participants	55 participants
		29.057 (4.484)	30.364 (4.143)
C11 D1	Number Analyzed	114 participants	48 participants
		29.146 (4.207)	30.688 (3.926)
C12 D1	Number Analyzed	105 participants	44 participants
		29.648 (3.752)	30.727 (3.896)
C13 D1	Number Analyzed	99 participants	44 participants
		29.545 (4.056)	31.483 (3.602)
C14 D1	Number Analyzed	95 participants	37 participants
		29.579 (4.186)	31.027 (3.790)
C15 D1	Number Analyzed	85 participants	37 participants
		29.859 (4.438)	30.730 (3.724)
C16 D1	Number Analyzed	82 participants	33 participants
		29.683 (4.242)	31.515 (3.242)
C17 D1	Number Analyzed	78 participants	30 participants
		29.564 (4.695)	31.567 (3.884)
C18 D1	Number Analyzed	71 participants	28 participants
		29.380 (4.752)	31.107 (4.425)
C19 D1	Number Analyzed	57 participants	24 participants
		29.737 (4.414)	31.417 (3.911)
C20 D1	Number Analyzed	45 participants	21 participants
		29.844 (4.527)	30.762 (4.122)
C21 D1	Number Analyzed	36 participants	18 participants
		30.889 (3.115)	30.056 (4.372)
C22 D1	Number Analyzed	23 participants	12 participants
		31.696 (3.081)	31.000 (3.275)
C23 D1	Number Analyzed	14 participants	7 participants
		31.357 (3.388)	31.143 (4.413)
End of treatment	Number Analyzed	72 participants	42 participants
		26.556 (5.487)	26.786 (5.982)
Follow-up	Number Analyzed	41 participants	26 participants
		26.805 (6.373)	26.769 (6.095)

12. Other Pre-specified Outcome

Title	Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants
Description	FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).
Time Frame	Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)

Outcome Measure Data

Analysis Population Description

FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

Arm/Group Title		Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)
Arm/Group Description:		Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed		134	69
Mean (Standard Deviation); Unit of Measure: units on a scale
C1 D1	Number Analyzed	134 participants	69 participants
		31.020 (3.986)	31.489 (4.538)
C2 D1	Number Analyzed	127 participants	66 participants
		30.600 (3.892)	30.682 (3.895)
C3 D1	Number Analyzed	124 participants	57 participants
		30.645 (3.681)	30.965 (3.803)
C4 D1	Number Analyzed	116 participants	53 participants
		30.103 (4.558)	30.679 (3.980)
C5 D1	Number Analyzed	111 participants	48 participants
		30.676 (4.271)	31.063 (3.629)
C6 D1	Number Analyzed	108 participants	41 participants
		30.731 (3.973)	31.439 (4.249)
C7 D1	Number Analyzed	100 participants	38 participants
		30.920 (4.373)	30.632 (4.365)
C8 D1	Number Analyzed	89 participants	37 participants
		30.966 (4.144)	30.703 (5.195)
C9 D1	Number Analyzed	82 participants	33 participants
		31.012 (3.783)	30.667 (4.884)
C10 D1	Number Analyzed	74 participants	27 participants
		30.986 (4.133)	30.926 (4.215)
C11 D1	Number Analyzed	66 participants	22 participants
		31.212 (4.033)	32.045 (3.579)
C12 D1	Number Analyzed	59 participants	22 participants
		31.356 (3.443)	32.000 (3.338)
C13 D1	Number Analyzed	55 participants	20 participants
		31.418 (3.775)	32.100 (2.989)
C14 D1	Number Analyzed	50 participants	15 participants
		32.100 (3.321)	32.800 (2.274)
C15 D1	Number Analyzed	44 participants	13 participants
		32.000 (2.861)	32.769 (2.279)
C16 D1	Number Analyzed	38 participants	12 participants
		31.921 (3.372)	33.167 (2.167)
C17 D1	Number Analyzed	33 participants	10 participants
		32.061 (3.344)	32.800 (2.898)
C18 D1	Number Analyzed	29 participants	8 participants
		31.931 (3.116)	32.625 (2.615)
C19 D1	Number Analyzed	22 participants	7 participants
		32.364 (2.341)	32.429 (4.429)
C20 D1	Number Analyzed	21 participants	6 participants
		31.905 (2.998)	33.500 (2.168)
C21 D1	Number Analyzed	16 participants	6 participants
		33.125 (2.473)	33.500 (2.345)
End of treatment	Number Analyzed	37 participants	27 participants
		28.216 (5.662)	29.519 (4.661)
Follow-up	Number Analyzed	13 participants	12 participants
		24.692 (4.366)	27.500 (6.762)

