A Study of Atezolizumab Compared With Chemotherapy in Par... | NCT02302807

ID	Type	Description	Link
2014-003231-19	EudraCT Number

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Atezolizumab	Experimental	Atezolizumab will be administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants will receive atezolizumab as long as they continue to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.	Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Arm B: Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)	Active Comparator	Participants randomized to the chemotherapy arm will receive vinflunine, paclitaxel, or docetaxel per the investigator's choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.	Drug: Docetaxel Drug: Paclitaxel Drug: Vinflunine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody	Drug	Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.

Measure	Description	Time Frame
Overall Survival (OS)	OS was defined as time from randomization to death from any cause.	Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled

Measure	Description	Time Frame
Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1	PFS was defined as the time between the date of randomization and the date of first documented progression of disease (PD) or death, whichever occurred first. PD was determined on the basis of investigator assessment with use of RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters had to demonstrate an absolute increase of >/= 5 millimeters (mm).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra).
Representative tumor specimens as specified by the protocol
Disease progression during or following treatment with at least one platinum-containing regimen for inoperable, locally advanced or metastatic UBC or disease recurrence
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy greater than or equal to (>/=) 12 weeks
Measurable disease, as defined by RECIST v1.1
Adequate hematologic and end organ function
For women of childbearing potential, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel.
For men, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel, and agreement to refrain from donating sperm

Exclusion Criteria:

Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
Leptomeningeal disease
Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer
Pregnant and lactating women
Significant cardiovascular disease
Severe infections within 4 weeks prior to randomization
Major surgical procedure other than for diagnosis within 4 weeks prior to randomization
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
History of autoimmune disease
Prior allogeneic stem cell or solid organ transplant
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis
Administration of a live, attenuated vaccine within 4 weeks prior to randomization
Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1) or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Georgetown University Medical Center Lombardi Cancer Center		Washington D.C.	District of Columbia	20007	United States

PubMed Identifier	Type	Citation	Retractions
33902955	Derived	van der Heijden MS, Loriot Y, Duran I, Ravaud A, Retz M, Vogelzang NJ, Nelson B, Wang J, Shen X, Powles T. Atezolizumab Versus Chemotherapy in Patients with Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: A Long-term Overall Survival and Safety Update from the Phase 3 IMvigor211 Clinical Trial. Eur Urol. 2021 Jul;80(1):7-11. doi: 10.1016/j.eururo.2021.03.024. Epub 2021 Apr 23.
33241650

ID	Title	Description
FG000	Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)	Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 1, 2018

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

Overall Survival (OS)

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

Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.

Posted

Median

95% Confidence Interval

Months

Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled

ID	Title	Description
OG000	IC2/3 Chemotherapy	PD-L1 immunohistochemistry (IHC) score of IC2/3
OG001	IC2/3 Atezolizumab	PD-L1 immunohistochemistry (IHC) score of IC2/3
OG002	IC1/2/3 Chemotherapy	PD-L1 immunohistochemistry (IHC) score of IC1/2/3
OG003	IC1/2/3 Atezolizumab	PD-L1 immunohistochemistry (IHC) score of IC1/2/3
OG004	Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)	Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
OG005	Atezolizumab	Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

Units	Counts
Participants	OG000118 OG001116 OG002309 OG003

Title

Denominators

Categories

Title	Measurements
	OG00010.6(8.4 to 12.2) OG00111.1(8.6 to 15.5) OG0028.2(7.4 to 9.5) OG003

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		0.4134		Hazard Ratio (HR)	0.87			2-Sided	95	0.63	1.21					Superiority
OG002 OG003

Secondary

Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1

PFS was defined as the time between the date of randomization and the date of first documented progression of disease (PD) or death, whichever occurred first. PD was determined on the basis of investigator assessment with use of RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters had to demonstrate an absolute increase of >/= 5 millimeters (mm).

Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.

Posted

Median

95% Confidence Interval

months

Up to approximately 25 months after first participant enrolled

ID	Title	Description
OG000	Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)	Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
OG001	Atezolizumab	Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

Secondary

Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1

DOR was defined as the time from first occurrence of a CR or PR, whichever came first, to first documented PD or death, whichever occurred first. Disease progression was determined on the basis of investigator assessment with use of RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.

DOR analyses was performed on the subset of patients who achieved an objective response.

Posted

Median

95% Confidence Interval

months

Up to approximately 25 months after first participant enrolled

ID	Title	Description
OG000	Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)	Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
OG001	Atezolizumab

Secondary

Percentage of Participants With Adverse Events (AEs)

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), 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 adverse events.

Safety analyses was performed on all randomized patients who received any amount of study treatment, with patients grouped according to whether any amount of atezolizumab was received including the case when atezolizumab was received in error.

