A Study of Nivolumab Combined With Cabozantinib Compared... | NCT03141177

NCT03141177

ID	Type	Description	Link
2017-000759-20	EudraCT Number

Status Module

Name	Class
Exelixis	INDUSTRY
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Oversight 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
Doublet	Experimental	Nivolumab and Cabozantinib	Biological: Nivolumab Drug: Cabozantinib
Monotherapy	Active Comparator	Sunitinib	Drug: Sunitinib
Triplet	Experimental	Nivolumab, Ipilimumab, Cabozantinib *Enrollment to the triplet arm was discontinued by protocol amendment	Biological: Ipilimumab

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological	Specified dose on specified day	Doublet	Opdivo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study	From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	Overall Survival is defined as the time between the date of randomization and the date of death due to any cause. For participants that are alive, their survival time will be censored at the date of last contact date (or "last known alive date").	From randomization date to death date (Up to 31 months)

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0077		Daphne	Alabama	36526	United States
Local Institution - 0044

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41617395	Derived	Viray H, M Mantia C, Jegede OA, Atkins MB, Rosenblatt L, Choueiri TK, McDermott DF, Regan MM. Partitioned overall survival: comprehensive analysis of survival states over 4 years in CheckMate 9ER comparing first-line nivolumab plus cabozantinib versus sunitinib in advanced renal cell carcinoma. J Immunother Cancer. 2026 Jan 30;14(1):e013546. doi: 10.1136/jitc-2025-013546.
41239083

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Treatment A	Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
FG001	Treatment B	Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 3, 2019	Mar 17, 2022

Arm/Group Information

ID	Title	Description
BG000	Treatment A	Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
BG001	Treatment B	Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
BG002	Treatment C	Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
BG003	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
	BG00061.4± 10.2 BG00160.3± 9.5 BG00260.4± 10.6 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00074 BG00116 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00038 BG00113 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0003 BG0010 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)

PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study

All Randomized Participants of treatment A and treatment C

Posted

Median

95% Confidence Interval

Months

From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)

ID	Title	Description
OG000	Treatment A	Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG001	Treatment C	Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle

Units	Counts
Participants	OG000323 OG001328

Title

Denominators

Categories

Title	Measurements
	OG00016.59(12.45 to 24.94) OG0018.31(6.97 to 9.69)

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		Stratified Log-Rank		<0.0001		Hazard Ratio (HR)	0.51			2-Sided	95	0.41	0.64					Superiority	Treatment A over Treatment C

Secondary

Overall Survival (OS)

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

All Randomized Participants of treatment A and treatment C

Posted

Median

95% Confidence Interval

Months

From randomization date to death date (Up to 31 months)

ID	Title	Description
OG000	Treatment A	Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG001	Treatment C	Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle

Units	Counts
Participants	OG000

Secondary

Objective Response Rate (ORR)

Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants.

Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.

All Randomized Participants

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 31 Months

ID	Title	Description
OG000	Treatment A	Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG001	Treatment B	Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG002	Treatment C	Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle

Secondary

Number of Participants Experiencing Adverse Events (AEs)

Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.

All Treated Participants

Posted

Count of Participants

Participants

From first dose to 100 days following last dose (Up to 32 Months)

ID	Title	Description
OG000	Treatment A	Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG001	Treatment B	Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG002	Treatment C	Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle

Units	Counts
Participants

Secondary

Number of Participants Experiencing Serious Adverse Events (SAEs)

Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.

All Treated Participants

Posted

Count of Participants

Participants

From first to dose to 100 days following last dose (Up to 32 months)

ID	Title	Description
OG000	Treatment A	Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG001	Treatment B	Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG002	Treatment C	Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle

Units	Counts
Participants

Secondary

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

Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.

All Treated Participants

Posted

Count of Participants

Participants

From first dose to 30 days following last dose (Up to 30 months)

ID	Title	Description
OG000	Treatment A	Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG001	Treatment B	Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG002	Treatment C	Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle

Units	Counts
Participants

Secondary

Number of Deaths

Number of deaths due to any cause during the specified time frame.