13. Other Pre-specified Outcome

Title	Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame	Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)

Outcome Measure Data

Analysis Population Description

FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

Arm/Group Title		Axitinib (First-line Participants)	Sorafenib (First-line Participants)
Arm/Group Description:		Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed		183	94
Mean (Standard Deviation); Unit of Measure: units on a scale
C1 D1	Number Analyzed	183 participants	94 participants
		0.710 (0.254)	0.712 (0.272)
C2 D1	Number Analyzed	175 participants	90 participants
		0.709 (0.214)	0.693 (0.237)
C3 D1	Number Analyzed	163 participants	84 participants
		0.694 (0.251)	0.687 (0.261)
C4 D1	Number Analyzed	156 participants	81 participants
		0.696 (0.235)	0.668 (0.265)
C5 D1	Number Analyzed	153 participants	77 participants
		0.708 (0.221)	0.673 (0.269)
C6 D1	Number Analyzed	140 participants	72 participants
		0.683 (0.263)	0.641 (0.281)
C7 D1	Number Analyzed	139 participants	65 participants
		0.685 (0.225)	0.676 (0.255)
C8 D1	Number Analyzed	131 participants	60 participants
		0.678 (0.274)	0.717 (0.244)
C9 D1	Number Analyzed	126 participants	59 participants
		0.704 (0.239)	0.729 (0.202)
C10 D1	Number Analyzed	122 participants	55 participants
		0.682 (0.277)	0.723 (0.238)
C11 D1	Number Analyzed	114 participants	48 participants
		0.698 (0.260)	0.748 (0.199)
C12 D1	Number Analyzed	105 participants	44 participants
		0.708 (0.227)	0.742 (0.218)
C13 D1	Number Analyzed	99 participants	44 participants
		0.708 (0.253)	0.761 (0.220)
C14 D1	Number Analyzed	95 participants	37 participants
		0.703 (0.260)	0.731 (0.254)
C15 D1	Number Analyzed	85 participants	37 participants
		0.689 (0.269)	0.755 (0.225)
C16 D1	Number Analyzed	82 participants	33 participants
		0.702 (0.244)	0.775 (0.186)
C17 D1	Number Analyzed	78 participants	30 participants
		0.706 (0.250)	0.738 (0.250)
C18 D1	Number Analyzed	71 participants	28 participants
		0.699 (0.259)	0.777 (0.191)
C19 D1	Number Analyzed	56 participants	24 participants
		0.713 (0.256)	0.762 (0.261)
C20 D1	Number Analyzed	45 participants	21 participants
		0.699 (0.261)	0.710 (0.300)
C21 D1	Number Analyzed	36 participants	18 participants
		0.712 (0.232)	0.702 (0.307)
C22 D1	Number Analyzed	23 participants	12 participants
		0.737 (0.255)	0.774 (0.177)
C23 D1	Number Analyzed	14 participants	7 participants
		0.736 (0.275)	0.789 (0.187)
End of treatment	Number Analyzed	70 participants	42 participants
		0.635 (0.268)	0.588 (0.291)
Follow-up	Number Analyzed	41 participants	26 participants
		0.545 (0.434)	0.618 (0.254)

14. Other Pre-specified Outcome

Title	Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame	Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)

