An Investigational Immuno-therapy Study for Safety of Niv... | NCT02869789

NCT02869789

ID	Type	Description	Link
2016-002621-10	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Nivolumab in combination with Ipilimumab	Experimental	Specified dose on specified days	Drug: Nivolumab in combination with Ipilimumab

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab in combination with Ipilimumab	Drug	Specified dose on specified days	Nivolumab in combination with Ipilimumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs)	Drug related AEs are those events with relationship to study drug. If the relationship to study drug is missing, the AE will be considered as drug-related. The select AEs of interest are the following: Pulmonary, Renal, Gastrointestinal, Hepatic, Skin, Endocrine, and hypersensitivity/infusion reaction events. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death	From first dose to 30 days post last dose (Up to approximately 27 months)
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs)	imAEs are specific events that include pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, and endocrine (adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis). AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death	From first dose to 100 days post last dose (Up to approximately 29 months)

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first. Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0121		Birmingham	Alabama	35205	United States
Local Institution - 0148

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36725084	Derived	Ready NE, Audigier-Valette C, Goldman JW, Felip E, Ciuleanu TE, Rosario Garcia Campelo M, Jao K, Barlesi F, Bordenave S, Rijavec E, Urban L, Aucoin JS, Zannori C, Vermaelen K, Aren Frontera O, Curioni Fontecedro A, Sanchez-Gastaldo A, Juan-Vidal O, Linardou H, Poddubskaya E, Spigel DR, Ahmed S, Maio M, Li S, Chang H, Fiore J, Acevedo A, Paz-Ares L. First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817. J Immunother Cancer. 2023 Feb;11(2):e006127. doi: 10.1136/jitc-2022-006127.

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort A	First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
FG001	Cohort A1

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 2, 2019

Arm/Group Information

ID	Title	Description
BG000	Cohort A	First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
BG001	Cohort A1	First-line NSCLC special population: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
BG002	Cohort B	Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
BG003	Cohort C	First-line NSCLC high tumor mutational burden (H-TMB >= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
BG004	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, Customized

Number

Participants

Title

Denominators

Categories

< 65 years old

Title	Measurements
	BG000183 BG00181 BG002200 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000155 BG00171 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00010 BG00113 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

Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs)

Drug related AEs are those events with relationship to study drug. If the relationship to study drug is missing, the AE will be considered as drug-related. The select AEs of interest are the following: Pulmonary, Renal, Gastrointestinal, Hepatic, Skin, Endocrine, and hypersensitivity/infusion reaction events. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death

All treated participants as pre-specified in Cohort A, B, and C

Posted

Count of Participants

Participants

From first dose to 30 days post last dose (Up to approximately 27 months)

ID	Title	Description
OG000	Cohort A	First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
OG001	Cohort B	Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
OG002	Cohort C	First-line NSCLC high tumor mutational burden (H-TMB >= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first

Units	Counts
Participants	OG000391 OG001395 OG00257

Title

Denominators

Categories

Gastrointestinal AEs grade 3-4

Title	Measurements
	OG00019 OG00115 OG0024

Gastrointestinal AEs grade 5

Primary

Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs)

imAEs are specific events that include pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, and endocrine (adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis). AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death

All treated participants as pre-specified in Cohort A, B, and C

Posted

Count of Participants

Participants

From first dose to 100 days post last dose (Up to approximately 29 months)

ID	Title	Description
OG000	Cohort A	First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
OG001	Cohort B	Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
OG002	Cohort C

Secondary

Progression Free Survival (PFS)

PFS is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.

Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.

All treated participants as pre-specified in Cohort A, B, and C

Posted

Median

95% Confidence Interval

Months

From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months)

ID	Title	Description
OG000	Cohort A	First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
OG001	Cohort B	Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
OG002

Secondary

Overall Survival (OS)

OS is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive.

All treated participants as pre-specified in Cohort A, B, and C

Posted

Median

95% Confidence Interval

Months

From first dosing date to the date of death (Up to approximately 67 months)

ID	Title	Description
OG000	Cohort A	First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
OG001	Cohort B	Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
OG002	Cohort C	First-line NSCLC high tumor mutational burden (H-TMB >= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first

Secondary

Objective Response Rate (ORR)

ORR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR).

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

PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

All treated participants as pre-specified in Cohort A, B, and C

Posted

Number

95% Confidence Interval

Percentage of participants

From first dosing date up to approximately 67 months

ID	Title	Description
OG000	Cohort A	First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
OG001	Cohort B	Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
OG002	Cohort C	First-line NSCLC high tumor mutational burden (H-TMB >= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first

Secondary

Duration of Response (DoR)

DoR is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression per RECIST 1.1, or death due to any cause, whichever occurs first.

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

PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

All treated participants with confirmed CR or PR as pre-specified in Cohort A, B, and C

Posted

Median

95% Confidence Interval

Months

From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months)

ID	Title	Description
OG000	Cohort A	First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
OG001	Cohort B	Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first

Secondary

Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L)

FACT-L is a quality-of-life questionnaire which includes Lung Cancer Subscale (LCS) that assesses the treatment impact on lung cancer related symptoms in 5 domains: Physical, social/family, emotional, and functional well-being using a 5-point scale (0=not at all; 1=a little bit, 2=somewhat; 3=quite a bit; 4=very much) added to obtain total score. The ranges of possible total scores are 0-136 for the FACT-L with a higher score representing better quality of life, improved symptomatology and enhanced physical/functional outcomes. According to Functional Assessment of Chronic Illness Therapy scoring guidelines, in the event of missing responses for some of the questions, scores will be prorated using the average of the other answers in that scale.

Baseline is defined as events that occur before the date/time of first dose. Post treatment visits include follow-up (FU) visit 1, FU visit 2, and subsequent survival FU visits to occur every 3 months up until survival FU visit 18.

All treated participants who have an assessment at baseline and at least 1 follow-up assessment as pre-specified in Cohort A, B, and C

Posted

Mean

Standard Deviation

Units on a Scale

From baseline and up to subsequent survival follow-up visit 18 (Up to approximately 67 months)

ID	Title	Description
OG000	Cohort A	First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first

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	Cohort A	First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	294	391	264	391	362	391
EG001	Cohort A1	First-line NSCLC special population: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	166	198	149	198	174	198
EG002	Cohort B	Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	334	395	282	395	346	395
EG003	Cohort C	First-line NSCLC high tumor mutational burden (H-TMB >= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	32	57	42	57	56	57

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0012 affected198 at risk EG0024 affected395 at risk EG0032 affected57 at risk
Autoimmune anaemia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0004 affected391 at risk EG0010 affected198 at risk EG0023 affected395 at risk EG003
Immune thrombocytopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Acute coronary syndrome	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Acute myocardial infarction	Cardiac disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0011 affected198 at risk EG0023 affected395 at risk EG003
Angina unstable	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Arrhythmia	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Atrial fibrillation	Cardiac disorders	25.0	Systematic Assessment	EG0007 affected391 at risk EG0011 affected198 at risk EG0022 affected395 at risk EG003
Atrial flutter	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Cardiac arrest	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Cardiac failure	Cardiac disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Cardiac failure congestive	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Cardiac tamponade	Cardiac disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Cardiogenic shock	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Cardiopulmonary failure	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Intracardiac thrombus	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Myocardial infarction	Cardiac disorders	25.0	Systematic Assessment	EG0003 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Myocarditis	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Pericardial effusion	Cardiac disorders	25.0	Systematic Assessment	EG0006 affected391 at risk EG0012 affected198 at risk EG0021 affected395 at risk EG003
Pericarditis	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Sinus tachycardia	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Supraventricular tachycardia	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Vertigo	Ear and labyrinth disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Adrenal insufficiency	Endocrine disorders	25.0	Systematic Assessment	EG0006 affected391 at risk EG0012 affected198 at risk EG0024 affected395 at risk EG003
Adrenocorticotropic hormone deficiency	Endocrine disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0012 affected198 at risk EG0020 affected395 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Euthyroid sick syndrome	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Hyperthyroidism	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0023 affected395 at risk EG003
Hypophysitis	Endocrine disorders	25.0	Systematic Assessment	EG0003 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Hypopituitarism	Endocrine disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Hypothyroidism	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Inappropriate antidiuretic hormone secretion	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Lymphocytic hypophysitis	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Thyroiditis	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Ophthalmoplegia	Eye disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Abdominal pain	Gastrointestinal disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Ascites	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Autoimmune colitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Barrett's oesophagus	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Chronic gastritis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Colitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0005 affected391 at risk EG0013 affected198 at risk EG0026 affected395 at risk EG003
Constipation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Diaphragmatic hernia	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Diarrhoea	Gastrointestinal disorders	25.0	Systematic Assessment	EG0007 affected391 at risk EG0014 affected198 at risk EG00211 affected395 at risk EG003
Diverticular perforation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Dysphagia	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0013 affected198 at risk EG0022 affected395 at risk EG003
Enteritis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Enterocolitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Gastric perforation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Gastric ulcer	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Gastritis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Gastrointestinal necrosis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Gastrointestinal toxicity	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Haematochezia	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0003 affected391 at risk EG0014 affected198 at risk EG0025 affected395 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Intestinal perforation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Large intestine perforation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Mouth ulceration	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Nausea	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0013 affected198 at risk EG0020 affected395 at risk EG003
Oesophagitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Pancreatitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Stomatitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Subileus	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Vomiting	Gastrointestinal disorders	25.0	Systematic Assessment	EG0003 affected391 at risk EG0013 affected198 at risk EG0022 affected395 at risk EG003
Asthenia	General disorders	25.0	Systematic Assessment	EG0004 affected391 at risk EG0011 affected198 at risk EG0022 affected395 at risk EG003
Chest pain	General disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Chills	General disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Death	General disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Disease progression	General disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Fatigue	General disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
General physical health deterioration	General disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0013 affected198 at risk EG0023 affected395 at risk EG003
Hyperthermia	General disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Mucosal inflammation	General disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Multiple organ dysfunction syndrome	General disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0012 affected198 at risk EG0021 affected395 at risk EG003
Non-cardiac chest pain	General disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Oedema peripheral	General disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Pain	General disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0024 affected395 at risk EG003