All Treated Participants

Posted

Count of Participants

Participants

From first dose to (up to 31 months) following first dose

ID	Title	Description
OG000	Treatment A	Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG001	Treatment B	Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG002	Treatment C	Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle

Units	Counts
Participants	OG000

Secondary

Number of Participants With Laboratory Abnormalities

Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame.

All Treated Participants

Posted

Count of Participants

Participants

From first dose to 30 days following last dose (Up to 30 Months)

ID	Title	Description
OG000	Treatment A	Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG001	Treatment B	Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG002	Treatment C	Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle

Units	Counts
Participants

Secondary

Number of Participants With Laboratory Values Grade Shifting From Baseline

Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.

All Treated Participants

Posted

Count of Participants

Participants

From first dose to 30 days following last dose (Up to 30 Months)

ID	Title	Description
OG000	Treatment A	Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG001	Treatment B	Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
OG002	Treatment C	Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle

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	Treatment A	Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	67	320	160	320	316	320
EG001	Treatment B	Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	14	50	28	50	48	50
EG002	Treatment C	Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle	99	320	144	320	306	320

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0011 affected50 at risk EG00211 affected320 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Febrile neutropenia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Pancytopenia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Thrombocytopenia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0023 affected320 at risk
Acute myocardial infarction	Cardiac disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Atrial fibrillation	Cardiac disorders	22.1	Systematic Assessment	EG0003 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Atrial tachycardia	Cardiac disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Atrioventricular block complete	Cardiac disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Bradycardia	Cardiac disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Cardiac arrest	Cardiac disorders	22.1	Systematic Assessment	EG0003 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Cardiac failure	Cardiac disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Cardiac failure acute	Cardiac disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Cardiac failure congestive	Cardiac disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Cardio-respiratory arrest	Cardiac disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Intracardiac thrombus	Cardiac disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Myocardial infarction	Cardiac disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0011 affected50 at risk EG0021 affected320 at risk
Myocardial ischaemia	Cardiac disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Myocarditis	Cardiac disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Vertigo	Ear and labyrinth disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Adrenal haemorrhage	Endocrine disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Adrenal insufficiency	Endocrine disorders	22.1	Systematic Assessment	EG0006 affected320 at risk EG0012 affected50 at risk EG0020 affected320 at risk
Adrenocorticotropic hormone deficiency	Endocrine disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Hyperthyroidism	Endocrine disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Hypophysitis	Endocrine disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Hypothalamo-pituitary disorder	Endocrine disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Hypothyroidism	Endocrine disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Thyroiditis acute	Endocrine disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Vision blurred	Eye disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Abdominal distension	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Abdominal hernia	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Abdominal pain	Gastrointestinal disorders	22.1	Systematic Assessment	EG0003 affected320 at risk EG0010 affected50 at risk EG0024 affected320 at risk
Anal fistula	Gastrointestinal disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Colitis	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Colitis microscopic	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Colonic fistula	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Constipation	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0021 affected320 at risk
Diarrhoea	Gastrointestinal disorders	22.1	Systematic Assessment	EG00015 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Dysphagia	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Enteritis	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Epigastric discomfort	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Gastric haemorrhage	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Inguinal hernia	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Intestinal obstruction	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Intestinal perforation	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Intussusception	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Large intestine perforation	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Nausea	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Obstruction gastric	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Oesophagitis	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Pancreatitis	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Pancreatitis acute	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Small intestinal obstruction	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Small intestinal perforation	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Stomatitis	Gastrointestinal disorders	22.1	Systematic Assessment	EG0003 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Vomiting	Gastrointestinal disorders	22.1	Systematic Assessment	EG0005 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Asthenia	General disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0011 affected50 at risk EG0022 affected320 at risk
Chills	General disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Condition aggravated	General disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Death	General disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0011 affected50 at risk EG0022 affected320 at risk
Face oedema	General disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Fatigue	General disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
General physical health deterioration	General disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0011 affected50 at risk EG0021 affected320 at risk
Hernia	General disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Inflammation	General disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Malaise	General disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Mucosal inflammation	General disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Necrosis	General disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Pain	General disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0026 affected320 at risk
Pyrexia	General disorders	22.1	Systematic Assessment	EG0004 affected320 at risk EG0010 affected50 at risk EG0025 affected320 at risk
Sudden death	General disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Autoimmune hepatitis	Hepatobiliary disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Bile duct stone	Hepatobiliary disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Cholangitis	Hepatobiliary disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Cholecystitis	Hepatobiliary disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Cholecystitis acute	Hepatobiliary disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Cholestasis	Hepatobiliary disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Drug-induced liver injury	Hepatobiliary disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0021 affected320 at risk
Hepatic cirrhosis	Hepatobiliary disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Hepatic failure	Hepatobiliary disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Hepatic function abnormal	Hepatobiliary disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Hepatitis	Hepatobiliary disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0012 affected50 at risk EG0020 affected320 at risk
Hepatotoxicity	Hepatobiliary disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0011 affected50 at risk EG0021 affected320 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Jaundice	Hepatobiliary disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Portal vein thrombosis	Hepatobiliary disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Anaphylactic reaction	Immune system disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Abdominal sepsis	Infections and infestations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Appendicitis perforated	Infections and infestations	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Bronchitis pneumococcal	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Campylobacter infection	Infections and infestations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Cellulitis	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Clostridium difficile colitis	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Clostridium difficile infection	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Cystitis	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Dengue fever	Infections and infestations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Diverticulitis	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Encephalitis	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Febrile infection	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Gastroenteritis viral	Infections and infestations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Haematoma infection	Infections and infestations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Herpes zoster	Infections and infestations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Infection	Infections and infestations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Infectious pleural effusion	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Large intestine infection	Infections and infestations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Lower respiratory tract infection	Infections and infestations	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Lung abscess	Infections and infestations	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Otitis externa	Infections and infestations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Pneumocystis jirovecii infection	Infections and infestations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Pneumonia	Infections and infestations	22.1	Systematic Assessment	EG0009 affected320 at risk EG0014 affected50 at risk EG0028 affected320 at risk