Outcome Measure Data

Analysis Population Description

FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

Arm/Group Title		Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)
Arm/Group Description:		Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed		134	69
Mean (Standard Deviation); Unit of Measure: units on a scale
C1 D1	Number Analyzed	134 participants	69 participants
		0.812 (0.225)	0.831 (0.186)
C2 D1	Number Analyzed	127 participants	65 participants
		0.769 (0.218)	0.754 (0.251)
C3 D1	Number Analyzed	124 participants	58 participants
		0.772 (0.206)	0.755 (0.278)
C4 D1	Number Analyzed	116 participants	53 participants
		0.737 (0.272)	0.759 (0.211)
C5 D1	Number Analyzed	111 participants	48 participants
		0.780 (0.203)	0.768 (0.275)
C6 D1	Number Analyzed	108 participants	41 participants
		0.767 (0.251)	0.753 (0.245)
C7 D1	Number Analyzed	100 participants	38 participants
		0.762 (0.252)	0.768 (0.239)
C8 D1	Number Analyzed	89 participants	37 participants
		0.758 (0.241)	0.733 (0.339)
C9 D1	Number Analyzed	82 participants	33 participants
		0.796 (0.203)	0.794 (0.262)
C10 D1	Number Analyzed	74 participants	27 participants
		0.768 (0.243)	0.820 (0.169)
C11 D1	Number Analyzed	66 participants	22 participants
		0.792 (0.210)	0.848 (0.158)
C12 D1	Number Analyzed	59 participants	22 participants
		0.797 (0.201)	0.837 (0.157)
C13 D1	Number Analyzed	55 participants	20 participants
		0.786 (0.217)	0.814 (0.156)
C14 D1	Number Analyzed	50 participants	15 participants
		0.833 (0.162)	0.871 (0.131)
C15 D1	Number Analyzed	44 participants	13 participants
		0.819 (0.151)	0.829 (0.152)
C16 D1	Number Analyzed	38 participants	12 participants
		0.811 (0.186)	0.828 (0.142)
C17 D1	Number Analyzed	33 participants	10 participants
		0.834 (0.158)	0.865 (0.122)
C18 D1	Number Analyzed	29 participants	8 participants
		0.830 (0.164)	0.829 (0.160)
C19 D1	Number Analyzed	22 participants	7 participants
		0.830 (0.148)	0.861 (0.139)
C20 D1	Number Analyzed	21 participants	6 participants
		0.832 (0.163)	0.923 (0.129)
C21 D1	Number Analyzed	16 participants	6 participants
		0.859 (0.155)	0.852 (0.176)
End of treatment	Number Analyzed	37 participants	27 participants
		0.582 (0.406)	0.623 (0.296)
Follow-up	Number Analyzed	13 participants	12 participants
		0.429 (0.358)	0.418 (0.565)

15. Other Pre-specified Outcome

Title	Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.
Time Frame	Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)

Outcome Measure Data

Analysis Population Description

FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

Arm/Group Title		Axitinib (First-line Participants)	Sorafenib (First-line Participants)
Arm/Group Description:		Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed		182	94
Mean (Standard Deviation); Unit of Measure: units on a scale
C1 D1	Number Analyzed	182 participants	94 participants
		71.181 (19.641)	72.362 (16.466)
C2 D1	Number Analyzed	175 participants	90 participants
		71.714 (16.583)	72.422 (14.576)
C3 D1	Number Analyzed	165 participants	83 participants
		72.006 (16.971)	71.241 (16.252)
C4 D1	Number Analyzed	156 participants	81 participants
		72.179 (16.980)	72.086 (14.904)
C5 D1	Number Analyzed	153 participants	78 participants
		72.451 (18.237)	73.615 (14.665)
C6 D1	Number Analyzed	141 participants	72 participants
		71.574 (18.929)	69.944 (17.535)
C7 D1	Number Analyzed	139 participants	65 participants
		71.050 (18.967)	73.923 (13.998)
C8 D1	Number Analyzed	131 participants	60 participants
		71.031 (19.081)	73.183 (16.674)
C9 D1	Number Analyzed	126 participants	59 participants
		72.690 (18.789)	73.780 (16.180)
C10 D1	Number Analyzed	122 participants	55 participants
		72.910 (19.354)	72.400 (18.814)
C11 D1	Number Analyzed	114 participants	48 participants
		72.763 (18.174)	72.271 (18.512)
C12 D1	Number Analyzed	105 participants	44 participants
		73.610 (18.275)	75.295 (17.052)
C13 D1	Number Analyzed	99 participants	44 participants
		73.030 (18.348)	75.432 (17.907)
C14 D1	Number Analyzed	95 participants	37 participants
		73.147 (17.546)	75.108 (18.371)
C15 D1	Number Analyzed	85 participants	37 participants
		74.494 (17.938)	74.405 (17.650)
C16 D1	Number Analyzed	82 participants	33 participants
		73.878 (18.289)	75.818 (17.716)
C17 D1	Number Analyzed	78 participants	30 participants
		73.090 (17.717)	74.333 (18.654)
C18 D1	Number Analyzed	71 participants	28 participants
		73.817 (17.288)	75.571 (18.550)
C19 D1	Number Analyzed	56 participants	24 participants
		72.089 (18.169)	75.125 (20.919)
C20 D1	Number Analyzed	45 participants	21 participants
		74.244 (17.044)	74.190 (20.425)
C21 D1	Number Analyzed	36 participants	18 participants
		75.694 (11.918)	70.500 (21.637)
C22 D1	Number Analyzed	23 participants	12 participants
		78.000 (12.544)	73.917 (15.900)
C23 D1	Number Analyzed	14 participants	7 participants
		77.143 (12.697)	72.571 (14.820)
End of treatment	Number Analyzed	71 participants	42 participants
		67.254 (19.495)	67.048 (22.570)
Follow-up	Number Analyzed	41 participants	26 participants
		69.195 (20.366)	64.885 (19.916)