Performance status decreased	General disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0011 affected198 at risk EG0023 affected395 at risk EG003
Pyrexia	General disorders	25.0	Systematic Assessment	EG0005 affected391 at risk EG0018 affected198 at risk EG0027 affected395 at risk EG003
Sudden death	General disorders	25.0	Systematic Assessment	EG0006 affected391 at risk EG0014 affected198 at risk EG0024 affected395 at risk EG003
Ulcer	General disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Biliary cirrhosis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Cholangitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Cholecystitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Hepatic failure	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Hepatic haematoma	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Hepatitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0012 affected198 at risk EG0021 affected395 at risk EG003
Hepatitis toxic	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	25.0	Systematic Assessment	EG0004 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Liver disorder	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Liver injury	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Anaphylactic reaction	Immune system disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Contrast media allergy	Immune system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Hypersensitivity	Immune system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Abscess	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Appendicitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Arthritis bacterial	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Atypical pneumonia	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Bacteraemia	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Bacterial infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0012 affected198 at risk EG0020 affected395 at risk EG003
Bronchitis	Infections and infestations	25.0	Systematic Assessment	EG0002 affected391 at risk EG0013 affected198 at risk EG0027 affected395 at risk EG003
Bronchitis bacterial	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Cellulitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Cholecystitis infective	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Clostridium difficile colitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Clostridium difficile infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Colonic abscess	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Cystitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Device related infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Diarrhoea infectious	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Diverticulitis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Diverticulitis intestinal perforated	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Encephalitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0014 affected198 at risk EG0021 affected395 at risk EG003
Erysipelas	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Escherichia urinary tract infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Fungal oesophagitis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Gastroenteritis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Infectious pleural effusion	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Infective spondylitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Influenza	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0012 affected198 at risk EG0021 affected395 at risk EG003
Liver abscess	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Lower respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Lung abscess	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Oral candidiasis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Orchitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Peritonitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Pneumococcal sepsis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Pneumonia	Infections and infestations	25.0	Systematic Assessment	EG00021 affected391 at risk EG0016 affected198 at risk EG00226 affected395 at risk EG003
Pneumonia aspiration	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Pneumonia bacterial	Infections and infestations	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Post procedural infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Pyelonephritis acute	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG0007 affected391 at risk EG0014 affected198 at risk EG0023 affected395 at risk EG003
Sepsis	Infections and infestations	25.0	Systematic Assessment	EG0007 affected391 at risk EG0014 affected198 at risk EG0025 affected395 at risk EG003
Septic shock	Infections and infestations	25.0	Systematic Assessment	EG0005 affected391 at risk EG0012 affected198 at risk EG0022 affected395 at risk EG003
Skin infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Staphylococcal infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Staphylococcal sepsis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Upper respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Urinary tract infection	Infections and infestations	25.0	Systematic Assessment	EG0002 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Urosepsis	Infections and infestations	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Viral infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Anastomotic stenosis	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Fall	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Incision site impaired healing	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0004 affected391 at risk EG0011 affected198 at risk EG0022 affected395 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Overdose	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Poisoning	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Recall phenomenon	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Wound evisceration	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Amylase increased	Investigations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Blood creatinine increased	Investigations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Blood gases abnormal	Investigations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
C-reactive protein increased	Investigations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
General physical condition abnormal	Investigations	25.0	Systematic Assessment	EG0002 affected391 at risk EG0012 affected198 at risk EG0020 affected395 at risk EG003
Influenza B virus test positive	Investigations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
