A Study of Nivolumab and Ipilimumab and Nivolumab Alone i... | NCT04340193

NCT04340193

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nivolumab + Ipilimumab + TACE	Experimental	TACE (Trans-arterial ChemoEmbolization)	Drug: nivolumab Drug: ipilimumab Procedure: TACE
Nivolumab + TACE	Experimental		Drug: nivolumab Procedure: TACE
TACE	Active Comparator		Procedure: TACE

Name	Type	Description	Arm Group Labels	Other Names
nivolumab	Drug	Specified dose on specified days	Nivolumab + Ipilimumab + TACE Nivolumab + TACE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.	From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Serious Adverse Events (SAEs)	Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose that results in death, Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) or requires inpatient hospitalization or causes prolongation of existing hospitalization, or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event.	From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants Who Died	Number of participants who died due to any cause are summarized.	From first dose and 100 days after last dose of study therapy (up to approximately 27 months)
Number of Participants With Adverse Events Leading to Study Drug Discontinuation	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.	From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0189		Coronado	California	92118	United States
Local Institution

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	NIVO+IPI+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.

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	Dec 1, 2021

Arm/Group Information

ID	Title	Description
BG000	NIVO+IPI+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
BG001	NIVO+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
BG002	TACE	Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00072.3± 10.28 BG00162.7± 11.19 BG00270.3± 8.89 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0011 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0011 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG0003 BG0013 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 Adverse Events

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

All treated participants included all enrolled participants who received at least one dose of any study treatment.

Posted

Count of Participants

Participants

From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

ID	Title	Description
OG000	NIVO+IPI+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
OG001	NIVO+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
OG002	TACE	Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.

Units	Counts
Participants	OG0009 OG0019 OG0028

Title

Denominators

Categories

Title	Measurements
	OG0009 OG0019 OG0028

Primary

Number of Participants With Serious Adverse Events (SAEs)

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose that results in death, Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) or requires inpatient hospitalization or causes prolongation of existing hospitalization, or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event.

All treated participants included all enrolled participants who received at least one dose of any study treatment.

Posted

Count of Participants

Participants

From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

ID	Title	Description
OG000	NIVO+IPI+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
OG001	NIVO+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.

Primary

Number of Participants Who Died

Number of participants who died due to any cause are summarized.

All treated participants included all enrolled participants who received at least one dose of any study treatment.

Posted

Count of Participants

Participants

From first dose and 100 days after last dose of study therapy (up to approximately 27 months)

ID	Title	Description
OG000	NIVO+IPI+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
OG001	NIVO+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.

Primary

Number of Participants With Adverse Events Leading to Study Drug Discontinuation

All treated participants included all enrolled participants who received at least one dose of any study treatment.

Posted

Count of Participants

Participants

From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

ID	Title	Description
OG000	NIVO+IPI+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
OG001	NIVO+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.

Primary

Number of Participants With Worst Grade (Grade 3/4) Laboratory Results

Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). Highest grade measured for hemoglobin and albumin was Grade 3.

All treated participants included all enrolled participants who received at least one dose of any study treatment.

Posted

Count of Participants

Participants

From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

ID	Title	Description
OG000	NIVO+IPI+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
OG001	NIVO+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.

Primary

Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

Blood samples were collected for specific thyroid test.

All treated participants with at least one on-treatment thyroid stimulating hormone (TSH) measurement.

Posted

Count of Participants

Participants

From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

ID	Title	Description
OG000	NIVO+IPI+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
OG001	NIVO+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.

Primary

Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests

Blood samples were collected for specific liver tests.

All treated participants included all enrolled participants who received at least one dose of any study treatment.

Posted

Count of Participants

Participants

From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

ID	Title	Description
OG000	NIVO+IPI+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
OG001	NIVO+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.

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	NIVO+IPI+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.	2	9	7	9	9	9
EG001	NIVO+TACE	Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.	2	9	6	9	9	9
EG002	TACE	Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.	0	8	2	8	8	8

