A Study of Atezolizumab in Combination With Cabozantinib... | NCT04338269

NCT04338269

Status Module

Name	Class
Exelixis	INDUSTRY
Chugai Pharmaceutical	INDUSTRY

Label	Type	Description	Intervention Names
Atezo+Cabo	Experimental	Participants will receive atezolizumab every 3 weeks on Day 1 of each 21-day cycle (1 cycle=21 days) plus oral tablets of cabozantinib every day.	Drug: Atezolizumab Drug: Cabozantinib
Cabozantinib	Active Comparator	Participants will receive cabozantinib every day.	Drug: Cabozantinib

Name	Type	Description	Arm Group Labels	Other Names
Atezolizumab	Drug	Atezolizumab 1200 mg will be administered at a fixed dose on Day 1 of each 21-day cycle by IV infusion every 3 weeks.	Atezo+Cabo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS) as Assessed by an Independent Review Facility (IRF) (IRF-PFS) According to RECIST v1.1	PFS was defined as the time from randomization to the first occurrence to PD, as determined by the IRF per RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm). Data for participants who did not experience PD or death was censored at the last tumor assessment date. Data for participants with no post-baseline tumor assessments was censored at the randomization date. PFS was estimated using Kaplan-Meier (KM) method.	From randomization to the first occurrence of PD according to RECIST v1.1, or death from any cause, whichever occurred first (up to 2 years 5 months)
Overall Survival (OS)	OS was defined as the time from randomization to death due to any cause. Data for 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 without post-baseline information were censored at the date of randomization. OS was estimated using KM method.	From randomization to death due to any cause (up to 2 years 5 months).

Secondary Outcomes

Measure	Description	Time Frame
PFS Assessed by the Investigators (INV-PFS), According to RECIST v1.1	PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Data for participants who did not experience PD or death was censored at the last tumor assessment date. Data for participants with no post-baseline tumor assessments were censored at the randomization date. PFS was estimated using KM method.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed locally advanced or metastatic clear cell or non-clear cell (papillary, chromophobe, and unclassified only) RCC. RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation.
Radiographic disease progression to prior ICI therapy for RCC. Patients who experienced radiographic tumor progression during or within 6 months after the last dose of adjuvant ICI are also eligible. ICI is defined by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, durvalumab, or nivolumab. Only patients for whom the immediate preceding line of therapy was an ICI are allowed.
Measurable disease per RECIST v1.1
Evaluable IMDC risk score
Archival tumor specimen, and pretreatment tumor tissue from fresh biopsy at screening, if clinically feasible. Both archival and fresh samples are preferred.
KPS score of >=70
Recovery to baseline or Grade </= 1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable in the opinion of the investigator. Grade 2 alopecia is allowed for study participation
Adequate hematologic and end-organ function
Negative HIV test at screening
Negative hepatitis B testing at screening
Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria:

Treatment with anti-cancer therapy within 14 days prior to initiation of study treatment
Patients received cabozantinib at any time prior to screening
Patients who received more than one ICI treatment in the locally advanced or metastatic setting
Patients who received more than two prior lines of therapy in the locally advanced or metastatic setting
Patients who have received a mammalian target of rapamycin (mTOR) inhibitor in any setting
Symptomatic, untreated, or actively progressing CNS metastases
History of leptomeningeal disease
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
History of malignancy other than renal carcinoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Radiotherapy for RCC within 14 days prior to Day 1 of Cycle 1
Active tuberculosis
Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after final dose of atezolizumab and 4 months after final dose of cabozantinib
Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety
Pharmacologically uncompensated, symptomatic hypothyroidism
Uncontrolled hypertension defined as sustained blood pressure >150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment (all countries except France); sustained BP > 140 mmHg systolic or > 90 mmHg diastolic despite optimal antihypertensive treatment (France only)
Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, unstable arrhythmia, or unstable angina) within 3 months prior to initiation of study treatment
Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1
History of congenital QT syndrome
History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g. clopidogrel)

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona		Tucson	Arizona	85724-5030	United States
City of Hope Comprehensive Cancer Center

PubMed Identifier	Type	Citation	Retractions
37290461	Derived	Pal SK, Albiges L, Tomczak P, Suarez C, Voss MH, de Velasco G, Chahoud J, Mochalova A, Procopio G, Mahammedi H, Zengerling F, Kim C, Osawa T, Angel M, Gupta S, Khan O, Bergthold G, Liu B, Kalaitzidou M, Huseni M, Scheffold C, Powles T, Choueiri TK. Atezolizumab plus cabozantinib versus cabozantinib monotherapy for patients with renal cell carcinoma after progression with previous immune checkpoint inhibitor treatment (CONTACT-03): a multicentre, randomised, open-label, phase 3 trial. Lancet. 2023 Jul 15;402(10397):185-195. doi: 10.1016/S0140-6736(23)00922-4. Epub 2023 Jun 5.
35304832

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cabozantinib (Control)	Participants received cabozantinib, 60 milligrams (mg), orally (PO), on Days 1-21 of each 21-day cycle until disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1), unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 22, 2023	Feb 27, 2026

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival (PFS) as Assessed by an Independent Review Facility (IRF) (IRF-PFS) According to RECIST v1.1

PFS was defined as the time from randomization to the first occurrence to PD, as determined by the IRF per RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm). Data for participants who did not experience PD or death was censored at the last tumor assessment date. Data for participants with no post-baseline tumor assessments was censored at the randomization date. PFS was estimated using Kaplan-Meier (KM) method.

ITT population included all randomized participants, whether or not the participant received the assigned treatment.

Posted

Median

95% Confidence Interval

months

From randomization to the first occurrence of PD according to RECIST v1.1, or death from any cause, whichever occurred first (up to 2 years 5 months)

ID	Title	Description
OG000	Cabozantinib (Control)	Participants received cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST V1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.
OG001	Atezolizumab + Cabozantinib	Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each 21-day cycle in combination with cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.

Units	Counts
Participants	OG000259 OG001263

Title

Denominators

Categories

Title	Measurements
	OG00010.81(9.95 to 12.45) OG00110.55(9.76 to 12.25)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Stratified	0.7844		Hazard Ratio (HR)	1.03			2-Sided	95	0.83	1.28			Hazard ratios were estimated by Cox regression. If at least one stratum had <10 events at the time of analysis, the stratification factor that contains the level with the smallest number of participants were removed from the stratified analysis.		Other	Stratified Cox Proportional Hazards Model

Primary

Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. Data for 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 without post-baseline information were censored at the date of randomization. OS was estimated using KM method.

ITT population included all randomized participants, whether or not the participant received the assigned treatment.

Posted

Median

95% Confidence Interval

months

From randomization to death due to any cause (up to 2 years 5 months).

ID	Title	Description
OG000	Cabozantinib (Control)	Participants received cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST V1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.
OG001	Atezolizumab + Cabozantinib	Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each 21-day cycle in combination with cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.

Units

Secondary

PFS Assessed by the Investigators (INV-PFS), According to RECIST v1.1

PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Data for participants who did not experience PD or death was censored at the last tumor assessment date. Data for participants with no post-baseline tumor assessments were censored at the randomization date. PFS was estimated using KM method.

ITT population included all randomized participants, whether or not the participant received the assigned treatment.

Posted

Median

95% Confidence Interval

months

From randomization to the first occurrence of PD according to RECIST v1.1, or death from any cause, whichever occurred first (up to 2 years 5 months)

ID	Title	Description
OG000	Cabozantinib (Control)	Participants received cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST V1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.
OG001	Atezolizumab + Cabozantinib	Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each 21-day cycle in combination with cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.

Secondary

Investigator-assessed Objective Response Rate (ORR) (INV-ORR), According to RECIST v1.1

ORR was defined as the percentage of participants with an objective response i.e. a complete response (CR) or partial response (PR) at two consecutive tumor assessments at least 28 days apart, as determined by the investigator per RECIST v1.1. CR was defined as the disappearance of all target lesions, and any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.

ORR-evaluable population included all randomized participants with measurable disease at baseline.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 2 years 5 months

ID	Title	Description
OG000	Cabozantinib (Control)	Participants received cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST V1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.
OG001	Atezolizumab + Cabozantinib	Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each 21-day cycle in combination with cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.

Secondary

IRF-assessed ORR (IRF-ORR) According to RECIST v1.1

ORR was defined as the percentage of participants with an objective response i.e. a CR or PR at two consecutive tumor assessments at least 28 days apart, as determined by the IRF per RECIST v1.1. CR was defined as the disappearance of all target lesions, and any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.

ORR-evaluable population included all randomized participants with measurable disease at baseline.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 2 years 5 months

ID	Title	Description
OG000	Cabozantinib (Control)	Participants received cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST V1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.
OG001	Atezolizumab + Cabozantinib	Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each 21-day cycle in combination with cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.

