A Study of Atezolizumab as Adjuvant Therapy in Participan... | NCT03024996

ID	Type	Description	Link
2016-001881-27	EudraCT Number

Label	Type	Description	Intervention Names
Atezolizumab	Experimental	Participants will receive atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).	Drug: Atezolizumab
Placebo	Placebo Comparator	Participants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Atezolizumab	Drug	Atezolizumab 1200 mg IV infusion q3w	Atezolizumab

Measure	Description	Time Frame
Investigator-assessed Disease-Free Survival (DFS)	Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS.	From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)

Measure	Description	Time Frame
Overall Survival (OS)	OS was defined as the time from randomization to death from any cause.	From baseline up to death due to any cause (up to approximately 64 months)
Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic- Scottsdale		Scottsdale	Arizona	85259	United States
City of Hope National Medical Center

PubMed Identifier	Type	Citation	Retractions
36099926	Derived	Pal SK, Uzzo R, Karam JA, Master VA, Donskov F, Suarez C, Albiges L, Rini B, Tomita Y, Kann AG, Procopio G, Massari F, Zibelman M, Antonyan I, Huseni M, Basu D, Ci B, Leung W, Khan O, Dubey S, Bex A. Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2022 Oct 1;400(10358):1103-1116. doi: 10.1016/S0140-6736(22)01658-0. Epub 2022 Sep 10.
33526329

ID	Title	Description
FG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
FG001	Placebo

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 12, 2021	Apr 18, 2023

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

Investigator-assessed Disease-Free Survival (DFS)

Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS.

The Intent-to-Treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Posted

Median

95% Confidence Interval

Months

From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
OG001	Placebo	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Units	Counts
Participants	OG000390 OG001388

Title

Denominators

Categories

Title	Measurements
	OG00057.2(44.6 to NA)NA = small number of events to calculate the upper CI limit OG00149.5(47.4 to NA)NA = small number of events to calculate the upper CI limit

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		0.4950		Hazard Ratio (HR)	0.93			2-Sided	95	0.75	1.15					Superiority

Secondary

Overall Survival (OS)

OS was defined as the time from randomization to death from any cause.

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Posted

Median

95% Confidence Interval

Months

From baseline up to death due to any cause (up to approximately 64 months)

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
OG001	Placebo	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Units	Counts
Participants	OG000

Secondary

Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3

Investigator assessed DFS for participants with PD-L1 expression of IC1/2/3 vs IC0, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. PD-L1 IC0 was defined as <1% and IC1/2/3 was defined as >=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC.

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Posted

Median

95% Confidence Interval

Months

From baseline until first occurrence of DFS event (up to approximately 64 months)

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
OG001	Placebo	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Secondary

Independent Review Facility (IRF)-Assessed DFS

IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first.

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Posted

Median

95% Confidence Interval

Months

From baseline until first documented recurrence event (up to approximately 64 months)

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
OG001	Placebo	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Units	Counts
Participants	OG000

Secondary

IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3

IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. PD-L1 IC0 was defined as <1% and IC1/2/3 was defined as >=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay.

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Posted

Median

95% Confidence Interval

Months

From baseline until first occurrence of DFS event (up to approximately 64 months)

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
OG001	Placebo	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Units	Counts
Participants

Secondary

IRF-assessed Event-free Survival (EFS)

IRF-assessed EFS was defined as the time from randomization to death from any cause, or the first documented recurrence in participants without baseline disease by IRF or the first documented disease progression in participants identified as having baseline disease by IRF, whichever occurred first. Disease progression was defined as either unequivocal progression of baseline disease or new unequivocal lesions.

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Posted

Median

95% Confidence Interval

Months

From baseline until first documented recurrence event (up to approximately 64 months)

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
OG001	Placebo	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Units	Counts
Participants

Secondary

Disease-Specific Survival

Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC).

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Posted

Median

95% Confidence Interval

Months

From baseline up to death due to RCC (up to approximately 64 months)

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
OG001	Placebo	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Units	Counts
Participants	OG000

Secondary

Distant Metastasis-Free Survival

Distant metastasis-free survival, defined as the time from randomization to death from any cause or the date of diagnosis of distant (i.e., non-locoregional) metastases assessed by the investigator, whichever occurred first.

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Posted

Median

95% Confidence Interval

Months

From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months)

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
OG001	Placebo	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Units	Counts
Participants

Secondary

Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3

IRF-assessed DFS was defined as the percentage of participants being alive and free of recurrence assessed by IRF at Year 1, 2, and 3 after randomization.

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Posted

Number

Percentage of Participants

Up to 3 years

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
OG001	Placebo	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3

Investigator-assessed DFS rate was defined as the percentage of participants being alive and free of recurrence assessed by investigator at Year 1, 2, and 3 after randomization.

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Posted

Number

Percentage of Participants

Up to 3 years

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
OG001	Placebo	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Adverse Events

An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.

The safety population included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.

Posted

Count of Participants

Participants

From baseline up to death due to any cause (up to approximately 71 months)

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
OG001	Placebo	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Units

Secondary

Maximum Serum Concentration (Cmax) of Atezolizumab

The pharmacokinetic (PK) population included all randomized participants who received any any dose of study treatment and who had at least one measurable post-baseline PK sample available.

Posted

Mean

Standard Deviation

Micrograms per milliliter (ug/mL)

Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Units	Counts
Participants	OG000

Secondary

Minimum Serum Concentration (Cmin) of Atezolizumab

The PK population included all randomized participants who received any any dose of study treatment and who had at least one measurable post-baseline PK sample available.

