A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC) (IMmotion151)

• ClinicalTrials.gov Identifier: NCT02420821
• Recruitment Status: Completed
• First Posted: April 20, 2015
• Results First Posted: October 3, 2018
• Last Update Posted: January 30, 2023
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Renal Cell Carcinoma
• Interventions: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Bevacizumab; Drug: Sunitinib
• Enrollment: 915

Participant Flow

Recruitment Details
Pre-assignment Details	A total of 1228 participants were screened, out of which, 915 participants were enrolled into the study.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description	Participants received sunitinib at a dose of 50 milligrams (mg) administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to disease progression (PD) as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 milligrams per kilogram (mg/kg) administered via intravenous (IV) infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Period Title: Overall Study
Started	461	454
Completed	1	1
Not Completed	460	453
Reason Not Completed
Lost to Follow-up	6	6
Non-compliance	0	2
Physician Decision	6	2
Withdrawal by Subject	32	25
Death	270	263
Study Terminated By Sponsor	145	149
Patient refused end of treatment visit due to Covid-19	0	1
Adverse Event	0	1
Protinuria	0	1
Progressive Disease	1	1
Disease Progression	0	1
Patient missing record of discontinuation from Atezo.	0	1

Baseline Characteristics

Arm/Group Title		Sunitinib	Atezolizumab + Bevacizumab	Total
Arm/Group Description		Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Total of all reporting groups
Overall Number of Baseline Participants		461	454	915
Baseline Analysis Population Description		Analysis was performed on the intent-to-treat (ITT) population, which included all randomized participants whether or not the assigned study treatment was received.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	461 participants	454 participants	915 participants
		59.9 (9.9)	61.6 (10.4)	60.7 (10.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	461 participants	454 participants	915 participants
	Female	109 23.6%	137 30.2%	246 26.9%
	Male	352 76.4%	317 69.8%	669 73.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	461 participants	454 participants	915 participants
	Hispanic or Latino	32 6.9%	25 5.5%	57 6.2%
	Not Hispanic or Latino	386 83.7%	391 86.1%	777 84.9%
	Unknown or Not Reported	43 9.3%	38 8.4%	81 8.9%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	461 participants	454 participants	915 participants
	American Indian or Alaska Native	1 0.2%	2 0.4%	3 0.3%
	Asian	77 16.7%	94 20.7%	171 18.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	1 0.2%	1 0.1%
	Black or African American	4 0.9%	1 0.2%	5 0.5%
	White	334 72.5%	326 71.8%	660 72.1%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	45 9.8%	30 6.6%	75 8.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population
Description	Tumor response was assessed by the investigator according to RECIST v1.1. Disease Progression (PD) was defined as greater than or equal to (>/=) 20 percent (%) relative increase in the sum of diameters (SoD) of all target lesions (TLs), taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 millimeters (mm); >/=1 new lesion(s); and/or unequivocal progression of existing non-TLs.
Time Frame	Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the PD-L1-Selected Population, which included all participants in the ITT population whose PD-L1 status was immune cell (IC)1/2/3 at the time of randomization.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	184	178
Measure Type: Number; Unit of Measure: percentage of participants
	69.6	58.4

2. Primary Outcome

Title	Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population
Description	PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed >/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% confidence interval (CI) was assessed using the method of Brookmeyer and Crowley.
Time Frame	Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the PD-L1-Selected Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	184	178
Median (95% Confidence Interval); Unit of Measure: months
	7.5; (6.8 to 9.7)	11.2; (8.6 to 14.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0205
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.57 to 0.95
	Estimation Comments	Hazard ratio was estimated by Cox regression.

3. Primary Outcome

Title	Percentage of Participants Who Died of Any Cause in ITT Population
Description	Percentage of participants who died of any cause was reported.
Time Frame	Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ITT Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	461	454
Measure Type: Number; Unit of Measure: percentage of participants
	55.3	54.8

4. Primary Outcome

Title	Overall Survival (OS) in ITT Population
Description	OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Time Frame	Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ITT Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	461	454
Median (95% Confidence Interval); Unit of Measure: months
	35.3; (28.6 to 42.1)	36.1; (31.5 to 42.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2675
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.08
	Estimation Comments	Hazard ratio was estimated by Cox regression.

5. Secondary Outcome

Title	Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population
Description	Percentage of participants who died of any cause was reported.
Time Frame	Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the PD-L1-Selected Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	184	178
Measure Type: Number; Unit of Measure: percentage of participants
	56.5	53.9

6. Secondary Outcome

Title	OS in PD-L1-Selected Population
Description	OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Time Frame	Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the PD-L1-Selected Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	184	178
Median (95% Confidence Interval); Unit of Measure: months
	31.6; (23.3 to 42.1)	38.7; (29.0 to 49.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.263
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.64 to 1.13
	Estimation Comments	Hazard ratio was estimated by Cox regression.

7. Secondary Outcome

Title	Percentage of Participants With PD as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 or Death From Any Cause in ITT Population
Description	Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs.
Time Frame	Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ITT Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	461	454
Measure Type: Number; Unit of Measure: percentage of participants
	63.6	60.4

8. Secondary Outcome

Title	PFS as Determined by an IRC According to RECIST v1.1 in ITT Population
Description	PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Time Frame	Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ITT Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	461	454
Median (95% Confidence Interval); Unit of Measure: months
	8.3; (7.0 to 9.7)	9.6; (8.3 to 11.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1218
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.04
	Estimation Comments	Hazard ratio was estimated by Cox regression.

9. Secondary Outcome

Title	Percentage of Participants With PD as Determined by an IRC According to RECIST v1.1 or Death From Any Cause in PD-L1-Selected Population
Description	Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs.
Time Frame	Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the PD-L1-Selected Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	184	178
Measure Type: Number; Unit of Measure: percentage of participants
	64.7	62.9

10. Secondary Outcome

Title	PFS as Determined by an IRC According to RECIST v1.1 in PD-L1-Selected Population
Description	PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Time Frame	Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the PD-L1-Selected Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	184	178
Median (95% Confidence Interval); Unit of Measure: months
	7.2; (6.1 to 11.1)	8.9; (6.9 to 12.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6138
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.21
	Estimation Comments	Hazard ratio was estimated by Cox regression.

11. Secondary Outcome

Title	Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator According to RECIST v1.1 in Objective Response Rate (ORR)-Evaluable Population
Description	Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to less than (<) 10 mm. PR was defined as >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.
Time Frame	Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ORR-Evaluable Population, which included all participants in the ITT population with measurable disease at baseline, as determined by the investigator.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	460	454
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	33.3; (28.97 to 37.77)	36.6; (32.12 to 41.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2733
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	3.30
	Confidence Interval	(2-Sided) 95%; -3.09 to 9.70
	Estimation Comments	95% CI for difference in response rates was constructed using Wald method.

12. Secondary Outcome

Title	Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 in DOR-Evaluable Population
Description	DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.
Time Frame	Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on DOR-Evaluable Population, which included all participants with a CR/PR in the ORR-Evaluable Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	153	166
Median (95% Confidence Interval); Unit of Measure: months
	14.2 [1]; (11.3 to NA)	16.6 [1]; (15.4 to NA)

[1]

Upper limit of 95% CI could not be estimated due to high number of censored participants.

13. Secondary Outcome

Title	Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1 in ORR-Evaluable Population
Description	Tumor response was assessed by an IRC according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR was defined as >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.
Time Frame	Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ORR-Evaluable Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	460	454
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	31.3; (27.09 to 35.76)	33.3; (28.94 to 37.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5121
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	1.96
	Confidence Interval	(2-Sided) 95%; -4.32 to 8.24
	Estimation Comments	95% CI for difference in response rates was constructed using Wald method.

14. Secondary Outcome

Title	DOR as Determined by an IRC According to RECIST v1.1 in DOR-Evaluable Population
Description	DOR was defined as the time from the first occurrence of CR/PR to PD as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.
Time Frame	Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the DOR-Evaluable Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	144	151
Median (95% Confidence Interval); Unit of Measure: months
	18.6 [1]; (13.8 to NA)	NA [2]; (16.8 to NA)

[1]

Upper limit of 95% CI could not be estimated due to high number of censored participants.

[2]

Median and Upper limit of 95% CI could not be estimated due to high number of censored participants.

15. Secondary Outcome

Title	Percentage of Participants With PD as Determined by the Investigator According to Immune-Modified RECIST or Death From Any Cause in ITT Population
Description	Tumor response was assessed by the investigator according to immune-modified RECIST. PD was defined as >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm.
Time Frame	Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ITT Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	461	454
Measure Type: Number; Unit of Measure: percentage of participants
	58.1	55.1

16. Secondary Outcome

Title	PFS as Determined by the Investigator According to Immune-Modified RECIST in ITT Population
Description	PFS was defined as the time from randomization to PD, as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Time Frame	Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ITT Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	461	454
Median (95% Confidence Interval); Unit of Measure: months
	12.3; (9.8 to 13.7)	13.9; (12.5 to 15.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0606
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.01
	Estimation Comments	Hazard ratio was estimated by Cox regression.

17. Secondary Outcome

Title	Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Immune-Modified RECIST in ORR-Evaluable Population
Description	Tumor response was assessed by the investigator according to immune-modified RECIST. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs or reduction in short axis of any pathological lymph nodes to <10 mm. PR was defined as >/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.
Time Frame	Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ORR-Evaluable Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	460	454
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	35.0; (30.64 to 39.55)	40.1; (35.55 to 44.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1011
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	5.09
	Confidence Interval	(2-Sided) 95%; -1.40 to 11.58
	Estimation Comments	95% CI for difference in response rates was constructed using Wald method.

18. Secondary Outcome

Title	DOR as Determined by the Investigator According to Immune-Modified RECIST in DOR-Evaluable Population
Description	DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. PD: >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.
Time Frame	Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on DOR-Evaluable Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	161	182
Median (95% Confidence Interval); Unit of Measure: months
	19.4; (13.1 to 20.0)	19.4 [1]; (16.5 to NA)

[1]

Upper limit of 95% CI could not be estimated due to high number of censored participants.

19. Secondary Outcome

Title	Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in ITT Population
Description	Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs.
Time Frame	Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ITT Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	461	454
Measure Type: Number; Unit of Measure: percentage of participants
	63.8	60.1

20. Secondary Outcome

Title	PFS as Determined by the Investigator According to RECIST v1.1 in ITT Population
Description	PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed >/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Time Frame	Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ITT Population.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	461	454
Median (95% Confidence Interval); Unit of Measure: months
	8.4; (7.5 to 9.7)	11.2; (9.6 to 13.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0254
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; 0.70 to 0.98
	Estimation Comments	Hazard ratio was estimated by Cox regression.

21. Secondary Outcome

Title	Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in Participants With Sarcomatoid Histology
Description	Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs.
Time Frame	Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ITT Population participants with sarcomatoid histology (defined by investigator-assessed conventional histopathology).

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	74	68
Measure Type: Number; Unit of Measure: percentage of participants
	85.1	67.6

22. Secondary Outcome

Title	PFS as Determined by the Investigator According to RECIST v1.1 in Participants With Sarcomatoid Histology
Description	PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Time Frame	Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ITT Population participants with sarcomatoid histology.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	74	68
Median (95% Confidence Interval); Unit of Measure: months
	5.3; (3.3 to 6.7)	8.3; (5.4 to 12.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0020
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.52
	Confidence Interval	(2-Sided) 95%; 0.34 to 0.79
	Estimation Comments	Hazard ratio was estimated by Cox regression.

23. Secondary Outcome

Title	Percentage of Participants Who Died of Any Cause in Participants With Sarcomatoid Histology
Description	Percentage of participants with sarcomatoid histology who died of any cause was reported.
Time Frame	Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ITT Population participants with sarcomatoid histology.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	74	68
Measure Type: Number; Unit of Measure: percentage of participants
	77.0	64.7

24. Secondary Outcome

Title	OS in Participants With Sarcomatoid Histology
Description	OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Time Frame	Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ITT Population participants with sarcomatoid histology.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	74	68
Median (95% Confidence Interval); Unit of Measure: months
	15.4; (10.4 to 19.5)	21.7; (15.3 to 35.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0497
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 95%; 0.43 to 1.00
	Estimation Comments	Hazard ratio was estimated by Cox regression.

25. Secondary Outcome

Title	Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
Description	The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part II, participants were asked to rate how much the symptoms have interfered with 6 areas of function (general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely) and total Part II score was calculated as an average of 6-item scores. Repeated measures model-estimated least-squares (LS) mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement. Here, 'Number Analyzed' = number of participants evaluable at specified time point.
Time Frame	Baseline (Day 1 Cycle 1); Day 22 Cycle 1; Day 1 and 22 of every cycle from Cycle 2 up to Cycle 19; Cycle length = 42 days

Outcome Measure Data

Analysis Population Description

Analysis was performed on the patient-reported outcome (PRO)-Evaluable Population, which included all participants with a non-missing baseline PRO assessment and >/=1 post-baseline PRO assessment.

Arm/Group Title		Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:		Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed		359	373
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
Change at Cycle1 Day 22	Number Analyzed	260 participants	301 participants
		1.28 (0.13)	0.54 (0.13)
Change at Cycle 2 Day 1	Number Analyzed	276 participants	305 participants
		0.76 (0.13)	0.56 (0.13)
Change at Cycle 2 Day 22	Number Analyzed	248 participants	284 participants
		1.58 (0.13)	0.56 (0.13)
Change at Cycle 3 Day 1	Number Analyzed	253 participants	297 participants
		1.05 (0.13)	0.53 (0.13)
Change at Cycle 3 Day 22	Number Analyzed	226 participants	279 participants
		1.63 (0.14)	0.61 (0.13)
Change at Cycle 4 Day 1	Number Analyzed	230 participants	266 participants
		1.02 (0.14)	0.59 (0.13)
Change at Cycle 4 Day 22	Number Analyzed	217 participants	252 participants
		1.55 (0.14)	0.57 (0.14)
Change at Cycle 5 Day 1	Number Analyzed	211 participants	238 participants
		1.18 (0.15)	0.72 (0.14)
Change at Cycle 5 Day 22	Number Analyzed	196 participants	238 participants
		1.56 (0.15)	0.78 (0.14)
Change at Cycle 6 Day 1	Number Analyzed	198 participants	224 participants
		1.03 (0.15)	0.82 (0.14)
Change at Cycle 6 Day 22	Number Analyzed	183 participants	207 participants
		1.44 (0.15)	0.80 (0.15)
Change at Cycle 7 Day 1	Number Analyzed	173 participants	200 participants
		1.15 (0.16)	0.72 (0.15)
Change at Cycle 7 Day 22	Number Analyzed	163 participants	191 participants
		1.43 (0.16)	0.66 (0.15)
Change at Cycle 8 Day 1	Number Analyzed	161 participants	192 participants
		1.06 (0.16)	0.76 (0.15)
Change at Cycle 8 Day 22	Number Analyzed	150 participants	186 participants
		1.34 (0.17)	0.69 (0.15)
Change at Cycle 9 Day 1	Number Analyzed	146 participants	185 participants
		1.05 (0.17)	0.67 (0.16)
Change at Cycle 9 Day 22	Number Analyzed	135 participants	172 participants
		1.46 (0.18)	0.56 (0.16)
Change at Cycle 10 Day 1	Number Analyzed	131 participants	169 participants
		1.24 (0.18)	0.61 (0.16)
Change at Cycle 10 Day 22	Number Analyzed	78 participants	151 participants
		1.61 (0.20)	0.60 (0.17)
Change at Cycle 11 Day 1	Number Analyzed	100 participants	134 participants
		1.12 (0.19)	0.62 (0.17)
Change at Cycle 11 Day 22	Number Analyzed	59 participants	122 participants
		1.45 (0.21)	0.61 (0.18)
Change at Cycle 12 Day 1	Number Analyzed	73 participants	110 participants
		1.02 (0.21)	0.53 (0.18)
Change at Cycle 12 Day 22	Number Analyzed	47 participants	93 participants
		1.45 (0.24)	0.69 (0.20)
Change at Cycle 13 Day 1	Number Analyzed	52 participants	81 participants
		0.79 (0.24)	0.80 (0.21)
Change at Cycle 13 Day 22	Number Analyzed	36 participants	72 participants
		1.09 (0.27)	0.73 (0.22)
Change at Cycle 14 Day 1	Number Analyzed	39 participants	57 participants
		0.86 (0.27)	0.73 (0.24)
Change at Cycle 14 Day 22	Number Analyzed	27 participants	54 participants
		1.22 (0.31)	0.83 (0.25)
Change at Cycle 15 Day 1	Number Analyzed	31 participants	43 participants
		0.93 (0.31)	0.78 (0.27)
Change at Cycle 15 Day 22	Number Analyzed	17 participants	36 participants
		1.67 (0.37)	0.88 (0.29)
Change at Cycle 16 Day 1	Number Analyzed	20 participants	27 participants
		0.90 (0.38)	0.98 (0.32)
Change at Cycle 16 Day 22	Number Analyzed	13 participants	22 participants
		1.30 (0.43)	1.32 (0.36)
Change at Cycle 17 Day 1	Number Analyzed	13 participants	19 participants
		0.80 (0.46)	1.18 (0.40)
Change at Cycle 17 Day 22	Number Analyzed	9 participants	11 participants
		0.92 (0.53)	0.95 (0.47)
Change at Cycle 18 Day 1	Number Analyzed	6 participants	9 participants
		0.75 (0.64)	0.75 (0.53)
Change at Cycle 18 Day 22	Number Analyzed	3 participants	6 participants
		0.65 (0.86)	0.87 (0.63)
Change at Cycle 19 Day 1	Number Analyzed	1 participants	5 participants
		0.29 (1.58)	0.80 (0.73)
Change at Cycle 19 Day 22	Number Analyzed	0 participants	2 participants
			0.88 (1.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.74
	Confidence Interval	(2-Sided) 95%; -1.06 to -0.43
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2085
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95%; -0.51 to 0.11
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.02
	Confidence Interval	(2-Sided) 95%; -1.33 to -0.71
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0013
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95%; -0.82 to -0.20
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.02
	Confidence Interval	(2-Sided) 95%; -1.34 to -0.70
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0098
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95%; -0.76 to -0.10
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.98
	Confidence Interval	(2-Sided) 95%; -1.32 to -0.65
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0080
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.46
	Confidence Interval	(2-Sided) 95%; -0.80 to -0.12
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.78
	Confidence Interval	(2-Sided) 95%; -1.13 to -0.44
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2512
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 95%; -0.56 to 0.15
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0005
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95%; -1.01 to -0.28
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0247
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95%; -0.80 to -0.05
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.77
	Confidence Interval	(2-Sided) 95%; -1.15 to -0.39
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1411
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95%; -0.68 to 0.10
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0014
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95%; -1.05 to -0.25
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0728
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.37
	Confidence Interval	(2-Sided) 95%; -0.78 to 0.03
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.90
	Confidence Interval	(2-Sided) 95%; -1.32 to -0.49
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0041
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.62
	Confidence Interval	(2-Sided) 95%; -1.05 to -0.20
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.00
	Confidence Interval	(2-Sided) 95%; -1.46 to -0.55
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0353
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.50
	Confidence Interval	(2-Sided) 95%; -0.96 to -0.03
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0011
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.85
	Confidence Interval	(2-Sided) 95%; -1.35 to -0.34
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0582
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.50
	Confidence Interval	(2-Sided) 95%; -1.01 to 0.02
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0089
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.76
	Confidence Interval	(2-Sided) 95%; -1.32 to -0.19
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9575
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -0.57 to 0.61
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2745
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 95%; -1.01 to 0.29
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7088
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 95%; -0.81 to 0.55
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3077
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95%; -1.13 to 0.36
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7112
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95%; -0.93 to 0.63
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0837
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.79
	Confidence Interval	(2-Sided) 95%; -1.69 to 0.11
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8655
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 95%; -0.88 to 1.04
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9725
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -1.07 to 1.11
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5285
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.38
	Confidence Interval	(2-Sided) 95%; -0.80 to 1.55
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9663
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95%; -1.34 to 1.40
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9914
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 95%; -1.61 to 1.63
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8345
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95%; -1.85 to 2.30
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7725
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.50
	Confidence Interval	(2-Sided) 95%; -2.90 to 3.91
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

