Trial Outcomes & Findings for Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer (NCT NCT00338884)

Last Updated: 2012-08-31

Results Overview

OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting \> = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

120 participants

Primary outcome timeframe

From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter

Results posted on

2012-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	Sunitinib 37.5 milligrams (mg) oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Overall Study STARTED	120
Overall Study Received Treatment	119
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	78

Reasons for withdrawal

Reasons for withdrawal
Measure	Sunitinib 37.5 milligrams (mg) oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Overall Study Objective Disease Progression or Relapse	44
Overall Study Adverse Event	14
Overall Study Death	8
Overall Study Other	4
Overall Study Global Deterioration of Health Status	3
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	1
Overall Study Randomized But Did Not Receive Treatment	1

Baseline Characteristics

Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib n=119 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Age, Customized 18 to 44 years	14 participants n=5 Participants
Age, Customized 45 to 64 years	69 participants n=5 Participants
Age, Customized > = 65 years	36 participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	90 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter

Population: Safety Population=all enrolled subjects who received at least 1 dose of sunitinib. For OR rate analysis, subjects who did not have a baseline assessment of disease were excluded from the analysis. Number of participants analyzed = number of subjects evaluable for OR analysis.

Outcome measures

Outcome measures
Measure	Sunitinib n=116 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Number of Subjects With Overall Confirmed Objective Response (OR)	41 participants

SECONDARY outcome

Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause

Population: Safety population subgroup of subjects with a confirmed objective tumor response. DR was only calculated for the subgroup of subjects with a confirmed objective response.

Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as \[the end date for DR minus first CR or PR that was subsequently confirmed +1\]/7.

Outcome measures

Outcome measures
Measure	Sunitinib n=41 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Duration of Response (DR)	7.14 months Interval 6.28 to 8.0

SECONDARY outcome

Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter

Population: Safety population. 64 subjects were censored. Number of participants analyzed = number of subjects evaluable for tumor progression analysis.

Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST.

Outcome measures

Outcome measures
Measure	Sunitinib n=118 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Time to Tumor Progression (TTP)	10.0 months Interval 7.2 to The upper confidence interval was not reached.

SECONDARY outcome

Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death

Population: Safety population. Number of participants analyzed = number of subjects evaluable for PFS analysis.

Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7.

Outcome measures

Outcome measures
Measure	Sunitinib n=118 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Progression-Free Survival (PFS)	9.0 months Interval 5.6 to 11.1

SECONDARY outcome

Timeframe: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year

Population: Safety population. Number of participants analyzed = number of subjects evaluable for 1 year survival analysis.

One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.

Outcome measures

Outcome measures
Measure	Sunitinib n=118 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1-Year Survival	67.8 percent chance of survival Interval 59.2 to 76.3

SECONDARY outcome

Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Population: Pharmacokinetic (PK) population = treated and had least 1 PK sample taken. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.

Ctrough = the concentration prior to study drug administration.

Outcome measures

Outcome measures
Measure	Sunitinib n=111 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 1 (n=111)	7.15 nanograms (ng)/milliliter (mL) Standard Deviation 18.80
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 3 (n=108)	54.78 nanograms (ng)/milliliter (mL) Standard Deviation 23.67
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 5 (n=106)	45.64 nanograms (ng)/milliliter (mL) Standard Deviation 22.83
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 7 (n=104)	46.35 nanograms (ng)/milliliter (mL) Standard Deviation 21.98
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 9 (n=97)	47.54 nanograms (ng)/milliliter (mL) Standard Deviation 24.96
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 13 (n=93)	41.29 nanograms (ng)/milliliter (mL) Standard Deviation 22.41
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 17 (n=82)	41.65 nanograms (ng)/milliliter (mL) Standard Deviation 20.25
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 21 (n=73)	35.95 nanograms (ng)/milliliter (mL) Standard Deviation 20.38
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 25 (n=70)	36.39 nanograms (ng)/milliliter (mL) Standard Deviation 20.72
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 29 (n=58)	38.01 nanograms (ng)/milliliter (mL) Standard Deviation 21.24
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 33 (n=58)	33.72 nanograms (ng)/milliliter (mL) Standard Deviation 18.94
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 37 (n=50)	36.04 nanograms (ng)/milliliter (mL) Standard Deviation 16.48
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 41 (n=49)	33.33 nanograms (ng)/milliliter (mL) Standard Deviation 15.80
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 45 (n=44)	36.20 nanograms (ng)/milliliter (mL) Standard Deviation 13.79
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 49 (n=40)	36.49 nanograms (ng)/milliliter (mL) Standard Deviation 13.10
Trough Plasma Concentrations (Ctrough) of Sunitinib Day 1, Week 53 (n=33)	33.10 nanograms (ng)/milliliter (mL) Standard Deviation 16.18

SECONDARY outcome

Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Population: PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.

Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.

