Study of Nivolumab Combined With Ipilimumab Versus Pemetr... | NCT02899299

NCT02899299

ID	Type	Description	Link
2016-001859-43	EudraCT Number

Status Module

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nivolumab and Ipilimumab	Experimental	Specified dose on specified days	Biological: Nivolumab Biological: Ipilimumab
Pemetrexed and Cisplatin (or Carboplatin)	Active Comparator	Specified dose on specified days	Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.	From randomization to the date of death (Up to 40 Months)

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)	Objective Response Rate is defined as the percentage of randomized participants who achieve a best overall response of complete response (CR) or partial response (PR) per Blinded Independent Central Review (BICR) assessments. Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. Per RECIST 1.1 for solid tumors, confirmation of response required: CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Ucsf		San Francisco	California	94143	United States
Local Institution - 0014

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41734361	Derived	Scherpereel A, Baas P, Nowak AK, Tsao AS, Fujimoto N, Peters S, Mansfield AS, Popat S, Bautista Aragon Y, Talbot T, Grossi F, Kowalski D, Kaplan MA, Cardona AF, Soomro R, Hu N, Lee A, Ip V, Hung YH, Zalcman G. Five-Year Clinical Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Unresectable Pleural Mesothelioma in CheckMate 743. J Clin Oncol. 2026 Mar 20;44(9):742-749. doi: 10.1200/JCO-25-01328. Epub 2026 Feb 24.
35367910

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Treatment A	Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
FG001	Treatment B	Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 25, 2019	Mar 24, 2021

Arm/Group Information

ID	Title	Description
BG000	Treatment A	Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
BG001	Treatment B	Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00068.7± 8.5 BG00167.8± 9.7 BG00268.2± 9.1

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00069 BG00169 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00019 BG00119 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0014 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival (OS)

Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.

All Randomized Participants

Posted

Median

95% Confidence Interval

Months

From randomization to the date of death (Up to 40 Months)

ID	Title	Description
OG000	Treatment A	Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
OG001	Treatment B	Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles

Units	Counts
Participants	OG000303 OG001302

Title

Denominators

Categories

Title	Measurements
	OG00018.07(16.82 to 21.45) OG00114.09(12.45 to 16.23)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Stratified Log Rank	This is 2 sided p-value from log-rank test stratified by histology and sex as entered in the IRT	0.0020	Boundary for statistical significance was a p-value < 0.0345	Hazard Ratio (HR)	0.74			2-Sided	96.6	0.60	0.91			Stratified Cox proportional hazard model		Superiority	Treatment A over Treatment B

Secondary

Objective Response Rate (ORR)

Objective Response Rate is defined as the percentage of randomized participants who achieve a best overall response of complete response (CR) or partial response (PR) per Blinded Independent Central Review (BICR) assessments. Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. Per RECIST 1.1 for solid tumors, confirmation of response required:

All Randomized Participants

Posted

Number

95% Confidence Interval

Percentage of Participants

From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months)

ID	Title	Description
OG000	Treatment A	Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
OG001	Treatment B	Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles

Units

Secondary

Disease Control Rate (DCR)

Disease Control Rate is defined as the percentage of all randomized participants whose Best Overall Response was complete response (CR), partial response (PR), stable disease (SD) or Non-CR/Non-PD as assessed by Blinded Independent Central Review (BICR). Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. Per RECIST 1.1 for solid tumors, confirmation of response required:

CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Non-CR/Non-PD: Persistence of one or more non-target lesion(s).

All Randomized Participants

Posted

Number

95% Confidence Interval

Percentage of Participants

From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months

ID	Title	Description
OG000	Treatment A	Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
OG001	Treatment B	Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles

Secondary

Progression Free Survival (PFS)

Progression Free Survival is defined as the time between the date of randomization and the date of first documented tumor progression per Blinded Independent Central Review (BICR) assessments (using adapted m-RECIST and RECIST 1.1), or death due to any cause, whichever occurs first. Participants who received subsequent anticancer therapy prior to documented progression were censored at the date of the last evaluable tumor assessment conducted on or prior to the date of initiation of the subsequent anticancer therapy.

Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.

