A Study of NKTR-214 Combined With Nivolumab vs Nivolumab... | NCT03635983

NCT03635983

ID	Type	Description	Link
2018-001423-40	EudraCT Number
17-214-08	Other Identifier	Nektar Therapeutics

Status Module

Name	Class
Nektar Therapeutics	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Combination	Experimental	NKTR-214 + Nivolumab	Biological: NKTR-214 Biological: Nivolumab
Monotherapy	Experimental	Nivolumab	Biological: Nivolumab

Name	Type	Description	Arm Group Labels	Other Names
NKTR-214	Biological	Specified dose on specified days	Combination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)	ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.	From date of randomization to disease progression (Up to 37 months)
Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)	PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per blinded independent central review (BICR), or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.	From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
Overall Survival (OS)	OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who do not have a date of death will be censored on the last date for which a participant was known to be alive.	From date of randomization to date of death (Up to 37 months)

Secondary Outcomes

Measure	Description	Time Frame
Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)	CBR, or equivalently the disease control rate (DCR) is defined as the percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by blinded independent central review (BICR) using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0187		Tucson	Arizona	85724	United States
Local Institution - 0014

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37651676	Derived	Diab A, Gogas H, Sandhu S, Long GV, Ascierto PA, Larkin J, Sznol M, Franke F, Ciuleanu TE, Pereira C, Munoz Couselo E, Bronzon Damian F, Schenker M, Perfetti A, Lebbe C, Quereux G, Meier F, Curti BD, Rojas C, Arriaga Y, Yang H, Zhou M, Ravimohan S, Statkevich P, Tagliaferri MA, Khushalani NI. Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results. J Clin Oncol. 2023 Oct 20;41(30):4756-4767. doi: 10.1200/JCO.23.00172. Epub 2023 Aug 31.
32723187

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
FG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 19, 2022

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
	BG00061.3± 13.2 BG00160.4± 13.5 BG00260.8± 13.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000162 BG001163 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00081 BG00173 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000379 BG001379 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

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)

ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

All randomized participants with at least 6 months of follow-up at the time point of the final ORR analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date.

Posted

Number

95% Confidence Interval

Percentage of participants

From date of randomization to disease progression (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units	Counts
Participants	OG000271 OG001272

Title

Denominators

Categories

Title	Measurements
	OG00027.7(22.4 to 33.4) OG00136.0(30.3 to 42.0)

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	Bempegaldesleukin+Nivolumab over Nivolumab	Stratified Cochran-Mantel-Haenszel	two-sided	0.0311		Estimate of Odds Ratio (OR)	0.66			2-Sided	95	0.45	0.96			Strata adjusted odds ratio (NKTR-214 + Nivolumab over Nivolumab) using Mantel-Haenszel method.		Superiority

Primary

Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)

PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per blinded independent central review (BICR), or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units	Counts
Participants	OG000

Primary

Overall Survival (OS)

OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who do not have a date of death will be censored on the last date for which a participant was known to be alive.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From date of randomization to date of death (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units	Counts
Participants	OG000

Secondary

Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)

CBR, or equivalently the disease control rate (DCR) is defined as the percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by blinded independent central review (BICR) using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.

Posted

Number

95% Confidence Interval

Percentage of participants

From date of randomization to disease progression (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units

Secondary

Duration of Response (DoR) Per Blinded Independent Central Review (BICR)

DOR is defined for participants who have a confirmed complete response (CR) or partial results (PR) as the date from first documented CR or PR using RECIST v 1.1 to the date of the documentation of disease progression per blinded independent central review (BICR) assessment or death due to any cause, whichever is earlier. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

All randomized participants with partial or complete response and at least 6 months of follow-up at the time point of the final objective response rate analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date.

Posted

Median

95% Confidence Interval

Months

From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units

Secondary

Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)

Time to response (TTR) is defined for participants who had a confirmed complete response (CR) or partial response (PR) as the time from the date of randomization to date of first documented CR or PR per blinded independent central review (BICR) assessment using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

Posted

Median

Full Range

Months

From date of randomization to disease progression (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units	Counts
Participants

Secondary

Objective Response Rate (ORR) Per Investigator

ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per investigator assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

Posted

Number

95% Confidence Interval

Percentage of participants

From date of randomization to disease progression (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units	Counts
Participants

Secondary

Progression-free Survival (PFS) Per Investigator

PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per investigator, or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units	Counts
Participants	OG000

Secondary

Clinical Benefit Rate (CBR) Per Investigator

CBR, or equivalently the disease control rate (DCR) is defined as the percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by investigator using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Posted

Number

95% Confidence Interval

Percentage of participants

From date of randomization to disease progression (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units	Counts

Secondary

Duration of Response (DoR) Per Investigator

DOR is defined for participants who have a confirmed complete response (CR) or partial results (PR) as the date from first documented CR or PR using RECIST v 1.1 to the date of the documentation of disease progression per investigator assessment or death due to any cause, whichever is earlier. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

Posted

Median

95% Confidence Interval

Months

From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units	Counts

Secondary

Time to Objective Response (TTR) Per Investigator

Time to response (TTR) is defined for participants who had a confirmed complete response (CR) or partial response (PR) as the time from the date of randomization to date of first documented CR or PR per investigator assessment using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

Posted

Median

Full Range

Months

From date of randomization to disease progression (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units	Counts
Participants

Secondary

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status

ORR by baseline PD-L1 tumor cells expression (PD-L1 negative: <1%) vs. (PD-L1 positive: >=1%). ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

All randomized participants with PD-L1 data available at baseline and at least 6 months of follow-up at the time point of the final objective response rate analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date

Posted

Number

95% Confidence Interval

Percentage of participants

From date of randomization to disease progression (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units

Secondary

Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status

PFS by baseline PD-L1 tumor cells expression (PD-L1 negative: <1%) vs. (PD-L1 positive: >=1%). PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per blinded independent central review (BICR), or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.

All randomized participants with PD-L1 data available at baseline

Posted

Median

95% Confidence Interval

Months

From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units	Counts
Participants

Secondary

Overall Survival (OS) by Baseline PD-L1 Status

OS by baseline PD-L1 tumor cells expression (PD-L1 negative: <1%) vs. (PD-L1 positive: >=1%). OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who do not have a date of death will be censored on the last date for which a participant was known to be alive.

All randomized participants with PD-L1 data available at baseline

Posted

Median

95% Confidence Interval

Months

From date of randomization to date of death (Up to 37 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units	Counts
Participants	OG000

Secondary

Number of Participants With Adverse Events (AEs)

Number of participants with any grade adverse events (AEs) including treatment-related AEs, AEs leading to discontinuation of any drug, serious adverse events (SAEs), treatment-related SAEs, and deaths from first dose to 30 days post last dose. An 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 post last dose (Average of 11 months and a maximum up to 26 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units	Counts
Participants

Secondary

Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline

Number of participants with on-treatment laboratory parameters that worsened relative to baseline. Parameters include hematology, chemistry, liver function, and renal function using worst grade (grade 1-4 and grade 3-4) per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5 criteria.

Grade 1=Mild event Grade 2=Moderate event Grade 3=Severe event Grade 4=Life threatening event

All treated participants with laboratory baseline measures

Posted

Count of Participants

Participants

From first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months)

ID	Title	Description
OG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
OG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0003 affected388 at risk EG0012 affected382 at risk
Eosinophilia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0003 affected388 at risk EG0010 affected382 at risk
Lymph node haemorrhage	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Lymphadenopathy	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Pancytopenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Thrombocytopenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Acute myocardial infarction	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Angina pectoris	Cardiac disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0010 affected382 at risk
Atrial fibrillation	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Atrial tachycardia	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Bradyarrhythmia	Cardiac disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Cardiac arrest	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Cardiac failure	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Cardio-respiratory arrest	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Cardiogenic shock	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Cardiovascular disorder	Cardiac disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Myocardial infarction	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Myocarditis	Cardiac disorders	26.1	Systematic Assessment	EG0003 affected388 at risk EG0014 affected382 at risk
Myopericarditis	Cardiac disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Pericardial effusion	Cardiac disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Right ventricular failure	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Sinus node dysfunction	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Tachycardia	Cardiac disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0010 affected382 at risk
Ventricular tachycardia	Cardiac disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Adrenal insufficiency	Endocrine disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Hypophysitis	Endocrine disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Hypothyroidism	Endocrine disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Thyroiditis	Endocrine disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Uveitis	Eye disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Abdominal pain	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0013 affected382 at risk
Abdominal pain upper	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Abdominal wall haematoma	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Ascites	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0013 affected382 at risk
Autoimmune colitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0003 affected388 at risk EG0012 affected382 at risk
Autoimmune pancreatitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0012 affected382 at risk
Colitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0013 affected382 at risk
Colitis ulcerative	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Constipation	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0012 affected382 at risk
Diarrhoea	Gastrointestinal disorders	26.1	Systematic Assessment	EG0003 affected388 at risk EG0016 affected382 at risk
Dysphagia	Gastrointestinal disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0010 affected382 at risk
Gastric haemorrhage	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Gastric ulcer	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Gastritis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Ileus	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0012 affected382 at risk
Immune-mediated pancreatitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Inguinal hernia	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Intestinal obstruction	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Intestinal perforation	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Nausea	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Obstructive pancreatitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Pancreatitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0012 affected382 at risk
Pancreatitis acute	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Rectal haemorrhage	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Vomiting	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Asthenia	General disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Chest pain	General disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0010 affected382 at risk
Death	General disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Drowning	General disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Face oedema	General disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0010 affected382 at risk
Fatigue	General disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0014 affected382 at risk
General physical health deterioration	General disorders	26.1	Systematic Assessment	EG0004 affected388 at risk EG0013 affected382 at risk
Hanging	General disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Implant site haemorrhage	General disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Localised oedema	General disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Mucosal inflammation	General disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Non-cardiac chest pain	General disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Pain	General disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Pyrexia	General disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0014 affected382 at risk
Sudden death	General disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0012 affected382 at risk
Systemic inflammatory response syndrome	General disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Autoimmune hepatitis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Biliary obstruction	Hepatobiliary disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Cholangitis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Cholecystitis acute	Hepatobiliary disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Cholestasis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Hepatic cytolysis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Hepatic failure	Hepatobiliary disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Hepatitis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Portal vein thrombosis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Anaphylactic reaction	Immune system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Anaphylactic shock	Immune system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Contrast media allergy	Immune system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Cytokine release syndrome	Immune system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Sarcoidosis	Immune system disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Bacteraemia	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Bacterial infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Biliary tract infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
COVID-19	Infections and infestations	26.1	Systematic Assessment	EG0002 affected388 at risk EG0015 affected382 at risk
COVID-19 pneumonia	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0012 affected382 at risk
Cellulitis	Infections and infestations	26.1	Systematic Assessment	EG0002 affected388 at risk EG0011 affected382 at risk
Cystitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Cystitis klebsiella	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Diverticulitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Encephalitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Erysipelas	Infections and infestations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Gastroenteritis	Infections and infestations	26.1	Systematic Assessment	EG0002 affected388 at risk EG0010 affected382 at risk
Herpes zoster	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Infection	Infections and infestations	26.1	Systematic Assessment	EG0002 affected388 at risk EG0010 affected382 at risk
Influenza	Infections and infestations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Klebsiella urinary tract infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Localised infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Meningitis bacterial	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Orchitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Osteomyelitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Periorbital cellulitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Peritonitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Pneumonia	Infections and infestations	26.1	Systematic Assessment	EG0004 affected388 at risk EG0018 affected382 at risk
Pneumonia aspiration	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Pneumonia bacterial	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Sepsis	Infections and infestations	26.1	Systematic Assessment	EG0005 affected388 at risk EG0014 affected382 at risk
Septic shock	Infections and infestations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Severe acute respiratory syndrome	Infections and infestations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Skin infection	Infections and infestations	26.1	Systematic Assessment	EG0003 affected388 at risk EG0010 affected382 at risk
Soft tissue infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Subcutaneous abscess	Infections and infestations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Tonsillitis bacterial	Infections and infestations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Upper respiratory tract infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Urinary tract infection	Infections and infestations	26.1	Systematic Assessment	EG0002 affected388 at risk EG0011 affected382 at risk
Urosepsis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0013 affected382 at risk
Fall	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Head injury	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Immunisation reaction	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Infusion related reaction	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0002 affected388 at risk EG0010 affected382 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Postoperative ileus	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Spinal fracture	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Subdural haematoma	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Wrist fracture	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Alanine aminotransferase increased	Investigations	26.1	Systematic Assessment	EG0002 affected388 at risk EG0011 affected382 at risk
Aspartate aminotransferase increased	Investigations	26.1	Systematic Assessment	EG0003 affected388 at risk EG0011 affected382 at risk
Blood creatinine increased	Investigations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Lipase increased	Investigations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0013 affected382 at risk
Liver function test increased	Investigations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Lymph node palpable	Investigations	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Troponin increased	Investigations	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Decreased appetite	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Dehydration	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Hyperglycaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0012 affected382 at risk
Hypokalaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Hyponatraemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0003 affected388 at risk EG0012 affected382 at risk
Metabolic acidosis	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0012 affected382 at risk
Back pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0012 affected382 at risk
Groin pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0010 affected382 at risk
Morphoea	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0013 affected382 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Myositis	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0015 affected382 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0012 affected382 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected388 at risk EG0012 affected382 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected388 at risk EG0013 affected382 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Intestinal metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected388 at risk EG0012 affected382 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG00037 affected388 at risk EG00140 affected382 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0002 affected388 at risk EG0010 affected382 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected388 at risk EG0013 affected382 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Oncologic complication	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected388 at risk EG0012 affected382 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Cerebral haemorrhage	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Cerebral infarction	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Cerebral ischaemia	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Cerebrovascular accident	Nervous system disorders	26.1	Systematic Assessment	EG0007 affected388 at risk EG0011 affected382 at risk
Cerebrovascular disorder	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Dizziness	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Encephalitis autoimmune	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0012 affected382 at risk
Encephalopathy	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Facial paralysis	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Guillain-Barre syndrome	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Haemorrhage intracranial	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Headache	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Hemiparesis	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Hydrocephalus	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Ischaemic stroke	Nervous system disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0013 affected382 at risk
Myasthenia gravis	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Nervous system disorder	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Paraesthesia	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Polyneuropathy	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Presyncope	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0012 affected382 at risk
Seizure	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0014 affected382 at risk
Spinal cord compression	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0014 affected382 at risk
Syncope	Nervous system disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0012 affected382 at risk
Transient ischaemic attack	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Adjustment disorder	Psychiatric disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Confusional state	Psychiatric disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Disorientation	Psychiatric disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Suicide attempt	Psychiatric disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Acute kidney injury	Renal and urinary disorders	26.1	Systematic Assessment	EG0007 affected388 at risk EG0013 affected382 at risk
Autoimmune nephritis	Renal and urinary disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0013 affected382 at risk
Chronic kidney disease	Renal and urinary disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Hydronephrosis	Renal and urinary disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Pelvi-ureteric obstruction	Renal and urinary disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Renal colic	Renal and urinary disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Prostatitis	Reproductive system and breast disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Testicular mass	Reproductive system and breast disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0012 affected382 at risk