26. Secondary Outcome

Title	Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
Description	The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part I, participants were asked to rate how severe the symptoms (pain, fatigue, nausea, disturbed sleep, feeling of being distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, feeling sad, vomiting, numbness or tingling, rash/skin changes, headache, mouth/throat sores, and diarrhea) were when "at their worst" in the last 24 hours. Each item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Mixed-effects model-estimated LS mean score for change from baseline at the end-of treatment is reported for each item, where a negative value indicates improvement.
Time Frame	Baseline; End of Treatment (EoT) visit (up to approximately 27 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the PRO-Evaluable Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.

Arm/Group Title	Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	337	358
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
Pain: Change at EoT	1.41 (0.15)	0.92 (0.15)
Fatigue: Change at EoT	1.83 (0.15)	1.20 (0.15)
Nausea: Change at EoT	1.20 (0.11)	0.29 (0.11)
Disturbed sleep: Change at EoT	0.71 (0.14)	0.19 (0.14)
Feelings of being distressed: Change at EoT	0.82 (0.14)	0.25 (0.14)
Shortness of breath: Change at EoT	1.15 (0.13)	0.58 (0.13)
Remembering things: Change at EoT	0.93 (0.12)	0.60 (0.11)
Lack of appetite: Change at EoT	1.59 (0.14)	0.40 (0.14)
Drowsy: Change at EoT	1.32 (0.14)	0.79 (0.14)
Dry mouth: Change at EoT	1.67 (0.15)	0.67 (0.15)
Feeling sad: Change at EoT	0.88 (0.14)	0.28 (0.14)
Vomiting: Change at EoT	0.66 (0.09)	0.08 (0.09)
Numbness or tingling: Change at EoT	1.01 (0.12)	0.67 (0.12)
Rash/skin changes: Change at EoT	2.08 (0.13)	1.00 (0.13)
Headache: Change at EoT	0.70 (0.11)	0.66 (0.11)
Mouth/throat sores: Change at EoT	1.76 (0.13)	0.74 (0.13)
Diarrhea: Change at EoT	1.37 (0.10)	0.29 (0.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Pain: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0010
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95%; -0.77 to -0.20
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Fatigue: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.63
	Confidence Interval	(2-Sided) 95%; -0.91 to -0.34
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Nausea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.91
	Confidence Interval	(2-Sided) 95%; -1.13 to -0.69
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Disturbed sleep: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.52
	Confidence Interval	(2-Sided) 95%; -0.79 to -0.25
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Feelings of being distressed: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.56
	Confidence Interval	(2-Sided) 95%; -0.84 to -0.29
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Shortness of breath: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.56
	Confidence Interval	(2-Sided) 95%; -0.81 to -0.32
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Remembering things: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0036
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 95%; -0.56 to -0.11
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Lack of appetite: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.19
	Confidence Interval	(2-Sided) 95%; -1.46 to -0.91
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Drowsy: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.54
	Confidence Interval	(2-Sided) 95%; -0.81 to -0.27
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Dry mouth: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.00
	Confidence Interval	(2-Sided) 95%; -1.28 to -0.71
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Feeling sad: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.60
	Confidence Interval	(2-Sided) 95%; -0.87 to -0.33
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Vomiting: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.58
	Confidence Interval	(2-Sided) 95%; -0.75 to -0.41
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Numbness or tingling: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0051
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) 95%; -0.58 to -0.10
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Rash/Skin Changes: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.08
	Confidence Interval	(2-Sided) 95%; -1.33 to -0.83
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Headache: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6541
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 95%; -0.26 to 0.16
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Mouth/Throat Sores: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.02
	Confidence Interval	(2-Sided) 95%; -1.28 to -0.76
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Diarrhea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.07
	Confidence Interval	(2-Sided) 95%; -1.27 to -0.88
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

27. Secondary Outcome

Title	Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
Description	The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI interference subscale (6 items) assessed the impact of fatigue on global domains (general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely). Change from baseline in the mean score of all 6 items at each timepoint is reported, where a negative value indicates improvement.
Time Frame	Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days

Outcome Measure Data

Analysis Population Description

Analysis was performed on the PRO-Evaluable Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point.

Arm/Group Title		Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:		Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed		368	381
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	Number Analyzed	368 participants	381 participants
		2.11 (2.23)	2.08 (2.38)
Change at Cycle 1 Day 8	Number Analyzed	352 participants	356 participants
		0.30 (1.88)	0.37 (1.76)
Change at Cycle 1 Day 15	Number Analyzed	339 participants	352 participants
		1.26 (2.49)	1.06 (2.42)
Change at Cycle 1 Day 22	Number Analyzed	258 participants	298 participants
		1.34 (2.44)	0.57 (2.04)
Change at Cycle 1 Day 29	Number Analyzed	329 participants	348 participants
		1.48 (2.63)	0.66 (2.28)
Change at Cycle 1 Day 36	Number Analyzed	311 participants	344 participants
		0.95 (2.29)	0.74 (2.20)
Change at Cycle 2 Day 1	Number Analyzed	271 participants	293 participants
		0.38 (2.03)	0.43 (2.09)
Change at Cycle 2 Day 8	Number Analyzed	307 participants	336 participants
		0.63 (2.17)	0.68 (2.33)
Change at Cycle 2 Day 15	Number Analyzed	310 participants	319 participants
		1.10 (2.35)	0.55 (2.29)
Change at Cycle 2 Day 22	Number Analyzed	245 participants	277 participants
		1.24 (2.65)	0.26 (2.14)
Change at Cycle 2 Day 29	Number Analyzed	302 participants	303 participants
		1.45 (2.61)	0.51 (2.14)
Change at Cycle 2 Day 36	Number Analyzed	291 participants	311 participants
		1.11 (2.46)	0.43 (2.17)
Change at Cycle 3 Day 1	Number Analyzed	238 participants	278 participants
		0.76 (2.27)	0.21 (2.12)
Change at Cycle 3 Day 22	Number Analyzed	229 participants	279 participants
		1.43 (2.41)	0.36 (2.20)
Change at Cycle 4 Day 1	Number Analyzed	231 participants	266 participants
		0.76 (2.27)	0.38 (2.16)
Change at Cycle 4 Day 22	Number Analyzed	219 participants	252 participants
		1.47 (2.60)	0.44 (2.33)
Change at Cycle 5 Day 1	Number Analyzed	212 participants	239 participants
		1.01 (2.46)	0.52 (2.31)
Change at Cycle 5 Day 22	Number Analyzed	197 participants	238 participants
		1.38 (2.22)	0.61 (2.27)
Change at Cycle 6 Day 1	Number Analyzed	199 participants	224 participants
		0.88 (2.24)	0.59 (2.15)
Change at Cycle 6 Day 22	Number Analyzed	184 participants	207 participants
		1.25 (2.42)	0.52 (2.22)
Change at Cycle 7 Day 1	Number Analyzed	174 participants	200 participants
		0.82 (2.35)	0.61 (2.17)
Change at Cycle 7 Day 22	Number Analyzed	164 participants	191 participants
		1.05 (2.31)	0.47 (2.16)
Change at Cycle 8 Day 1	Number Analyzed	162 participants	192 participants
		0.87 (2.21)	0.63 (2.36)
Change at Cycle 8 Day 22	Number Analyzed	151 participants	186 participants
		1.22 (2.21)	0.52 (2.05)
Change at Cycle 9 Day 1	Number Analyzed	147 participants	185 participants
		0.93 (2.25)	0.57 (2.27)
Change at Cycle 9 Day 22	Number Analyzed	136 participants	172 participants
		1.35 (2.37)	0.37 (2.15)
Change at Cycle 10 Day 1	Number Analyzed	132 participants	169 participants
		1.09 (2.53)	0.56 (1.96)
Change at Cycle 10 Day 22	Number Analyzed	78 participants	151 participants
		1.62 (2.75)	0.52 (1.95)
Change at Cycle 11 Day 1	Number Analyzed	101 participants	134 participants
		0.95 (2.29)	0.60 (1.92)
Change at Cycle 11 Day 22	Number Analyzed	59 participants	122 participants
		0.88 (2.57)	0.57 (1.78)
Change at Cycle 12 Day 1	Number Analyzed	73 participants	111 participants
		0.89 (2.45)	0.35 (1.75)
Change at Cycle 12 Day 22	Number Analyzed	47 participants	93 participants
		0.97 (2.46)	0.58 (1.96)
Change at Cycle 13 Day 1	Number Analyzed	52 participants	81 participants
		0.84 (2.29)	0.36 (1.88)
Change at Cycle 13 Day 22	Number Analyzed	36 participants	72 participants
		0.76 (2.70)	0.56 (2.06)
Change at Cycle 14 Day 1	Number Analyzed	39 participants	57 participants
		0.80 (2.33)	0.73 (1.80)
Change at Cycle 14 Day 22	Number Analyzed	27 participants	54 participants
		0.69 (2.73)	0.94 (1.96)
Change at Cycle 15 Day 1	Number Analyzed	31 participants	43 participants
		0.95 (2.42)	0.61 (1.41)
Change at Cycle 15 Day 22	Number Analyzed	17 participants	36 participants
		1.05 (3.22)	0.91 (1.28)
Change at Cycle 16 Day 1	Number Analyzed	20 participants	27 participants
		0.13 (1.49)	1.02 (1.69)
Change at Cycle 16 Day 22	Number Analyzed	13 participants	22 participants
		1.05 (1.83)	1.55 (1.96)
Change at Cycle 17 Day 1	Number Analyzed	13 participants	19 participants
		0.53 (1.41)	1.25 (1.97)
Change at Cycle 17 Day 22	Number Analyzed	9 participants	11 participants
		1.43 (2.16)	0.41 (1.48)
Change at Cycle 18 Day 1	Number Analyzed	7 participants	9 participants
		0.79 (1.34)	0.35 (1.46)
Change at Cycle 18 Day 22	Number Analyzed	3 participants	6 participants
		1.28 (2.21)	0.17 (1.15)
Change at Cycle 19 Day 1	Number Analyzed	1 participants	5 participants
		0.00	-0.80 (0.84)
Change at Cycle 19 Day 22	Number Analyzed	0 participants	2 participants
			-0.25 (0.82)
Change at 6 weeks after EoT	Number Analyzed	70 participants	42 participants
		2.31 (2.52)	1.83 (2.52)
Change at 12 weeks after EoT	Number Analyzed	59 participants	36 participants
		1.71 (2.66)	1.97 (2.63)
Change at 24 weeks after EoT	Number Analyzed	31 participants	25 participants
		2.38 (3.11)	2.15 (3.30)
Change at 36 weeks after EoT	Number Analyzed	14 participants	18 participants
		2.40 (3.32)	1.15 (2.72)
Change at EoT	Number Analyzed	168 participants	127 participants
		1.57 (2.80)	1.62 (2.98)
Change Within 30 Days of PD	Number Analyzed	194 participants	184 participants
		1.74 (2.64)	0.74 (2.35)

28. Secondary Outcome

Title	Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
Description	The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI worst fatigue item assessed the severity of fatigue at its worst in the last 24 hours. The item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Change from baseline in the score at each time point is reported, where a negative value indicates improvement.
Time Frame	Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days

Outcome Measure Data

Analysis Population Description

Analysis was performed on the PRO-Evaluable Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point.

Arm/Group Title		Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:		Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed		368	381
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	Number Analyzed	368 participants	381 participants
		3.08 (2.66)	2.98 (2.69)
Change at Cycle 1 Day 8	Number Analyzed	352 participants	356 participants
		0.34 (2.35)	0.50 (2.29)
Change at Cycle 1 Day 15	Number Analyzed	339 participants	352 participants
		1.32 (2.82)	1.26 (2.92)
Change at Cycle 1 Day 22	Number Analyzed	258 participants	298 participants
		1.52 (2.86)	0.49 (2.30)
Change at Cycle 1 Day 29	Number Analyzed	329 participants	348 participants
		1.55 (2.99)	0.88 (2.62)
Change at Cycle 1 Day 36	Number Analyzed	311 participants	344 participants
		0.77 (2.82)	0.86 (2.50)
Change at Cycle 2 Day 1	Number Analyzed	271 participants	293 participants
		0.40 (2.50)	0.45 (2.52)
Change at Cycle 2 Day 8	Number Analyzed	307 participants	336 participants
		0.56 (2.68)	0.87 (2.82)
Change at Cycle 2 Day 15	Number Analyzed	310 participants	319 participants
		1.09 (2.82)	0.71 (2.78)
Change at Cycle 2 Day 22	Number Analyzed	245 participants	277 participants
		1.42 (3.01)	0.31 (2.53)
Change at Cycle 2 Day 29	Number Analyzed	302 participants	303 participants
		1.43 (3.08)	0.62 (2.66)
Change at Cycle 2 Day 36	Number Analyzed	291 participants	311 participants
		1.09 (3.01)	0.48 (2.76)
Change at Cycle 3 Day 1	Number Analyzed	238 participants	278 participants
		0.42 (2.68)	0.40 (2.57)
Change at Cycle 3 Day 22	Number Analyzed	229 participants	279 participants
		1.57 (2.98)	0.57 (2.64)
Change at Cycle 4 Day 1	Number Analyzed	231 participants	266 participants
		0.64 (2.76)	0.54 (2.49)
Change at Cycle 4 Day 22	Number Analyzed	219 participants	252 participants
		1.46 (3.14)	0.58 (2.74)
Change at Cycle 5 Day 1	Number Analyzed	212 participants	239 participants
		0.81 (2.75)	0.62 (2.79)
Change at Cycle 5 Day 22	Number Analyzed	197 participants	238 participants
		1.60 (2.87)	0.69 (2.83)
Change at Cycle 6 Day 1	Number Analyzed	199 participants	224 participants
		0.90 (2.78)	0.86 (2.73)
Change at Cycle 6 Day 22	Number Analyzed	184 participants	207 participants
		1.35 (2.79)	0.53 (2.66)
Change at Cycle 7 Day 1	Number Analyzed	174 participants	200 participants
		0.79 (2.78)	0.79 (2.70)
Change at Cycle 7 Day 22	Number Analyzed	164 participants	191 participants
		1.22 (2.85)	0.65 (2.56)
Change at Cycle 8 Day 1	Number Analyzed	162 participants	192 participants
		0.79 (2.69)	0.75 (2.84)
Change at Cycle 8 Day 22	Number Analyzed	151 participants	186 participants
		1.40 (2.64)	0.78 (2.67)
Change at Cycle 9 Day 1	Number Analyzed	147 participants	185 participants
		0.97 (2.54)	0.61 (2.62)
Change at Cycle 9 Day 22	Number Analyzed	136 participants	172 participants
		1.54 (2.92)	0.57 (2.55)
Change at Cycle 10 Day 1	Number Analyzed	132 participants	169 participants
		0.95 (2.73)	0.69 (2.46)
Change at Cycle 10 Day 22	Number Analyzed	78 participants	151 participants
		1.74 (3.09)	0.63 (2.48)
Change at Cycle 11 Day 1	Number Analyzed	101 participants	134 participants
		0.73 (2.80)	0.74 (2.69)
Change at Cycle 11 Day 22	Number Analyzed	59 participants	122 participants
		1.15 (3.18)	0.74 (2.52)
Change at Cycle 12 Day 1	Number Analyzed	73 participants	111 participants
		0.78 (2.79)	0.61 (2.29)
Change at Cycle 12 Day 22	Number Analyzed	47 participants	93 participants
		1.32 (2.89)	0.74 (2.69)
Change at Cycle 13 Day 1	Number Analyzed	52 participants	81 participants
		0.35 (2.54)	0.49 (2.46)
Change at Cycle 13 Day 22	Number Analyzed	36 participants	72 participants
		0.72 (3.48)	0.65 (2.70)
Change at Cycle 14 Day 1	Number Analyzed	39 participants	57 participants
		0.56 (2.84)	0.81 (2.60)
Change at Cycle 14 Day 22	Number Analyzed	27 participants	54 participants
		0.37 (3.01)	1.04 (2.40)
Change at Cycle 15 Day 1	Number Analyzed	31 participants	43 participants
		0.52 (3.15)	0.93 (2.25)
Change at Cycle 15 Day 22	Number Analyzed	17 participants	36 participants
		0.59 (4.08)	0.97 (1.84)
Change at Cycle 16 Day 1	Number Analyzed	20 participants	27 participants
		-0.05 (2.61)	1.33 (1.92)
Change at Cycle 16 Day 22	Number Analyzed	13 participants	22 participants
		0.77 (3.70)	1.68 (2.10)
Change at Cycle 17 Day 1	Number Analyzed	13 participants	19 participants
		-0.62 (3.75)	1.68 (1.97)
Change at Cycle 17 Day 22	Number Analyzed	9 participants	11 participants
		1.44 (3.91)	1.18 (1.99)
Change at Cycle 18 Day 1	Number Analyzed	7 participants	9 participants
		0.00 (2.00)	1.33 (1.58)
Change at Cycle 18 Day 22	Number Analyzed	3 participants	6 participants
		1.00 (1.73)	1.00 (2.10)
Change at Cycle 19 Day 1	Number Analyzed	1 participants	5 participants
		-4.00	0.60 (1.34)
Change at Cycle 19 Day 22	Number Analyzed	0 participants	2 participants
			0.00 (0.00)
Change at 6 weeks after EoT	Number Analyzed	70 participants	42 participants
		2.43 (3.25)	2.40 (2.89)
Change at 12 weeks after EoT	Number Analyzed	59 participants	36 participants
		1.56 (3.41)	2.06 (3.14)
Change at 24 weeks after EoT	Number Analyzed	31 participants	25 participants
		1.58 (3.82)	1.92 (3.46)
Change at 36 weeks after EoT	Number Analyzed	14 participants	18 participants
		1.86 (4.37)	0.78 (2.86)
Change at EoT	Number Analyzed	168 participants	127 participants
		1.40 (3.13)	1.72 (2.84)
Change Within 30 Days of PD	Number Analyzed	194 participants	184 participants
		1.81 (3.16)	0.89 (2.58)

29. Secondary Outcome

Title	Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
Description	The FKSI-19 is a 19-item tool designed to assess the most important symptoms and concerns related to treatment effectiveness in advanced kidney cancer. The FKSI-19 GP5 item (bothered by the side effect of treatment) assessed side effects burden in the past 7 days on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Repeated measures model-estimated LS mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement.
Time Frame	Day 1 and 22 of every cycle (Baseline = Day 1 Cycle 1) up to Cycle 19; Cycle length = 42 days

Outcome Measure Data

Analysis Population Description

Analysis was performed on the PRO-Evaluable Population. Here, 'Number Analyzed' = number of participants evaluable at specified time point.

