Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®

Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. OS is the time from start of study treatment to death. Hazard ratio represents the relationship between sunitinib-induced hypertension and OS.

Time frame: Baseline to date of death (up to 12 months)

Population: FAS

Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. PFS is the time from start of study treatment to first documentation of tumor response to treatment. Hazard ratio represents the relationship between sunitinib-induced hypertension and PFS (presence/absence of hypertension).

Time frame: Baseline to date of first documentation of response to treatment (up to 12 months)

Population: FAS

OS is the duration from enrollment to death.

Time frame: Baseline to date of death (up to 12 months)

Population: FAS

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point.

Time frame: Month 12

Population: FAS. Percentages based on entire FAS population.

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point.

Time frame: Month 3

Population: FAS. Percentages based on entire FAS population.

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point.

Time frame: Month 6

Population: FAS. Percentages based on entire FAS population.

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point.

Time frame: Month 9

Population: FAS. Percentages based on entire FAS population.

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point.

Time frame: Week 6

Population: FAS. Percentages based on entire FAS population.

Hypertension was defined as follows. Grade 1: Asymptomatic, transient (less than \[\<\]24 hours) increase by \>20mm Hg (diastolic) or to \>150/100 mm Hg if previously within normal limits (WNL). Grade 2: Recurrent or persistent (24 hours or more) or symptomatic increase by \>20 mm Hg (diastolic) or to \>150/100 mm Hg if previously WNL. Grade 3: Requiring \>1 drug or more intensive therapy than previously. Grade 4: Life-threatening. Grade 5: Death.

Time frame: Baseline, Week 6, Months 3, 6, 9, 12

Population: FAS. n = number of participants with evaluable data at that time point.

TSH and FT4 levels were measured and hypothyroidism was defined as a TSH level \>5.0 mIU/L at that time point.

Time frame: Baseline, Months 3, 6, 9, 12

Population: FAS. n = number of participants with evaluable data at that time point.

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time frame: 12 months

Population: Full analysis set (FAS): all participants who received at least one dose of the study medication.

The period from study entry until disease progression, death, or date of last contact.

Time frame: Baseline to measured progressive disease (up to 12 months)

Population: FAS

Response categories for target lesions: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the longest dimensions, reference=baseline sum of longest dimensions; Progressive disease (PD): At least a 20% increase in the sum of the longest dimensions, or the appearance of 1 or more new lesions; Stable disease (SD): Not sufficient shrinkage to qualify for PR, not sufficient increase to qualify for PD; Reference for PD and SD: smallest sum of longest dimensions since treatment started.

Time frame: 12 months

Population: All participants

Sunitinib-induced hypertension: not present at baseline but developed through the study, or if present at baseline increased by more than (\>) 20% during the study. Grade 1: Asymptomatic, transient (less than \[\<\]24 hours) increase by \>20 millimeters of Mercury (mm Hg) (diastolic) or to \>150/100 mm Hg if previously within normal limits (WNL); Grade 2: Recurrent or persistent (\>=24 hours) or symptomatic increase by \>20 mm Hg (diastolic) or to \>150/100 mm Hg if previously WNL; Grade 3: Requiring \>1 drug or more intensive therapy than previously; Grade 4: Life-threatening; Grade 5: Death.

Time frame: Baseline up to 12 months

Population: All participants

Adverse events (AEs) or treatment-emergent adverse events (TEAEs) were defined as newly occurring or worsening after first dose. Study drug modifications included reduced dose or temporary discontinuation of treatment.

Time frame: Baseline up to 12 months

Population: Number of participants analyzed = All participants who required dose modification because of an adverse event. The total number of participants may exceed the number of participants analyzed because one participant may have reported more than one adverse event.