Secondary

Investigator-assessed Duration of Response (DOR) (INV-DOR), According to RECIST v1.1

DOR was defined as the time from the first occurrence of an objective response (CR or PR) to PD or death, whichever occurred first, as determined by the investigator per RECIST v1.1. CR was defined as the disappearance of all target lesions, and any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. DOR was estimated using KM method.

DOR-evaluable population included all randomized participants with measurable disease at baseline who experienced a confirmed objective response (CR or PR).

Posted

Median

95% Confidence Interval

months

From the date of first occurrence of a documented objective response to PD or death from any cause, whichever occurred first (up to 2 years 5 months)

ID	Title	Description
OG000	Cabozantinib (Control)	Participants received cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST V1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.
OG001	Atezolizumab + Cabozantinib

Secondary

IRF-assessed DOR (IRF-DOR) According to RECIST v1.1

DOR was defined as the time from the first occurrence of an objective response (CR or PR) to PD or death, whichever occurred first, as determined by IRF per RECIST v1.1. CR was defined as the disappearance of all target lesions, and any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. DOR was estimated using KM method.

DOR-evaluable population included all randomized participants with measurable disease at baseline who experienced a confirmed objective response (CR or PR).

Posted

Median

95% Confidence Interval

months

From the date of first occurrence of a documented objective response to PD or death from any cause, whichever occurred first (up to 2 years 5 months)

ID	Title	Description
OG000	Cabozantinib (Control)	Participants received cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST V1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.
OG001	Atezolizumab + Cabozantinib	Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each 21-day cycle in combination with cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.

Secondary

Number of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

SE population included all randomized participants who received at least one dose of study treatment.

Posted

Count of Participants

Participants

Up to approximately 50 months

ID	Title	Description
OG000	Cabozantinib (Control)	Participants received cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST V1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.
OG001	Atezolizumab + Cabozantinib	Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each 21-day cycle in combination with cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.

Secondary

Serum Concentration of Atezolizumab

Pharmacokinetic (PK) evaluable population included all participants who received at least one dose of atezolizumab and who had at least one post-baseline PK sample available. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms per milliliter (μg/mL)

Predose on Day 1 of Cycles 1, 2, 3, 4, 8, 12 and 16; 30 minutes postdose on Cycle 1 Day 1 (1 cycle = 21 days); Treatment discontinuation visit (up to approximately 46 months)

ID	Title	Description
OG000	Atezolizumab + Cabozantinib	Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each 21-day cycle in combination with cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.

Units	Counts
Participants	OG000

Secondary

Plasma Concentration of Cabozantinib

PK evaluable population included all participants who received at least one dose of atezolizumab and who had at least one post-baseline PK sample available. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Predose on Day 1 of Cycles 2, 3, and 4 (1 cycle = 21 days); Treatment discontinuation visit (up to approximately 48 months)

ID	Title	Description
OG000	Cabozantinib (Control)	Participants received cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST V1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.
OG001	Atezolizumab + Cabozantinib	Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each 21-day cycle in combination with cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.

Units	Counts

Secondary

Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab

Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response).

Atezolizumab ADA evaluable population included all participants who received at least one dose of atezolizumab treatment and with an ADA assay result from at least one sample result. Overall number analyzed is the number of participants with data available for analysis.