Outcome measures

Outcome measures
Measure	Sunitinib n=41 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 1 (CR or PR, n=39)	0.000 ng/mL Interval 0.0 to 71.3
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 3 (CR or PR, n=40)	57.900 ng/mL Interval 16.9 to 109.0
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 5 (CR or PR, n=38)	45.000 ng/mL Interval 2.02 to 93.6
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 7 (CR or PR, n=40)	45.400 ng/mL Interval 18.5 to 83.9
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 9 (CR or PR, n=38)	46.250 ng/mL Interval 0.0 to 74.0
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 13 (CR or PR, n=41)	40.000 ng/mL Interval 2.13 to 91.4
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 17 (CR or PR, n=38)	41.350 ng/mL Interval 0.0 to 83.0
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 21 (CR or PR, n=38)	34.400 ng/mL Interval 0.0 to 99.7
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 25 (CR or PR, n=37)	34.200 ng/mL Interval 0.0 to 92.7
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 29 (CR or PR, n=32)	34.450 ng/mL Interval 5.91 to 128.0
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 33 (CR or PR, n=33)	33.000 ng/mL Interval 0.0 to 64.9
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 37 (CR or PR, n=28)	35.350 ng/mL Interval 4.1 to 73.3
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 41 (CR or PR, n=28)	30.900 ng/mL Interval 6.15 to 77.0
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 45 (CR or PR, n=29)	34.000 ng/mL Interval 6.87 to 64.9
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 49 (CR or PR, n=26)	36.250 ng/mL Interval 6.97 to 69.7
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 53 (CR or PR, n=21)	28.600 ng/mL Interval 0.0 to 72.6
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 1 (PD, n=16)	0.000 ng/mL Interval 0.0 to 51.1
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 3 (PD, n=15)	50.200 ng/mL Interval 0.0 to 150.0
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 5 (PD, n=15)	45.600 ng/mL Interval 6.81 to 88.7
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 7 (PD, n=13)	35.600 ng/mL Interval 0.0 to 69.5
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 9 (PD, n=8)	39.050 ng/mL Interval 0.0 to 70.7
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 13 (PD, n=1)	25.100 ng/mL Interval 25.1 to 25.1
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 17 (PD, n=1)	28.200 ng/mL Interval 28.2 to 28.2
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 21 (PD, n=1)	47.700 ng/mL Interval 47.7 to 47.7
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 25 (PD, n=1)	22.700 ng/mL Interval 22.7 to 22.7
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 29 (PD, n=1)	23.700 ng/mL Interval 23.7 to 23.7
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Day 1, Week 33 (PD, n=1)	9.520 ng/mL Interval 9.52 to 9.52

SECONDARY outcome

Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.

Outcome measures

Outcome measures
Measure	Sunitinib n=88 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 1 (CR or PR or SD, n=83)	0.000 ng/mL Interval 0.0 to 88.4
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 3 (CR or PR or SD, n=83)	55.300 ng/mL Interval 16.9 to 114.0
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 5 (CR or PR or SD, n=83)	44.600 ng/mL Interval 1.39 to 96.8
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 7 (CR or PR or SD, n=86)	46.750 ng/mL Interval 0.0 to 118.0
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 9 (CR or PR or SD, n=85)	49.500 ng/mL Interval 0.0 to 150.0
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 13 (CR or PR or SD, n=88)	39.550 ng/mL Interval 0.0 to 106.0
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 17 (CR or PR or SD, n=79)	42.300 ng/mL Interval 0.0 to 132.0
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 21 (CR or PR or SD, n=71)	36.500 ng/mL Interval 0.0 to 99.7
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 25 (CR or PR or SD, n=68)	35.500 ng/mL Interval 0.0 to 92.7
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 29 (CR or PR or SD, n=56)	37.250 ng/mL Interval 0.0 to 128.0
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 33 (CR or PR or SD, n=56)	34.400 ng/mL Interval 0.0 to 102.0
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 37 (CR or PR or SD, n=49)	35.300 ng/mL Interval 4.1 to 74.2
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 41 (CR or PR or SD, n=49)	33.200 ng/mL Interval 0.0 to 77.0
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 45 (CR or PR or SD, n=44)	35.950 ng/mL Interval 1.96 to 64.9
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 49 (CR or PR or SD, n=40)	37.250 ng/mL Interval 6.97 to 69.7
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 53 (CR or PR or SD, n=32)	31.100 ng/mL Interval 0.0 to 72.6
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 1 (PD, n=16)	0.000 ng/mL Interval 0.0 to 51.1
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 3 (PD, n=15)	50.200 ng/mL Interval 0.0 to 150.0
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 5 (PD, n=15)	45.600 ng/mL Interval 6.81 to 88.7
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 7 (PD, n=13)	35.600 ng/mL Interval 0.0 to 69.5
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 9 (PD, n=8)	39.050 ng/mL Interval 0.0 to 70.7
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 13 (PD, n=1)	25.100 ng/mL Interval 25.1 to 25.1
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 17 (PD, n=1)	28.200 ng/mL Interval 28.2 to 28.2
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 21 (PD, n=1)	47.700 ng/mL Interval 47.7 to 47.7
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 25 (PD, n=1)	22.700 ng/mL Interval 22.7 to 22.7
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 29 (PD, n=1)	23.700 ng/mL Interval 23.7 to 23.7
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Day 1, Week 33 (PD, n=1)	9.520 ng/mL Interval 9.52 to 9.52

SECONDARY outcome

Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Population: PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.

Ctrough = the concentration prior to study drug administration.

Outcome measures

Outcome measures
Measure	Sunitinib n=111 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 1 (n=111)	2.62 ng/mL Standard Deviation 6.88
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 3 (n=108)	20.27 ng/mL Standard Deviation 8.17
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 5 (n=106)	20.25 ng/mL Standard Deviation 11.73
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 7 (n=104)	20.41 ng/mL Standard Deviation 12.45
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 9 (n=97)	21.18 ng/mL Standard Deviation 13.07
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 13 (n=93)	20.01 ng/mL Standard Deviation 13.88
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 17 (n=82)	19.76 ng/mL Standard Deviation 12.84
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 21 (n=73)	17.13 ng/mL Standard Deviation 11.64
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 25 (n=70)	17.30 ng/mL Standard Deviation 12.75
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 29 (n=58)	17.38 ng/mL Standard Deviation 11.76
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 33 (n=58)	16.55 ng/mL Standard Deviation 12.20
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 37 (n=50)	15.71 ng/mL Standard Deviation 6.70
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 41 (n=49)	16.50 ng/mL Standard Deviation 8.95
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 45 (n=44)	15.61 ng/mL Standard Deviation 7.66
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 49 (n=40)	16.57 ng/mL Standard Deviation 7.65
Ctrough of SU-012662 (Sunitinib's Metabolite) Day 1, Week 53 (n=33)	13.81 ng/mL Standard Deviation 7.21

SECONDARY outcome

Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.