Posted

Mean

Standard Deviation

ug/mL

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab

The immunogenicity analysis population will consist of all participants with at least one ADA assessment for atezolizumab. The post-baseline ADA evaluable population included all participants who received at least one dose of atezolizumab and with at least one post-dose ADA assessment.

Posted

Count of Participants

Participants

Predose (hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)

ID	Title	Description
OG000	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected390 at risk EG0010 events0 affected383 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Angina pectoris	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected390 at risk EG0010 events0 affected383 at risk
Atrial flutter	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Myocardial infarction	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Myocarditis	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Tachycardia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0011 events1 affected383 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Basedow's disease	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Blindness unilateral	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Colitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0004 events3 affected390 at risk EG0010 events0 affected383 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected390 at risk EG0011 events1 affected383 at risk
Eosinophilic colitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0011 events1 affected383 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0012 events2 affected383 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected390 at risk EG0010 events0 affected383 at risk
Asthenia	General disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected390 at risk EG0010 events0 affected383 at risk
Death	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Influenza like illness	General disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected390 at risk EG0010 events0 affected383 at risk
Non-cardiac chest pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Polyp	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Pyrexia	General disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected390 at risk EG0010 events0 affected383 at risk
Ulcer	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0013 events3 affected383 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Hypersensitivity	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Immune-mediated adverse reaction	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Systemic immune activation	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Cellulitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0011 events1 affected383 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Diverticulitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Erysipelas	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Herpes ophthalmic	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Influenza	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Lower respiratory tract infection viral	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Mediastinitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Meningitis aseptic	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Pharyngeal abscess	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Pharyngitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected390 at risk EG0012 events2 affected383 at risk
Salpingitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0012 events2 affected383 at risk
Sinusitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Streptococcal infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected390 at risk EG0013 events3 affected383 at risk
Urosepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0011 events1 affected383 at risk
Alanine aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected390 at risk EG0012 events2 affected383 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Polymyositis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0011 events1 affected383 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Aphasia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Axonal neuropathy	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0012 events2 affected383 at risk
Dizziness	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Encephalopathy	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0012 events2 affected383 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Paraesthesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Presyncope	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0012 events2 affected383 at risk
Seizure	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Syncope	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected390 at risk EG0011 events1 affected383 at risk
Tremor	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Depression	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0013 events3 affected383 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected390 at risk EG0011 events1 affected383 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Dermatitis psoriasiform	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk
Hypertension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Hypotension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected390 at risk EG0011 events1 affected383 at risk
Vasculitis	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected390 at risk EG0010 events0 affected383 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG00029 events24 affected390 at risk EG00115 events14 affected383 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG00021 events20 affected390 at risk EG0014 events4 affected383 at risk
Hypothyroidism	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG00062 events56 affected390 at risk EG00113 events12 affected383 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00031 events26 affected390 at risk EG00124 events23 affected383 at risk
Constipation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00029 events26 affected390 at risk EG00128 events26 affected383 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG000128 events85 affected390 at risk EG001125 events79 affected383 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00029 events26 affected390 at risk EG0016 events6 affected383 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00064 events46 affected390 at risk EG00177 events54 affected383 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00019 events18 affected390 at risk EG00129 events28 affected383 at risk
Asthenia	General disorders	MedDRA 25.1	Systematic Assessment	EG00047 events36 affected390 at risk EG00128 events26 affected383 at risk
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment	EG000145 events110 affected390 at risk EG001124 events93 affected383 at risk
Influenza like illness	General disorders	MedDRA 25.1	Systematic Assessment	EG00039 events29 affected390 at risk EG00127 events18 affected383 at risk
Oedema peripheral	General disorders	MedDRA 25.1	Systematic Assessment	EG00026 events21 affected390 at risk EG00119 events17 affected383 at risk
Pyrexia	General disorders	MedDRA 25.1	Systematic Assessment	EG00044 events41 affected390 at risk EG00132 events16 affected383 at risk
Nasopharyngitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG00030 events23 affected390 at risk EG00132 events26 affected383 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG00039 events33 affected390 at risk EG00131 events27 affected383 at risk
Alanine aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG00029 events26 affected390 at risk EG00115 events12 affected383 at risk
Blood creatinine increased	Investigations	MedDRA 25.1	Systematic Assessment	EG00036 events29 affected390 at risk EG00139 events29 affected383 at risk
Weight increased	Investigations	MedDRA 25.1	Systematic Assessment	EG00013 events11 affected390 at risk EG00122 events21 affected383 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG00026 events21 affected390 at risk EG00116 events16 affected383 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG000101 events78 affected390 at risk EG00175 events57 affected383 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG00052 events43 affected390 at risk EG00155 events45 affected383 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG00040 events35 affected390 at risk EG00139 events25 affected383 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG00020 events18 affected390 at risk EG00124 events20 affected383 at risk
Dizziness	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG00030 events29 affected390 at risk EG00133 events29 affected383 at risk
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG00065 events51 affected390 at risk EG00172 events49 affected383 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG00063 events51 affected390 at risk EG00151 events48 affected383 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG00034 events26 affected390 at risk EG00118 events16 affected383 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG00094 events74 affected390 at risk EG00161 events48 affected383 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG00055 events46 affected390 at risk EG00124 events20 affected383 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG00033 events25 affected390 at risk EG00117 events14 affected383 at risk
Hypertension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG00020 events19 affected390 at risk EG00141 events36 affected383 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	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
BG001	Placebo	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
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	Atezolizumab	Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	57	390	69	390	329	390
EG001	Placebo	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	55	388	46	383	290	383