Posted

Number

percentage

Up to approximately 46 months after first participant enrolled

ID	Title	Description
OG000	Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)	Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
OG001	Atezolizumab	Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

Secondary

Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab

Participants were considered post-baseline ATA positive if they had post-baseline ATAs to Atezolizumab that were treatment-induced or treatment-enhanced. Participants had treatment-induced ATAs if they had a baseline-negative ATA result and developed ATAs at any time after initial drug administration. Participants had treatment-enhanced ATAs if they had a baseline-positive ATA result that showed an enhanced signal that was >/= 0.60 titer units at any time after initial drug initiation.

ATA evaluable population is defined as patients who received atezolizumab treatment and had at least one post-treatment ATA result.

Posted

Number

percentage of participants

Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)

ID	Title	Description
OG000	Atezolizumab	Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
OG001	IC1/2/3 Atezolizumab	PD-L1 immunohistochemistry (IHC) score of IC2/3

Secondary

Minimum Observed Serum Atezolizumab Concentration (Cmin)

Cmin was measured for all participants that received at least one dose of Atezolizumab.

The PK-evaluable population is defined as patients who received atezolizumab treatment and had at least one measureable PK concentration.

Posted

Geometric Mean

Standard Deviation

mcg/mL

ID	Title	Description
OG000	Atezolizumab	Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Unconfirmed Objective Response Rate (ORR) as Determined by the Investigator With Use of Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)

ORR was defined as the percentage of participants, who had an objective response. Objective response was defined as either a complete response (CR) or partial response (PR) as determined by the investigator with use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). Objective response in this study did not need to be a confirmed response. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. ORR=CR+PR

ORR analyses was performed on all randomized patients who had measureable disease at baseline

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 25 months after first participant enrolled

ID	Title	Description
OG000	Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)	Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
OG001	Atezolizumab	Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

Secondary

Maximum Observed Serum Atezolizumab Concentration (Cmax)

Cmax was measured for all participants that received at least one dose of Atezolizumab.

The PK-evaluable population is defined as patients who received atezolizumab treatment and had at least one measureable PK concentration.

Posted

Geometric Mean

Standard Deviation

mcg/mL

30 minutes post dose on Day 1 of Cycles 1

ID	Title	Description
OG000	Atezolizumab	Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Global Health Status Scale

The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.

All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment.

Posted

Mean

Standard Deviation

units of a scale

Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)

ID	Title	Description
OG000	Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)	Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
OG001	Atezolizumab

Secondary

Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Physical Functioning Scale

All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment.

Posted

Mean

Standard Deviation

units of a scale

Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)

ID	Title	Description
OG000	Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)	Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
OG001	Atezolizumab

Secondary

Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Fatigue Symptom Scale

All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment.

Posted

Mean

Standard Deviation

units of a scale

Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)

ID	Title	Description
OG000	Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)	Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
OG001	Atezolizumab