Posted

Number

percentage of participants

Up to approximately 24 months

ID	Title	Description
OG000	Atezolizumab + Cabozantinib	Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each 21-day cycle in combination with cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0013 events3 affected262 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events1 affected262 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events2 affected262 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events2 affected262 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Atrial fibrillation	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Bradycardia	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Cardiac arrest	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Cardiac failure	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0010 events0 affected262 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Myocardial infarction	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events2 affected262 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Pericardial effusion	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Cataract	Eye disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0003 events3 affected256 at risk EG0010 events0 affected262 at risk
Anal fistula	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0010 events0 affected262 at risk
Ascites	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Colitis	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events2 affected262 at risk
Colonic fistula	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0016 events6 affected262 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Dysphagia	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events2 affected262 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Faecaloma	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0013 events3 affected262 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events2 affected262 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0012 events2 affected262 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0013 events3 affected262 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Asthenia	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0015 events4 affected262 at risk
Death	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0004 events4 affected256 at risk EG0013 events3 affected262 at risk
Fatigue	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events2 affected262 at risk
General physical health deterioration	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0012 events1 affected262 at risk
Generalised oedema	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Malaise	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Oedema peripheral	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Pain	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0004 events3 affected256 at risk EG0012 events2 affected262 at risk
Pyrexia	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0017 events7 affected262 at risk
Biliary colic	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Biliary obstruction	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Cholangitis	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0013 events3 affected262 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0012 events2 affected262 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Hepatitis	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Liver injury	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Anaphylactic reaction	Immune system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events1 affected262 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Abdominal abscess	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Abscess limb	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Anal abscess	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0003 events1 affected256 at risk EG0010 events0 affected262 at risk
Appendicitis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0003 events3 affected256 at risk EG0011 events1 affected262 at risk
Aspergilloma	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Bacteraemia	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0012 events2 affected262 at risk
COVID-19	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0005 events5 affected256 at risk EG0014 events4 affected262 at risk
Cellulitis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Chronic sinusitis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Coronavirus infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Device related infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Diverticulitis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Encephalitis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0002 events1 affected256 at risk EG0011 events1 affected262 at risk
Febrile infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0002 events1 affected256 at risk EG0010 events0 affected262 at risk
Fournier's gangrene	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Human herpesvirus 6 encephalitis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Infected skin ulcer	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Influenza	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Kidney infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Meningitis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Osteomyelitis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Otitis externa	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Pharyngitis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Pneumonia	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0005 events5 affected256 at risk EG0014 events4 affected262 at risk
Pneumonia aspiration	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Pneumonia bacterial	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Pneumonia fungal	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Sepsis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0016 events5 affected262 at risk
Soft tissue infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Spinal cord infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Suspected COVID-19	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Tuberculosis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0016 events6 affected262 at risk
Vascular device infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0003 events2 affected256 at risk EG0011 events1 affected262 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0010 events0 affected262 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Alanine aminotransferase increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Blood creatinine increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Blood pressure increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Fibrin D dimer increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Platelet count decreased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0012 events2 affected262 at risk
SARS-CoV-2 test positive	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
White blood cell count decreased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events2 affected262 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0011 events1 affected262 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0014 events4 affected262 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0015 events5 affected262 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0012 events2 affected262 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0012 events2 affected262 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Immune-mediated arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events2 affected262 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0004 events2 affected256 at risk EG0010 events0 affected262 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events2 affected262 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Enchondromatosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0014 events4 affected262 at risk
Cerebrovascular stenosis	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Immune-mediated encephalitis	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Loss of consciousness	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Neurotoxicity	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Polyneuropathy	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Presyncope	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Radicular pain	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Seizure	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Syncope	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events2 affected262 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0010 events0 affected262 at risk
Device malfunction	Product Issues	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Confusional state	Psychiatric disorders	MedDRA Version 27.1	Systematic Assessment	EG0003 events2 affected256 at risk EG0012 events2 affected262 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0018 events6 affected262 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Nephritis	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Proteinuria	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Renal failure	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Urinary retention	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0010 events0 affected262 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Prostatic obstruction	Reproductive system and breast disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0015 events5 affected262 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0010 events0 affected262 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0013 events1 affected262 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0006 events6 affected256 at risk EG00112 events12 affected262 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0013 events2 affected262 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Deep vein thrombosis	Vascular disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Embolism	Vascular disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected256 at risk EG0010 events0 affected262 at risk