Pneumonia necrotising	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Pulmonary sepsis	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Pyelonephritis	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Respiratory tract infection	Infections and infestations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Sepsis	Infections and infestations	22.1	Systematic Assessment	EG0004 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Septic shock	Infections and infestations	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Soft tissue infection	Infections and infestations	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Tuberculosis	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Upper respiratory tract infection	Infections and infestations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Urinary tract infection	Infections and infestations	22.1	Systematic Assessment	EG0007 affected320 at risk EG0010 affected50 at risk EG0025 affected320 at risk
Clavicle fracture	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Compression fracture	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Fall	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Femur fracture	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Infusion related reaction	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Overdose	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Radiation injury	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Spinal fracture	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Alanine aminotransferase increased	Investigations	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Aspartate aminotransferase increased	Investigations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Bordetella test positive	Investigations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Ejection fraction decreased	Investigations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Escherichia test positive	Investigations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Hepatic enzyme increased	Investigations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Human rhinovirus test positive	Investigations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Influenza A virus test positive	Investigations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Liver function test abnormal	Investigations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Platelet count decreased	Investigations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Transaminases increased	Investigations	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Decreased appetite	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0023 affected320 at risk
Dehydration	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0003 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Hypercalcaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0024 affected320 at risk
Hyperglycaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0011 affected50 at risk EG0023 affected320 at risk
Hyperkalaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Hypoglycaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Hyponatraemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0007 affected320 at risk EG0011 affected50 at risk EG0025 affected320 at risk
Metabolic disorder	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Arthritis	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Back pain	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0003 affected320 at risk EG0010 affected50 at risk EG0024 affected320 at risk
Bone lesion	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Bone pain	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Flank pain	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0023 affected320 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Neck pain	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Trismus	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Intracranial tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG00024 affected320 at risk EG0014 affected50 at risk EG00223 affected320 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0024 affected320 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Renal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0003 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Altered state of consciousness	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Aphasia	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Central nervous system lesion	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Cerebral haemorrhage	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Cerebral ischaemia	Nervous system disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Dizziness	Nervous system disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Encephalopathy	Nervous system disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Guillain-Barre syndrome	Nervous system disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Haemorrhage intracranial	Nervous system disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Headache	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Hydrocephalus	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Ischaemic stroke	Nervous system disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Lethargy	Nervous system disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Presyncope	Nervous system disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Sciatica	Nervous system disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Seizure	Nervous system disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Syncope	Nervous system disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0012 affected50 at risk EG0021 affected320 at risk