Outcome measures

Outcome measures
Measure	Sunitinib n=41 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 1 (CR or PR, n=39)	0.000 ng/mL Interval 0.0 to 23.8
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 3 (CR or PR, n=40)	18.250 ng/mL Interval 6.75 to 36.1
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 5 (CR or PR, n=38)	16.650 ng/mL Interval 2.34 to 41.2
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 7 (CR or PR, n=40)	17.300 ng/mL Interval 7.18 to 46.6
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 9 (CR or PR, n=38)	15.100 ng/mL Interval 0.0 to 45.2
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 13 (CR or PR, n=41)	15.900 ng/mL Interval 3.54 to 81.9
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 17 (CR or PR, n=38)	14.300 ng/mL Interval 0.0 to 45.3
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 21 (CR or PR, n=38)	12.600 ng/mL Interval 0.0 to 52.1
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 25 (CR or PR, n=37)	14.500 ng/mL Interval 0.0 to 80.3
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 29 (CR or PR, n=32)	12.850 ng/mL Interval 3.23 to 60.3
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 33 (CR or PR, n=33)	12.800 ng/mL Interval 1.01 to 31.4
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 37 (CR or PR, n=28)	14.350 ng/mL Interval 4.52 to 31.0
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 41 (CR or PR, n=28)	14.000 ng/mL Interval 6.31 to 40.8
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 45 (CR or PR, n=29)	13.400 ng/mL Interval 6.08 to 39.2
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 49 (CR or PR, n=26)	14.700 ng/mL Interval 4.62 to 33.1
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 53 (CR or PR, n=21)	11.600 ng/mL Interval 0.0 to 24.6
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 1 (PD, n=16)	0.000 ng/mL Interval 0.0 to 16.6
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 3 (PD, n=15)	20.000 ng/mL Interval 0.0 to 39.7
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 5 (PD, n=15)	18.800 ng/mL Interval 5.81 to 49.1
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 7 (PD, n=13)	14.300 ng/mL Interval 0.0 to 58.5
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 9 (PD, n=8)	16.550 ng/mL Interval 0.0 to 54.1
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 13 (PD, n=1)	9.710 ng/mL Interval 9.71 to 9.71
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 17 (PD, n=1)	12.600 ng/mL Interval 12.6 to 12.6
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 21 (PD, n=1)	23.400 ng/mL Interval 23.4 to 23.4
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 25 (PD, n=1)	29.400 ng/mL Interval 29.4 to 29.4
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 29 (PD, n=1)	13.700 ng/mL Interval 13.7 to 13.7
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Day 1, Week 33 (PD, n=1)	4.360 ng/mL Interval 4.36 to 4.36

SECONDARY outcome

Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.

Outcome measures

Outcome measures
Measure	Sunitinib n=88 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 1 (CR or PR or SD, n=83)	0.000 ng/mL Interval 0.0 to 34.6
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 3 (CR or PR or SD, n=83)	18.800 ng/mL Interval 6.75 to 54.1
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 5 (CR or PR or SD, n=83)	17.300 ng/mL Interval 0.0 to 70.6
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 7 (CR or PR or SD, n=86)	17.900 ng/mL Interval 0.0 to 76.3
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 9 (CR or PR or SD, n=85)	18.700 ng/mL Interval 0.0 to 57.7
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 13 (CR or PR or SD, n=88)	16.350 ng/mL Interval 1.31 to 81.9
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 17 (CR or PR or SD, n=79)	14.600 ng/mL Interval 0.0 to 61.1
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 21 (CR or PR or SD, n=71)	14.100 ng/mL Interval 0.0 to 52.8
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 25 (CR or PR or SD, n=68)	14.950 ng/mL Interval 0.0 to 80.3
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 29 (CR or PR or SD, n=56)	14.900 ng/mL Interval 0.0 to 60.3
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 33 (CR or PR or SD, n=56)	14.050 ng/mL Interval 1.01 to 71.9
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 37 (CR or PR or SD, n=49)	15.500 ng/mL Interval 4.52 to 36.2
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 41 (CR or PR or SD, n=49)	15.400 ng/mL Interval 0.0 to 43.5
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 45 (CR or PR or SD, n=44)	13.700 ng/mL Interval 6.08 to 39.2
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 49 (CR or PR or SD, n=40)	14.700 ng/mL Interval 4.62 to 42.9
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 53 (CR or PR or SD, n=32)	11.450 ng/mL Interval 0.0 to 27.1
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 1 (PD, n=16)	0.000 ng/mL Interval 0.0 to 16.6
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 3 (PD, n=15)	20.000 ng/mL Interval 0.0 to 39.7
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 5 (PD, n=15)	18.800 ng/mL Interval 5.81 to 49.1
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 7 (PD, n=13)	14.300 ng/mL Interval 0.0 to 58.5
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 9 (PD, n=8)	16.550 ng/mL Interval 0.0 to 54.1
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 13 (PD, n=1)	9.710 ng/mL Interval 9.71 to 9.71
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 17 (PD, n=1)	12.600 ng/mL Interval 12.6 to 12.6
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 21 (PD, n=1)	23.400 ng/mL Interval 23.4 to 23.4
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 25 (PD, n=1)	29.400 ng/mL Interval 29.4 to 29.4
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 29 (PD, n=1)	13.700 ng/mL Interval 13.7 to 13.7
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Day 1, Week 33 (PD, n=1)	4.360 ng/mL Interval 4.36 to 4.36

SECONDARY outcome

Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Population: PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.

Ctrough = the concentration prior to study drug administration.