Hypertension	Vascular disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0012 events2 affected262 at risk
Thrombosis	Vascular disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0011 events1 affected262 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0012 events2 affected262 at risk
Disease progression	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Hypersensitivity	Immune system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Abscess jaw	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Bronchitis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Herpes zoster	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Urosepsis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Vena cava injury	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Weight decreased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Bile duct adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Nervous system disorder	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Thrombotic cerebral infarction	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected256 at risk EG0010 events0 affected262 at risk
Obstructive sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk
Peripheral ischaemia	Vascular disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected256 at risk EG0011 events1 affected262 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG00074 events50 affected256 at risk EG00173 events59 affected262 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG00038 events19 affected256 at risk EG00131 events15 affected262 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG00035 events23 affected256 at risk EG00128 events21 affected262 at risk
Hypothyroidism	Endocrine disorders	MedDRA Version 27.1	Systematic Assessment	EG000116 events97 affected256 at risk EG001125 events100 affected262 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00042 events33 affected256 at risk EG00122 events17 affected262 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00020 events18 affected256 at risk EG00130 events27 affected262 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00049 events43 affected256 at risk EG00147 events39 affected262 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG000370 events180 affected256 at risk EG001344 events172 affected262 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00025 events21 affected256 at risk EG00133 events27 affected262 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG000141 events95 affected256 at risk EG001106 events81 affected262 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00049 events43 affected256 at risk EG00173 events53 affected262 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00082 events43 affected256 at risk EG00158 events38 affected262 at risk
Asthenia	General disorders	MedDRA Version 27.1	Systematic Assessment	EG00094 events77 affected256 at risk EG001119 events75 affected262 at risk
Fatigue	General disorders	MedDRA Version 27.1	Systematic Assessment	EG00084 events61 affected256 at risk EG001104 events75 affected262 at risk
Mucosal inflammation	General disorders	MedDRA Version 27.1	Systematic Assessment	EG00075 events52 affected256 at risk EG00158 events46 affected262 at risk
Oedema peripheral	General disorders	MedDRA Version 27.1	Systematic Assessment	EG00012 events12 affected256 at risk EG00117 events16 affected262 at risk
Pyrexia	General disorders	MedDRA Version 27.1	Systematic Assessment	EG00020 events15 affected256 at risk EG00141 events36 affected262 at risk
COVID-19	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG00035 events33 affected256 at risk EG00144 events37 affected262 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG00024 events17 affected256 at risk EG00152 events27 affected262 at risk
Alanine aminotransferase increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG00092 events59 affected256 at risk EG001106 events65 affected262 at risk
Aspartate aminotransferase increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG00097 events62 affected256 at risk EG00193 events64 affected262 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG00017 events15 affected256 at risk EG00120 events17 affected262 at risk
Blood bilirubin increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG00024 events13 affected256 at risk EG00115 events12 affected262 at risk
Blood creatinine increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG00028 events19 affected256 at risk EG00133 events26 affected262 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG00016 events14 affected256 at risk EG00119 events15 affected262 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG00014 events13 affected256 at risk EG00121 events21 affected262 at risk
Weight decreased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG00080 events64 affected256 at risk EG00154 events47 affected262 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG000123 events99 affected256 at risk EG001129 events101 affected262 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG00030 events18 affected256 at risk EG00114 events6 affected262 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG00023 events21 affected256 at risk EG00127 events21 affected262 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG00032 events19 affected256 at risk EG00130 events21 affected262 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG00042 events31 affected256 at risk EG00141 events27 affected262 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG00074 events46 affected256 at risk EG00166 events39 affected262 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG00039 events27 affected256 at risk EG00133 events24 affected262 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00037 events28 affected256 at risk EG00139 events32 affected262 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00021 events20 affected256 at risk EG00131 events29 affected262 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00010 events8 affected256 at risk EG00117 events15 affected262 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00015 events14 affected256 at risk EG00121 events20 affected262 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00027 events25 affected256 at risk EG00118 events17 affected262 at risk
Dizziness	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG00010 events9 affected256 at risk EG00129 events24 affected262 at risk
Dysgeusia	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG00043 events38 affected256 at risk EG00142 events39 affected262 at risk
Headache	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG00033 events28 affected256 at risk EG00139 events31 affected262 at risk
Insomnia	Psychiatric disorders	MedDRA Version 27.1	Systematic Assessment	EG00014 events14 affected256 at risk EG00122 events21 affected262 at risk
Proteinuria	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG00058 events44 affected256 at risk EG00172 events46 affected262 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00031 events26 affected256 at risk EG00139 events32 affected262 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00032 events31 affected256 at risk EG00144 events39 affected262 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00022 events21 affected256 at risk EG00127 events23 affected262 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00025 events18 affected256 at risk EG00116 events13 affected262 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00011 events11 affected256 at risk EG00122 events18 affected262 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00014 events14 affected256 at risk EG00110 events9 affected262 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00024 events21 affected256 at risk EG00114 events12 affected262 at risk
Hair colour changes	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00019 events19 affected256 at risk EG0019 events9 affected262 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG000137 events107 affected256 at risk EG001139 events102 affected262 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00021 events20 affected256 at risk EG00129 events24 affected262 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00032 events27 affected256 at risk EG00146 events35 affected262 at risk
Hypertension	Vascular disorders	MedDRA Version 27.1	Systematic Assessment	EG000104 events86 affected256 at risk EG00182 events74 affected262 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00012 events9 affected256 at risk EG00120 events14 affected262 at risk

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D007680	Kidney Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases

ID	Title	Description
BG000	Cabozantinib (Control)	Participants received cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST V1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.
BG001	Atezolizumab + Cabozantinib	Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each 21-day cycle in combination with cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cabozantinib (Control)	Participants received cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST V1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.	118	259	95	256	251	256
EG001	Atezolizumab + Cabozantinib	Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each 21-day cycle in combination with cabozantinib, 60 mg, PO, on Days 1-21 of each 21-day cycle until PD per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to PD as determined by the investigator.	129	263	141	262	255	262