Confusional state	Psychiatric disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Delirium	Psychiatric disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Acute kidney injury	Renal and urinary disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0026 affected320 at risk
Azotaemia	Renal and urinary disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Bladder tamponade	Renal and urinary disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Haematuria	Renal and urinary disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0023 affected320 at risk
Nephritis	Renal and urinary disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Proteinuria	Renal and urinary disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Renal colic	Renal and urinary disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Renal failure	Renal and urinary disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Urinary retention	Renal and urinary disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Ovarian cyst	Reproductive system and breast disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Prostatitis	Reproductive system and breast disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0022 affected320 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Cough	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0003 affected320 at risk EG0011 affected50 at risk EG0023 affected320 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Mediastinal haemorrhage	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0029 affected320 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0009 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0009 affected320 at risk EG0010 affected50 at risk EG0023 affected320 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0029 affected320 at risk
Dermatitis	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Peau d'orange	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Rash	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Rash papular	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Central venous catheterisation	Surgical and medical procedures	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG0020 affected320 at risk
Surgery	Surgical and medical procedures	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Arterial thrombosis	Vascular disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Bleeding varicose vein	Vascular disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Deep vein thrombosis	Vascular disorders	22.1	Systematic Assessment	EG0003 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Embolism	Vascular disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Hypertension	Vascular disorders	22.1	Systematic Assessment	EG0003 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Hypotension	Vascular disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0011 affected50 at risk EG0023 affected320 at risk
Peripheral ischaemia	Vascular disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Thrombosis	Vascular disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0021 affected320 at risk
Vascular occlusion	Vascular disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk
Venous thrombosis limb	Vascular disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0010 affected50 at risk EG0020 affected320 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG00048 affected320 at risk EG0018 affected50 at risk EG00285 affected320 at risk
Leukopenia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG0007 affected320 at risk EG0010 affected50 at risk EG00224 affected320 at risk
Neutropenia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG00015 affected320 at risk EG0014 affected50 at risk EG00250 affected320 at risk
Thrombocytopenia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG00025 affected320 at risk EG0013 affected50 at risk EG00262 affected320 at risk
Hyperthyroidism	Endocrine disorders	22.1	Systematic Assessment	EG00031 affected320 at risk EG0013 affected50 at risk EG0029 affected320 at risk
Hypothyroidism	Endocrine disorders	22.1	Systematic Assessment	EG000109 affected320 at risk EG00115 affected50 at risk EG00295 affected320 at risk
Abdominal distension	Gastrointestinal disorders	22.1	Systematic Assessment	EG0005 affected320 at risk EG0013 affected50 at risk EG0027 affected320 at risk
Abdominal pain	Gastrointestinal disorders	22.1	Systematic Assessment	EG00050 affected320 at risk EG0019 affected50 at risk EG00225 affected320 at risk
Abdominal pain upper	Gastrointestinal disorders	22.1	Systematic Assessment	EG00022 affected320 at risk EG0016 affected50 at risk EG00221 affected320 at risk
Colitis	Gastrointestinal disorders	22.1	Systematic Assessment	EG0006 affected320 at risk EG0014 affected50 at risk EG0021 affected320 at risk
Constipation	Gastrointestinal disorders	22.1	Systematic Assessment	EG00039 affected320 at risk EG00112 affected50 at risk EG00241 affected320 at risk
Diarrhoea	Gastrointestinal disorders	22.1	Systematic Assessment	EG000202 affected320 at risk EG00128 affected50 at risk EG002151 affected320 at risk
Dry mouth	Gastrointestinal disorders	22.1	Systematic Assessment	EG00021 affected320 at risk EG0013 affected50 at risk EG00212 affected320 at risk
Dyspepsia	Gastrointestinal disorders	22.1	Systematic Assessment	EG00026 affected320 at risk EG0014 affected50 at risk EG00240 affected320 at risk
Gastritis	Gastrointestinal disorders	22.1	Systematic Assessment	EG0009 affected320 at risk EG0014 affected50 at risk EG0027 affected320 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	22.1	Systematic Assessment	EG00025 affected320 at risk EG0014 affected50 at risk EG00236 affected320 at risk