International normalised ratio increased	Investigations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Lipase increased	Investigations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Liver function test increased	Investigations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Neutrophil count decreased	Investigations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Oxygen saturation decreased	Investigations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Platelet count decreased	Investigations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Transaminases increased	Investigations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Troponin increased	Investigations	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Weight decreased	Investigations	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Acidosis	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Dehydration	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0012 affected198 at risk EG0022 affected395 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0003 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0004 affected391 at risk EG0013 affected198 at risk EG0021 affected395 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0013 affected198 at risk EG0020 affected395 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0004 affected391 at risk EG0012 affected198 at risk EG0023 affected395 at risk EG003
Hypophagia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Steroid diabetes	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0015 affected198 at risk EG0022 affected395 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0003 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Osteolysis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0011 affected198 at risk EG0022 affected395 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Polymyositis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Lymphangiosis carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG00081 affected391 at risk EG00164 affected198 at risk EG002144 affected395 at risk EG003
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Pericardial effusion malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Respiratory tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Tumour compression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Tumour obstruction	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Aphasia	Nervous system disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0023 affected395 at risk EG003
Balance disorder	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Brain oedema	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Burning sensation	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Central nervous system lesion	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Cerebral haemorrhage	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Cerebral ischaemia	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Cerebrovascular accident	Nervous system disorders	25.0	Systematic Assessment	EG0003 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Cluster headache	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Dizziness	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Embolic stroke	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Encephalitis autoimmune	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Encephalopathy	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Epilepsy	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Febrile convulsion	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Guillain-Barre syndrome	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Haemorrhage intracranial	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Headache	Nervous system disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0013 affected198 at risk EG0020 affected395 at risk EG003
Hemianopia homonymous	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Hemiparesis	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Immune-mediated encephalitis	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Intracranial pressure increased	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Ischaemic cerebral infarction	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Loss of consciousness	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Monoparesis	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Motor dysfunction	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Myasthenic syndrome	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Neurological decompensation	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Optic neuritis	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Paraesthesia	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Paresis	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Pyramidal tract syndrome	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Seizure	Nervous system disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Somnolence	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Spinal cord compression	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Status epilepticus	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Syncope	Nervous system disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Transient aphasia	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Transient ischaemic attack	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Vasogenic cerebral oedema	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Device dislocation	Product Issues	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Device loosening	Product Issues	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Agitation	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Confusional state	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0012 affected198 at risk EG0022 affected395 at risk EG003
Delirium	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Disorientation	Psychiatric disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Mental status changes	Psychiatric disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Schizophrenia	Psychiatric disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Acute kidney injury	Renal and urinary disorders	25.0	Systematic Assessment	EG0004 affected391 at risk EG0010 affected198 at risk EG0028 affected395 at risk EG003
Chronic kidney disease	Renal and urinary disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Cystitis haemorrhagic	Renal and urinary disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Haematuria	Renal and urinary disorders	25.0	Systematic Assessment	EG0003 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Hydronephrosis	Renal and urinary disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Immune-mediated nephritis	Renal and urinary disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Renal failure	Renal and urinary disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Breast inflammation	Reproductive system and breast disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Breast pain	Reproductive system and breast disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Pelvic pain	Reproductive system and breast disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Alveolitis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0022 affected395 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Bronchostenosis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0006 affected391 at risk EG0013 affected198 at risk EG0027 affected395 at risk EG003