16. Other Pre-specified Outcome

Title	Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.
Time Frame	Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)

Outcome Measure Data

Analysis Population Description

FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

Arm/Group Title		Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)
Arm/Group Description:		Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Number of Participants Analyzed		134	69
Mean (Standard Deviation); Unit of Measure: units on a scale
C1 D1	Number Analyzed	134 participants	69 participants
		82.799 (13.351)	82.058 (14.021)
C2 D1	Number Analyzed	127 participants	65 participants
		81.102 (13.895)	78.231 (15.823)
C3 D1	Number Analyzed	124 participants	58 participants
		80.895 (13.387)	80.534 (16.453)
C4 D1	Number Analyzed	116 participants	53 participants
		81.138 (13.508)	81.245 (14.590)
C5 D1	Number Analyzed	111 participants	48 participants
		83.018 (12.829)	80.250 (15.495)
C6 D1	Number Analyzed	108 participants	41 participants
		82.222 (13.793)	80.829 (15.091)
C7 D1	Number Analyzed	100 participants	38 participants
		82.900 (13.287)	80.868 (16.140)
C8 D1	Number Analyzed	89 participants	37 participants
		83.382 (12.636)	81.000 (14.606)
C9 D1	Number Analyzed	82 participants	33 participants
		84.171 (11.260)	83.788 (10.349)
C10 D1	Number Analyzed	74 participants	27 participants
		83.041 (13.042)	82.778 (11.440)
C11 D1	Number Analyzed	66 participants	22 participants
		84.136 (14.231)	83.000 (11.832)
C12 D1	Number Analyzed	59 participants	22 participants
		84.305 (13.211)	83.500 (12.188)
C13 D1	Number Analyzed	55 participants	20 participants
		82.927 (17.317)	83.300 (11.263)
C14 D1	Number Analyzed	50 participants	15 participants
		86.520 (10.831)	86.667 (8.715)
C15 D1	Number Analyzed	44 participants	13 participants
		85.841 (11.783)	86.462 (8.678)
C16 D1	Number Analyzed	38 participants	12 participants
		87.579 (10.391)	86.083 (8.816)
C17 D1	Number Analyzed	33 participants	10 participants
		88.424 (10.866)	84.300 (10.328)
C18 D1	Number Analyzed	29 participants	8 participants
		86.586 (13.605)	83.125 (8.839)
C19 D1	Number Analyzed	22 participants	7 participants
		89.500 (8.684)	82.143 (11.495)
C20 D1	Number Analyzed	21 participants	6 participants
		90.333 (8.679)	86.000 (9.695)
C21 D1	Number Analyzed	16 participants	6 participants
		90.313 (9.741)	84.167 (9.704)
End of treatment	Number Analyzed	37 participants	27 participants
		75.568 (17.934)	74.741 (17.623)
Follow-up	Number Analyzed	13 participants	12 participants
		58.154 (20.760)	64.333 (25.564)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Arm/Group Title	Axitinib (First-line Participants)	Sorafenib (First-line Participants)	Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)
Arm/Group Description	Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
All-Cause Mortality
	Axitinib (First-line Participants)	Sorafenib (First-line Participants)	Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	117/173 (67.63%)	63/88 (71.59%)	9/11 (81.82%)	3/5 (60.00%)
Serious Adverse Events
	Axitinib (First-line Participants)	Sorafenib (First-line Participants)	Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	77/173 (44.51%)	26/88 (29.55%)	6/11 (54.55%)	3/5 (60.00%)
Blood and lymphatic system disorders
Anaemia * 1	0/173 (0.00%)	1/88 (1.14%)	3/11 (27.27%)	1/5 (20.00%)
Thrombocytopenia * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Cardiac disorders
Angina pectoris * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Myocardial infarction * 1	3/173 (1.73%)	2/88 (2.27%)	0/11 (0.00%)	0/5 (0.00%)
Myocardial ischaemia * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Acute myocardial infarction * 1	1/173 (0.58%)	2/88 (2.27%)	1/11 (9.09%)	0/5 (0.00%)
Atrial flutter * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Cardiac arrest * 1	3/173 (1.73%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Cardio-respiratory arrest * 1	2/173 (1.16%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Atrioventricular block second degree * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Ischaemic cardiomyopathy * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Gastrointestinal disorders
Abdominal pain * 1	1/173 (0.58%)	3/88 (3.41%)	2/11 (18.18%)	1/5 (20.00%)
Anal fistula * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Diarrhoea * 1	8/173 (4.62%)	2/88 (2.27%)	1/11 (9.09%)	0/5 (0.00%)
Gastritis * 1	1/173 (0.58%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Oesophagitis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Upper gastrointestinal haemorrhage * 1	1/173 (0.58%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Abdominal distension * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Gastric haemorrhage * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Gastric ulcer * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Gastrointestinal haemorrhage * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Impaired gastric emptying * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Melaena * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Nausea * 1	1/173 (0.58%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Oesophageal varices haemorrhage * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Peptic ulcer * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Proctitis * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Rectal haemorrhage * 1	3/173 (1.73%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Retroperitoneal haematoma * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Vomiting * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Abdominal pain upper * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
General disorders
Death * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Multiple organ dysfunction syndrome * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Disease progression * 1	20/173 (11.56%)	6/88 (6.82%)	0/11 (0.00%)	0/5 (0.00%)