Nausea	Gastrointestinal disorders	22.1	Systematic Assessment	EG00086 affected320 at risk EG00115 affected50 at risk EG00299 affected320 at risk
Oral dysaesthesia	Gastrointestinal disorders	22.1	Systematic Assessment	EG0002 affected320 at risk EG0013 affected50 at risk EG0020 affected320 at risk
Stomatitis	Gastrointestinal disorders	22.1	Systematic Assessment	EG00054 affected320 at risk EG0018 affected50 at risk EG00282 affected320 at risk
Vomiting	Gastrointestinal disorders	22.1	Systematic Assessment	EG00053 affected320 at risk EG00110 affected50 at risk EG00266 affected320 at risk
Asthenia	General disorders	22.1	Systematic Assessment	EG00071 affected320 at risk EG00113 affected50 at risk EG00258 affected320 at risk
Chest pain	General disorders	22.1	Systematic Assessment	EG0008 affected320 at risk EG0013 affected50 at risk EG0028 affected320 at risk
Fatigue	General disorders	22.1	Systematic Assessment	EG000102 affected320 at risk EG00119 affected50 at risk EG002112 affected320 at risk
Malaise	General disorders	22.1	Systematic Assessment	EG00012 affected320 at risk EG0012 affected50 at risk EG00217 affected320 at risk
Mucosal inflammation	General disorders	22.1	Systematic Assessment	EG00066 affected320 at risk EG00113 affected50 at risk EG00280 affected320 at risk
Oedema peripheral	General disorders	22.1	Systematic Assessment	EG00035 affected320 at risk EG0018 affected50 at risk EG00228 affected320 at risk
Pain	General disorders	22.1	Systematic Assessment	EG00016 affected320 at risk EG0014 affected50 at risk EG00217 affected320 at risk
Pyrexia	General disorders	22.1	Systematic Assessment	EG00038 affected320 at risk EG00112 affected50 at risk EG00225 affected320 at risk
Hepatotoxicity	Hepatobiliary disorders	22.1	Systematic Assessment	EG00016 affected320 at risk EG00110 affected50 at risk EG00212 affected320 at risk
Hypersensitivity	Immune system disorders	22.1	Systematic Assessment	EG0004 affected320 at risk EG0013 affected50 at risk EG0024 affected320 at risk
Bronchitis	Infections and infestations	22.1	Systematic Assessment	EG0009 affected320 at risk EG0013 affected50 at risk EG0027 affected320 at risk
Nasopharyngitis	Infections and infestations	22.1	Systematic Assessment	EG00022 affected320 at risk EG0015 affected50 at risk EG00214 affected320 at risk
Upper respiratory tract infection	Infections and infestations	22.1	Systematic Assessment	EG00035 affected320 at risk EG0015 affected50 at risk EG00212 affected320 at risk
Urinary tract infection	Infections and infestations	22.1	Systematic Assessment	EG00023 affected320 at risk EG0019 affected50 at risk EG00217 affected320 at risk
Infusion related reaction	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0003 affected320 at risk EG0013 affected50 at risk EG0021 affected320 at risk
Alanine aminotransferase increased	Investigations	22.1	Systematic Assessment	EG00090 affected320 at risk EG00121 affected50 at risk EG00228 affected320 at risk
Amylase increased	Investigations	22.1	Systematic Assessment	EG00048 affected320 at risk EG0018 affected50 at risk EG00229 affected320 at risk
Aspartate aminotransferase increased	Investigations	22.1	Systematic Assessment	EG00082 affected320 at risk EG00116 affected50 at risk EG00236 affected320 at risk
Blood alkaline phosphatase increased	Investigations	22.1	Systematic Assessment	EG00037 affected320 at risk EG0018 affected50 at risk EG00227 affected320 at risk
Blood bilirubin increased	Investigations	22.1	Systematic Assessment	EG00018 affected320 at risk EG0016 affected50 at risk EG00213 affected320 at risk
Blood cholesterol increased	Investigations	22.1	Systematic Assessment	EG0007 affected320 at risk EG0014 affected50 at risk EG00210 affected320 at risk
Blood creatinine increased	Investigations	22.1	Systematic Assessment	EG00043 affected320 at risk EG0017 affected50 at risk EG00243 affected320 at risk
Blood sodium decreased	Investigations	22.1	Systematic Assessment	EG0006 affected320 at risk EG0013 affected50 at risk EG0022 affected320 at risk
Blood thyroid stimulating hormone decreased	Investigations	22.1	Systematic Assessment	EG0001 affected320 at risk EG0015 affected50 at risk EG0022 affected320 at risk
Blood thyroid stimulating hormone increased	Investigations	22.1	Systematic Assessment	EG00027 affected320 at risk EG0013 affected50 at risk EG00220 affected320 at risk
Lipase increased	Investigations	22.1	Systematic Assessment	EG00054 affected320 at risk EG00113 affected50 at risk EG00238 affected320 at risk
Lymphocyte count decreased	Investigations	22.1	Systematic Assessment	EG0006 affected320 at risk EG0013 affected50 at risk EG00210 affected320 at risk
Neutrophil count decreased	Investigations	22.1	Systematic Assessment	EG00012 affected320 at risk EG0012 affected50 at risk EG00227 affected320 at risk
Platelet count decreased	Investigations	22.1	Systematic Assessment	EG00018 affected320 at risk EG0016 affected50 at risk EG00260 affected320 at risk
Transaminases increased	Investigations	22.1	Systematic Assessment	EG00012 affected320 at risk EG0014 affected50 at risk EG0025 affected320 at risk
Weight decreased	Investigations	22.1	Systematic Assessment	EG00036 affected320 at risk EG0018 affected50 at risk EG00210 affected320 at risk
White blood cell count decreased	Investigations	22.1	Systematic Assessment	EG0007 affected320 at risk EG0014 affected50 at risk EG00218 affected320 at risk
Decreased appetite	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG00092 affected320 at risk EG00115 affected50 at risk EG00266 affected320 at risk
Hyperglycaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG00028 affected320 at risk EG0013 affected50 at risk EG00214 affected320 at risk
Hyperkalaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG00021 affected320 at risk EG0014 affected50 at risk EG0026 affected320 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG00018 affected320 at risk EG0014 affected50 at risk EG00212 affected320 at risk
Hypocalcaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG00022 affected320 at risk EG0014 affected50 at risk EG0027 affected320 at risk
Hypoglycaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0004 affected320 at risk EG0013 affected50 at risk EG0025 affected320 at risk
Hypokalaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG00018 affected320 at risk EG0012 affected50 at risk EG00211 affected320 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG00044 affected320 at risk EG0013 affected50 at risk EG00215 affected320 at risk
Hyponatraemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG00048 affected320 at risk EG0018 affected50 at risk EG00228 affected320 at risk
Hypophosphataemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG00046 affected320 at risk EG0016 affected50 at risk EG00218 affected320 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG00059 affected320 at risk EG0017 affected50 at risk EG00229 affected320 at risk
Back pain	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG00056 affected320 at risk EG00111 affected50 at risk EG00238 affected320 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG00038 affected320 at risk EG0017 affected50 at risk EG0025 affected320 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG00017 affected320 at risk EG0013 affected50 at risk EG00210 affected320 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected320 at risk EG0013 affected50 at risk EG0022 affected320 at risk
Myalgia	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG00016 affected320 at risk EG00111 affected50 at risk EG00223 affected320 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG00030 affected320 at risk EG0016 affected50 at risk EG00229 affected320 at risk
Dizziness	Nervous system disorders	22.1	Systematic Assessment	EG00032 affected320 at risk EG0019 affected50 at risk EG00219 affected320 at risk
Dysgeusia	Nervous system disorders	22.1	Systematic Assessment	EG00076 affected320 at risk EG0019 affected50 at risk EG00270 affected320 at risk
Headache	Nervous system disorders	22.1	Systematic Assessment	EG00050 affected320 at risk EG0019 affected50 at risk EG00236 affected320 at risk
Paraesthesia	Nervous system disorders	22.1	Systematic Assessment	EG00011 affected320 at risk EG0013 affected50 at risk EG0028 affected320 at risk
Anxiety	Psychiatric disorders	22.1	Systematic Assessment	EG0008 affected320 at risk EG0014 affected50 at risk EG0029 affected320 at risk
Depression	Psychiatric disorders	22.1	Systematic Assessment	EG00015 affected320 at risk EG0013 affected50 at risk EG0029 affected320 at risk
Insomnia	Psychiatric disorders	22.1	Systematic Assessment	EG00027 affected320 at risk EG0016 affected50 at risk EG00217 affected320 at risk
Proteinuria	Renal and urinary disorders	22.1	Systematic Assessment	EG00033 affected320 at risk EG0012 affected50 at risk EG00225 affected320 at risk
Renal failure	Renal and urinary disorders	22.1	Systematic Assessment	EG00010 affected320 at risk EG0013 affected50 at risk EG0024 affected320 at risk
Cough	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG00058 affected320 at risk EG00114 affected50 at risk EG00251 affected320 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG00056 affected320 at risk EG0017 affected50 at risk EG00211 affected320 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG00030 affected320 at risk EG0016 affected50 at risk EG00227 affected320 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG00022 affected320 at risk EG0012 affected50 at risk EG00232 affected320 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG00030 affected320 at risk EG0015 affected50 at risk EG00211 affected320 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG00012 affected320 at risk EG0013 affected50 at risk EG0023 affected320 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG00012 affected320 at risk EG0013 affected50 at risk EG0023 affected320 at risk
Alopecia	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG00017 affected320 at risk EG0013 affected50 at risk EG0026 affected320 at risk
Dry skin	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG00021 affected320 at risk EG0012 affected50 at risk EG00215 affected320 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG000128 affected320 at risk EG00120 affected50 at risk EG002130 affected320 at risk
Pruritus	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG00060 affected320 at risk EG00111 affected50 at risk EG00215 affected320 at risk
Rash	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG00069 affected320 at risk EG00115 affected50 at risk EG00226 affected320 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG00027 affected320 at risk EG0015 affected50 at risk EG0026 affected320 at risk
Yellow skin	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0000 affected320 at risk EG0011 affected50 at risk EG00222 affected320 at risk
Hypertension	Vascular disorders	22.1	Systematic Assessment	EG000112 affected320 at risk EG00118 affected50 at risk EG002121 affected320 at risk
Hypotension	Vascular disorders	22.1	Systematic Assessment	EG00013 affected320 at risk EG0014 affected50 at risk EG0023 affected320 at risk

Ancestor Terms

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

Ancestor Terms

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
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Term
D000077594	Nivolumab
C558660	cabozantinib
D000077210	Sunitinib
D000074324	Ipilimumab