All Randomized Participants

Posted

Median

95% Confidence Interval

Months

From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)

ID	Title	Description
OG000	Treatment A	Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
OG001	Treatment B	Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles

Units	Counts
Participants

Secondary

Overall Survival (OS) According to PD-L1 Expression Level

All PD-L1 evaluable participants with baseline expression <1% or ≥1%

Posted

Median

95% Confidence Interval

Months

From randomization date to the date of death (Up to 76 Months)

ID	Title	Description
OG000	Treatment A	Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
OG001	Treatment B	Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles

Units	Counts
Participants	OG000

Secondary

Progression Free Survival (PFS) According to PD-L1 Expression Level

PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by progression free survival (PFS) analysis. PFS is defined as the time between the date of randomization and the date of first documented tumor progression per Blinded Independent Central Review (BICR) assessments (using adapted m-RECIST and RECIST 1.1), or death due to any cause, whichever occurs first. Participants who received subsequent anticancer therapy prior to documented progression were censored at the date of the last evaluable tumor assessment conducted on or prior to the date of initiation of the subsequent anticancer therapy.

Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.

All PD-L1 evaluable participants with baseline expression <1% or ≥1%

Posted

Median

95% Confidence Interval

Months

From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)

ID	Title	Description
OG000	Treatment A	Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
OG001	Treatment B	Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles

Secondary

Objective Response Rate (ORR) According to PD-L1 Expression Level

PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by objective response rate (ORR) analysis. ORR is defined as the percentage of participants who achieve a best overall response of complete response (CR) or partial response (PR) per Blinded Independent Central Review (BICR) assessments. Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure.

per RECIST 1.1 for solid tumors, confirmation of response required: CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.

All PD-L1 evaluable participants with baseline expression <1% or ≥1%

Posted

Number

95% Confidence Interval

Percentage of Participants

From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months)

ID	Title	Description
OG000	Treatment A	Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
OG001	Treatment B

Post-Hoc

Extended Collection: Overall Survival (OS)

Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.

All Randomized Participants

Posted

Median

95% Confidence Interval

Months

From randomization date to the date of death (Up to 76 Months)

ID	Title	Description
OG000	Treatment A	Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
OG001	Treatment B	Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg	Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W	251	303	188	300	277	300
EG001	Pemetrexed Plus Cisplatin or Carboplatin	Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles	259	302	106	284	264	284