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0005 events5 affected443 at risk EG0019 events9 affected459 at risk
Bone Marrow Failure	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0010 events0 affected459 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG00025 events22 affected443 at risk EG0011 events1 affected459 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG00015 events14 affected443 at risk EG0010 events0 affected459 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0012 events2 affected459 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0010 events0 affected459 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Angina Pectoris	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Atrioventricular Block	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Cardiac Arrest	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Pericardial Effusion	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Hypothyroidism	Endocrine disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Cataract	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0012 events1 affected459 at risk
Macular Fibrosis	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Papilloedema	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Visual Impairment	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0009 events9 affected443 at risk EG0015 events5 affected459 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0013 events3 affected459 at risk
Anal Haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Ascites	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Autoimmune Colitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Colitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0013 events3 affected459 at risk
Colitis Ulcerative	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Constipation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG00023 events20 affected443 at risk EG0012 events2 affected459 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0003 events3 affected443 at risk EG0016 events6 affected459 at risk
Duodenal Obstruction	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Enteritis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Enterovesical Fistula	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Gastric Haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Ileal Perforation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Ileus	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0006 events6 affected443 at risk EG0012 events1 affected459 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0012 events2 affected459 at risk
Intestinal Perforation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Jejunal Perforation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Large Intestinal Obstruction	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0012 events2 affected459 at risk
Nausea	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0004 events4 affected443 at risk EG0010 events0 affected459 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0013 events3 affected459 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0004 events4 affected443 at risk EG0011 events1 affected459 at risk
Subileus	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0004 events4 affected443 at risk EG0013 events2 affected459 at risk
Vomiting	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0015 events4 affected459 at risk
Death	General disorders	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0013 events3 affected459 at risk
Fatigue	General disorders	MedDRA (21.1)	Systematic Assessment	EG0006 events5 affected443 at risk EG0014 events4 affected459 at risk
General Physical Health Deterioration	General disorders	MedDRA (21.1)	Systematic Assessment	EG0004 events4 affected443 at risk EG0012 events2 affected459 at risk
Influenza Like Illness	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Injection Site Reaction	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Malaise	General disorders	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0011 events1 affected459 at risk
Multiple Organ Dysfunction Syndrome	General disorders	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0010 events0 affected459 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Obstruction	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Oedema	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Oedema Peripheral	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Pain	General disorders	MedDRA (21.1)	Systematic Assessment	EG0004 events4 affected443 at risk EG0013 events3 affected459 at risk
Peripheral Swelling	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Pyrexia	General disorders	MedDRA (21.1)	Systematic Assessment	EG0005 events5 affected443 at risk EG00118 events17 affected459 at risk
Strangulated Hernia	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0011 events1 affected459 at risk
Autoimmune Hepatitis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0015 events4 affected459 at risk
Biliary Dilation	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Hepatocellular Injury	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Jaundice	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Portal Vein Thrombosis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Hypersensitivity	Immune system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Arthritis Infective	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Bacteraemia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Bacterial Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Bronchitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Cystitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Device Related Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Enterococcal Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 events1 affected443 at risk EG0010 events0 affected459 at risk
Enterococcal Sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Erysipelas	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0013 events1 affected459 at risk
Escherichia Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Escherichia Pyelonephritis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Escherichia Sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0011 events1 affected459 at risk
Gastroenteritis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0003 events3 affected443 at risk EG0011 events1 affected459 at risk
Kidney Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Klebsiella Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Lung Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Meningoencephalitis Viral	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Neutropenic Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Neutropenic Sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0010 events0 affected459 at risk
Ophthalmic Herpes Zoster	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Peritonitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Pneumonia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0007 events7 affected443 at risk EG0015 events4 affected459 at risk
Pyelonephritis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0013 events3 affected459 at risk
Sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG00016 events15 affected443 at risk EG0018 events8 affected459 at risk
Septic Shock	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0012 events2 affected459 at risk
Spinal Cord Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Staphylococcal Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Toxic Shock Syndrome	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG00017 events14 affected443 at risk EG00125 events21 affected459 at risk
Urinary Tract Infection Bacterial	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Urosepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG00012 events12 affected443 at risk EG0012 events2 affected459 at risk
Compression Fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Infusion Related Reaction	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Stoma Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Toxicity to Various Agents	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0011 events1 affected459 at risk
Urostomy Complication	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Blood Bilirubin Increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0012 events2 affected459 at risk
Blood Creatinine Increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0011 events1 affected459 at risk
Liver Function Test Abnormal	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Neutrophil Count Decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0004 events4 affected443 at risk EG0010 events0 affected459 at risk
Platelet Count Decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Transaminases Increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
White Blood Cell Count Decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0004 events3 affected443 at risk EG0012 events2 affected459 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Failure to Thrive	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0013 events3 affected459 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events1 affected459 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0011 events1 affected459 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0003 events3 affected443 at risk EG0014 events4 affected459 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0011 events1 affected459 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0004 events4 affected443 at risk EG0016 events6 affected459 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0003 events3 affected443 at risk EG0011 events1 affected459 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0011 events1 affected459 at risk
