A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alo... | NCT03470922

NCT03470922

ID	Type	Description	Link
2024-510913-13	Other Identifier	EU CT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Relatlimab + Nivolumab	Experimental	Combination	Biological: Relatlimab Biological: Nivolumab
Arm B: Nivolumab	Experimental	Monotherapy	Biological: Nivolumab

Name	Type	Description	Arm Group Labels	Other Names
Relatlimab	Biological	Specified dose on specified day	Arm A: Relatlimab + Nivolumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.	From randomization to date of first documented tumor progression or death (up to approximately 33 months)

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date").	From randomization to the date of death (up to approximately 3 years)

Other Outcomes

Measure	Description	Time Frame
The Number of Participants Experiencing Adverse Events (AEs)	The number of participants experiencing adverse events (AEs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.	From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0010		Tucson	Arizona	85724-5024	United States
Local Institution - 0020

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41811823	Derived	Bautista J, Echeverria CE, Maldonado-Noboa I, Adatty-Molina J, Suarez Urresta S, Coral-Riofrio EC, Araujo-Abad S, Kyriakidis NC, Lopez-Cortes A. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy. J Immunol Res. 2026;2026(1):e7864229. doi: 10.1155/jimr/7864229.
40940136	Derived

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A: Relatlimab + Nivolumab	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 23, 2020	Jan 25, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Arm A: Relatlimab + Nivolumab	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.
BG001	Arm B: Nivolumab	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00061.2± 14.1 BG00161.2± 14.0 BG00261.2± 14.0

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000145 BG001153 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00027 BG00120 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival (PFS)

Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to date of first documented tumor progression or death (up to approximately 33 months)

ID	Title	Description
OG000	Arm A: Relatlimab + Nivolumab	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.
OG001	Arm B: Nivolumab	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.

Units	Counts
Participants	OG000355 OG001359

Title

Denominators

Categories

Title	Measurements
	OG00010.12(6.37 to 15.74) OG0014.63(3.38 to 5.62)

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	Log-rank test stratified by LAG-3 (≥ 1% vs < 1%), BRAF (mutation positive vs mutation wild-type), AJCC M-stage (M0/M1any[0] vs M1any[1])	0.0055		Cox Proportional Hazard	0.75			2-Sided	95	0.62	0.92					Superiority

Secondary

Overall Survival (OS)

Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date").

Not Posted

Dec 2031

From randomization to the date of death (up to approximately 3 years)

Participants

Secondary

Overall Response Rate (ORR)

Objective response rate (ORR) is defined as the number of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) based on BICR assessments (using RECIST v1.1 criteria).

Not Posted

Dec 2031

From randomization up to approximately 3 years

Participants

Other Pre-specified

The Number of Participants Experiencing Adverse Events (AEs)

The number of participants experiencing adverse events (AEs).

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

All treated participants

Posted

Count of Participants

Participants

From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

ID	Title	Description
OG000	Arm A: Relatlimab + Nivolumab	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.
OG001	Arm B: Nivolumab	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.

Units	Counts

Other Pre-specified

The Number of Participants Experiencing Serious Adverse Events (SAEs)

The number of participants experiencing serious adverse events (SAEs).

A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.

All treated participants

Posted

Count of Participants

Participants

From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

ID	Title	Description
OG000	Arm A: Relatlimab + Nivolumab	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.
OG001	Arm B: Nivolumab	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.

Other Pre-specified

The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

The number of participants experiencing adverse events (AEs) leading to discontinuation.

All treated participants

Posted

Count of Participants

Participants

From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

ID	Title	Description
OG000	Arm A: Relatlimab + Nivolumab	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.
OG001	Arm B: Nivolumab	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.

Units

Other Pre-specified

The Number of Participant Deaths in the Study

The number of participant deaths in the study.

All treated participants

Posted

Count of Participants

Participants

From first dose up to approximately 33 months

ID	Title	Description
OG000	Arm A: Relatlimab + Nivolumab	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.
OG001	Arm B: Nivolumab	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.

Units	Counts
Participants	OG000

Other Pre-specified

The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests

The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units.

All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter

Posted

Count of Participants

Participants

From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

ID	Title	Description
OG000	Arm A: Relatlimab + Nivolumab	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.
OG001	Arm B: Nivolumab	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.

Units	Counts
Participants

Other Pre-specified

The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests

The number of participants with clinical laboratory test abnormalities in specific thyroid tests based on US conventional units.

All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter.

Posted

Count of Participants

Participants

From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

ID	Title	Description
OG000	Arm A: Relatlimab + Nivolumab	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.
OG001	Arm B: Nivolumab	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: Relatlimab + Nivolumab	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	108	355	155	355	314	355
EG001	Arm B: Nivolumab	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.	119	359	140	359	298	359