Asthenia * 1	2/173 (1.16%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Chest pain * 1	2/173 (1.16%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
General physical health deterioration * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Impaired healing * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Mucosal inflammation * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Pyrexia * 1	1/173 (0.58%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Sudden death * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Hepatobiliary disorders
Cholecystitis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Cholecystitis acute * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Infections and infestations
Cellulitis * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Gastroenteritis * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Upper respiratory tract infection * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Anal abscess * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Abscess * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Cholecystitis infective * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Pneumonia * 1	4/173 (2.31%)	1/88 (1.14%)	1/11 (9.09%)	1/5 (20.00%)
Pyelonephritis * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Sepsis * 1	2/173 (1.16%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Skin bacterial infection * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Tonsillitis * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Urinary tract infection * 1	2/173 (1.16%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Wound infection * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Injury, poisoning and procedural complications
Ankle fracture * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Facial bones fracture * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Humerus fracture * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Multiple injuries * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Patella fracture * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Upper limb fracture * 1	0/173 (0.00%)	1/88 (1.14%)	1/11 (9.09%)	0/5 (0.00%)
Wound dehiscence * 1	2/173 (1.16%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Hip fracture * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Contusion * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Investigations
Haemoglobin decreased * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Metabolism and nutrition disorders
Decreased appetite * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Dehydration * 1	1/173 (0.58%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Hyperkalaemia * 1	0/173 (0.00%)	2/88 (2.27%)	0/11 (0.00%)	0/5 (0.00%)
Musculoskeletal and connective tissue disorders
Back pain * 1	1/173 (0.58%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Muscular weakness * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Pathological fracture * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac neoplasm unspecified * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Renal cancer * 1	2/173 (1.16%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Renal cancer metastatic * 1	2/173 (1.16%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Renal cell carcinoma * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Tumour haemorrhage * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Malignant neoplasm progression * 1	3/173 (1.73%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Lung neoplasm malignant * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Nervous system disorders
Axonal and demyelinating polyneuropathy * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	1/5 (20.00%)
Haemorrhagic stroke * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Cerebrovascular accident * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Ischaemic stroke * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Cerebral haemorrhage * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Cerebral ischaemia * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Paraparesis * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Spinal cord compression * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Syncope * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Renal and urinary disorders
Ureteric obstruction * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Dysuria * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Haematuria * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Urinary retention * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Chronic obstructive pulmonary disease * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Epistaxis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Pleural effusion * 1	2/173 (1.16%)	3/88 (3.41%)	0/11 (0.00%)	0/5 (0.00%)
Pulmonary embolism * 1	2/173 (1.16%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Atelectasis * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Dyspnoea * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Haemoptysis * 1	1/173 (0.58%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Pleurisy * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Pulmonary oedema * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Respiratory distress * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Respiratory failure * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Skin and subcutaneous tissue disorders
Erythema multiforme * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Palmar-plantar erythrodysaesthesia syndrome * 1	0/173 (0.00%)	2/88 (2.27%)	0/11 (0.00%)	0/5 (0.00%)
Vascular disorders
Angiopathy * 1	0/173 (0.00%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Hypertensive crisis * 1	1/173 (0.58%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