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Diarrhoea	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Haematemesis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Rectal haemorrhage	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Non-cardiac chest pain	General disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Pyrexia	General disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0013 affected9 at risk EG0020 affected8 at risk
Hepatic failure	Hepatobiliary disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Hepatic infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Klebsiella bacteraemia	Infections and infestations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Alanine aminotransferase increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Aspartate aminotransferase increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Blood bilirubin increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
International normalised ratio increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Cell death	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Hyponatraemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Bursitis	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Encephalopathy	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Hepatic encephalopathy	Nervous system disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0012 affected9 at risk EG0022 affected8 at risk
Leukopenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Neutropenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Thrombocytopenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Cardiovascular disorder	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Tachycardia	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Adrenal insufficiency	Endocrine disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Hyperthyroidism	Endocrine disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Hypothyroidism	Endocrine disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Thyroiditis	Endocrine disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Abdominal distension	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Abdominal pain	Gastrointestinal disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0013 affected9 at risk EG0022 affected8 at risk
Abdominal pain lower	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Abdominal pain upper	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Anal haemorrhage	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Ascites	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0021 affected8 at risk
Chronic gastritis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Colitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Constipation	Gastrointestinal disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0012 affected9 at risk EG0024 affected8 at risk
Dental caries	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Diarrhoea	Gastrointestinal disorders	26.1	Systematic Assessment	EG0003 affected9 at risk EG0012 affected9 at risk EG0023 affected8 at risk
Dyspepsia	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0022 affected8 at risk
Faeces discoloured	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Gastric ulcer	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0022 affected8 at risk
Gastritis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Melaena	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Nausea	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0012 affected9 at risk EG0022 affected8 at risk
Portal hypertensive gastropathy	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Stomatitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Toothache	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Varices oesophageal	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Vomiting	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Asthenia	General disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0012 affected9 at risk EG0021 affected8 at risk
Device related thrombosis	General disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Fatigue	General disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Feeling hot	General disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Inflammation	General disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Mucosal inflammation	General disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Oedema peripheral	General disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0023 affected8 at risk
Pyrexia	General disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0013 affected9 at risk EG0022 affected8 at risk
Cholecystitis acute	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Hypertransaminasaemia	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Contrast media allergy	Immune system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Abdominal infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Anal abscess	Infections and infestations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Bacteriuria	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
COVID-19	Infections and infestations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Cystitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Dermo-hypodermitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Enteritis infectious	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Genital herpes	Infections and infestations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Helicobacter infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Herpes simplex	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Influenza	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Pharyngitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Pneumonia	Infections and infestations	26.1	Systematic Assessment	EG0002 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Pneumonia aspiration	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Respiratory tract infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Rhinitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Urinary tract infection	Infections and infestations	26.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Vulvovaginal mycotic infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Bone contusion	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Craniofacial fracture	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Fall	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Hepatobiliary procedural complication	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Incision site pain	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Limb injury	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Post embolisation syndrome	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Skin injury	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Tooth fracture	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Alanine aminotransferase increased	Investigations	26.1	Systematic Assessment	EG0002 affected9 at risk EG0012 affected9 at risk EG0021 affected8 at risk
Aspartate aminotransferase increased	Investigations	26.1	Systematic Assessment	EG0002 affected9 at risk EG0012 affected9 at risk EG0020 affected8 at risk
Blood alkaline phosphatase increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Blood bilirubin increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0012 affected9 at risk EG0020 affected8 at risk
Blood creatinine increased	Investigations	26.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Blood thyroid stimulating hormone increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Gamma-glutamyltransferase increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Gastric pH decreased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Inflammatory marker increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Lipase increased	Investigations	26.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Lymphocyte count decreased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Neutrophil count decreased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Oxygen saturation decreased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Weight decreased	Investigations	26.1	Systematic Assessment	EG0002 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Weight increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Decreased appetite	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0023 affected8 at risk
Diabetes mellitus	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Fluid retention	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Hyperammonaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Hyperglycaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Hyperkalaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0012 affected9 at risk EG0022 affected8 at risk
Hypocalcaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Hypoglycaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Hypokalaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0022 affected8 at risk
Arthritis	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Back pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0021 affected8 at risk
Bursitis	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Flank pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Myalgia	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0022 affected8 at risk
Dizziness	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Encephalopathy	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Hepatic encephalopathy	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Neuralgia	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Neuropathy peripheral	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Paraesthesia	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Peripheral sensory neuropathy	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Insomnia	Psychiatric disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0021 affected8 at risk
Dysuria	Renal and urinary disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Haematuria	Renal and urinary disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Hypertonic bladder	Renal and urinary disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Cough	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Eczema	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0011 affected9 at risk EG0021 affected8 at risk
Erythema	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Pruritus	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0003 affected9 at risk EG0014 affected9 at risk EG0022 affected8 at risk
Psoriasis	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Rash	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0011 affected9 at risk EG0023 affected8 at risk
Rash macular	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Haematoma	Vascular disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Raynaud's phenomenon	Vascular disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected8 at risk

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D008107	Liver 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