Outcome measures

Outcome measures
Measure	Sunitinib n=111 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 17 (n=82)	61.41 ng/mL Standard Deviation 30.43
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 1 (n=111)	9.77 ng/mL Standard Deviation 25.09
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 3 (n=108)	75.04 ng/mL Standard Deviation 29.48
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 5 (n=106)	65.89 ng/mL Standard Deviation 32.37
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 7 (n=104)	66.76 ng/mL Standard Deviation 32.03
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 9 (n=97)	68.72 ng/mL Standard Deviation 35.01
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 13 (n=93)	61.31 ng/mL Standard Deviation 33.31
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 21 (n=73)	53.09 ng/mL Standard Deviation 30.50
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 25 (n=70)	53.69 ng/mL Standard Deviation 31.52
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 29 (n=58)	55.39 ng/mL Standard Deviation 31.40
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 33 (n=58)	50.27 ng/mL Standard Deviation 29.55
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 37 (n=50)	51.74 ng/mL Standard Deviation 20.54
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 41 (n=49)	49.83 ng/mL Standard Deviation 23.68
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 45 (n=44)	51.82 ng/mL Standard Deviation 19.15
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 49 (n=40)	53.07 ng/mL Standard Deviation 18.25
Ctrough of Total Drug (Sunitinib + SU-012662) Day 1, Week 53 (n=33)	46.91 ng/mL Standard Deviation 21.56

SECONDARY outcome

Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.

Outcome measures

Outcome measures
Measure	Sunitinib n=41 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 1 (CR or PR, n=39)	0.000 ng/mL Interval 0.0 to 95.1
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 3 (CR or PR, n=40)	76.950 ng/mL Interval 23.65 to 139.9
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 5 (CR or PR, n=38)	65.900 ng/mL Interval 4.36 to 125.5
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 7 (CR or PR, n=40)	66.100 ng/mL Interval 28.02 to 120.4
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 9 (CR or PR, n=38)	65.150 ng/mL Interval 0.0 to 118.3
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 13 (CR or PR, n=41)	57.600 ng/mL Interval 5.67 to 158.5
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 17 (CR or PR, n=38)	55.660 ng/mL Interval 0.0 to 128.2
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 21 (CR or PR, n=38)	47.370 ng/mL Interval 0.0 to 135.3
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 25 (CR or PR, n=37)	50.700 ng/mL Interval 0.0 to 173.0
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 29 (CR or PR, n=32)	50.650 ng/mL Interval 10.78 to 185.0
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 33 (CR or PR, n=33)	46.000 ng/mL Interval 1.01 to 85.5
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 37 (CR or PR, n=28)	49.750 ng/mL Interval 8.62 to 98.9
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 41 (CR or PR, n=28)	43.365 ng/mL Interval 12.46 to 106.0
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 45 (CR or PR, n=29)	45.200 ng/mL Interval 14.39 to 102.6
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 49 (CR or PR, n=26)	49.975 ng/mL Interval 11.59 to 89.0
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 53 (CR or PR, n=21)	41.000 ng/mL Interval 0.0 to 90.5
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 1 (PD, n=16)	0.000 ng/mL Interval 0.0 to 67.7
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 3 (PD, n=15)	69.000 ng/mL Interval 0.0 to 183.0
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 5 (PD, n=15)	64.700 ng/mL Interval 12.62 to 129.6
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 7 (PD, n=13)	50.200 ng/mL Interval 0.0 to 128.0
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 9 (PD, n=8)	55.850 ng/mL Interval 0.0 to 124.8
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 13 (PD, n=1)	34.810 ng/mL Interval 34.81 to 34.81
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 17 (PD, n=1)	40.800 ng/mL Interval 40.8 to 40.8
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 21 (PD, n=1)	71.100 ng/mL Interval 71.1 to 71.1
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 25 (PD, n=1)	52.100 ng/mL Interval 52.1 to 52.1
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 29 (PD, n=1)	37.400 ng/mL Interval 37.4 to 37.4
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Day 1, Week 33 (PD, n=1)	13.880 ng/mL Interval 13.88 to 13.88

SECONDARY outcome

Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.

Outcome measures

Outcome measures
Measure	Sunitinib n=88 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 1 (CR or PR or SD, n=83)	0.000 ng/mL Interval 0.0 to 103.3
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 3 (CR or PR or SD, n=83)	75.000 ng/mL Interval 23.65 to 166.1
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 5 (CR or PR or SD, n=83)	63.300 ng/mL Interval 1.47 to 157.6
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 7 (CR or PR or SD, n=86)	66.400 ng/mL Interval 0.0 to 194.3
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 9 (CR or PR or SD, n=85)	70.600 ng/mL Interval 0.0 to 201.4
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 13 (CR or PR or SD, n=88)	57.600 ng/mL Interval 1.31 to 158.5
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 17 (CR or PR or SD, n=79)	58.100 ng/mL Interval 0.0 to 183.5
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 21 (CR or PR or SD, n=71)	49.860 ng/mL Interval 0.0 to 135.3
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 25 (CR or PR or SD, n=68)	51.150 ng/mL Interval 0.0 to 173.0
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 29 (CR or PR or SD, n=56)	53.500 ng/mL Interval 0.0 to 185.0
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 33 (CR or PR or SD, n=56)	50.050 ng/mL Interval 1.01 to 173.9
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 37 (CR or PR or SD, n=49)	50.800 ng/mL Interval 8.62 to 102.4
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 41 (CR or PR or SD, n=49)	48.000 ng/mL Interval 0.0 to 106.0
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 45 (CR or PR or SD, n=44)	50.500 ng/mL Interval 9.93 to 102.6
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 49 (CR or PR or SD, n=40)	54.885 ng/mL Interval 11.59 to 89.0
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 53 (CR or PR or SD, n=32)	42.160 ng/mL Interval 0.0 to 90.5
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 1 (PD, n=16)	0.000 ng/mL Interval 0.0 to 67.7
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 3 (PD, n=15)	69.000 ng/mL Interval 0.0 to 183.0
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 5 (PD, n=15)	64.700 ng/mL Interval 12.62 to 129.6
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 7 (PD, n=13)	50.200 ng/mL Interval 0.0 to 128.0
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 9 (PD, n=8)	55.850 ng/mL Interval 0.0 to 124.8
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 13 (PD, n=1)	34.810 ng/mL Interval 34.81 to 34.81
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 17 (PD, n=1)	40.800 ng/mL Interval 40.8 to 40.8
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 21 (PD, n=1)	71.100 ng/mL Interval 71.1 to 71.1
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 25 (PD, n=1)	52.100 ng/mL Interval 52.1 to 52.1
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 29 (PD, n=1)	37.400 ng/mL Interval 37.4 to 37.4
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Day 1, Week 33 (PD, n=1)	13.880 ng/mL Interval 13.88 to 13.88

SECONDARY outcome

Timeframe: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Population: Ctrough correlation analyses with SAEs were not performed due to low frequency of individual SAEs.

Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline.

Outcome measures

Outcome measures
Measure	Sunitinib n=113 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline	154.8 picograms (pg)/mL Standard Deviation 186.6

SECONDARY outcome

Timeframe: Baseline (Cycle 1, Day 1)

Population: Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.

Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.

Outcome measures

Outcome measures
Measure	Sunitinib n=45 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD) Cycle 1, Day 1 (PD, n=16)	109.300 pg/mL Interval 44.4 to 1199.3
VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD) Cycle 1, Day 1 (CR or PR, n=39)	73.600 pg/mL Interval 19.2 to 454.9

SECONDARY outcome

Timeframe: Baseline (Cycle 1, Day 1)

Population: Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.

Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.

Outcome measures

Outcome measures
Measure	Sunitinib n=101 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Cycle 1, Day 1 (CR or PR or SD, n=85)	86.400 pg/mL Interval 14.1 to 624.5
VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Cycle 1, Day 1 (PD, n=16)	109.300 pg/mL Interval 44.4 to 1199.3

SECONDARY outcome

Timeframe: Baseline to Day 1 of Weeks 3 through 53

Population: Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point.

VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).

Outcome measures

Outcome measures
Measure	Sunitinib n=113 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
VEGF Ratio to Baseline at Each Time Point Day 1, Week 3 (n=108)	2.9 ratio Standard Deviation 2.8
VEGF Ratio to Baseline at Each Time Point Day 1, Week 5 (n=104)	2.6 ratio Standard Deviation 2.9
VEGF Ratio to Baseline at Each Time Point Day 1, Week 7 (n=101)	2.6 ratio Standard Deviation 2
VEGF Ratio to Baseline at Each Time Point Day 1, Week 9 (n=95)	3.4 ratio Standard Deviation 3.3
VEGF Ratio to Baseline at Each Time Point Day 1, Week 13 (n=91)	3.2 ratio Standard Deviation 3.4
VEGF Ratio to Baseline at Each Time Point Day 1, Week 17 (n=78)	2.8 ratio Standard Deviation 2.4
VEGF Ratio to Baseline at Each Time Point Day 1, Week 21 (n=70)	2.6 ratio Standard Deviation 2.1
VEGF Ratio to Baseline at Each Time Point Day 1, Week 25 (n=67)	3 ratio Standard Deviation 3.2
VEGF Ratio to Baseline at Each Time Point Day 1, Week 29 (n=55)	2.5 ratio Standard Deviation 1.8
VEGF Ratio to Baseline at Each Time Point Day 1, Week 33 (n=54)	2.3 ratio Standard Deviation 1.4
VEGF Ratio to Baseline at Each Time Point Day 1, Week 37 (n=49)	2.7 ratio Standard Deviation 2.1
VEGF Ratio to Baseline at Each Time Point Day 1, Week 41 (n=48)	5.5 ratio Standard Deviation 20.5
VEGF Ratio to Baseline at Each Time Point Day 1, Week 45 (n=41)	2.9 ratio Standard Deviation 2.1
VEGF Ratio to Baseline at Each Time Point Day 1, Week 49 (n=37)	2.8 ratio Standard Deviation 1.8
VEGF Ratio to Baseline at Each Time Point Day 1, Week 53 (n=30)	3.2 ratio Standard Deviation 3

SECONDARY outcome

Timeframe: Baseline to Day 1 of Weeks 3 through 53

Population: Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.

Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).

Outcome measures

Outcome measures
Measure	Sunitinib n=53 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 3 (CR or PR, n=38)	1.999 ratio Interval 0.42 to 19.96
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 3 (PD, n=15)	1.948 ratio Interval 0.2 to 5.81
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 5 (CR or PR, n=37)	1.383 ratio Interval 0.41 to 6.67
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 5 (PD, n=15)	2.471 ratio Interval 0.09 to 10.93
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 7 (CR or PR, n=39)	1.761 ratio Interval 0.4 to 8.56
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 7 (PD, n=13)	1.405 ratio Interval 0.88 to 6.35
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 9 (CR or PR, n=37)	2.215 ratio Interval 0.54 to 14.65
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 9 (PD, n=8)	1.176 ratio Interval 0.32 to 5.6
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 13 (CR or PR, n=39)	1.753 ratio Interval 0.33 to 21.39
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 13 (PD, n=2)	3.921 ratio Interval 1.51 to 6.33
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 17 (CR or PR, n=36)	2.012 ratio Interval 0.41 to 14.32
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 17 (PD, n=1)	0.988 ratio Interval 0.988 to 0.988
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 21 (CR or PR, n=36)	1.523 ratio Interval 0.24 to 8.75
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 21 (PD, n=1)	1.510 ratio Interval 1.51 to 1.51
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 25 (CR or PR, n=35)	1.809 ratio Interval 0.43 to 21.36
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 25 (PD, n=1)	1.433 ratio Interval 1.433 to 1.433
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 29 (CR or PR, n=30)	1.805 ratio Interval 0.4 to 6.04
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 29 (PD, n=1)	1.929 ratio Interval 1.929 to 1.929
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 33 (CR or PR, n=31)	2.248 ratio Interval 0.4 to 6.86
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 33 (PD, n=1)	1.063 ratio Interval 1.063 to 1.063
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 37 (CR or PR, n=28)	2.179 ratio Interval 0.59 to 7.15
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 41 (CR or PR, n=28)	1.864 ratio Interval 0.51 to 7.84
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 45 (CR or PR, n=27)	2.240 ratio Interval 0.22 to 8.81
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 49 (CR or PR, n=24)	2.707 ratio Interval 0.75 to 8.24
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 53 (CR or PR, n=19)	2.863 ratio Interval 0.66 to 15.81

SECONDARY outcome

Timeframe: Baseline to Day 1 of Weeks 3 through 53

Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 12 weeks\] versus PD).