1 Term from vocabulary, MedDRA v23.1; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Axitinib (First-line Participants)	Sorafenib (First-line Participants)	Axitinib (Second-line Participants)	Sorafenib (Second-line Participants)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	161/173 (93.06%)	83/88 (94.32%)	11/11 (100.00%)	5/5 (100.00%)
Blood and lymphatic system disorders
Anaemia * 1	15/173 (8.67%)	9/88 (10.23%)	2/11 (18.18%)	2/5 (40.00%)
Anisocytosis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Macrocytosis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Polychromasia * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Thrombocytopenia * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Thrombocytosis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Ear and labyrinth disorders
Tinnitus * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Endocrine disorders
Hypothyroidism * 1	36/173 (20.81%)	5/88 (5.68%)	3/11 (27.27%)	0/5 (0.00%)
Hyperthyroidism * 1	0/173 (0.00%)	0/88 (0.00%)	2/11 (18.18%)	0/5 (0.00%)
Eye disorders
Vision blurred * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Gastrointestinal disorders
Abdominal pain * 1	17/173 (9.83%)	8/88 (9.09%)	3/11 (27.27%)	0/5 (0.00%)
Abdominal pain upper * 1	32/173 (18.50%)	7/88 (7.95%)	2/11 (18.18%)	0/5 (0.00%)
Constipation * 1	17/173 (9.83%)	10/88 (11.36%)	2/11 (18.18%)	1/5 (20.00%)
Diarrhoea * 1	88/173 (50.87%)	34/88 (38.64%)	6/11 (54.55%)	2/5 (40.00%)
Mouth ulceration * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Nausea * 1	38/173 (21.97%)	15/88 (17.05%)	1/11 (9.09%)	0/5 (0.00%)
Stomatitis * 1	20/173 (11.56%)	4/88 (4.55%)	2/11 (18.18%)	1/5 (20.00%)
Vomiting * 1	38/173 (21.97%)	11/88 (12.50%)	0/11 (0.00%)	0/5 (0.00%)
Abdominal distension * 1	9/173 (5.20%)	1/88 (1.14%)	1/11 (9.09%)	0/5 (0.00%)
Dry mouth * 1	10/173 (5.78%)	1/88 (1.14%)	0/11 (0.00%)	0/5 (0.00%)
Dyspepsia * 1	13/173 (7.51%)	3/88 (3.41%)	1/11 (9.09%)	0/5 (0.00%)
Flatulence * 1	10/173 (5.78%)	3/88 (3.41%)	0/11 (0.00%)	0/5 (0.00%)
Abdominal discomfort * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Anal fissure * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Cheilitis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Duodenitis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Gastric ulcer * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Gastrooesophageal reflux disease * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Gingival bleeding * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Glossodynia * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Haematemesis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Haemorrhoids * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Hiatus hernia * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Hyperchlorhydria * 1	0/173 (0.00%)	0/88 (0.00%)	2/11 (18.18%)	0/5 (0.00%)
Melaena * 1	0/173 (0.00%)	0/88 (0.00%)	2/11 (18.18%)	0/5 (0.00%)
Oesophagitis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Oral disorder * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Rectal haemorrhage * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Toothache * 1	0/173 (0.00%)	0/88 (0.00%)	2/11 (18.18%)	0/5 (0.00%)
Upper gastrointestinal haemorrhage * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
General disorders
Chest pain * 1	9/173 (5.20%)	7/88 (7.95%)	1/11 (9.09%)	1/5 (20.00%)
Fatigue * 1	55/173 (31.79%)	25/88 (28.41%)	4/11 (36.36%)	2/5 (40.00%)
Pyrexia * 1	9/173 (5.20%)	4/88 (4.55%)	2/11 (18.18%)	0/5 (0.00%)
Asthenia * 1	41/173 (23.70%)	15/88 (17.05%)	5/11 (45.45%)	0/5 (0.00%)
Mucosal inflammation * 1	21/173 (12.14%)	9/88 (10.23%)	1/11 (9.09%)	0/5 (0.00%)
Oedema peripheral * 1	10/173 (5.78%)	4/88 (4.55%)	1/11 (9.09%)	0/5 (0.00%)
Infections and infestations
Nasopharyngitis * 1	10/173 (5.78%)	3/88 (3.41%)	2/11 (18.18%)	0/5 (0.00%)
Upper respiratory tract infection * 1	14/173 (8.09%)	1/88 (1.14%)	0/11 (0.00%)	1/5 (20.00%)
Urinary tract infection * 1	10/173 (5.78%)	4/88 (4.55%)	2/11 (18.18%)	0/5 (0.00%)
Haemorrhoid infection * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Pharyngotonsillitis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Rhinitis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Sinusitis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Tonsillitis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Tooth infection * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Injury, poisoning and procedural complications
Fall * 1	10/173 (5.78%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Mucosal excoriation * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Skin abrasion * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Spinal compression fracture * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Investigations
Alanine aminotransferase increased * 1	19/173 (10.98%)	8/88 (9.09%)	0/11 (0.00%)	0/5 (0.00%)
Aspartate aminotransferase increased * 1	17/173 (9.83%)	8/88 (9.09%)	0/11 (0.00%)	0/5 (0.00%)
Blood alkaline phosphatase increased * 1	7/173 (4.05%)	6/88 (6.82%)	0/11 (0.00%)	0/5 (0.00%)
Blood creatinine increased * 1	14/173 (8.09%)	6/88 (6.82%)	2/11 (18.18%)	1/5 (20.00%)
Blood phosphorus decreased * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	1/5 (20.00%)
Blood thyroid stimulating hormone increased * 1	17/173 (9.83%)	2/88 (2.27%)	1/11 (9.09%)	0/5 (0.00%)
Haemoglobin decreased * 1	0/173 (0.00%)	0/88 (0.00%)	2/11 (18.18%)	0/5 (0.00%)
Weight decreased * 1	70/173 (40.46%)	24/88 (27.27%)	4/11 (36.36%)	1/5 (20.00%)
Lipase increased * 1	7/173 (4.05%)	5/88 (5.68%)	2/11 (18.18%)	1/5 (20.00%)
Amylase increased * 1	0/173 (0.00%)	0/88 (0.00%)	3/11 (27.27%)	1/5 (20.00%)
Blood bicarbonate decreased * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	1/5 (20.00%)