Diaphragmatic paralysis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00014 affected391 at risk EG0019 affected198 at risk EG00222 affected395 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0005 affected391 at risk EG0012 affected198 at risk EG0025 affected395 at risk EG003
Hypersensitivity pneumonitis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0008 affected391 at risk EG0014 affected198 at risk EG0024 affected395 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00023 affected391 at risk EG0011 affected198 at risk EG00217 affected395 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0016 affected198 at risk EG0024 affected395 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0022 affected395 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0009 affected391 at risk EG0012 affected198 at risk EG0022 affected395 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Eosinophilic cellulitis	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Pustular psoriasis	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Rash	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0011 affected198 at risk EG0022 affected395 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Skin necrosis	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Toxic skin eruption	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Brachiocephalic vein thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Deep vein thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0003 affected391 at risk EG0012 affected198 at risk EG0022 affected395 at risk EG003
Embolism	Vascular disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Exsanguination	Vascular disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Hypotension	Vascular disorders	25.0	Systematic Assessment	EG0003 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Infarction	Vascular disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Peripheral ischaemia	Vascular disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Subclavian vein thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003
Superior vena cava syndrome	Vascular disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0021 affected395 at risk EG003
Thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Vena cava thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0010 affected198 at risk EG0021 affected395 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG00053 affected391 at risk EG00135 affected198 at risk EG00253 affected395 at risk EG00313 affected57 at risk
Atrial fibrillation	Cardiac disorders	25.0	Systematic Assessment	EG00013 affected391 at risk EG0016 affected198 at risk EG0028 affected395 at risk EG003
Adrenal insufficiency	Endocrine disorders	25.0	Systematic Assessment	EG0009 affected391 at risk EG0014 affected198 at risk EG0027 affected395 at risk EG003
Hyperthyroidism	Endocrine disorders	25.0	Systematic Assessment	EG00031 affected391 at risk EG00117 affected198 at risk EG00235 affected395 at risk EG003
Hypothyroidism	Endocrine disorders	25.0	Systematic Assessment	EG00055 affected391 at risk EG00114 affected198 at risk EG00245 affected395 at risk EG003
Dry eye	Eye disorders	25.0	Systematic Assessment	EG0007 affected391 at risk EG0011 affected198 at risk EG0024 affected395 at risk EG003
Vision blurred	Eye disorders	25.0	Systematic Assessment	EG00010 affected391 at risk EG0016 affected198 at risk EG0025 affected395 at risk EG003
Abdominal pain	Gastrointestinal disorders	25.0	Systematic Assessment	EG00033 affected391 at risk EG0015 affected198 at risk EG00221 affected395 at risk EG003
Colitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0009 affected391 at risk EG0017 affected198 at risk EG0023 affected395 at risk EG003
Constipation	Gastrointestinal disorders	25.0	Systematic Assessment	EG00069 affected391 at risk EG00126 affected198 at risk EG00253 affected395 at risk EG003
Diarrhoea	Gastrointestinal disorders	25.0	Systematic Assessment	EG000122 affected391 at risk EG00148 affected198 at risk EG00280 affected395 at risk EG003
Dry mouth	Gastrointestinal disorders	25.0	Systematic Assessment	EG00020 affected391 at risk EG0014 affected198 at risk EG00212 affected395 at risk EG003
Dysphagia	Gastrointestinal disorders	25.0	Systematic Assessment	EG00012 affected391 at risk EG0014 affected198 at risk EG00211 affected395 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	25.0	Systematic Assessment	EG00013 affected391 at risk EG0011 affected198 at risk EG0023 affected395 at risk EG003
Nausea	Gastrointestinal disorders	25.0	Systematic Assessment	EG00097 affected391 at risk EG00140 affected198 at risk EG00265 affected395 at risk EG003
Oral pain	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected391 at risk EG0010 affected198 at risk EG0020 affected395 at risk EG003
Vomiting	Gastrointestinal disorders	25.0	Systematic Assessment	EG00063 affected391 at risk EG00118 affected198 at risk EG00252 affected395 at risk EG003
Asthenia	General disorders	25.0	Systematic Assessment	EG00084 affected391 at risk EG00145 affected198 at risk EG00267 affected395 at risk EG003
Chills	General disorders	25.0	Systematic Assessment	EG00016 affected391 at risk EG0012 affected198 at risk EG00210 affected395 at risk EG003
Fatigue	General disorders	25.0	Systematic Assessment	EG000140 affected391 at risk EG00139 affected198 at risk EG00287 affected395 at risk EG003
Localised oedema	General disorders	25.0	Systematic Assessment	EG0000 affected391 at risk EG0011 affected198 at risk EG0020 affected395 at risk EG003
Malaise	General disorders	25.0	Systematic Assessment	EG0007 affected391 at risk EG0011 affected198 at risk EG0023 affected395 at risk EG003
Non-cardiac chest pain	General disorders	25.0	Systematic Assessment	EG00011 affected391 at risk EG0018 affected198 at risk EG00211 affected395 at risk EG003
Oedema peripheral	General disorders	25.0	Systematic Assessment	EG00039 affected391 at risk EG00114 affected198 at risk EG00232 affected395 at risk EG003
Pain	General disorders	25.0	Systematic Assessment	EG00020 affected391 at risk EG0016 affected198 at risk EG00210 affected395 at risk EG003
Pyrexia	General disorders	25.0	Systematic Assessment	EG00066 affected391 at risk EG00125 affected198 at risk EG00251 affected395 at risk EG003
Bronchitis	Infections and infestations	25.0	Systematic Assessment	EG00018 affected391 at risk EG0018 affected198 at risk EG00223 affected395 at risk EG003
Nasopharyngitis	Infections and infestations	25.0	Systematic Assessment	EG00029 affected391 at risk EG00110 affected198 at risk EG00214 affected395 at risk EG003