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0005 affected300 at risk EG0019 affected284 at risk
Febrile neutropenia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0013 affected284 at risk
Haematotoxicity	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Myelosuppression	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Neutropenia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0011 affected284 at risk
Pancytopenia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0013 affected284 at risk
Thrombocytopenia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Thrombocytopenic purpura	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Acute coronary syndrome	Cardiac disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0011 affected284 at risk
Acute myocardial infarction	Cardiac disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Aortic valve disease	Cardiac disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Atrial fibrillation	Cardiac disorders	26.0	Systematic Assessment	EG0003 affected300 at risk EG0011 affected284 at risk
Atrial flutter	Cardiac disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Atrial thrombosis	Cardiac disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Cardiac arrest	Cardiac disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0011 affected284 at risk
Cardiac failure	Cardiac disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0010 affected284 at risk
Cardiac failure acute	Cardiac disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Cardio-respiratory arrest	Cardiac disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Cardiomyopathy	Cardiac disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Myocardial infarction	Cardiac disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0011 affected284 at risk
Myocarditis	Cardiac disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Pleuropericarditis	Cardiac disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Tachycardia	Cardiac disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Ventricular tachycardia	Cardiac disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Adrenal insufficiency	Endocrine disorders	26.0	Systematic Assessment	EG0003 affected300 at risk EG0010 affected284 at risk
Adrenocorticotropic hormone deficiency	Endocrine disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Hypercalcaemia of malignancy	Endocrine disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Hypophysitis	Endocrine disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Hypopituitarism	Endocrine disorders	26.0	Systematic Assessment	EG0004 affected300 at risk EG0010 affected284 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Opsoclonus myoclonus	Eye disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Retinal detachment	Eye disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Abdominal distension	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0011 affected284 at risk
Abdominal hernia	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Abdominal pain	Gastrointestinal disorders	26.0	Systematic Assessment	EG0005 affected300 at risk EG0012 affected284 at risk
Abdominal pain upper	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Anal fissure	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Ascites	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Colitis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0009 affected300 at risk EG0010 affected284 at risk
Constipation	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0011 affected284 at risk
Diarrhoea	Gastrointestinal disorders	26.0	Systematic Assessment	EG0005 affected300 at risk EG0011 affected284 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Dysphagia	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Enteritis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Enterocolitis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0010 affected284 at risk
Gastric haemorrhage	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Gastritis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Gastritis erosive	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Ileus	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Inguinal hernia	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Nausea	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0011 affected284 at risk
Oesophagitis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Overflow diarrhoea	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Pancreatitis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0003 affected300 at risk EG0010 affected284 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Small intestinal obstruction	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Subileus	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Superior mesenteric artery dissection	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Vomiting	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0012 affected284 at risk
Asthenia	General disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0012 affected284 at risk
Chest pain	General disorders	26.0	Systematic Assessment	EG0004 affected300 at risk EG0014 affected284 at risk
Fatigue	General disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
General physical health deterioration	General disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0011 affected284 at risk
Hyperpyrexia	General disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0010 affected284 at risk
Hyperthermia	General disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Illness	General disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Malaise	General disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0011 affected284 at risk
Mucosal inflammation	General disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Non-cardiac chest pain	General disorders	26.0	Systematic Assessment	EG0004 affected300 at risk EG0011 affected284 at risk
Oedema peripheral	General disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Pain	General disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Performance status decreased	General disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Pyrexia	General disorders	26.0	Systematic Assessment	EG00016 affected300 at risk EG0014 affected284 at risk
Autoimmune hepatitis	Hepatobiliary disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Biliary obstruction	Hepatobiliary disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Cholecystitis	Hepatobiliary disorders	26.0	Systematic Assessment	EG0003 affected300 at risk EG0010 affected284 at risk
Drug-induced liver injury	Hepatobiliary disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0010 affected284 at risk
Hepatic function abnormal	Hepatobiliary disorders	26.0	Systematic Assessment	EG0005 affected300 at risk EG0010 affected284 at risk
Hepatitis	Hepatobiliary disorders	26.0	Systematic Assessment	EG0003 affected300 at risk EG0010 affected284 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	26.0	Systematic Assessment	EG0005 affected300 at risk EG0010 affected284 at risk