Arm/Group Title		Sunitinib	Atezolizumab + Bevacizumab
Arm/Group Description:		Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed		359	373
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
Change at Cycle1 Day 22	Number Analyzed	260 participants	301 participants
		-1.08 (0.06)	-0.36 (0.06)
Change at Cycle 2 Day 1	Number Analyzed	276 participants	305 participants
		-0.87 (0.06)	-0.45 (0.06)
Change at Cycle 2 Day 22	Number Analyzed	248 participants	283 participants
		-1.13 (0.06)	-0.43 (0.06)
Change at Cycle 3 Day 1	Number Analyzed	253 participants	297 participants
		-1.07 (0.06)	-0.49 (0.06)
Change at Cycle 3 Day 22	Number Analyzed	226 participants	279 participants
		-1.22 (0.06)	-0.45 (0.06)
Change at Cycle 4 Day 1	Number Analyzed	230 participants	266 participants
		-1.07 (0.06)	-0.45 (0.06)
Change at Cycle 4 Day 22	Number Analyzed	215 participants	252 participants
		-1.31 (0.07)	-0.49 (0.06)
Change at Cycle 5 Day 1	Number Analyzed	210 participants	238 participants
		-1.17 (0.07)	-0.52 (0.06)
Change at Cycle 5 Day 22	Number Analyzed	196 participants	238 participants
		-1.38 (0.07)	-0.55 (0.06)
Change at Cycle 6 Day 1	Number Analyzed	198 participants	223 participants
		-1.14 (0.07)	-0.51 (0.06)
Change at Cycle 6 Day 22	Number Analyzed	183 participants	207 participants
		-1.27 (0.07)	-0.56 (0.07)
Change at Cycle 7 Day 1	Number Analyzed	173 participants	200 participants
		-1.09 (0.07)	-0.61 (0.07)
Change at Cycle 7 Day 22	Number Analyzed	163 participants	191 participants
		-1.25 (0.07)	-0.58 (0.07)
Change at Cycle 8 Day 1	Number Analyzed	161 participants	191 participants
		-1.08 (0.08)	-0.61 (0.07)
Change at Cycle 8 Day 22	Number Analyzed	150 participants	186 participants
		-1.22 (0.08)	-0.62 (0.07)
Change at Cycle 9 Day 1	Number Analyzed	146 participants	185 participants
		-1.08 (0.08)	-0.60 (0.07)
Change at Cycle 9 Day 22	Number Analyzed	135 participants	172 participants
		-1.23 (0.08)	-0.52 (0.07)
Change at Cycle 10 Day 1	Number Analyzed	131 participants	169 participants
		-1.06 (0.08)	-0.53 (0.07)
Change at Cycle 10 Day 22	Number Analyzed	77 participants	150 participants
		-1.30 (0.09)	-0.57 (0.08)
Change at Cycle 11 Day 1	Number Analyzed	100 participants	134 participants
		-1.16 (0.09)	-0.52 (0.08)
Change at Cycle 11 Day 22	Number Analyzed	59 participants	122 participants
		-1.28 (0.11)	-0.54 (0.08)
Change at Cycle 12 Day 1	Number Analyzed	73 participants	110 participants
		-1.05 (0.10)	-0.62 (0.09)
Change at Cycle 12 Day 22	Number Analyzed	47 participants	93 participants
		-1.17 (0.12)	-0.56 (0.09)
Change at Cycle 13 Day 1	Number Analyzed	52 participants	81 participants
		-1.15 (0.12)	-0.62 (0.10)
Change at Cycle 13 Day 22	Number Analyzed	36 participants	72 participants
		-1.20 (0.14)	-0.64 (0.11)
Change at Cycle 14 Day 1	Number Analyzed	39 participants	57 participants
		-0.94 (0.14)	-0.61 (0.12)
Change at Cycle 14 Day 22	Number Analyzed	27 participants	54 participants
		-1.32 (0.16)	-0.65 (0.12)
Change at Cycle 15 Day 1	Number Analyzed	31 participants	43 participants
		-0.91 (0.15)	-0.62 (0.13)
Change at Cycle 15 Day 22	Number Analyzed	17 participants	36 participants
		-1.16 (0.19)	-0.72 (0.14)
Change at Cycle 16 Day 1	Number Analyzed	20 participants	27 participants
		-1.06 (0.19)	-0.58 (0.16)
Change at Cycle 16 Day 22	Number Analyzed	13 participants	22 participants
		-1.34 (0.22)	-0.41 (0.18)
Change at Cycle 17 Day 1	Number Analyzed	13 participants	19 participants
		-1.10 (0.23)	-0.56 (0.20)
Change at Cycle 17 Day 22	Number Analyzed	9 participants	11 participants
		-1.02 (0.27)	-0.44 (0.24)
Change at Cycle 18 Day 1	Number Analyzed	6 participants	9 participants
		-1.01 (0.33)	-0.38 (0.27)
Change at Cycle 18 Day 22	Number Analyzed	3 participants	6 participants
		-0.81 (0.46)	-0.48 (0.33)
Change at Cycle 19 Day 1	Number Analyzed	1 participants	5 participants
		-1.27 (0.84)	-0.75 (0.38)
Change at Cycle 19 Day 22	Number Analyzed	0 participants	2 participants
			-0.93 (0.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.58 to 0.87
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.42
	Confidence Interval	(2-Sided) 95%; 0.28 to 0.57
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95%; 0.55 to 0.84
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 95%; 0.44 to 0.73
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.92
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 95%; 0.46 to 0.78
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.66 to 0.97
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.65
	Confidence Interval	(2-Sided) 95%; 0.49 to 0.81
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; 0.66 to 0.99
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95%; 0.46 to 0.80
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.54 to 0.89
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.47
	Confidence Interval	(2-Sided) 95%; 0.30 to 0.65
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95%; 0.49 to 0.86
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.47
	Confidence Interval	(2-Sided) 95%; 0.29 to 0.66
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95%; 0.41 to 0.79
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 95%; 0.29 to 0.68
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95%; 0.52 to 0.91
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 95%; 0.33 to 0.73
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95%; 0.51 to 0.96
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95%; 0.41 to 0.86
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95%; 0.49 to 0.99
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0010
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.42
	Confidence Interval	(2-Sided) 95%; 0.17 to 0.68
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95%; 0.32 to 0.89
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0005
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.52
	Confidence Interval	(2-Sided) 95%; 0.23 to 0.82
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0008
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 95%; 0.23 to 0.88
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0591
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.33
	Confidence Interval	(2-Sided) 95%; -0.01 to 0.67
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0005
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 95%; 0.29 to 1.05
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1378
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.30
	Confidence Interval	(2-Sided) 95%; -0.09 to 0.68
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0650
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.43
	Confidence Interval	(2-Sided) 95%; -0.03 to 0.89
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0531
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 95%; -0.01 to 0.96
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0011
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.37 to 1.49
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0708
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.55
	Confidence Interval	(2-Sided) 95%; -0.05 to 1.14
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1078
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 95%; -0.13 to 1.29
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1487
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 95%; -0.22 to 1.47
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5537
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.33
	Confidence Interval	(2-Sided) 95%; -0.77 to 1.43
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Atezolizumab + Bevacizumab
	Comments	Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5743
	Comments	[Not Specified]
	Method	Repeated measures model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.52
	Confidence Interval	(2-Sided) 95%; -1.29 to 2.33
	Estimation Comments	Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.

30. Secondary Outcome

Title	Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Description	The number of participants with "Treatment-induced ATAs" and "Treatment-enhanced ATA" against atezolizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result. Here, 'Overall Number of Participants Analyzed' = number of participants with a non-missing baseline ATA sample; 'Number Analyzed' = number of participants with a non-missing ATA sample at indicated timepoint.
Time Frame	Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycles 2, 4, and 8, and every eight cycles thereafter up to EoT [up to approximately 27 months] and 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ATA-Evaluable Population, which included all participants in the Atezolizumab + Bevacizumab arm with a non-missing baseline ATA sample and >/=1 post-baseline ATA sample.

Arm/Group Title		Atezolizumab + Bevacizumab
Arm/Group Description:		Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed		446
Measure Type: Number; Unit of Measure: participants
Baseline: ATA Positive Participants	Number Analyzed	446 participants
		16
Post-Baseline: Treatment-Induced ATA	Number Analyzed	433 participants
		95
Post-Baseline: Treatment-Enhanced ATA	Number Analyzed	433 participants
		1

31. Secondary Outcome

Title	Number of Participants With ATAs Against Bevacizumab
Description	The number of participants with "Treatment-induced ATAs" and "Treatment-enhanced ATA" against bevacizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.
Time Frame	Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycle 3, at EoT [up to approximately 27 months] and at 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ATA-Evaluable Population. Here, 'Overall Number of Participants Analyzed' = number of participants with a non-missing baseline ATA sample; 'Number Analyzed' = number of participants with a non-missing ATA sample at indicated timepoint.

