Study of Nivolumab in Combination With Ipilimumab Compare... | NCT02741570

NCT02741570

ID	Type	Description	Link
2016-000725-39	EudraCT Number

Status Module

Name	Class
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
Nivolumab and Ipilimumab	Experimental	Specified dose on specified days	Biological: Nivolumab Biological: Ipilimumab
Extreme Regimen	Active Comparator	Specified dose on specified days	Drug: Cetuximab/Erbitux Drug: Cisplatin/Platinol Drug: Carboplatin/Paraplatin Drug: Fluorouracil/Adrucil

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological		Nivolumab and Ipilimumab	BMS-936558 Opdivo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20	Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)	From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
Overall Survival (OS) in All Randomized Participants	Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)	From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1	Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0134		Tucson	Arizona	85724-5024	United States
Local Institution - 0135

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36473143	Derived	Haddad RI, Harrington K, Tahara M, Ferris RL, Gillison M, Fayette J, Daste A, Koralewski P, Zurawski B, Taberna M, Saba NF, Mak M, Kawecki A, Girotto G, Alvarez Avitia MA, Even C, Toledo JGR, Guminski A, Muller-Richter U, Kiyota N, Roberts M, Khan TA, Miller-Moslin K, Wei L, Argiris A. Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651. J Clin Oncol. 2023 Apr 20;41(12):2166-2180. doi: 10.1200/JCO.22.00332. Epub 2022 Dec 6.
33684371

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
FG001	EXTREME Regimen

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	Dec 19, 2019	Aug 31, 2023

Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.

Arm/Group Information

ID	Title	Description
BG000	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
BG001	EXTREME Regimen	Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00060.4± 9.7 BG00160.9± 9.5 BG00260.6± 9.6

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 65	BG000310 BG001295 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00092 BG00178 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00040 BG00143 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0007 BG0015 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

Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20

Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)

All randomized PD-L1 CPS >= 20 participants

Posted

Median

95% Confidence Interval

Months

From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)

ID	Title	Description
OG000	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
OG001	EXTREME Regimen	Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.

Units	Counts
Participants	OG000185 OG001178

Title

Denominators

Categories

Title	Measurements
	OG00017.58(13.77 to 21.98) OG00114.59(12.32 to 15.97)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	stratified regular log-rank test	0.0469		Hazard Ratio (HR)	0.78			2-Sided	97.51	0.59	1.03					Superiority

Primary

Overall Survival (OS) in All Randomized Participants

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)

ID	Title	Description
OG000	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
OG001	EXTREME Regimen	Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.

Secondary

Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1

All randomized PD-L1 CPS ≥ 1 participants

Posted

Median

95% Confidence Interval

Months

From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)

ID	Title	Description
OG000	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
OG001	EXTREME Regimen	Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.

Secondary

Progression Free Survival (PFS)

PFS is defined as the time between the date of randomization and the date of first documented tumor progression, based on Blinded Independent Central Review (BICR) assessments (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last tumor assessment. Participants who receive subsequent anti-cancer therapy prior to documented progression, will be censored on the date of their last tumor assessment prior to subsequent therapy. (Based on Kaplan-Meier Estimates)

Progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

All randomized participants and randomized PD-L1 CPS >= 20 participants

Posted

Median

95% Confidence Interval

Months

From randomization to disease progression or death (Up to approximately 65 months)

ID	Title	Description
OG000	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
OG001	EXTREME Regimen	Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.

Secondary

Objective Response Rate (ORR)

Objective Response Rate (ORR) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria by blinded independent central review (BICR) assessment.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

All randomized participants and randomized PD-L1 CPS >= 20 participants

Posted

Number

95% Confidence Interval

Percent

From randomization up to approximately 65 months

ID	Title	Description
OG000	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
OG001	EXTREME Regimen	Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.

Secondary

Duration of Objective Response (DOR)

The time between the first documented response (Complete response (CR) or partial response (PR)) and progression or death, per RECIST 1.1 by blinded independent central review (BICR) assessment. (Based on Kaplan-Meier Estimates)

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

All randomized participants and randomized PD-L1 CPS >= 20 participants with a BOR response of CR or PR

Posted

Median

95% Confidence Interval

Months

From randomization to the first documented response (CR or PR) and progression (up to approximately 65 months)

ID	Title	Description
OG000	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
OG001	EXTREME Regimen	Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.