Contrast media allergy	Immune system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Drug hypersensitivity	Immune system disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Infusion related hypersensitivity reaction	Immune system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Abscess intestinal	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Arthritis bacterial	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Bronchitis	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Candida sepsis	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Device related infection	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0011 affected284 at risk
Empyema	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Encephalitis	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0011 affected284 at risk
Escherichia urinary tract infection	Infections and infestations	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Gastroenteritis	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0011 affected284 at risk
Gastroenteritis viral	Infections and infestations	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Infectious pleural effusion	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Influenza	Infections and infestations	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Klebsiella urinary tract infection	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Lower respiratory tract infection	Infections and infestations	26.0	Systematic Assessment	EG0002 affected300 at risk EG0011 affected284 at risk
Otitis externa fungal	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Pleural infection	Infections and infestations	26.0	Systematic Assessment	EG0002 affected300 at risk EG0011 affected284 at risk
Pleurisy bacterial	Infections and infestations	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Pneumonia	Infections and infestations	26.0	Systematic Assessment	EG00014 affected300 at risk EG0016 affected284 at risk
Pneumonia aspiration	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0011 affected284 at risk
Respiratory tract infection	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0011 affected284 at risk
Sepsis	Infections and infestations	26.0	Systematic Assessment	EG0003 affected300 at risk EG0012 affected284 at risk
Septic shock	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0011 affected284 at risk
Skin infection	Infections and infestations	26.0	Systematic Assessment	EG0002 affected300 at risk EG0010 affected284 at risk
Staphylococcal sepsis	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Upper respiratory tract infection	Infections and infestations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Fracture	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Head injury	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0001 affected300 at risk EG0011 affected284 at risk
Heat exhaustion	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Hip fracture	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Infusion related reaction	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0006 affected300 at risk EG0010 affected284 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Subdural haematoma	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Vascular access complication	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Alanine aminotransferase increased	Investigations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Aspartate aminotransferase increased	Investigations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Blood creatinine increased	Investigations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
C-reactive protein increased	Investigations	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
General physical condition abnormal	Investigations	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Cachexia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Dehydration	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Diabetes mellitus	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0011 affected284 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Hypercalcaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0004 affected300 at risk EG0011 affected284 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Hyperkalaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Hypoglycaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Hypokalaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0011 affected284 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Hyponatraemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0012 affected284 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0003 affected300 at risk EG0010 affected284 at risk
Back pain	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Myositis	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0010 affected284 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0000 affected300 at risk EG0012 affected284 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG00051 affected300 at risk EG00142 affected284 at risk
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Cauda equina syndrome	Nervous system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Cerebrovascular accident	Nervous system disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0011 affected284 at risk
Cognitive disorder	Nervous system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Limbic encephalitis	Nervous system disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0010 affected284 at risk
Migraine	Nervous system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Myasthenia gravis	Nervous system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Myasthenic syndrome	Nervous system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Myelitis transverse	Nervous system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Neuralgia	Nervous system disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Neurological symptom	Nervous system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Presyncope	Nervous system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Seizure	Nervous system disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0010 affected284 at risk
Subarachnoid haemorrhage	Nervous system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Syncope	Nervous system disorders	26.0	Systematic Assessment	EG0003 affected300 at risk EG0010 affected284 at risk
Transient ischaemic attack	Nervous system disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Completed suicide	Psychiatric disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Depression	Psychiatric disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Insomnia	Psychiatric disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Mental status changes	Psychiatric disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Acute kidney injury	Renal and urinary disorders	26.0	Systematic Assessment	EG0007 affected300 at risk EG0012 affected284 at risk
Haematuria	Renal and urinary disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Nephrolithiasis	Renal and urinary disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Nephrotic syndrome	Renal and urinary disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Renal failure	Renal and urinary disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0011 affected284 at risk