Outcome measures

Outcome measures
Measure	Sunitinib n=98 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 25 (PD, n=1)	1.433 ratio Interval 1.433 to 1.433
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 29 (CR or PR or SD, n=53)	1.831 ratio Interval 0.4 to 8.18
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 29 (PD, n=1)	1.929 ratio Interval 1.929 to 1.929
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 33 (CR or PR or SD, n=53)	2.200 ratio Interval 0.4 to 6.86
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 33 (PD, n=1)	1.063 ratio Interval 1.063 to 1.063
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 37 (CR or PR or SD, n=48)	2.201 ratio Interval 0.53 to 8.76
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 41 (CR or PR or SD, n=48)	1.859 ratio Interval 0.51 to 144.13
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 45 (CR or PR or SD, n=41)	2.484 ratio Interval 0.22 to 8.81
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 49 (CR or PR or SD, n=37)	2.329 ratio Interval 0.75 to 8.24
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 53 (CR or PR or SD, n=29)	2.431 ratio Interval 0.66 to 15.81
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 3 (CR or PR or SD, n=83)	2.127 ratio Interval 0.3 to 19.96
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 3 (PD, n=15)	1.948 ratio Interval 0.2 to 5.81
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 5 (CR or PR or SD, n=81)	1.574 ratio Interval 0.24 to 24.75
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 5 (PD, n=15)	2.471 ratio Interval 0.09 to 10.93
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 7 (CR or PR or SD, n=84)	1.798 ratio Interval 0.3 to 10.01
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 7 (PD, n=13)	1.405 ratio Interval 0.88 to 6.35
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 9 (CR or PR or SD, n=83)	2.481 ratio Interval 0.35 to 17.14
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 9 (PD, n=8)	1.176 ratio Interval 0.32 to 5.6
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 13 (CR or PR or SD, n=85)	1.890 ratio Interval 0.28 to 21.39
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 13 (PD, n=2)	3.921 ratio Interval 1.51 to 6.33
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 17 (CR or PR or SD, n=76)	2.070 ratio Interval 0.26 to 14.23
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 17 (PD, n=1)	0.988 ratio Interval 0.988 to 0.988
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 21 (CR or PR or SD, n=68)	1.972 ratio Interval 0.24 to 10.66
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 21 (PD, n=1)	1.510 ratio Interval 1.51 to 1.51
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 25 (CR or PR or SD, n=65)	1.906 ratio Interval 0.43 to 21.36

SECONDARY outcome

Timeframe: Baseline

Population: Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline.

Outcome measures

Outcome measures
Measure	Sunitinib n=113 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline	9163.4 pg/mL Standard Deviation 2215.8

SECONDARY outcome

Timeframe: Baseline (Cycle 1, Day 1)

Population: Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.

Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.

Outcome measures

Outcome measures
Measure	Sunitinib n=56 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD) Cycle 1, Day 1 (CR or PR, n=40)	9968.000 pg/mL Interval 3612.0 to 14080.0
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD) Cycle 1, Day 1 (PD, n=16)	8342.750 pg/mL Interval 5838.5 to 13987.5

SECONDARY outcome

Timeframe: Baseline (Cycle 1, Day 1)

Population: Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.

Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.

Outcome measures

Outcome measures
Measure	Sunitinib n=101 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Cycle 1, Day 1 (CR or PR or SD, n=85)	9772.500 pg/mL Interval 3612.0 to 14080.0
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Cycle 1, Day 1 (PD, n=16)	8342.750 pg/mL Interval 5838.5 to 13987.5

SECONDARY outcome

Timeframe: Baseline to Day 1 of Weeks 3 through 53

Population: Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point.

sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).

Outcome measures

Outcome measures
Measure	Sunitinib n=113 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 3 (n=106)	0.7 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 5 (n=104)	0.6 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 7 (n=101)	0.6 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 9 (n=95)	0.6 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 13 (n=91)	0.6 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 17 (n=79)	0.6 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 21 (n=69)	0.6 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 25 (n=68)	0.6 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 29 (n=55)	0.6 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 33 (n=55)	0.6 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 37 (n=50)	0.6 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 41 (n=48)	0.6 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 45 (n=42)	0.6 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 49 (n=38)	0.6 ratio Standard Deviation 0.2
sVEGFR2 Ratio to Baseline at Each Time Point Day 1, Week 53 (n=31)	0.7 ratio Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline to Day 1 of Weeks 3 through 53

Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).