Pneumonia	Infections and infestations	25.0	Systematic Assessment	EG00023 affected391 at risk EG00115 affected198 at risk EG00217 affected395 at risk EG003
Upper respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG00023 affected391 at risk EG0016 affected198 at risk EG00223 affected395 at risk EG003
Urinary tract infection	Infections and infestations	25.0	Systematic Assessment	EG00024 affected391 at risk EG0017 affected198 at risk EG00211 affected395 at risk EG003
Fall	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG00012 affected391 at risk EG0012 affected198 at risk EG0028 affected395 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG00022 affected391 at risk EG0012 affected198 at risk EG00211 affected395 at risk EG003
Alanine aminotransferase increased	Investigations	25.0	Systematic Assessment	EG00020 affected391 at risk EG00112 affected198 at risk EG00219 affected395 at risk EG003
Amylase increased	Investigations	25.0	Systematic Assessment	EG00027 affected391 at risk EG00119 affected198 at risk EG00231 affected395 at risk EG003
Aspartate aminotransferase increased	Investigations	25.0	Systematic Assessment	EG00014 affected391 at risk EG00111 affected198 at risk EG00218 affected395 at risk EG003
Blood alkaline phosphatase increased	Investigations	25.0	Systematic Assessment	EG00010 affected391 at risk EG0018 affected198 at risk EG00220 affected395 at risk EG003
Blood creatinine increased	Investigations	25.0	Systematic Assessment	EG00018 affected391 at risk EG00111 affected198 at risk EG00222 affected395 at risk EG003
Lipase increased	Investigations	25.0	Systematic Assessment	EG00035 affected391 at risk EG00118 affected198 at risk EG00231 affected395 at risk EG003
Lymphocyte count decreased	Investigations	25.0	Systematic Assessment	EG0003 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Neutrophil count decreased	Investigations	25.0	Systematic Assessment	EG0003 affected391 at risk EG0011 affected198 at risk EG0024 affected395 at risk EG003
Weight decreased	Investigations	25.0	Systematic Assessment	EG00033 affected391 at risk EG00116 affected198 at risk EG00223 affected395 at risk EG003
Weight increased	Investigations	25.0	Systematic Assessment	EG0004 affected391 at risk EG0012 affected198 at risk EG0025 affected395 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00096 affected391 at risk EG00138 affected198 at risk EG00283 affected395 at risk EG003
Dehydration	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00026 affected391 at risk EG0016 affected198 at risk EG00212 affected395 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00012 affected391 at risk EG00111 affected198 at risk EG00221 affected395 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0008 affected391 at risk EG0014 affected198 at risk EG0028 affected395 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00011 affected391 at risk EG0017 affected198 at risk EG0029 affected395 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00031 affected391 at risk EG00112 affected198 at risk EG00224 affected395 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00012 affected391 at risk EG0014 affected198 at risk EG0024 affected395 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00018 affected391 at risk EG00113 affected198 at risk EG00229 affected395 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00063 affected391 at risk EG00125 affected198 at risk EG00244 affected395 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0006 affected391 at risk EG0017 affected198 at risk EG0023 affected395 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00051 affected391 at risk EG00115 affected198 at risk EG00247 affected395 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00014 affected391 at risk EG0015 affected198 at risk EG00215 affected395 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00012 affected391 at risk EG0011 affected198 at risk EG0027 affected395 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00019 affected391 at risk EG0013 affected198 at risk EG00215 affected395 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00030 affected391 at risk EG0017 affected198 at risk EG00227 affected395 at risk EG003
Dizziness	Nervous system disorders	25.0	Systematic Assessment	EG00032 affected391 at risk EG00115 affected198 at risk EG00224 affected395 at risk EG003
Headache	Nervous system disorders	25.0	Systematic Assessment	EG00054 affected391 at risk EG00126 affected198 at risk EG00234 affected395 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	25.0	Systematic Assessment	EG0002 affected391 at risk EG0010 affected198 at risk EG0022 affected395 at risk EG003
Anxiety	Psychiatric disorders	25.0	Systematic Assessment	EG00019 affected391 at risk EG0018 affected198 at risk EG00211 affected395 at risk EG003
Depression	Psychiatric disorders	25.0	Systematic Assessment	EG00021 affected391 at risk EG0011 affected198 at risk EG0026 affected395 at risk EG003
Insomnia	Psychiatric disorders	25.0	Systematic Assessment	EG00034 affected391 at risk EG00114 affected198 at risk EG00217 affected395 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0007 affected391 at risk EG0015 affected198 at risk EG0028 affected395 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00098 affected391 at risk EG00122 affected198 at risk EG00271 affected395 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00085 affected391 at risk EG00141 affected198 at risk EG00285 affected395 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00020 affected391 at risk EG00110 affected198 at risk EG00221 affected395 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0007 affected391 at risk EG0014 affected198 at risk EG00210 affected395 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0008 affected391 at risk EG0011 affected198 at risk EG0025 affected395 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00031 affected391 at risk EG0014 affected198 at risk EG00218 affected395 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00031 affected391 at risk EG00113 affected198 at risk EG00228 affected395 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00029 affected391 at risk EG0019 affected198 at risk EG00224 affected395 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00010 affected391 at risk EG0016 affected198 at risk EG00220 affected395 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00082 affected391 at risk EG00132 affected198 at risk EG00279 affected395 at risk EG003
Rash	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00059 affected391 at risk EG00131 affected198 at risk EG00252 affected395 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00030 affected391 at risk EG0016 affected198 at risk EG00216 affected395 at risk EG003
Hypotension	Vascular disorders	25.0	Systematic Assessment	EG00020 affected391 at risk EG0015 affected198 at risk EG00212 affected395 at risk EG003

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

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