Pathological Fracture	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Mantle Cell Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Tumor Associated Fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Brain Oedema	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Dizziness	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Dyskinesia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Epilepsy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Headache	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Leukoencephalopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Radiculopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Sciatica	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Syncope	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Device Dislocation	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Device Occlusion	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0005 events3 affected443 at risk EG0012 events1 affected459 at risk
Completed Suicide	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Confusional State	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0006 events6 affected443 at risk EG00112 events11 affected459 at risk
Anuria	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Bladder Perforation	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Bladder Tamponade	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Haematuria	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0009 events7 affected443 at risk EG00119 events10 affected459 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0013 events3 affected459 at risk
Postrenal Failure	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Renal Failure	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0005 events5 affected443 at risk EG0014 events4 affected459 at risk
Renal Haematoma	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Urethral Haemorrhage	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Urinary Bladder Haemorrhage	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Urinary Retention	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0016 events6 affected459 at risk
Urinary Tract Obstruction	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Urinary Tract Pain	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Urinoma	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0017 events7 affected459 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0012 events2 affected459 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0011 events1 affected459 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0014 events4 affected459 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0014 events4 affected459 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Toxic Epidermal Necrolysis	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0014 events4 affected459 at risk
Embolism	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Hypertension	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0002 events2 affected443 at risk EG0010 events0 affected459 at risk
Thrombophlebitis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0003 events3 affected443 at risk EG0010 events0 affected459 at risk
Thrombosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Enterocolitis Haemorrhagic	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Gastrointestinal Disorder	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Asthenia	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0012 events2 affected459 at risk
Unevaluable Event	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Escherichia Bacteraemia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Influenza	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Pyonephrosis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Vascular Device Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0004 events4 affected443 at risk EG0010 events0 affected459 at risk
Skin Injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Gamma-Glutamyltransferase Increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Gouty Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Cancer Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Parkinson's Disease	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Genital Haemorrhage	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk
Internal Haemorrhage	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 events1 affected443 at risk EG0010 events0 affected459 at risk
Adrenal Insufficiency	Endocrine disorders	MedDRA (21.1)	Systematic Assessment	EG0000 events0 affected443 at risk EG0011 events1 affected459 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG000142 events124 affected443 at risk EG00194 events90 affected459 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG00075 events57 affected443 at risk EG0016 events5 affected459 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG00063 events58 affected443 at risk EG00160 events52 affected459 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG00032 events27 affected443 at risk EG00123 events23 affected459 at risk
Constipation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG000221 events163 affected443 at risk EG001147 events131 affected459 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG000115 events94 affected443 at risk EG001145 events97 affected459 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0008 events8 affected443 at risk EG00136 events30 affected459 at risk
Nausea	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG000171 events137 affected443 at risk EG001124 events106 affected459 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG00041 events35 affected443 at risk EG00116 events13 affected459 at risk
Vomiting	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG000108 events81 affected443 at risk EG00167 events55 affected459 at risk
Asthenia	General disorders	MedDRA (21.1)	Systematic Assessment	EG000144 events107 affected443 at risk EG001108 events92 affected459 at risk
Fatigue	General disorders	MedDRA (21.1)	Systematic Assessment	EG000162 events136 affected443 at risk EG001153 events129 affected459 at risk
Mucosal Inflammation	General disorders	MedDRA (21.1)	Systematic Assessment	EG00064 events47 affected443 at risk EG00130 events27 affected459 at risk
Oedema Peripheral	General disorders	MedDRA (21.1)	Systematic Assessment	EG00043 events36 affected443 at risk EG00159 events52 affected459 at risk
Pain	General disorders	MedDRA (21.1)	Systematic Assessment	EG00034 events31 affected443 at risk EG00124 events24 affected459 at risk
Pyrexia	General disorders	MedDRA (21.1)	Systematic Assessment	EG00076 events62 affected443 at risk EG001128 events93 affected459 at risk
Nasopharyngitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG00015 events11 affected443 at risk EG00143 events27 affected459 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG00076 events58 affected443 at risk EG001141 events84 affected459 at risk
Blood Creatinine Increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG00012 events11 affected443 at risk EG00138 events36 affected459 at risk
Neutrophil Count Decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG00049 events26 affected443 at risk EG0010 events0 affected459 at risk
Weight Decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG00046 events45 affected443 at risk EG00147 events47 affected459 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG000136 events113 affected443 at risk EG001147 events135 affected459 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG00026 events23 affected443 at risk EG00117 events16 affected459 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG00079 events60 affected443 at risk EG00166 events47 affected459 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG00053 events51 affected443 at risk EG00195 events80 affected459 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG00028 events24 affected443 at risk EG00127 events24 affected459 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG00068 events55 affected443 at risk EG00127 events25 affected459 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG00055 events48 affected443 at risk EG00146 events37 affected459 at risk
Dizziness	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG00032 events30 affected443 at risk EG00129 events29 affected459 at risk
Dysgeusia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG00027 events25 affected443 at risk EG00114 events12 affected459 at risk
Headache	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG00035 events26 affected443 at risk EG00144 events38 affected459 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG00067 events55 affected443 at risk EG0019 events8 affected459 at risk
Paraesthesia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG00032 events29 affected443 at risk EG00118 events18 affected459 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG00043 events41 affected443 at risk EG0017 events6 affected459 at risk
Anxiety	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG00024 events24 affected443 at risk EG00127 events27 affected459 at risk
Insomnia	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG00042 events42 affected443 at risk EG00148 events45 affected459 at risk
Haematuria	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG00032 events26 affected443 at risk EG00160 events45 affected459 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG00036 events30 affected443 at risk EG00169 events59 affected459 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG00050 events46 affected443 at risk EG00170 events62 affected459 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG000127 events125 affected443 at risk EG0011 events1 affected459 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG00027 events19 affected443 at risk EG00186 events64 affected459 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG00037 events28 affected443 at risk EG00172 events54 affected459 at risk
Hypertension	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG00022 events20 affected443 at risk EG00124 events23 affected459 at risk

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)	Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
BG001	Atezolizumab	Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression 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	Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)	Participants randomized to the chemotherapy arm will receive vinflunine, paclitaxel, or docetaxel per the investigator's choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.	393	443	189	443	417	443
EG001	Atezolizumab	Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.	379	459	192	459	413	459

ID	Term
C000594389	atezolizumab
D000077143	Docetaxel
D017239	Paclitaxel
C111217	vinflunine