Outcome measures

Outcome measures
Measure	Sunitinib n=40 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 45 (CR or PR, n=28)	0.535 ratio Interval 0.34 to 1.05
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 49 (CR or PR, n=25)	0.555 ratio Interval 0.35 to 0.9
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 53 (CR or PR, n=20)	0.630 ratio Interval 0.36 to 0.85
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 3 (CR or PR, n=39)	0.704 ratio Interval 0.54 to 1.19
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 3 (PD, n=15)	0.653 ratio Interval 0.52 to 1.37
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 5 (CR or PR, n=38)	0.638 ratio Interval 0.36 to 0.97
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 5 (PD, n=15)	0.531 ratio Interval 0.37 to 0.89
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 7 (CR or PR, n=40)	0.596 ratio Interval 0.32 to 1.04
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 7 (PD, n=13)	0.574 ratio Interval 0.38 to 0.9
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 9 (CR or PR, n=38)	0.562 ratio Interval 0.28 to 1.34
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 9 (PD, n=8)	0.603 ratio Interval 0.39 to 1.48
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 13 (CR or PR, n=40)	0.555 ratio Interval 0.18 to 0.89
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 13 (PD, n=2)	0.529 ratio Interval 0.51 to 0.55
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 17 (CR or PR, n=37)	0.545 ratio Interval 0.23 to 0.93
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 17 (PD, n=1)	0.687 ratio Interval 0.687 to 0.687
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 21 (CR or PR, n=36)	0.566 ratio Interval 0.31 to 0.93
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 21 (PD, n=1)	0.540 ratio Interval 0.54 to 0.54
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 25 (CR or PR, n=36)	0.564 ratio Interval 0.29 to 0.96
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 25 (PD, n=1)	0.509 ratio Interval 0.509 to 0.509
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 29 (CR or PR, n=30)	0.564 ratio Interval 0.28 to 0.86
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 29 (PD, n=1)	0.671 ratio Interval 0.671 to 0.671
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 33 (CR or PR, n=32)	0.547 ratio Interval 0.24 to 0.91
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 33 (PD, n=1)	0.610 ratio Interval 0.61 to 0.61
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 37 (CR or PR, n=29)	0.554 ratio Interval 0.39 to 0.96
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Day 1, Week 41 (CR or PR, n=29)	0.561 ratio Interval 0.39 to 0.93

SECONDARY outcome

Timeframe: Baseline to Day 1 of Weeks 3 through 53

Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 12 weeks\] versus PD).

Outcome measures

Outcome measures
Measure	Sunitinib n=96 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 21 (CR or PR or SD, n=67)	0.548 ratio Interval 0.26 to 1.39
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 21 (PD, n=1)	0.540 ratio Interval 0.54 to 0.54
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 25 (CR or PR or SD, n=66)	0.570 ratio Interval 0.29 to 1.28
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 25 (PD, n=1)	0.509 ratio Interval 0.509 to 0.509
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 29 (CR or PR or SD, n=53)	0.556 ratio Interval 0.28 to 1.19
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 29 (PD, n=1)	0.671 ratio Interval 0.671 to 0.671
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 33 (CR or PR or SD, n=54)	0.569 ratio Interval 0.24 to 1.24
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 33 (PD, n=1)	0.610 ratio Interval 0.61 to 0.61
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 37 (CR or PR or SD, n=49)	0.559 ratio Interval 0.31 to 1.54
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 41 (CR or PR or SD, n=48)	0.572 ratio Interval 0.29 to 1.17
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 45 (CR or PR or SD, n=42)	0.538 ratio Interval 0.34 to 1.2
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 49 (CR or PR or SD, n=38)	0.569 ratio Interval 0.33 to 1.76
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 53 (CR or PR or SD, n=30)	0.638 ratio Interval 0.36 to 1.56
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 3 (CR or PR or SD, n=81)	0.691 ratio Interval 0.29 to 1.54
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 3 (PD, n=15)	0.653 ratio Interval 0.52 to 1.37
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 5 (CR or PR or SD, n=81)	0.625 ratio Interval 0.31 to 1.36
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 5 (PD, n=15)	0.531 ratio Interval 0.37 to 0.89
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 7 (CR or PR or SD, n=84)	0.599 ratio Interval 0.31 to 1.3
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 7 (PD, n=13)	0.574 ratio Interval 0.38 to 0.9
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 9 (CR or PR or SD, n=83)	0.563 ratio Interval 0.15 to 1.34
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 9 (PD, n=8)	0.603 ratio Interval 0.39 to 1.48
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 13 (CR or PR or SD, n=85)	0.534 ratio Interval 0.18 to 1.4
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 13 (PD, n=2)	0.529 ratio Interval 0.51 to 0.55
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 17 (CR or PR or SD, n=77)	0.524 ratio Interval 0.23 to 1.25
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Day 1, Week 17 (PD, n=1)	0.687 ratio Interval 0.687 to 0.687

SECONDARY outcome

Timeframe: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)

Population: Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point.

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only.

Outcome measures

Outcome measures
Measure	Sunitinib n=118 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Patient-Assessed Fatigue Week 33 (n=55)	36.00 scores on a scale Standard Deviation 11.22
Patient-Assessed Fatigue Baseline (n=118)	39.29 scores on a scale Standard Deviation 9.55
Patient-Assessed Fatigue Week 3 (n=113)	36.98 scores on a scale Standard Deviation 11.38
Patient-Assessed Fatigue Week 5 (n=110)	35.44 scores on a scale Standard Deviation 10.87
Patient-Assessed Fatigue Week 7 (n=106)	36.54 scores on a scale Standard Deviation 10.86
Patient-Assessed Fatigue Week 9 (n=97)	36.82 scores on a scale Standard Deviation 9.43
Patient-Assessed Fatigue Week 11 (n=93)	35.94 scores on a scale Standard Deviation 9.75
Patient-Assessed Fatigue Week 13 (n=90)	36.58 scores on a scale Standard Deviation 10.32
Patient-Assessed Fatigue Week 17 (n=80)	37.44 scores on a scale Standard Deviation 9.83
Patient-Assessed Fatigue Week 21 (n=71)	38.42 scores on a scale Standard Deviation 10.08
Patient-Assessed Fatigue Week 25 (n=62)	38.05 scores on a scale Standard Deviation 9.69
Patient-Assessed Fatigue Week 29 (n=60)	36.77 scores on a scale Standard Deviation 10.89
Patient-Assessed Fatigue Week 37 (n=52)	37.88 scores on a scale Standard Deviation 9.77
Patient-Assessed Fatigue Week 41 (n=50)	36.96 scores on a scale Standard Deviation 10.74
Patient-Assessed Fatigue Week 45 (n=42)	38.71 scores on a scale Standard Deviation 8.66
Patient-Assessed Fatigue Week 49 (n=41)	39.32 scores on a scale Standard Deviation 8.98
Patient-Assessed Fatigue Week 53 (End of Treatment) (n=40)	39.05 scores on a scale Standard Deviation 8.62

SECONDARY outcome

Timeframe: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)

Population: Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point.

FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-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). End of treatment assessment was for subjects who completed the study only.

Outcome measures

Outcome measures
Measure	Sunitinib n=109 Participants 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Cancer Related Symptoms, Well-Being, and Concerns Baseline (n=109)	44.68 scores on a scale Standard Deviation 7.78
Cancer Related Symptoms, Well-Being, and Concerns Week 3 (n=104)	43.69 scores on a scale Standard Deviation 8.38
Cancer Related Symptoms, Well-Being, and Concerns Week 5 (n=101)	42.71 scores on a scale Standard Deviation 8.64
Cancer Related Symptoms, Well-Being, and Concerns Week 7 (n=97)	43.69 scores on a scale Standard Deviation 7.99
Cancer Related Symptoms, Well-Being, and Concerns Week 9 (n=88)	44.11 scores on a scale Standard Deviation 7.55
Cancer Related Symptoms, Well-Being, and Concerns Week 11 (n=84)	43.26 scores on a scale Standard Deviation 7.88
Cancer Related Symptoms, Well-Being, and Concerns Week 13 (n=81)	43.49 scores on a scale Standard Deviation 8.01
Cancer Related Symptoms, Well-Being, and Concerns Week 17 (n=72)	44.21 scores on a scale Standard Deviation 7.34
Cancer Related Symptoms, Well-Being, and Concerns Week 21 (n=63)	45.51 scores on a scale Standard Deviation 7.50
Cancer Related Symptoms, Well-Being, and Concerns Week 25 (n=55)	45.42 scores on a scale Standard Deviation 8.00
Cancer Related Symptoms, Well-Being, and Concerns Week 29 (n=55)	44.64 scores on a scale Standard Deviation 8.42
Cancer Related Symptoms, Well-Being, and Concerns Week 33 (n=50)	44.06 scores on a scale Standard Deviation 8.35
Cancer Related Symptoms, Well-Being, and Concerns Week 37 (n=47)	45.23 scores on a scale Standard Deviation 8.03
Cancer Related Symptoms, Well-Being, and Concerns Week 41 (n=45)	44.71 scores on a scale Standard Deviation 8.16
Cancer Related Symptoms, Well-Being, and Concerns Week 45 (n=37)	46.73 scores on a scale Standard Deviation 6.94
Cancer Related Symptoms, Well-Being, and Concerns Week 49 (n=36)	45.92 scores on a scale Standard Deviation 7.31
Cancer Related Symptoms, Well-Being, and Concerns Week 53 (End of Treatment) (n=35)	45.94 scores on a scale Standard Deviation 7.29

Adverse Events

Sunitinib

Serious events: 45 serious events

Other events: 117 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sunitinib n=119 participants at risk 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Blood and lymphatic system disorders Thrombocytopenia	1.7% 2/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure congestive	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Pancreatitis acute	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastric haemorrhage	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haematochezia	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Melaena	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Duodenitis	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	2.5% 3/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	1.7% 2/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	4.2% 5/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Large intestinal obstruction	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Erosive oesophagitis	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Catheter related complication	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	2.5% 3/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chills	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	6.7% 8/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Gait disturbance	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Gallbladder disorder	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Jaundice	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Lower respiratory tract infection	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	2.5% 3/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Septic shock	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Femur fracture	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Joint dislocation	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Chemical poisoning	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Procedural complication	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Eastern cooperative oncology group performance status worsened	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Electrolyte imbalance	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	2.5% 3/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Flank pain	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial tumour haemorrhage	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Haemorrhage intracranial	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hemiplegia	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Peripheral sensory neuropathy	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Spinal cord compression	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Suicide attempt	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure	1.7% 2/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.7% 2/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.7% 2/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.5% 3/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.7% 2/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.5% 3/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	1.7% 2/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin ulcer	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	1.7% 2/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertensive crisis	0.84% 1/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	Sunitinib n=119 participants at risk 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
Blood and lymphatic system disorders Anaemia	21.8% 26/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	18.5% 22/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	14.3% 17/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Hypothyroidism	5.9% 7/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distension	5.9% 7/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	15.1% 18/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	13.4% 16/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	18.5% 22/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	52.1% 62/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	5.9% 7/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	15.1% 18/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastritis	5.9% 7/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.0% 6/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gingivitis	5.9% 7/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	29.4% 35/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	14.3% 17/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	21.8% 26/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	21.8% 26/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Face oedema	10.1% 12/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	35.3% 42/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	31.1% 37/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema	7.6% 9/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	7.6% 9/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	6.7% 8/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	8.4% 10/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	8.4% 10/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	10.9% 13/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	8.4% 10/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood alkaline phosphatase increased	5.9% 7/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	10.9% 13/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Lipase increased	8.4% 10/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Neutrophil count decreased	9.2% 11/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Platelet count decreased	15.1% 18/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	15.1% 18/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations White blood cell count decreased	8.4% 10/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Anorexia	36.1% 43/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	7.6% 9/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	11.8% 14/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	7.6% 9/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	10.9% 13/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	6.7% 8/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	26.9% 32/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	10.9% 13/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Neuropathy peripheral	8.4% 10/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	11.8% 14/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	15.1% 18/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.7% 8/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.6% 15/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.4% 10/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hair colour changes	9.2% 11/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	41.2% 49/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Periorbital oedema	6.7% 8/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Petechiae	5.9% 7/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	16.8% 20/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin discolouration	22.7% 27/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Yellow skin	12.6% 15/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	25.2% 30/119 The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

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Results disclosure agreements

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

Restriction type: OTHER