Post-Hoc

Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 - Extended Collection

All randomized PD-L1 CPS >= 20 participants

Posted

Median

95% Confidence Interval

Months

From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)

ID	Title	Description
OG000	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
OG001	EXTREME Regimen	Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.

Post-Hoc

Overall Survival (OS) in All Randomized Participants - Extended Collection

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)

ID	Title	Description
OG000	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
OG001	EXTREME Regimen	Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.

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	Nivolumab + Ipilimumab	Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.	388	472	313	468	420	468
EG001	EXTREME Regimen	Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.	406	475	290	441	429	441

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG00118 affected441 at risk
Bone marrow failure	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Cytopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Febrile neutropenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0006 affected468 at risk EG00124 affected441 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Leukopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Myelosuppression	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Neutropenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Pancytopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0013 affected441 at risk
Thrombocytopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0013 affected441 at risk
Acute coronary syndrome	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Acute myocardial infarction	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Angina pectoris	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Arrhythmia	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Atrial fibrillation	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0012 affected441 at risk
Atrial flutter	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Cardiac arrest	Cardiac disorders	25.0	Systematic Assessment	EG0004 affected468 at risk EG0011 affected441 at risk
Cardiac tamponade	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Cardio-respiratory arrest	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Cardiogenic shock	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Immune-mediated myocarditis	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Myocardial infarction	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Myocardial ischaemia	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Palpitations	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Pericardial effusion	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Pericarditis	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Tachycardia	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Adrenal insufficiency	Endocrine disorders	25.0	Systematic Assessment	EG0004 affected468 at risk EG0010 affected441 at risk
Adrenocorticotropic hormone deficiency	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Autoimmune thyroiditis	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Hyperthyroidism	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Hypophysitis	Endocrine disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Hypopituitarism	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Hypothyroidism	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Immune-mediated hypophysitis	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Lymphocytic hypophysitis	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Secondary adrenocortical insufficiency	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Corneal perforation	Eye disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Abdominal pain	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Abdominal pain upper	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Alcoholic pancreatitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Autoimmune colitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Colitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG00010 affected468 at risk EG0012 affected441 at risk
Constipation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0013 affected441 at risk
Cyclic vomiting syndrome	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Diarrhoea	Gastrointestinal disorders	25.0	Systematic Assessment	EG0009 affected468 at risk EG0018 affected441 at risk
Duodenal perforation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Duodenal ulcer	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Dyspepsia	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Dysphagia	Gastrointestinal disorders	25.0	Systematic Assessment	EG0008 affected468 at risk EG00110 affected441 at risk
Gastric ulcer	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Gastritis erosive	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Haematemesis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Intestinal obstruction	Gastrointestinal disorders	25.0	Systematic Assessment	EG0003 affected468 at risk EG0011 affected441 at risk
Intestinal perforation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Mechanical ileus	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Melaena	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Mesenteric haematoma	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Mouth haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0003 affected468 at risk EG0013 affected441 at risk
Nausea	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0014 affected441 at risk
Oesophageal stenosis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Oral cavity fistula	Gastrointestinal disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0011 affected441 at risk
Pancreatic failure	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Pancreatic pseudocyst	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Pancreatitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Rectal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Stomatitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0016 affected441 at risk
Subileus	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Swollen tongue	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0003 affected468 at risk EG0010 affected441 at risk
Vomiting	Gastrointestinal disorders	25.0	Systematic Assessment	EG0004 affected468 at risk EG0014 affected441 at risk
Asthenia	General disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0013 affected441 at risk
Chest pain	General disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Complication associated with device	General disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Death	General disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Disease progression	General disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Face oedema	General disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Fatigue	General disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
General physical health deterioration	General disorders	25.0	Systematic Assessment	EG0004 affected468 at risk EG0016 affected441 at risk
Inflammation	General disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Influenza like illness	General disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Lithiasis	General disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Localised oedema	General disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Mucosal haemorrhage	General disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Mucosal inflammation	General disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0017 affected441 at risk
Multiple organ dysfunction syndrome	General disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Non-cardiac chest pain	General disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0012 affected441 at risk
Pain	General disorders	25.0	Systematic Assessment	EG0003 affected468 at risk EG0012 affected441 at risk
Performance status decreased	General disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Pneumatosis	General disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Pyrexia	General disorders	25.0	Systematic Assessment	EG0004 affected468 at risk EG0019 affected441 at risk
Stenosis	General disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Sudden cardiac death	General disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Sudden death	General disorders	25.0	Systematic Assessment	EG0007 affected468 at risk EG0018 affected441 at risk
Suprapubic pain	General disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Swelling face	General disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Ulcer haemorrhage	General disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Autoimmune hepatitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0004 affected468 at risk EG0010 affected441 at risk
Cholecystitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0003 affected468 at risk EG0011 affected441 at risk
Cholecystocholangitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Hepatic cytolysis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Hepatic failure	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Hepatic function abnormal	Hepatobiliary disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Hepatitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0003 affected468 at risk EG0011 affected441 at risk
Hepatitis acute	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Hypertransaminasaemia	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Anaphylactic shock	Immune system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Hypersensitivity	Immune system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Infusion related hypersensitivity reaction	Immune system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Abscess limb	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Abscess neck	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Actinomycosis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Anal abscess	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Arthritis infective	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Bacteraemia	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0013 affected441 at risk
Bacterial infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Bacterial sepsis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Bronchitis	Infections and infestations	25.0	Systematic Assessment	EG0002 affected468 at risk EG0012 affected441 at risk
Candida infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Catheter site infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Cellulitis	Infections and infestations	25.0	Systematic Assessment	EG0005 affected468 at risk EG0014 affected441 at risk
Clostridium difficile colitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Cystitis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Device related infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0013 affected441 at risk
Device related sepsis	Infections and infestations	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Diverticulitis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Emphysematous cystitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Enterobacter sepsis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Epiglottitis	Infections and infestations	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Erysipelas	Infections and infestations	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Febrile infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Fungal infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Gastroenteritis	Infections and infestations	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Gastrointestinal infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Herpes zoster	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Herpes zoster oticus	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Impetigo	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Infected fistula	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Infection	Infections and infestations	25.0	Systematic Assessment	EG0003 affected468 at risk EG0012 affected441 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Infective spondylitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Influenza	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Laryngitis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Localised infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Lower respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Lung abscess	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Mediastinitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Medical device site infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Meningitis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Mucosal infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Neutropenic infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Neutropenic sepsis	Infections and infestations	25.0	Systematic Assessment	EG0003 affected468 at risk EG0011 affected441 at risk
Oral infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Otitis externa	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Paronychia	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Periorbital cellulitis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Pleurisy viral	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Pneumonia	Infections and infestations	25.0	Systematic Assessment	EG00025 affected468 at risk EG00131 affected441 at risk
Pneumonia aspiration	Infections and infestations	25.0	Systematic Assessment	EG0008 affected468 at risk EG0017 affected441 at risk
Pneumonia bacterial	Infections and infestations	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Pneumonia cytomegaloviral	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Pneumonia klebsiella	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Pneumonia necrotising	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Pneumonia pseudomonal	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Pseudomonas infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Pulmonary sepsis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG0003 affected468 at risk EG0013 affected441 at risk
Sepsis	Infections and infestations	25.0	Systematic Assessment	EG00010 affected468 at risk EG00110 affected441 at risk
Septic shock	Infections and infestations	25.0	Systematic Assessment	EG0003 affected468 at risk EG0013 affected441 at risk
Sialoadenitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Sinusitis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Skin infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Soft tissue infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0013 affected441 at risk
Staphylococcal bacteraemia	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Staphylococcal infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Staphylococcal sepsis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Stoma site infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Streptococcal bacteraemia	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Subcutaneous abscess	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Tuberculosis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Upper respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG0003 affected468 at risk EG0010 affected441 at risk
Urinary tract infection	Infections and infestations	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Vascular access site cellulitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Vascular access site infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Vascular device infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Accidental overdose	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Device placement issue	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Facial bones fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Fall	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Humerus fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Infusion related reaction	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Post procedural complication	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Radiation injury	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Radiation necrosis	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Stoma site inflammation	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Stoma site ulcer	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Tracheal haemorrhage	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Tracheal obstruction	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Tracheostomy malfunction	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Unintentional medical device removal	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Wound dehiscence	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Wound necrosis	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Amylase increased	Investigations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Aspartate aminotransferase increased	Investigations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
C-reactive protein increased	Investigations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
General physical condition abnormal	Investigations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0012 affected441 at risk
Haemoglobin decreased	Investigations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Hepatic enzyme increased	Investigations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Lipase increased	Investigations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Liver function test increased	Investigations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Neutrophil count decreased	Investigations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0013 affected441 at risk
Platelet count decreased	Investigations	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Transaminases increased	Investigations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Weight decreased	Investigations	25.0	Systematic Assessment	EG0001 affected468 at risk EG0012 affected441 at risk
Cachexia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Decreased appetite	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0003 affected468 at risk EG0014 affected441 at risk
Dehydration	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0007 affected468 at risk EG0014 affected441 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Electrolyte depletion	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0015 affected441 at risk
Feeding disorder	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Gout	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Hyperamylasaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Hypercalcaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0007 affected468 at risk EG0012 affected441 at risk
Hyperglycaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0011 affected441 at risk
Hyperlipasaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Hypocalcaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Hypokalaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0017 affected441 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Hyponatraemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0003 affected468 at risk EG0014 affected441 at risk
Hypophosphataemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Malnutrition	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0003 affected468 at risk EG0013 affected441 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Arthritis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Back pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0011 affected441 at risk
Flank pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Immobilisation syndrome	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Jaw fistula	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0002 affected468 at risk EG0012 affected441 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Follicular lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Lentigo maligna	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG000101 affected468 at risk EG001100 affected441 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0004 affected468 at risk EG0012 affected441 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Oncologic complication	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0002 affected468 at risk EG0011 affected441 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG00021 affected468 at risk EG0019 affected441 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0002 affected468 at risk EG0011 affected441 at risk
Carotid artery stenosis	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Cerebral infarction	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Cerebrovascular accident	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0015 affected441 at risk
Complex regional pain syndrome	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Depressed level of consciousness	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Dizziness	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Encephalopathy	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Epilepsy	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Haemorrhage intracranial	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Hemiparesis	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Hypoaesthesia	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Hypotonia	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Ischaemic stroke	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Lumbar radiculopathy	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Metabolic encephalopathy	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Nervous system disorder	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Neuropathy peripheral	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Paraparesis	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Peripheral motor neuropathy	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Seizure	Nervous system disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Subarachnoid haemorrhage	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Syncope	Nervous system disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0013 affected441 at risk
Vocal cord paralysis	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Device dislocation	Product Issues	25.0	Systematic Assessment	EG0002 affected468 at risk EG0012 affected441 at risk
Device occlusion	Product Issues	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Anxiety	Psychiatric disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Completed suicide	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Delirium tremens	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Disorientation	Psychiatric disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Eating disorder	Psychiatric disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Hallucination	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Mania	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Suicide attempt	Psychiatric disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Acute kidney injury	Renal and urinary disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0017 affected441 at risk
Anuria	Renal and urinary disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Cystitis noninfective	Renal and urinary disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Nephritis	Renal and urinary disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Nephropathy	Renal and urinary disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Renal failure	Renal and urinary disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0013 affected441 at risk
Ureterolithiasis	Renal and urinary disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Urinary bladder polyp	Renal and urinary disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00014 affected468 at risk EG0013 affected441 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0012 affected441 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0010 affected441 at risk
Laryngeal dyspnoea	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Laryngeal obstruction	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Laryngeal stenosis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Lower respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0013 affected441 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0012 affected441 at risk
Obstructive sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0012 affected441 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0007 affected468 at risk EG0013 affected441 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0007 affected468 at risk EG0010 affected441 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0007 affected468 at risk EG0017 affected441 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0013 affected441 at risk
Tracheal fistula	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Pemphigus	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Pruritus	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Psoriasis	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Rash	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Aortic aneurysm rupture	Vascular disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Arterial haemorrhage	Vascular disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Circulatory collapse	Vascular disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Deep vein thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0013 affected441 at risk
Embolism	Vascular disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0012 affected441 at risk
Haemorrhage	Vascular disorders	25.0	Systematic Assessment	EG0003 affected468 at risk EG0010 affected441 at risk
Hypertension	Vascular disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Hypotension	Vascular disorders	25.0	Systematic Assessment	EG0002 affected468 at risk EG0013 affected441 at risk
Hypovolaemic shock	Vascular disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Internal haemorrhage	Vascular disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Lymphoedema	Vascular disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Orthostatic hypotension	Vascular disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0011 affected441 at risk
Peripheral artery occlusion	Vascular disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Peripheral ischaemia	Vascular disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk
Shock haemorrhagic	Vascular disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0011 affected441 at risk
Thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0000 affected468 at risk EG0012 affected441 at risk
Vascular rupture	Vascular disorders	25.0	Systematic Assessment	EG0001 affected468 at risk EG0010 affected441 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG000102 affected468 at risk EG001190 affected441 at risk
Leukopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0006 affected468 at risk EG00135 affected441 at risk
Lymphopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG00017 affected468 at risk EG00125 affected441 at risk
Neutropenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG00011 affected468 at risk EG001131 affected441 at risk
Thrombocytopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0007 affected468 at risk EG001109 affected441 at risk
Tinnitus	Ear and labyrinth disorders	25.0	Systematic Assessment	EG0004 affected468 at risk EG00127 affected441 at risk
Hyperthyroidism	Endocrine disorders	25.0	Systematic Assessment	EG00040 affected468 at risk EG0012 affected441 at risk
Hypothyroidism	Endocrine disorders	25.0	Systematic Assessment	EG00086 affected468 at risk EG00119 affected441 at risk
Abdominal pain	Gastrointestinal disorders	25.0	Systematic Assessment	EG00034 affected468 at risk EG00136 affected441 at risk
Constipation	Gastrointestinal disorders	25.0	Systematic Assessment	EG00095 affected468 at risk EG001157 affected441 at risk
Diarrhoea	Gastrointestinal disorders	25.0	Systematic Assessment	EG000104 affected468 at risk EG001141 affected441 at risk
Dyspepsia	Gastrointestinal disorders	25.0	Systematic Assessment	EG00012 affected468 at risk EG00129 affected441 at risk
Dysphagia	Gastrointestinal disorders	25.0	Systematic Assessment	EG00052 affected468 at risk EG00149 affected441 at risk
Nausea	Gastrointestinal disorders	25.0	Systematic Assessment	EG000101 affected468 at risk EG001226 affected441 at risk
Stomatitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG00024 affected468 at risk EG001104 affected441 at risk
Vomiting	Gastrointestinal disorders	25.0	Systematic Assessment	EG00057 affected468 at risk EG001121 affected441 at risk
Asthenia	General disorders	25.0	Systematic Assessment	EG00073 affected468 at risk EG001106 affected441 at risk
Fatigue	General disorders	25.0	Systematic Assessment	EG000123 affected468 at risk EG001154 affected441 at risk
Mucosal inflammation	General disorders	25.0	Systematic Assessment	EG00027 affected468 at risk EG001137 affected441 at risk
Oedema peripheral	General disorders	25.0	Systematic Assessment	EG00030 affected468 at risk EG00129 affected441 at risk
Pain	General disorders	25.0	Systematic Assessment	EG00026 affected468 at risk EG00115 affected441 at risk
Pyrexia	General disorders	25.0	Systematic Assessment	EG00049 affected468 at risk EG00146 affected441 at risk
Folliculitis	Infections and infestations	25.0	Systematic Assessment	EG0006 affected468 at risk EG00133 affected441 at risk
Oral candidiasis	Infections and infestations	25.0	Systematic Assessment	EG00019 affected468 at risk EG00129 affected441 at risk
Paronychia	Infections and infestations	25.0	Systematic Assessment	EG0009 affected468 at risk EG00195 affected441 at risk
Pneumonia	Infections and infestations	25.0	Systematic Assessment	EG00041 affected468 at risk EG00125 affected441 at risk
Upper respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG00026 affected468 at risk EG00119 affected441 at risk
Alanine aminotransferase increased	Investigations	25.0	Systematic Assessment	EG00035 affected468 at risk EG00123 affected441 at risk
Amylase increased	Investigations	25.0	Systematic Assessment	EG00032 affected468 at risk EG00118 affected441 at risk
Aspartate aminotransferase increased	Investigations	25.0	Systematic Assessment	EG00039 affected468 at risk EG00118 affected441 at risk
Blood alkaline phosphatase increased	Investigations	25.0	Systematic Assessment	EG00027 affected468 at risk EG00119 affected441 at risk
Blood creatinine increased	Investigations	25.0	Systematic Assessment	EG00017 affected468 at risk EG00134 affected441 at risk
Lipase increased	Investigations	25.0	Systematic Assessment	EG00050 affected468 at risk EG00119 affected441 at risk
Neutrophil count decreased	Investigations	25.0	Systematic Assessment	EG00019 affected468 at risk EG00166 affected441 at risk
Platelet count decreased	Investigations	25.0	Systematic Assessment	EG0007 affected468 at risk EG00160 affected441 at risk
Weight decreased	Investigations	25.0	Systematic Assessment	EG00057 affected468 at risk EG00181 affected441 at risk
White blood cell count decreased	Investigations	25.0	Systematic Assessment	EG00012 affected468 at risk EG00136 affected441 at risk
Decreased appetite	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00073 affected468 at risk EG001115 affected441 at risk
Dehydration	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0005 affected468 at risk EG00126 affected441 at risk
Hypercalcaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00031 affected468 at risk EG00114 affected441 at risk
Hyperglycaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00024 affected468 at risk EG00120 affected441 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00033 affected468 at risk EG00126 affected441 at risk
Hypocalcaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00013 affected468 at risk EG00145 affected441 at risk
Hypokalaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00027 affected468 at risk EG00193 affected441 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00034 affected468 at risk EG001146 affected441 at risk
Hyponatraemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00039 affected468 at risk EG00135 affected441 at risk
Hypophosphataemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00010 affected468 at risk EG00134 affected441 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00058 affected468 at risk EG00121 affected441 at risk
Back pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00026 affected468 at risk EG00121 affected441 at risk
Neck pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00038 affected468 at risk EG00138 affected441 at risk
Dizziness	Nervous system disorders	25.0	Systematic Assessment	EG00020 affected468 at risk EG00132 affected441 at risk
Headache	Nervous system disorders	25.0	Systematic Assessment	EG00030 affected468 at risk EG00131 affected441 at risk
Neuropathy peripheral	Nervous system disorders	25.0	Systematic Assessment	EG00010 affected468 at risk EG00134 affected441 at risk
Insomnia	Psychiatric disorders	25.0	Systematic Assessment	EG00035 affected468 at risk EG00137 affected441 at risk
Cough	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00063 affected468 at risk EG00134 affected441 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00059 affected468 at risk EG00153 affected441 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0005 affected468 at risk EG00131 affected441 at risk
Alopecia	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0006 affected468 at risk EG00140 affected441 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00023 affected468 at risk EG001147 affected441 at risk
Dry skin	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00035 affected468 at risk EG00179 affected441 at risk
Pruritus	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00088 affected468 at risk EG00138 affected441 at risk
Rash	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00090 affected468 at risk EG001177 affected441 at risk
Skin fissures	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0004 affected468 at risk EG00165 affected441 at risk
Hypotension	Vascular disorders	25.0	Systematic Assessment	EG00013 affected468 at risk EG00125 affected441 at risk

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
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
D000077594	Nivolumab
D000074324	Ipilimumab
D000068818	Cetuximab
D002945	Cisplatin
D016190	Carboplatin
D005472	Fluorouracil