Renal haemorrhage	Renal and urinary disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Renal impairment	Renal and urinary disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Urinary retention	Renal and urinary disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0010 affected284 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0003 affected300 at risk EG0011 affected284 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0009 affected300 at risk EG0018 affected284 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0012 affected284 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0003 affected300 at risk EG0011 affected284 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0009 affected300 at risk EG0013 affected284 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0003 affected300 at risk EG0010 affected284 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0009 affected300 at risk EG0010 affected284 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0012 affected284 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0006 affected300 at risk EG0013 affected284 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0010 affected284 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Cutaneous vasculitis	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG0010 affected284 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Deep vein thrombosis	Vascular disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG0011 affected284 at risk
Embolism	Vascular disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Giant cell arteritis	Vascular disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk
Superior vena cava syndrome	Vascular disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG0010 affected284 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG00041 affected300 at risk EG001118 affected284 at risk
Leukopenia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 affected300 at risk EG00125 affected284 at risk
Neutropenia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0005 affected300 at risk EG00179 affected284 at risk
Thrombocytopenia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0005 affected300 at risk EG00132 affected284 at risk
Hypothyroidism	Endocrine disorders	26.0	Systematic Assessment	EG00037 affected300 at risk EG0013 affected284 at risk
Lacrimation increased	Eye disorders	26.0	Systematic Assessment	EG0001 affected300 at risk EG00119 affected284 at risk
Abdominal pain	Gastrointestinal disorders	26.0	Systematic Assessment	EG00030 affected300 at risk EG00113 affected284 at risk
Constipation	Gastrointestinal disorders	26.0	Systematic Assessment	EG00057 affected300 at risk EG00186 affected284 at risk
Diarrhoea	Gastrointestinal disorders	26.0	Systematic Assessment	EG00096 affected300 at risk EG00134 affected284 at risk
Nausea	Gastrointestinal disorders	26.0	Systematic Assessment	EG00076 affected300 at risk EG001124 affected284 at risk
Vomiting	Gastrointestinal disorders	26.0	Systematic Assessment	EG00047 affected300 at risk EG00155 affected284 at risk
Asthenia	General disorders	26.0	Systematic Assessment	EG00052 affected300 at risk EG00158 affected284 at risk
Chest pain	General disorders	26.0	Systematic Assessment	EG00022 affected300 at risk EG00121 affected284 at risk
Fatigue	General disorders	26.0	Systematic Assessment	EG00090 affected300 at risk EG00178 affected284 at risk
Malaise	General disorders	26.0	Systematic Assessment	EG0008 affected300 at risk EG00117 affected284 at risk
Non-cardiac chest pain	General disorders	26.0	Systematic Assessment	EG00039 affected300 at risk EG00116 affected284 at risk
Oedema peripheral	General disorders	26.0	Systematic Assessment	EG00047 affected300 at risk EG00119 affected284 at risk
Pain	General disorders	26.0	Systematic Assessment	EG00020 affected300 at risk EG00111 affected284 at risk
Pyrexia	General disorders	26.0	Systematic Assessment	EG00050 affected300 at risk EG00114 affected284 at risk
Nasopharyngitis	Infections and infestations	26.0	Systematic Assessment	EG00021 affected300 at risk EG0018 affected284 at risk
Infusion related reaction	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG00022 affected300 at risk EG0012 affected284 at risk
Alanine aminotransferase increased	Investigations	26.0	Systematic Assessment	EG00022 affected300 at risk EG0014 affected284 at risk
Amylase increased	Investigations	26.0	Systematic Assessment	EG00024 affected300 at risk EG0014 affected284 at risk
Blood alkaline phosphatase increased	Investigations	26.0	Systematic Assessment	EG00018 affected300 at risk EG0013 affected284 at risk
Blood creatinine increased	Investigations	26.0	Systematic Assessment	EG00026 affected300 at risk EG00119 affected284 at risk
Lipase increased	Investigations	26.0	Systematic Assessment	EG00027 affected300 at risk EG0014 affected284 at risk
Weight decreased	Investigations	26.0	Systematic Assessment	EG00017 affected300 at risk EG00124 affected284 at risk
Decreased appetite	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG00072 affected300 at risk EG00175 affected284 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG00019 affected300 at risk EG00111 affected284 at risk
Hyponatraemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG00019 affected300 at risk EG00111 affected284 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG00049 affected300 at risk EG0019 affected284 at risk
Back pain	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG00021 affected300 at risk EG00113 affected284 at risk
Myalgia	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG00024 affected300 at risk EG0017 affected284 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG00018 affected300 at risk EG0019 affected284 at risk
Dizziness	Nervous system disorders	26.0	Systematic Assessment	EG00016 affected300 at risk EG00110 affected284 at risk
Dysgeusia	Nervous system disorders	26.0	Systematic Assessment	EG00015 affected300 at risk EG00122 affected284 at risk
Headache	Nervous system disorders	26.0	Systematic Assessment	EG00024 affected300 at risk EG00112 affected284 at risk
Neuropathy peripheral	Nervous system disorders	26.0	Systematic Assessment	EG0003 affected300 at risk EG00115 affected284 at risk
Insomnia	Psychiatric disorders	26.0	Systematic Assessment	EG00027 affected300 at risk EG00116 affected284 at risk
Cough	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG00065 affected300 at risk EG00125 affected284 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG00077 affected300 at risk EG00141 affected284 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0002 affected300 at risk EG00117 affected284 at risk
Dry skin	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG00016 affected300 at risk EG0017 affected284 at risk
Pruritus	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG00062 affected300 at risk EG0015 affected284 at risk
Rash	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG00060 affected300 at risk EG00121 affected284 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG00018 affected300 at risk EG0015 affected284 at risk
Hypertension	Vascular disorders	26.0	Systematic Assessment	EG00016 affected300 at risk EG0018 affected284 at risk

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000600	Amino Acids, Dicarboxylic
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals

ID	Term
D000236	Adenoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018301	Neoplasms, Mesothelial

ID	Term
D000077594	Nivolumab
D000074324	Ipilimumab
D000068437	Pemetrexed
D002945	Cisplatin
D016190	Carboplatin