Blood bilirubin increased * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Blood calcium increased * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Blood chloride increased * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Blood cholesterol increased * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Blood lactate dehydrogenase increased * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Blood urea increased * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Creatinine renal clearance decreased * 1	0/173 (0.00%)	0/88 (0.00%)	2/11 (18.18%)	0/5 (0.00%)
Eosinophil count increased * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Glomerular filtration rate decreased * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Haematocrit increased * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Haemoglobin increased * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
International normalised ratio increased * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Liver function test increased * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	2/5 (40.00%)
Lymphocyte percentage decreased * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Protein total decreased * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Tri-iodothyronine free decreased * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Blood pressure increased * 1	0/173 (0.00%)	0/88 (0.00%)	2/11 (18.18%)	0/5 (0.00%)
Metabolism and nutrition disorders
Decreased appetite * 1	48/173 (27.75%)	16/88 (18.18%)	5/11 (45.45%)	0/5 (0.00%)
Hyperkalaemia * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Hyperlipidaemia * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Hyperglycaemia * 1	6/173 (3.47%)	5/88 (5.68%)	0/11 (0.00%)	0/5 (0.00%)
Hyperuricaemia * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	28/173 (16.18%)	10/88 (11.36%)	5/11 (45.45%)	1/5 (20.00%)
Back pain * 1	29/173 (16.76%)	14/88 (15.91%)	6/11 (54.55%)	0/5 (0.00%)
Musculoskeletal pain * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Pain in extremity * 1	23/173 (13.29%)	6/88 (6.82%)	4/11 (36.36%)	0/5 (0.00%)
Muscle spasms * 1	3/173 (1.73%)	6/88 (6.82%)	0/11 (0.00%)	0/5 (0.00%)
Musculoskeletal chest pain * 1	7/173 (4.05%)	5/88 (5.68%)	0/11 (0.00%)	0/5 (0.00%)
Arthritis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Flank pain * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Gouty arthritis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Myalgia * 1	0/173 (0.00%)	0/88 (0.00%)	4/11 (36.36%)	0/5 (0.00%)
Osteoarthritis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Periarthritis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Joint swelling * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal neoplasm * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Nervous system disorders
Dizziness * 1	14/173 (8.09%)	2/88 (2.27%)	1/11 (9.09%)	0/5 (0.00%)
Headache * 1	23/173 (13.29%)	6/88 (6.82%)	1/11 (9.09%)	0/5 (0.00%)
Dizziness exertional * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Dysaesthesia * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Neuralgia * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Psychiatric disorders
Anxiety * 1	10/173 (5.78%)	0/88 (0.00%)	0/11 (0.00%)	0/5 (0.00%)
Insomnia * 1	10/173 (5.78%)	5/88 (5.68%)	1/11 (9.09%)	0/5 (0.00%)
Renal and urinary disorders
Proteinuria * 1	19/173 (10.98%)	9/88 (10.23%)	6/11 (54.55%)	0/5 (0.00%)
Chronic kidney disease * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Dysuria * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Haematuria * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Pollakiuria * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Reproductive system and breast disorders
Breast mass * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	33/173 (19.08%)	14/88 (15.91%)	2/11 (18.18%)	1/5 (20.00%)
Dysphonia * 1	37/173 (21.39%)	10/88 (11.36%)	0/11 (0.00%)	0/5 (0.00%)
Dyspnoea * 1	24/173 (13.87%)	11/88 (12.50%)	0/11 (0.00%)	0/5 (0.00%)
Pleural effusion * 1	3/173 (1.73%)	5/88 (5.68%)	0/11 (0.00%)	0/5 (0.00%)
Epistaxis * 1	7/173 (4.05%)	5/88 (5.68%)	0/11 (0.00%)	0/5 (0.00%)
Oropharyngeal pain * 1	12/173 (6.94%)	5/88 (5.68%)	4/11 (36.36%)	0/5 (0.00%)
Dry throat * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Skin and subcutaneous tissue disorders
Alopecia * 1	6/173 (3.47%)	17/88 (19.32%)	1/11 (9.09%)	1/5 (20.00%)
Palmar-plantar erythrodysaesthesia syndrome * 1	41/173 (23.70%)	31/88 (35.23%)	4/11 (36.36%)	4/5 (80.00%)
Rash * 1	15/173 (8.67%)	18/88 (20.45%)	1/11 (9.09%)	0/5 (0.00%)
Erythema * 1	5/173 (2.89%)	21/88 (23.86%)	0/11 (0.00%)	0/5 (0.00%)
Pruritus * 1	7/173 (4.05%)	9/88 (10.23%)	1/11 (9.09%)	1/5 (20.00%)
Skin exfoliation * 1	3/173 (1.73%)	6/88 (6.82%)	1/11 (9.09%)	0/5 (0.00%)
Blister * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Dry skin * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Eczema * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Pain of skin * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Pigmentation disorder * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Rash erythematous * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Skin fissures * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Skin hyperpigmentation * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Skin lesion * 1	0/173 (0.00%)	0/88 (0.00%)	2/11 (18.18%)	0/5 (0.00%)
Skin mass * 1	0/173 (0.00%)	0/88 (0.00%)	0/11 (0.00%)	1/5 (20.00%)
Skin toxicity * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Skin ulcer * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Surgical and medical procedures
Haemostasis * 1	0/173 (0.00%)	0/88 (0.00%)	1/11 (9.09%)	0/5 (0.00%)
Vascular disorders
Hypertension * 1	83/173 (47.98%)	28/88 (31.82%)	4/11 (36.36%)	1/5 (20.00%)
Hypotension * 1	13/173 (7.51%)	3/88 (3.41%)	0/11 (0.00%)	0/5 (0.00%)
1 Term from vocabulary, MedDRA v23.1; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