Alveolitis	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Asthma-chronic obstructive pulmonary disease overlap syndrome	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Autoimmune lung disease	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0012 affected382 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0011 affected382 at risk
Epiglottic polyp	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0003 affected388 at risk EG0011 affected382 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0012 affected382 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0004 affected388 at risk EG0012 affected382 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0013 affected382 at risk
Dermatitis exfoliative generalised	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Immune-mediated dermatitis	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Pain of skin	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Rash	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0010 affected382 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Sarcoid-like reaction	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Skin lesion	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0002 affected388 at risk EG0010 affected382 at risk
Arterial occlusive disease	Vascular disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Deep vein thrombosis	Vascular disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0011 affected382 at risk
Embolism	Vascular disorders	26.1	Systematic Assessment	EG0001 affected388 at risk EG0010 affected382 at risk
Hypotension	Vascular disorders	26.1	Systematic Assessment	EG0003 affected388 at risk EG0012 affected382 at risk
Ischaemia	Vascular disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Shock haemorrhagic	Vascular disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk
Vena cava thrombosis	Vascular disorders	26.1	Systematic Assessment	EG0000 affected388 at risk EG0011 affected382 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG00061 affected388 at risk EG00163 affected382 at risk
Eosinophilia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG00060 affected388 at risk EG0017 affected382 at risk
Hyperthyroidism	Endocrine disorders	26.1	Systematic Assessment	EG00049 affected388 at risk EG00128 affected382 at risk
Hypothyroidism	Endocrine disorders	26.1	Systematic Assessment	EG00074 affected388 at risk EG00152 affected382 at risk
Abdominal pain	Gastrointestinal disorders	26.1	Systematic Assessment	EG00033 affected388 at risk EG00134 affected382 at risk
Abdominal pain upper	Gastrointestinal disorders	26.1	Systematic Assessment	EG00029 affected388 at risk EG00116 affected382 at risk
Constipation	Gastrointestinal disorders	26.1	Systematic Assessment	EG00039 affected388 at risk EG00151 affected382 at risk
Diarrhoea	Gastrointestinal disorders	26.1	Systematic Assessment	EG00096 affected388 at risk EG00180 affected382 at risk
Dry mouth	Gastrointestinal disorders	26.1	Systematic Assessment	EG00021 affected388 at risk EG00113 affected382 at risk
Nausea	Gastrointestinal disorders	26.1	Systematic Assessment	EG000113 affected388 at risk EG00167 affected382 at risk
Vomiting	Gastrointestinal disorders	26.1	Systematic Assessment	EG00064 affected388 at risk EG00137 affected382 at risk
Asthenia	General disorders	26.1	Systematic Assessment	EG00068 affected388 at risk EG00142 affected382 at risk
Chills	General disorders	26.1	Systematic Assessment	EG00036 affected388 at risk EG0015 affected382 at risk
Face oedema	General disorders	26.1	Systematic Assessment	EG00020 affected388 at risk EG0010 affected382 at risk
Fatigue	General disorders	26.1	Systematic Assessment	EG000128 affected388 at risk EG001104 affected382 at risk
Influenza like illness	General disorders	26.1	Systematic Assessment	EG00071 affected388 at risk EG0019 affected382 at risk
Oedema peripheral	General disorders	26.1	Systematic Assessment	EG00040 affected388 at risk EG00130 affected382 at risk
Pyrexia	General disorders	26.1	Systematic Assessment	EG000147 affected388 at risk EG00139 affected382 at risk
COVID-19	Infections and infestations	26.1	Systematic Assessment	EG00032 affected388 at risk EG00131 affected382 at risk
Upper respiratory tract infection	Infections and infestations	26.1	Systematic Assessment	EG0009 affected388 at risk EG00120 affected382 at risk
Infusion related reaction	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG00048 affected388 at risk EG00115 affected382 at risk
Alanine aminotransferase increased	Investigations	26.1	Systematic Assessment	EG00031 affected388 at risk EG00139 affected382 at risk
Amylase increased	Investigations	26.1	Systematic Assessment	EG00020 affected388 at risk EG00129 affected382 at risk
Aspartate aminotransferase increased	Investigations	26.1	Systematic Assessment	EG00026 affected388 at risk EG00134 affected382 at risk
Blood alkaline phosphatase increased	Investigations	26.1	Systematic Assessment	EG00010 affected388 at risk EG00120 affected382 at risk
Blood creatine phosphokinase increased	Investigations	26.1	Systematic Assessment	EG00023 affected388 at risk EG00138 affected382 at risk
Blood creatinine increased	Investigations	26.1	Systematic Assessment	EG00020 affected388 at risk EG00128 affected382 at risk
Lipase increased	Investigations	26.1	Systematic Assessment	EG00022 affected388 at risk EG00137 affected382 at risk
Weight decreased	Investigations	26.1	Systematic Assessment	EG00016 affected388 at risk EG00122 affected382 at risk
Decreased appetite	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG00068 affected388 at risk EG00135 affected382 at risk
Hyperglycaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG00020 affected388 at risk EG00128 affected382 at risk
Hyponatraemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG00015 affected388 at risk EG00120 affected382 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG00099 affected388 at risk EG00167 affected382 at risk
Back pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG00035 affected388 at risk EG00147 affected382 at risk
Myalgia	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG00055 affected388 at risk EG00128 affected382 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG00034 affected388 at risk EG00136 affected382 at risk
Dizziness	Nervous system disorders	26.1	Systematic Assessment	EG00038 affected388 at risk EG00120 affected382 at risk
Headache	Nervous system disorders	26.1	Systematic Assessment	EG00064 affected388 at risk EG00156 affected382 at risk
Insomnia	Psychiatric disorders	26.1	Systematic Assessment	EG00031 affected388 at risk EG00124 affected382 at risk
Cough	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG00053 affected388 at risk EG00145 affected382 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG00031 affected388 at risk EG00131 affected382 at risk
Dry skin	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG00030 affected388 at risk EG00114 affected382 at risk
Erythema	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG00028 affected388 at risk EG0017 affected382 at risk
Pruritus	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG000121 affected388 at risk EG00180 affected382 at risk
Rash	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG000108 affected388 at risk EG00163 affected382 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG00030 affected388 at risk EG00118 affected382 at risk
Vitiligo	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG00035 affected388 at risk EG00134 affected382 at risk
Hypertension	Vascular disorders	26.1	Systematic Assessment	EG00027 affected388 at risk EG00134 affected382 at risk
Hypotension	Vascular disorders	26.1	Systematic Assessment	EG00033 affected388 at risk EG0016 affected382 at risk

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
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

ID	Title	Description
BG000	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks
BG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks
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	Bempegaldesleukin + Nivolumab	Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	170	391	161	388	357	388
EG001	Nivolumab	Nivolumab 360 mg IV every 3 weeks	173	392	172	382	336	382