Arm/Group Title		Atezolizumab + Bevacizumab
Arm/Group Description:		Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed		444
Measure Type: Number; Unit of Measure: participants
Baseline: ATA Positive Participants	Number Analyzed	444 participants
		24
Post-Baseline: Treatment-Induced ATA	Number Analyzed	433 participants
		4
Post-Baseline: Treatment-Enhanced ATA	Number Analyzed	433 participants
		0

32. Secondary Outcome

Title	Maximum Observed Serum Concentration (Cmax) for Atezolizumab
Description	Cmax for atezolizumab was estimated from plasma concentration versus time data.
Time Frame	30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Atezolizumab Pharmacokinetic (PK) Population, which included all participants who received atezolizumab treatment and had evaluable PK samples. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.

Arm/Group Title	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	435
Mean (Standard Deviation); Unit of Measure: micrograms per milliliter (mcg/mL)
	376 (90.2)

33. Secondary Outcome

Title	Minimum Observed Serum Concentration (Cmin) for Atezolizumab
Description	Cmin for atezolizumab was estimated from plasma concentration versus time data.
Time Frame	Predose (Hour 0) on Day 22 of Cycle 1; predose (Hour 0) on Day 1 of Cycles 2; Cycle length = 42 days

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Atezolizumab PK Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point.

Arm/Group Title		Atezolizumab + Bevacizumab
Arm/Group Description:		Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed		426
Mean (Standard Deviation); Unit of Measure: mcg/mL
Cycle 1 Day 22	Number Analyzed	426 participants
		85.6 (35.3)
Cycle 2 Day 1	Number Analyzed	407 participants
		127 (49.6)

34. Secondary Outcome

Title	Cmax for Bevacizumab
Description	Cmax for bevacizumab was estimated from plasma concentration versus time data.
Time Frame	30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Bevacizumab PK Population, which included all participants who received bevacizumab treatment and had evaluable PK samples. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.

Arm/Group Title	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	427
Mean (Standard Deviation); Unit of Measure: mcg/mL
	339 (104)

35. Secondary Outcome

Title	Cmin for Bevacizumab
Description	Cmin for bevacizumab was estimated from plasma concentration versus time data.
Time Frame	Pre-dose (Hour 0) on Day 1 of Cycle 3 (Cycle length = 42 days)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Bevacizumab PK Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure.

Arm/Group Title	Atezolizumab + Bevacizumab
Arm/Group Description:	Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
Overall Number of Participants Analyzed	363
Mean (Standard Deviation); Unit of Measure: mcg/mL
	135 (56.1)

Adverse Events

Time Frame	Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
Adverse Event Reporting Description	All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
Arm/Group Title	Sunitinib		Atezolizumab + Bevacizumab
Arm/Group Description	Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.		Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
All-Cause Mortality
	Sunitinib		Atezolizumab + Bevacizumab
	Affected / at Risk (%)		Affected / at Risk (%)
Total	270/461 (58.57%)		263/454 (57.93%)
Serious Adverse Events
	Sunitinib		Atezolizumab + Bevacizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	169/446 (37.89%)		191/451 (42.35%)
Blood and lymphatic system disorders
ANAEMIA † 1	4/446 (0.90%)	5	2/451 (0.44%)	3
FACTOR VIII INHIBITION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
FEBRILE NEUTROPENIA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
PANCYTOPENIA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
THROMBOCYTOPENIA † 1	4/446 (0.90%)	4	0/451 (0.00%)	0
Cardiac disorders
ACUTE CORONARY SYNDROME † 1	2/446 (0.45%)	2	3/451 (0.67%)	3
ACUTE MYOCARDIAL INFARCTION † 1	1/446 (0.22%)	1	3/451 (0.67%)	3
ANGINA PECTORIS † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
ATRIAL FIBRILLATION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
ATRIOVENTRICULAR BLOCK COMPLETE † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
BRADYCARDIA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
CARDIAC ARREST † 1	1/446 (0.22%)	1	2/451 (0.44%)	2
CARDIAC FAILURE † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
CORONARY ARTERY INSUFFICIENCY † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
MYOCARDIAL INFARCTION † 1	1/446 (0.22%)	1	9/451 (2.00%)	9
MYOCARDITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
SINUS BRADYCARDIA † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
Ear and labyrinth disorders
VERTIGO † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
Endocrine disorders
ADRENAL INSUFFICIENCY † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
GLUCOCORTICOID DEFICIENCY † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
HYPERTHYROIDISM † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
HYPOPHYSITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
HYPOTHYROIDISM † 1	5/446 (1.12%)	5	1/451 (0.22%)	1
Gastrointestinal disorders
ABDOMINAL PAIN † 1	3/446 (0.67%)	3	3/451 (0.67%)	3
ABDOMINAL PAIN UPPER † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
ANAL FISTULA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
ASCITES † 1	2/446 (0.45%)	2	0/451 (0.00%)	0
AUTOIMMUNE COLITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	2
COLITIS † 1	1/446 (0.22%)	1	4/451 (0.89%)	5
CONSTIPATION † 1	2/446 (0.45%)	2	2/451 (0.44%)	2
DIARRHOEA † 1	2/446 (0.45%)	2	7/451 (1.55%)	7
DUODENAL OBSTRUCTION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
DUODENAL ULCER † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
ENTERITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
ENTEROCOLITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
GASTRIC HAEMORRHAGE † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
GASTRIC PERFORATION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
GASTROINTESTINAL FISTULA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
GASTROINTESTINAL HAEMORRHAGE † 1	2/446 (0.45%)	2	2/451 (0.44%)	2
HAEMORRHOIDS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
ILEUS † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
IMMUNE-MEDIATED ENTEROCOLITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
INGUINAL HERNIA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
INTESTINAL OBSTRUCTION † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
INTESTINAL PERFORATION † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
LARGE INTESTINE PERFORATION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
LOWER GASTROINTESTINAL HAEMORRHAGE † 1	1/446 (0.22%)	1	2/451 (0.44%)	2
MECHANICAL ILEUS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
NAUSEA † 1	3/446 (0.67%)	3	2/451 (0.44%)	2
OESOPHAGEAL PERFORATION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
PANCREATITIS † 1	2/446 (0.45%)	3	1/451 (0.22%)	1
SMALL INTESTINAL HAEMORRHAGE † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
SMALL INTESTINAL PERFORATION † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
STOMATITIS † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
SUBILEUS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
UPPER GASTROINTESTINAL HAEMORRHAGE † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
VOMITING † 1	6/446 (1.35%)	6	3/451 (0.67%)	3
General disorders
ASTHENIA † 1	3/446 (0.67%)	4	4/451 (0.89%)	5
CHEST PAIN † 1	4/446 (0.90%)	4	3/451 (0.67%)	3
CHILLS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
DEATH † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
FATIGUE † 1	3/446 (0.67%)	3	1/451 (0.22%)	1
GAIT DISTURBANCE † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
INFLUENZA LIKE ILLNESS † 1	1/446 (0.22%)	1	3/451 (0.67%)	3
INFUSION SITE EXTRAVASATION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
MALAISE † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
MUCOSAL INFLAMMATION † 1	0/446 (0.00%)	0	1/451 (0.22%)	2
MULTIPLE ORGAN DYSFUNCTION SYNDROME † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
NON-CARDIAC CHEST PAIN † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
OEDEMA PERIPHERAL † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
PAIN † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
PERIPHERAL SWELLING † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
PYREXIA † 1	8/446 (1.79%)	9	13/451 (2.88%)	14
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME † 1	0/446 (0.00%)	0	3/451 (0.67%)	3
Hepatobiliary disorders
AUTOIMMUNE HEPATITIS † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
CHOLANGITIS ACUTE † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
CHOLECYSTITIS † 1	1/446 (0.22%)	1	3/451 (0.67%)	3
CHOLELITHIASIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
DRUG-INDUCED LIVER INJURY † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
HEPATIC FUNCTION ABNORMAL † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
HEPATIC STEATOSIS † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
HEPATITIS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
HEPATOTOXICITY † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
IMMUNE-MEDIATED HEPATITIS † 1	0/446 (0.00%)	0	3/451 (0.67%)	3
JAUNDICE † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
LIVER INJURY † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
Immune system disorders
CYTOKINE RELEASE SYNDROME † 1	0/446 (0.00%)	0	1/451 (0.22%)	2
DRUG HYPERSENSITIVITY † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
HYPERSENSITIVITY † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
SYSTEMIC IMMUNE ACTIVATION † 1	0/446 (0.00%)	0	3/451 (0.67%)	3
Infections and infestations
ABSCESS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
APPENDICITIS † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
APPENDICITIS PERFORATED † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
ATYPICAL PNEUMONIA † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
CAMPYLOBACTER INFECTION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
CELLULITIS † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
CLOSTRIDIUM DIFFICILE COLITIS † 1	1/446 (0.22%)	1	2/451 (0.44%)	2
CLOSTRIDIUM DIFFICILE INFECTION † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
COMPLICATED APPENDICITIS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
CYSTITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
DEVICE RELATED INFECTION † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
DIVERTICULITIS † 1	1/446 (0.22%)	1	3/451 (0.67%)	3
EAR INFECTION † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
EMPYEMA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
ENCEPHALITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
FEBRILE INFECTION † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
GASTROENTERITIS † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
HAEMATOMA INFECTION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
HERPES ZOSTER † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
INFECTION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
INFLUENZA † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
LOWER RESPIRATORY TRACT INFECTION † 1	1/446 (0.22%)	1	3/451 (0.67%)	3
LUNG ABSCESS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
MENINGITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
MENINGITIS ASEPTIC † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
ORCHITIS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
OSTEOMYELITIS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
PARONYCHIA † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
PERIRECTAL ABSCESS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
PERITONITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
PILONIDAL CYST † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
PNEUMONIA † 1	6/446 (1.35%)	6	10/451 (2.22%)	11
PNEUMONIA ASPIRATION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
PNEUMONIA MYCOPLASMAL † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
PNEUMONIA VIRAL † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
PYELONEPHRITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
PYELONEPHRITIS CHRONIC † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
RESPIRATORY TRACT INFECTION † 1	1/446 (0.22%)	1	2/451 (0.44%)	2
SCROTAL ABSCESS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
SEPSIS † 1	1/446 (0.22%)	1	2/451 (0.44%)	2
SEPTIC SHOCK † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
STAPHYLOCOCCAL BACTERAEMIA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
TUBERCULOSIS † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
UPPER RESPIRATORY TRACT INFECTION † 1	1/446 (0.22%)	1	2/451 (0.44%)	2
URINARY TRACT INFECTION † 1	2/446 (0.45%)	2	3/451 (0.67%)	3
UROSEPSIS † 1	1/446 (0.22%)	1	3/451 (0.67%)	3
WOUND INFECTION † 1	1/446 (0.22%)	1	2/451 (0.44%)	2
Injury, poisoning and procedural complications
ACCIDENT AT HOME † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
ANKLE FRACTURE † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
CONJUNCTIVAL LACERATION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
FALL † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
FEMORAL NECK FRACTURE † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
FEMUR FRACTURE † 1	2/446 (0.45%)	2	1/451 (0.22%)	1
GASTROINTESTINAL ANASTOMOTIC LEAK † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
HAND FRACTURE † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
HIP FRACTURE † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
INFUSION RELATED REACTION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
INJURY † 1	2/446 (0.45%)	2	1/451 (0.22%)	1
JOINT INJURY † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
NECK INJURY † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
POST PROCEDURAL HAEMORRHAGE † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
RIB FRACTURE † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
ROAD TRAFFIC ACCIDENT † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
SEROMA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
TENDON RUPTURE † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
TOOTH INJURY † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
TOXICITY TO VARIOUS AGENTS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
UPPER LIMB FRACTURE † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
VASCULAR PSEUDOANEURYSM † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
WOUND COMPLICATION † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
BLOOD CREATININE INCREASED † 1	1/446 (0.22%)	1	2/451 (0.44%)	2
BLOOD PHOSPHORUS DECREASED † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
BLOOD SODIUM DECREASED † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
HEPATIC ENZYME INCREASED † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
LIPASE INCREASED † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
LIVER FUNCTION TEST ABNORMAL † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
PLATELET COUNT DECREASED † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
TRANSAMINASES INCREASED † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
TROPONIN INCREASED † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
WEIGHT DECREASED † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
Metabolism and nutrition disorders
CACHEXIA † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
DECREASED APPETITE † 1	2/446 (0.45%)	2	1/451 (0.22%)	1
DEHYDRATION † 1	7/446 (1.57%)	7	4/451 (0.89%)	4
DIABETES MELLITUS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
DIABETES MELLITUS INADEQUATE CONTROL † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
HYPERCALCAEMIA † 1	4/446 (0.90%)	4	3/451 (0.67%)	3
HYPERGLYCAEMIA † 1	1/446 (0.22%)	1	2/451 (0.44%)	2
HYPERKALAEMIA † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
HYPOGLYCAEMIA † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
HYPONATRAEMIA † 1	3/446 (0.67%)	4	3/451 (0.67%)	3
HYPOPHOSPHATAEMIA † 1	1/446 (0.22%)	4	1/451 (0.22%)	1
METABOLIC ACIDOSIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
Musculoskeletal and connective tissue disorders
ARTHRALGIA † 1	1/446 (0.22%)	1	3/451 (0.67%)	4
BACK PAIN † 1	3/446 (0.67%)	3	3/451 (0.67%)	3
BONE PAIN † 1	1/446 (0.22%)	1	2/451 (0.44%)	2
BURSITIS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
FISTULA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
FLANK PAIN † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
GROIN PAIN † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
HAEMATOMA MUSCLE † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
INTERVERTEBRAL DISC PROTRUSION † 1	2/446 (0.45%)	2	0/451 (0.00%)	0
JOINT SWELLING † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
MOBILITY DECREASED † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
MUSCULAR WEAKNESS † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
MUSCULOSKELETAL CHEST PAIN † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
MYALGIA † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
MYOSITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
OSTEONECROSIS OF JAW † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
PAIN IN EXTREMITY † 1	1/446 (0.22%)	1	4/451 (0.89%)	4
PATHOLOGICAL FRACTURE † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
RHABDOMYOLYSIS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
SACRAL PAIN † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHOLANGIOCARCINOMA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
COLON NEOPLASM † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
GALLBLADDER CANCER † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
GASTRIC CANCER STAGE III † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
INTRACRANIAL TUMOUR HAEMORRHAGE † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
PROSTATE CANCER † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
TUMOUR HAEMORRHAGE † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
APHASIA † 1	0/446 (0.00%)	0	1/451 (0.22%)	2
CAROTID ARTERY STENOSIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
CEREBRAL INFARCTION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
CEREBRAL ISCHAEMIA † 1	2/446 (0.45%)	2	0/451 (0.00%)	0
CEREBROSPINAL FLUID LEAKAGE † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
CEREBROVASCULAR ACCIDENT † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
DEPRESSED LEVEL OF CONSCIOUSNESS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
DIZZINESS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
GENERALISED TONIC-CLONIC SEIZURE † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
GLIOSIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
HAEMORRHAGE INTRACRANIAL † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
HAEMORRHAGIC STROKE † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
HEADACHE † 1	2/446 (0.45%)	2	1/451 (0.22%)	1
INTRACRANIAL PRESSURE INCREASED † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
ISCHAEMIC STROKE † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
LACUNAR INFARCTION † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
LETHARGY † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
LUMBOSACRAL PLEXOPATHY † 1	0/446 (0.00%)	0	1/451 (0.22%)	2
NEUROPATHY PERIPHERAL † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
PARAPLEGIA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
PERIPHERAL SENSORY NEUROPATHY † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
SEIZURE † 1	1/446 (0.22%)	2	2/451 (0.44%)	2
SPINAL CORD COMPRESSION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
SYNCOPE † 1	2/446 (0.45%)	2	2/451 (0.44%)	2
THALAMUS HAEMORRHAGE † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
TRANSIENT ISCHAEMIC ATTACK † 1	2/446 (0.45%)	2	2/451 (0.44%)	2
Product Issues
DEVICE DISLOCATION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
Psychiatric disorders
MENTAL STATUS CHANGES † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
PSYCHOTIC DISORDER † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
Renal and urinary disorders
ACUTE KIDNEY INJURY † 1	11/446 (2.47%)	11	10/451 (2.22%)	10
CHRONIC KIDNEY DISEASE † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
HAEMATURIA † 1	4/446 (0.90%)	4	2/451 (0.44%)	2
NEPHRITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
NEPHROLITHIASIS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
NEPHROTIC SYNDROME † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
PROTEINURIA † 1	0/446 (0.00%)	0	3/451 (0.67%)	3
RENAL FAILURE † 1	1/446 (0.22%)	1	2/451 (0.44%)	2
RENAL IMPAIRMENT † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
TUBULOINTERSTITIAL NEPHRITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
URETERIC OBSTRUCTION † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
URINARY RETENTION † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
UROGENITAL HAEMORRHAGE † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
Reproductive system and breast disorders
PROSTATITIS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
ATELECTASIS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
CHRONIC OBSTRUCTIVE PULMONARY DISEASE † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
DYSPNOEA † 1	5/446 (1.12%)	6	4/451 (0.89%)	4
EPISTAXIS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
HYPOXIA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
INTERSTITIAL LUNG DISEASE † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
LARYNGEAL OEDEMA † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
PLEURAL EFFUSION † 1	1/446 (0.22%)	1	3/451 (0.67%)	3
PLEURISY † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
PNEUMONITIS † 1	0/446 (0.00%)	0	6/451 (1.33%)	8
PNEUMOTHORAX † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
PULMONARY EMBOLISM † 1	5/446 (1.12%)	5	5/451 (1.11%)	5
PULMONARY INFARCTION † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME † 1	0/446 (0.00%)	0	1/451 (0.22%)	2
RASH MACULAR † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
RASH MACULO-PAPULAR † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
TOXIC EPIDERMAL NECROLYSIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
Surgical and medical procedures
HERNIA REPAIR † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
Vascular disorders
ANEURYSM † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
AORTIC DISORDER † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
AORTIC DISSECTION † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
EMBOLISM † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
HAEMATOMA † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
HYPERTENSION † 1	1/446 (0.22%)	1	1/451 (0.22%)	1
HYPERTENSIVE CRISIS † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
HYPOTENSION † 1	1/446 (0.22%)	1	3/451 (0.67%)	3
PERIPHERAL ARTERY ANEURYSM † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
PERIPHERAL ISCHAEMIA † 1	0/446 (0.00%)	0	2/451 (0.44%)	2
SHOCK † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
SHOCK HAEMORRHAGIC † 1	1/446 (0.22%)	1	0/451 (0.00%)	0
VASCULITIS † 1	0/446 (0.00%)	0	1/451 (0.22%)	1
1 Term from vocabulary, MedDRA Version 24.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Sunitinib		Atezolizumab + Bevacizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	435/446 (97.53%)		437/451 (96.90%)
Blood and lymphatic system disorders
ANAEMIA † 1	104/446 (23.32%)	177	51/451 (11.31%)	81
LEUKOPENIA † 1	31/446 (6.95%)	65	5/451 (1.11%)	13
NEUTROPENIA † 1	62/446 (13.90%)	157	5/451 (1.11%)	7
THROMBOCYTOPENIA † 1	80/446 (17.94%)	172	15/451 (3.33%)	36
Endocrine disorders
HYPERTHYROIDISM † 1	14/446 (3.14%)	16	31/451 (6.87%)	32
HYPOTHYROIDISM † 1	130/446 (29.15%)	149	109/451 (24.17%)	123
Gastrointestinal disorders
ABDOMINAL PAIN † 1	42/446 (9.42%)	69	42/451 (9.31%)	51
ABDOMINAL PAIN UPPER † 1	40/446 (8.97%)	67	22/451 (4.88%)	24
CONSTIPATION † 1	68/446 (15.25%)	87	86/451 (19.07%)	106
DIARRHOEA † 1	239/446 (53.59%)	632	150/451 (33.26%)	273
DRY MOUTH † 1	25/446 (5.61%)	36	38/451 (8.43%)	52
DYSPEPSIA † 1	86/446 (19.28%)	110	34/451 (7.54%)	45
GASTROOESOPHAGEAL REFLUX DISEASE † 1	55/446 (12.33%)	65	15/451 (3.33%)	15
NAUSEA † 1	177/446 (39.69%)	320	100/451 (22.17%)	135
STOMATITIS † 1	103/446 (23.09%)	170	50/451 (11.09%)	67
TOOTHACHE † 1	18/446 (4.04%)	20	30/451 (6.65%)	38
VOMITING † 1	120/446 (26.91%)	210	59/451 (13.08%)	106
General disorders
ASTHENIA † 1	113/446 (25.34%)	201	83/451 (18.40%)	142
CHEST PAIN † 1	29/446 (6.50%)	30	23/451 (5.10%)	31
FATIGUE † 1	170/446 (38.12%)	302	162/451 (35.92%)	244
INFLUENZA LIKE ILLNESS † 1	20/446 (4.48%)	24	43/451 (9.53%)	73
MUCOSAL INFLAMMATION † 1	130/446 (29.15%)	233	45/451 (9.98%)	69
OEDEMA PERIPHERAL † 1	50/446 (11.21%)	69	65/451 (14.41%)	92
PAIN † 1	13/446 (2.91%)	15	25/451 (5.54%)	27
PYREXIA † 1	56/446 (12.56%)	68	78/451 (17.29%)	117
Infections and infestations
NASOPHARYNGITIS † 1	40/446 (8.97%)	52	47/451 (10.42%)	67
RHINITIS † 1	6/446 (1.35%)	6	25/451 (5.54%)	33
SINUSITIS † 1	11/446 (2.47%)	12	23/451 (5.10%)	34
UPPER RESPIRATORY TRACT INFECTION † 1	33/446 (7.40%)	38	52/451 (11.53%)	81
URINARY TRACT INFECTION † 1	24/446 (5.38%)	34	34/451 (7.54%)	56
Investigations
ALANINE AMINOTRANSFERASE INCREASED † 1	38/446 (8.52%)	56	31/451 (6.87%)	56
ASPARTATE AMINOTRANSFERASE INCREASED † 1	40/446 (8.97%)	58	28/451 (6.21%)	45
BLOOD CREATININE INCREASED † 1	40/446 (8.97%)	79	50/451 (11.09%)	87
NEUTROPHIL COUNT DECREASED † 1	28/446 (6.28%)	67	3/451 (0.67%)	3
PLATELET COUNT DECREASED † 1	47/446 (10.54%)	82	2/451 (0.44%)	2
WEIGHT DECREASED † 1	26/446 (5.83%)	36	48/451 (10.64%)	53
Metabolism and nutrition disorders
DECREASED APPETITE † 1	148/446 (33.18%)	213	94/451 (20.84%)	115
HYPERGLYCAEMIA † 1	17/446 (3.81%)	25	24/451 (5.32%)	35
HYPERKALAEMIA † 1	18/446 (4.04%)	26	35/451 (7.76%)	54
HYPONATRAEMIA † 1	19/446 (4.26%)	26	27/451 (5.99%)	39
Musculoskeletal and connective tissue disorders
ARTHRALGIA † 1	79/446 (17.71%)	95	135/451 (29.93%)	218
BACK PAIN † 1	57/446 (12.78%)	76	82/451 (18.18%)	95
MYALGIA † 1	25/446 (5.61%)	32	61/451 (13.53%)	75
NECK PAIN † 1	10/446 (2.24%)	11	24/451 (5.32%)	26
PAIN IN EXTREMITY † 1	38/446 (8.52%)	53	54/451 (11.97%)	88
Nervous system disorders
DIZZINESS † 1	28/446 (6.28%)	36	58/451 (12.86%)	73
DYSGEUSIA † 1	94/446 (21.08%)	129	27/451 (5.99%)	31
HEADACHE † 1	78/446 (17.49%)	104	111/451 (24.61%)	175
TASTE DISORDER † 1	37/446 (8.30%)	47	8/451 (1.77%)	8
Psychiatric disorders
ANXIETY † 1	15/446 (3.36%)	15	34/451 (7.54%)	36
INSOMNIA † 1	41/446 (9.19%)	44	45/451 (9.98%)	48
Renal and urinary disorders
HAEMATURIA † 1	26/446 (5.83%)	63	20/451 (4.43%)	33
PROTEINURIA † 1	37/446 (8.30%)	61	150/451 (33.26%)	311
Respiratory, thoracic and mediastinal disorders
COUGH † 1	98/446 (21.97%)	120	114/451 (25.28%)	159
DYSPHONIA † 1	18/446 (4.04%)	19	66/451 (14.63%)	75
DYSPNOEA † 1	44/446 (9.87%)	62	60/451 (13.30%)	79
EPISTAXIS † 1	70/446 (15.70%)	93	76/451 (16.85%)	98
OROPHARYNGEAL PAIN † 1	18/446 (4.04%)	23	43/451 (9.53%)	53
RHINORRHOEA † 1	8/446 (1.79%)	8	32/451 (7.10%)	43
Skin and subcutaneous tissue disorders
DRY SKIN † 1	42/446 (9.42%)	47	47/451 (10.42%)	58
HAIR COLOUR CHANGES † 1	34/446 (7.62%)	36	0/451 (0.00%)	0
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME † 1	200/446 (44.84%)	456	19/451 (4.21%)	21
PRURITUS † 1	35/446 (7.85%)	42	114/451 (25.28%)	170
RASH † 1	73/446 (16.37%)	99	100/451 (22.17%)	151
SKIN DISCOLOURATION † 1	28/446 (6.28%)	37	1/451 (0.22%)	1
YELLOW SKIN † 1	29/446 (6.50%)	42	1/451 (0.22%)	1
Vascular disorders
HYPERTENSION † 1	193/446 (43.27%)	349	183/451 (40.58%)	304
1 Term from vocabulary, MedDRA Version 24.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

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

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact

• Name/Title: Medical Communications
• Organization: Hoffmann-La Roche
• Phone: 800-821-8590
• EMail: genentech@druginfo.com

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

Motzer RJ, Powles T, Atkins MB, Escudier B, McDermott DF, Alekseev BY, Lee JL, Suarez C, Stroyakovskiy D, De Giorgi U, Donskov F, Mellado B, Banchereau R, Hamidi H, Khan O, Craine V, Huseni M, Flinn N, Dubey S, Rini BI. Final Overall Survival and Molecular Analysis in IMmotion151, a Phase 3 Trial Comparing Atezolizumab Plus Bevacizumab vs Sunitinib in Patients With Previously Untreated Metastatic Renal Cell Carcinoma. JAMA Oncol. 2022 Feb 1;8(2):275-280. doi: 10.1001/jamaoncol.2021.5981.

Atkins MB, Rini BI, Motzer RJ, Powles T, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Gurney H, Oudard S, Uemura M, Lam ET, Grullich C, Quach C, Carroll S, Ding B, Zhu QC, Piault-Louis E, Schiff C, Escudier B. Patient-Reported Outcomes from the Phase III Randomized IMmotion151 Trial: Atezolizumab + Bevacizumab versus Sunitinib in Treatment-Naive Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2020 Jun 1;26(11):2506-2514. doi: 10.1158/1078-0432.CCR-19-2838. Epub 2020 Mar 3.

Rini BI, Powles T, Atkins MB, Escudier B, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Lee JL, Hawkins R, Ravaud A, Alekseev B, Staehler M, Uemura M, De Giorgi U, Mellado B, Porta C, Melichar B, Gurney H, Bedke J, Choueiri TK, Parnis F, Khaznadar T, Thobhani A, Li S, Piault-Louis E, Frantz G, Huseni M, Schiff C, Green MC, Motzer RJ; IMmotion151 Study Group. Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial. Lancet. 2019 Jun 15;393(10189):2404-2415. doi: 10.1016/S0140-6736(19)30723-8. Epub 2019 May 9.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02420821
• Other Study ID Numbers: WO29637; 2014-004684-20 ( EudraCT Number )
• First Submitted: April 15, 2015
• First Posted: April 20, 2015
• Results First Submitted: August 21, 2018
• Results First Posted: October 3, 2018
• Last Update Posted: January 30, 2023