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acquired haemophilia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0005 affected355 at risk EG0014 affected359 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0004 affected355 at risk EG0012 affected359 at risk
Arrhythmia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Bradycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Cardiac disorder	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Cardiac failure	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Coronary artery disease	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Heart valve incompetence	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Immune-mediated myocarditis	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Myocardial infarction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0012 affected359 at risk
Myocarditis	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0004 affected355 at risk EG0011 affected359 at risk
Palpitations	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Right ventricular dysfunction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0010 affected359 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG0005 affected355 at risk EG0010 affected359 at risk
Adrenocortical insufficiency acute	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Adrenocorticotropic hormone deficiency	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Hypophysitis	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Lymphocytic hypophysitis	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Autoimmune uveitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Papilloedema	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Ulcerative keratitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Vision blurred	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Vogt-Koyanagi-Harada disease	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected355 at risk EG0010 affected359 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Ascites	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Autoimmune colitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Colitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0005 affected355 at risk EG0011 affected359 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected355 at risk EG0010 affected359 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0004 affected355 at risk EG0013 affected359 at risk
Gastric volvulus	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0011 affected359 at risk
Haemoperitoneum	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Melaena	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0010 affected359 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0013 affected359 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected355 at risk EG0011 affected359 at risk
Asthenia	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Death	General disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected355 at risk EG0011 affected359 at risk
Disease progression	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
General physical health deterioration	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0016 affected359 at risk
Inflammation	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Non-cardiac chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Oedema peripheral	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0012 affected359 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected355 at risk EG0015 affected359 at risk
Sudden death	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0012 affected359 at risk
Vascular stent stenosis	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0010 affected359 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Immune-mediated cholangitis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Infusion related hypersensitivity reaction	Immune system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Abscess soft tissue	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Arthritis infective	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Asymptomatic COVID-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Atypical pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Bacteraemia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Bronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
COVID-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 affected355 at risk EG0013 affected359 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Cellulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0012 affected359 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Device related infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Diverticulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0010 affected359 at risk
Encephalitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0011 affected359 at risk
Erysipelas	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0012 affected359 at risk
Febrile infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Infected seroma	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0011 affected359 at risk
Influenza	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Orchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0005 affected355 at risk EG0013 affected359 at risk
Postoperative wound infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Pyelonephritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Sepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 affected355 at risk EG0012 affected359 at risk
Septic shock	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0010 affected359 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Suspected COVID-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Tooth abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Tooth infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 affected355 at risk EG0016 affected359 at risk
Urosepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0012 affected359 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0012 affected359 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Post procedural discomfort	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Postoperative thrombosis	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Blood creatine phosphokinase MB increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Blood creatinine increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Lipase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Liver function test increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Respiratory syncytial virus test positive	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Transaminases increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Troponin T increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Troponin increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0003 affected355 at risk EG0012 affected359 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0011 affected359 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0010 affected359 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0011 affected359 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected355 at risk EG0013 affected359 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0012 affected359 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected355 at risk EG0010 affected359 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Autoimmune arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0004 affected355 at risk EG0012 affected359 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected355 at risk EG0010 affected359 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0012 affected359 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0010 affected359 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0014 affected359 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Clear cell sarcoma of soft tissue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG00039 affected355 at risk EG00147 affected359 at risk
Metastases to adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0004 affected355 at risk EG0013 affected359 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0013 affected359 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Tumour inflammation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Basilar artery thrombosis	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Brain oedema	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Dysdiadochokinesis	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Epilepsy	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Limbic encephalitis	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Optic neuritis	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Paraesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Paraplegia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Radiculopathy	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Seizure	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Spinal cord compression	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Syncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0012 affected359 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Confusional state	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Suicide attempt	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0013 affected359 at risk
Immune-mediated nephritis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Proteinuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Renal failure	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0010 affected359 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected355 at risk EG0012 affected359 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Immune-mediated pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Increased bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0012 affected359 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0004 affected355 at risk EG0011 affected359 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0010 affected359 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0013 affected359 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0011 affected359 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Tumour excision	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Aortic aneurysm	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Aortic thrombosis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Embolism	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0010 affected359 at risk
Hypertensive crisis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected355 at risk EG0011 affected359 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected355 at risk EG0010 affected359 at risk
Iliac artery stenosis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk
Shock	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected355 at risk EG0010 affected359 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG00050 affected355 at risk EG00137 affected359 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG00023 affected355 at risk EG00128 affected359 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG00058 affected355 at risk EG00147 affected359 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00031 affected355 at risk EG00131 affected359 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00039 affected355 at risk EG00125 affected359 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00082 affected355 at risk EG00162 affected359 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00028 affected355 at risk EG00118 affected359 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00063 affected355 at risk EG00159 affected359 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00033 affected355 at risk EG00120 affected359 at risk
Asthenia	General disorders	MedDRA 23.1	Systematic Assessment	EG00048 affected355 at risk EG00133 affected359 at risk
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG000104 affected355 at risk EG00174 affected359 at risk
Influenza like illness	General disorders	MedDRA 23.1	Systematic Assessment	EG00019 affected355 at risk EG00114 affected359 at risk
Oedema peripheral	General disorders	MedDRA 23.1	Systematic Assessment	EG00026 affected355 at risk EG00121 affected359 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG00044 affected355 at risk EG00133 affected359 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00038 affected355 at risk EG00129 affected359 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG00021 affected355 at risk EG00112 affected359 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG00036 affected355 at risk EG00121 affected359 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG00035 affected355 at risk EG00117 affected359 at risk
Blood creatinine increased	Investigations	MedDRA 23.1	Systematic Assessment	EG00021 affected355 at risk EG00112 affected359 at risk
Troponin increased	Investigations	MedDRA 23.1	Systematic Assessment	EG00027 affected355 at risk EG00118 affected359 at risk
Weight decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG00027 affected355 at risk EG00115 affected359 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00055 affected355 at risk EG00127 affected359 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00019 affected355 at risk EG00124 affected359 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00084 affected355 at risk EG00154 affected359 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00048 affected355 at risk EG00130 affected359 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00034 affected355 at risk EG00119 affected359 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00028 affected355 at risk EG00116 affected359 at risk
Dizziness	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG00021 affected355 at risk EG00124 affected359 at risk
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG00064 affected355 at risk EG00147 affected359 at risk
Paraesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG00018 affected355 at risk EG0015 affected359 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00050 affected355 at risk EG00138 affected359 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00033 affected355 at risk EG00122 affected359 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00088 affected355 at risk EG00162 affected359 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00062 affected355 at risk EG00149 affected359 at risk
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00039 affected355 at risk EG00137 affected359 at risk
Hypertension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG00021 affected355 at risk EG00114 affected359 at risk

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins