Efficacy Study of Nivolumab Compared to Ipilimumab in Pre... | NCT02388906

NCT02388906

ID	Type	Description	Link
2014-002351-26	EudraCT Number

Status Module

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ipilimumab and Placebo matching Nivolumab	Experimental		Drug: Ipilimumab Other: Placebo matching Nivolumab
Nivolumab and Placebo matching Ipilimumab	Experimental		Drug: Nivolumab Other: Placebo matching Ipilimumab

Name	Type	Description	Arm Group Labels	Other Names
Ipilimumab	Drug	Specified dose on specified days	Ipilimumab and Placebo matching Nivolumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence-free Survival (RFS)	RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.	up to 36 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as as the time between the date of randomization and the date of death.	up to 106.6 months
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0036		Little Rock	Arkansas	72205	United States
Local Institution - 0117

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41124198	Derived	Ascierto PA, Del Vecchio M, Merelli B, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Gaudy-Marqueste C, Pigozzo J, Marquez-Rodas I, Butler MO, Di Giacomo AM, Gligich O, De La Cruz-Merino L, Arenberger P, Atkinson V, Nathan P, Hill A, Millward M, Fecher LA, Khushalani NI, Queirolo P, Soomro R, Rathod D, Askelson M, Pe Benito M, Joseph D, Larkin J. Nivolumab for Resected Stage III or IV Melanoma at 9 Years. N Engl J Med. 2026 Jan 22;394(4):333-342. doi: 10.1056/NEJMoa2504966. Epub 2025 Oct 18.
39378385

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nivolumab 3 mg/kg	Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
FG001	Ipilimumab 10 mg/kg	Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 14, 2020	Apr 16, 2021

Arm/Group Information

ID	Title	Description
BG000	Nivolumab 3 mg/kg	Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
BG001	Ipilimumab 10 mg/kg	Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
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
	BG00054.4± 13.34 BG00153.6± 13.50 BG00254.0± 13.42

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000195 BG001184 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0006 BG0018 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 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

Recurrence-free Survival (RFS)

RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.

All randomized participants

Posted

Median

95% Confidence Interval

Months

up to 36 months

ID	Title	Description
OG000	Nivolumab 3 mg/kg	Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
OG001	Ipilimumab 10 mg/kg	Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

Units	Counts
Participants	OG000453 OG001453

Title

Denominators

Categories

Title	Measurements
	OG00052.37(42.51 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold OG00124.08(16.56 to 35.09)

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 log rank	0.0003		Hazard Ratio (HR)	0.71			2-Sided	95	0.60	0.86					Superiority

Secondary

Overall Survival (OS)

OS is defined as as the time between the date of randomization and the date of death.

All randomized Participants

Posted

Median

95% Confidence Interval

Months

up to 106.6 months

ID	Title	Description
OG000	Nivolumab 3 mg/kg	Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
OG001	Ipilimumab 10 mg/kg	Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

Units	Counts
Participants	OG000

Secondary

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events

the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of adverse events

All treated participants

Posted

Number

Participants

reported between first dose and 30 days after last dose of study therapy

ID	Title	Description
OG000	Nivolumab 3 mg/kg	Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
OG001	Ipilimumab 10 mg/kg	Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

Units	Counts
Participants	OG000

Secondary

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events

The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events

all treated participants

Posted

Number

Participants

reported between the first dose and 30 days after last dose of study therapy

ID	Title	Description
OG000	Nivolumab 3 mg/kg	Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
OG001	Ipilimumab 10 mg/kg	Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

Units	Counts
Participants	OG000

Secondary

the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths

the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of Deaths

All treated participants

Posted

Number

Participants

reported between first dose and 30 to 100 days after last dose of study therapy

ID	Title	Description
OG000	Nivolumab 3 mg/kg	Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
OG001	Ipilimumab 10 mg/kg	Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

Units	Counts
Participants	OG000

Secondary

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities

The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.

Participants with a CTC graded Laboratory Result for the given parameter from both Baseline and On-treatment

Posted

Number

Participants

reported after first dose and within 30 days of last dose of the study therapy

ID	Title	Description
OG000	Nivolumab 3 mg/kg	Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
OG001	Ipilimumab 10 mg/kg	Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

Units	Counts
Participants	OG000

Secondary

Recurrence-free Survival by PD-L1 Expression

Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)

All randomized Participants

Posted

Median

95% Confidence Interval

Months

up to 106.6 months

ID	Title	Description
OG000	Nivolumab 3 mg/kg	Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
OG001	Ipilimumab 10 mg/kg	Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

Units	Counts
Participants	OG000

Secondary

Health Related Quality of Life (HRQoL) Evaluation

HRQoL was measured by mean changes from baseline in EORTC-QLQ-C30 global health status/QoL composite scale and in remaining EORTC QLQ-C30 scales in all randomized participants.

EORTC QLQ-C30 is the most commonly used QoL instrument in melanoma clinical studies, is a 30-item instrument that has gained wide acceptance in oncology clinical studies and comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Except for the overall health status and global quality of life items, responses for all items are 4 point categorical scales ranging from 1 (Not at all) to 4 (Very much). The overall health status/quality of life responses are 7-point Likert scales for which higher score reflects higher health status/quality of life for the 7-point Likert scale.

All randomized Participants with values from the second follow-up visit

Posted

Mean

Standard Deviation

Scores on a scale

up to 36 months

ID	Title	Description
OG000	Nivolumab 3 mg/kg	Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
OG001	Ipilimumab 10 mg/kg	Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

Post-Hoc

Recurrence-free Survival (RFS)

All randomized participants

Posted

Median

95% Confidence Interval

Months

up to 114 months

ID	Title	Description
OG000	Nivolumab 3 mg/kg	Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
OG001	Ipilimumab 10 mg/kg	Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

Units	Counts
Participants	OG000

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 3 mg/kg	Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24	128	452	106	452	421	452
EG001	Ipilimumab 10 mg/kg	Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks	142	453	215	453	438	453

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0002 affected452 at risk EG0010 affected453 at risk
Lymph node pain	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Lymphadenopathy	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0013 affected453 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0011 affected453 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Angina pectoris	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Atrial fibrillation	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0012 affected453 at risk
Bradycardia	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Left ventricular dysfunction	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Myocardial ischaemia	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Deafness	Ear and labyrinth disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Adrenal insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0015 affected453 at risk
Adrenal suppression	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Adrenocortical insufficiency acute	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Glucocorticoid deficiency	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Hyperthyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0002 affected452 at risk EG0011 affected453 at risk
Hypophysitis	Endocrine disorders	27.1	Systematic Assessment	EG0003 affected452 at risk EG00118 affected453 at risk
Hypopituitarism	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Hypothalamo-pituitary disorder	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0011 affected453 at risk
Lymphocytic hypophysitis	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0015 affected453 at risk
Uveitis	Eye disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Vision blurred	Eye disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Abdominal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0013 affected453 at risk
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0011 affected453 at risk
Autoimmune colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0015 affected453 at risk
Colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0005 affected452 at risk EG00141 affected453 at risk
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0005 affected452 at risk EG00137 affected453 at risk
Duodenitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Enteritis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Enterocolitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Gastric ulcer	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Gastritis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0013 affected453 at risk
Gastrointestinal perforation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Glossitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Ileus	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Inguinal hernia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Intestinal perforation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Intussusception	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Large intestine perforation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0013 affected453 at risk
Pancreatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0012 affected453 at risk
Proctitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Small intestinal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Stomatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Subileus	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected452 at risk EG0012 affected453 at risk
Asthenia	General disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Facial pain	General disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Hyperthermia	General disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Influenza like illness	General disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Malaise	General disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Mucosal inflammation	General disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Non-cardiac chest pain	General disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0011 affected453 at risk
Pyrexia	General disorders	27.1	Systematic Assessment	EG0008 affected452 at risk EG00111 affected453 at risk
Autoimmune hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0011 affected453 at risk
Cholecystitis acute	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Cholestasis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Drug-induced liver injury	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0012 affected453 at risk
Hepatic cytolysis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0012 affected453 at risk
Hepatic function abnormal	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0012 affected453 at risk
Hepatic haemorrhage	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0017 affected453 at risk
Hepatitis acute	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Hepatobiliary disease	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Hepatotoxicity	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Hypertransaminasaemia	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0013 affected453 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Cytokine release syndrome	Immune system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Sarcoidosis	Immune system disorders	27.1	Systematic Assessment	EG0002 affected452 at risk EG0010 affected453 at risk
Anorectal infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Appendicitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Bacteraemia	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Bacterial infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Brain abscess	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Bronchitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Cellulitis	Infections and infestations	27.1	Systematic Assessment	EG0007 affected452 at risk EG0013 affected453 at risk
Clostridium difficile colitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Device related infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Encephalitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Erysipelas	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0013 affected453 at risk
Fungal sepsis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Gastroenteritis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Infected seroma	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Infectious mononucleosis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Lower respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Meningitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Meningitis aseptic	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Mucormycosis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Myelitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Pharyngitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Pharyngotonsillitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0004 affected452 at risk EG0016 affected453 at risk
Pneumonia fungal	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0011 affected453 at risk
Pulmonary sepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Rash pustular	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Sepsis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0013 affected453 at risk
Sinobronchitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Sinusitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Skin infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Soft tissue infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Staphylococcal bacteraemia	Infections and infestations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Staphylococcal infection	Infections and infestations	27.1	Systematic Assessment	EG0002 affected452 at risk EG0010 affected453 at risk
Tonsillitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Upper respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Urinary tract infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0013 affected453 at risk
Urosepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Viral infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Wound infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Hand fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Incisional hernia	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0002 affected452 at risk EG0015 affected453 at risk
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Blood bilirubin increased	Investigations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Blood creatine phosphokinase increased	Investigations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Body temperature increased	Investigations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Electrocardiogram abnormal	Investigations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Faecal volume increased	Investigations	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Hepatic enzyme increased	Investigations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Liver function test increased	Investigations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0013 affected453 at risk
Neutrophil count decreased	Investigations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Transaminases increased	Investigations	27.1	Systematic Assessment	EG0000 affected452 at risk EG0015 affected453 at risk
Dehydration	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0014 affected453 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Fulminant type 1 diabetes mellitus	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Hyperglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0012 affected453 at risk
Hyperkalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Hypocalcaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Hypokalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0012 affected453 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Arthritis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Myalgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0011 affected453 at risk
Neck pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0011 affected453 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0002 affected452 at risk EG0010 affected453 at risk
Temporomandibular pain and dysfunction syndrome	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0003 affected452 at risk EG0013 affected453 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0002 affected452 at risk EG0010 affected453 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0004 affected452 at risk EG0013 affected453 at risk
Melanoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG00010 affected452 at risk EG0011 affected453 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0002 affected452 at risk EG0011 affected453 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0003 affected452 at risk EG0010 affected453 at risk
Neoplasm recurrence	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected452 at risk EG0012 affected453 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0005 affected452 at risk EG0011 affected453 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Bell's palsy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Cerebrovascular accident	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Dysarthria	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Encephalopathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Facial nerve disorder	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Haemorrhage intracranial	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Headache	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0014 affected453 at risk
Hypotonia	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
IVth nerve disorder	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Loss of consciousness	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Miller Fisher syndrome	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Neuropathy peripheral	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Neurosarcoidosis	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Peripheral sensory neuropathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Polyneuropathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Syncope	Nervous system disorders	27.1	Systematic Assessment	EG0002 affected452 at risk EG0013 affected453 at risk
Transient ischaemic attack	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Dependence	Psychiatric disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Acute kidney injury	Renal and urinary disorders	27.1	Systematic Assessment	EG0003 affected452 at risk EG0011 affected453 at risk
Cystitis haemorrhagic	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Nephrolithiasis	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Renal colic	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0011 affected453 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0011 affected453 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0011 affected453 at risk
Autoimmune lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected452 at risk EG0011 affected453 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected452 at risk EG0010 affected453 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected452 at risk EG0015 affected453 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0014 affected453 at risk
Acne	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Dermatitis exfoliative generalised	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Eczema	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0014 affected453 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0002 affected452 at risk EG0011 affected453 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Urticaria	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Capillary leak syndrome	Vascular disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0012 affected453 at risk
Giant cell arteritis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Hypertension	Vascular disorders	27.1	Systematic Assessment	EG0001 affected452 at risk EG0010 affected453 at risk
Hypotension	Vascular disorders	27.1	Systematic Assessment	EG0002 affected452 at risk EG0012 affected453 at risk
Orthostatic hypotension	Vascular disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk
Venous thrombosis limb	Vascular disorders	27.1	Systematic Assessment	EG0000 affected452 at risk EG0011 affected453 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG00013 affected452 at risk EG00126 affected453 at risk
Hyperthyroidism	Endocrine disorders	27.1	Systematic Assessment	EG00037 affected452 at risk EG00122 affected453 at risk
Hypophysitis	Endocrine disorders	27.1	Systematic Assessment	EG0006 affected452 at risk EG00142 affected453 at risk
Hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG00053 affected452 at risk EG00135 affected453 at risk
Abdominal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG00053 affected452 at risk EG00178 affected453 at risk
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG00033 affected452 at risk EG00121 affected453 at risk
Colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG00010 affected452 at risk EG00130 affected453 at risk
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG00047 affected452 at risk EG00146 affected453 at risk
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG000171 affected452 at risk EG001250 affected453 at risk
Dry mouth	Gastrointestinal disorders	27.1	Systematic Assessment	EG00033 affected452 at risk EG00123 affected453 at risk
Dyspepsia	Gastrointestinal disorders	27.1	Systematic Assessment	EG00021 affected452 at risk EG00127 affected453 at risk
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG000110 affected452 at risk EG001135 affected453 at risk
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG00039 affected452 at risk EG00168 affected453 at risk
Asthenia	General disorders	27.1	Systematic Assessment	EG00074 affected452 at risk EG00172 affected453 at risk
Chills	General disorders	27.1	Systematic Assessment	EG00011 affected452 at risk EG00131 affected453 at risk
Fatigue	General disorders	27.1	Systematic Assessment	EG000193 affected452 at risk EG001197 affected453 at risk
Influenza like illness	General disorders	27.1	Systematic Assessment	EG00032 affected452 at risk EG00139 affected453 at risk
Oedema peripheral	General disorders	27.1	Systematic Assessment	EG00024 affected452 at risk EG00129 affected453 at risk
Pyrexia	General disorders	27.1	Systematic Assessment	EG00039 affected452 at risk EG001105 affected453 at risk
Nasopharyngitis	Infections and infestations	27.1	Systematic Assessment	EG00053 affected452 at risk EG00124 affected453 at risk
Upper respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG00043 affected452 at risk EG00132 affected453 at risk
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG00038 affected452 at risk EG00188 affected453 at risk
Amylase increased	Investigations	27.1	Systematic Assessment	EG00029 affected452 at risk EG00126 affected453 at risk
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG00031 affected452 at risk EG00175 affected453 at risk
Blood alkaline phosphatase increased	Investigations	27.1	Systematic Assessment	EG0004 affected452 at risk EG00126 affected453 at risk
Lipase increased	Investigations	27.1	Systematic Assessment	EG00036 affected452 at risk EG00141 affected453 at risk
Weight decreased	Investigations	27.1	Systematic Assessment	EG00011 affected452 at risk EG00135 affected453 at risk
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00043 affected452 at risk EG00169 affected453 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG000103 affected452 at risk EG00180 affected453 at risk
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00049 affected452 at risk EG00146 affected453 at risk
Myalgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00060 affected452 at risk EG00135 affected453 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00042 affected452 at risk EG00136 affected453 at risk
Dizziness	Nervous system disorders	27.1	Systematic Assessment	EG00047 affected452 at risk EG00139 affected453 at risk
Headache	Nervous system disorders	27.1	Systematic Assessment	EG000109 affected452 at risk EG001148 affected453 at risk
Anxiety	Psychiatric disorders	27.1	Systematic Assessment	EG00025 affected452 at risk EG00121 affected453 at risk
Insomnia	Psychiatric disorders	27.1	Systematic Assessment	EG00035 affected452 at risk EG00143 affected453 at risk
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00084 affected452 at risk EG00183 affected453 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00034 affected452 at risk EG00145 affected453 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00024 affected452 at risk EG00117 affected453 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00030 affected452 at risk EG00137 affected453 at risk
Erythema	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00031 affected452 at risk EG00123 affected453 at risk
Pruritus	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG000136 affected452 at risk EG001179 affected453 at risk
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG000122 affected452 at risk EG001166 affected453 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00027 affected452 at risk EG00152 affected453 at risk
Hypertension	Vascular disorders	27.1	Systematic Assessment	EG00033 affected452 at risk EG00124 affected453 at risk

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

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