The objective of the statistical analysis for secondary endpoints was to summarize data using descriptive statistics without performing any hypothesis testing. Safety analysis did not include data from all China participants due to inability to obtain timely approval to use data in accordance to HGRAC regulations.

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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 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.gov_Inquiries@pfizer.com

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

Rini BI, Atkins MB, Choueiri TK, Thomaidou D, Rosbrook B, Thakur M, Hutson TE. Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2021 Oct;19(5):e306-e312. doi: 10.1016/j.clgc.2021.03.019. Epub 2021 Apr 5.

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.

Hutson TE, Al-Shukri S, Stus VP, Lipatov ON, Shparyk Y, Bair AH, Rosbrook B, Andrews GI, Vogelzang NJ. Axitinib Versus Sorafenib in First-Line Metastatic Renal Cell Carcinoma: Overall Survival From a Randomized Phase III Trial. Clin Genitourin Cancer. 2017 Feb;15(1):72-76. doi: 10.1016/j.clgc.2016.05.008. Epub 2016 May 27.

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.

Qin S, Bi F, Jin J, Cheng Y, Guo J, Ren X, Huang Y, Tarazi J, Tang J, Chen C, Kim S, Ye D. Axitinib versus sorafenib as a second-line therapy in Asian patients with metastatic renal cell carcinoma: results from a randomized registrational study. Onco Targets Ther. 2015 Jun 8;8:1363-73. doi: 10.2147/OTT.S83302. eCollection 2015.

Hutson TE, Lesovoy V, Al-Shukri S, Stus VP, Lipatov ON, Bair AH, Rosbrook B, Chen C, Kim S, Vogelzang NJ. Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1287-94. doi: 10.1016/S1470-2045(13)70465-0. Epub 2013 Oct 25.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00920816
• Other Study ID Numbers: A4061051; 2010-018585-23 ( EudraCT Number )
• First Submitted: June 11, 2009
• First Posted: June 15, 2009
• Results First Submitted: July 26, 2013
• Results First Posted: February 4, 2014
• Last Update Posted: May 6, 2022