A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilim... | NCT02864251

NCT02864251

ID	Type	Description	Link
2017-002672-38	EudraCT Number

Status Module

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nivolumab+Platinum doublet chemotherapy	Experimental		Biological: Nivolumab Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin
Nivolumab + Ipilimumab	Experimental	Enrollment is closed for this arm	Biological: Nivolumab Biological: Ipilimumab
Platinum doublet chemotherapy	Active Comparator		Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological	Specified dose on specified days	Nivolumab + Ipilimumab Nivolumab+Platinum doublet chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR)	PFS is defined as the time between the date of randomization and the date of first documented tumor progression, as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Participants who died without reported progression will be considered to have progressed on the date of their death. Subsequent therapy was accounted for by censoring at the last evaluable tumor assessment on or prior to the date of subsequent therapy. Progression is the appearance of one or more new lesions. RECIST - "response evaluation criteria in solid tumors" is a standard system to measure tumor response to treatment. Based on Kaplan-Meier estimates	From randomization to the date of first documented tumor progression or death (approximately 58 months)

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive. Median based on Kaplan-Meier Estimates	From randomization to the date of death due to any cause (up to approximately 67 months)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed stage IV or recurrent EGFR mutated NSCLC with disease progression on one or two prior lines of treatment with EGFR TKIs (allowed TKIs must be approved by the local health authority, including but not limited to erlotinib, gefitinib, afatinib, dacomitinib and osimertinib). In osimertinib treated subjects, T790 testing is not required.
No evidence of exon 20 T790M mutation obtained at progression on prior first- or second-generation EGFR TKI therapy. For participants who were treated with osimertinib, T790M testing is not required.
Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC).
Participants are eligible if central nervous system (CNS) metastases are considered to be adequately controlled/treated before or during the screening period and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization). Participants with asymptomatic CNS metastasis are eligible.
Eastern Cooperative Group (ECOG) Performance Status 0-1
Life expectancy is at least 3 months

Exclusion Criteria:

Known EGFR mutation, T790M positive who failed 1L first- or second-generation TKI should receive osimertinib first as the standard of care (SOC). These participants are only eligible if they fail osimertinib as 2L.
who have progressed within 3 months of the first dose of 1L or 2L EGFR TKI.
Carcinomatous meningitis
Active, known or suspected autoimmune disease are excluded
ALK translocation
Known SCLC transformation
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol defined inclusion/exclusion criteria apply

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

Facility	Status	City	State	ZIP	Country	Contacts
Pacific Shores Medical Group		Long Beach	California	90808	United States
Local Institution - 0029

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38252907	Derived	Mok T, Nakagawa K, Park K, Ohe Y, Girard N, Kim HR, Wu YL, Gainor J, Lee SH, Chiu CH, Kim SW, Yang CT, Wu CL, Wu L, Lin MC, Samol J, Ichikado K, Wang M, Zhang X, Sylvester J, Li S, Forslund A, Yang JC. Nivolumab Plus Chemotherapy in Epidermal Growth Factor Receptor-Mutated Metastatic Non-Small-Cell Lung Cancer After Disease Progression on Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: Final Results of CheckMate 722. J Clin Oncol. 2024 Apr 10;42(11):1252-1264. doi: 10.1200/JCO.23.01017. Epub 2024 Jan 22.

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A: Nivolumab Plus Platinum-doublet Chemotherapy	Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles. Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle. Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 30, 2020

Arm/Group Information

ID	Title	Description
BG000	Arm A: Nivolumab Plus Platinum-doublet Chemotherapy	Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles. Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle. Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
BG001	Arm B: Nivolumab Plus Ipilimumab	Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.
BG002	Arm C: Platinum Doublet Chemotherapy	Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles. Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle. Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first. Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.
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
	BG00062.3± 10.6 BG00161.9± 10.6 BG00260.7± 10.1 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00083 BG00137 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR)

PFS is defined as the time between the date of randomization and the date of first documented tumor progression, as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first.

Participants who died without reported progression will be considered to have progressed on the date of their death. Subsequent therapy was accounted for by censoring at the last evaluable tumor assessment on or prior to the date of subsequent therapy.

Progression is the appearance of one or more new lesions. RECIST - "response evaluation criteria in solid tumors" is a standard system to measure tumor response to treatment.

Based on Kaplan-Meier estimates

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to the date of first documented tumor progression or death (approximately 58 months)

ID	Title	Description
OG000	Arm A: Nivolumab Plus Platinum-doublet Chemotherapy	Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles. Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle. Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
OG001	Arm B: Nivolumab Plus Ipilimumab	Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.
OG002	Arm C: Platinum Doublet Chemotherapy	Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles. Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle. Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first. Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.

Units	Counts
Participants	OG000144 OG00173 OG002150

Title

Denominators

Categories

Title	Measurements
	OG0005.59(4.47 to 6.80) OG0011.54(1.41 to 2.63) OG0025.45(4.40 to 5.65)

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 OG002		Log Rank		0.0528	Log-rank test stratified by PD-L1 expression (>= 1% vs <1%/indeterminate/not evaluable), brain metastases (presence vs absence), smoking history (current/former vs never smoker), and prior osimertinib use (yes vs no) from IRT.	Hazard Ratio (HR)	0.75			2-Sided	95	0.56	1.00			Arm A over Arm C Stratified Cox proportional hazard model.		Superiority

Secondary

Overall Survival (OS)

Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.

Median based on Kaplan-Meier Estimates

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to the date of death due to any cause (up to approximately 67 months)

ID	Title	Description
OG000	Arm A: Nivolumab Plus Platinum-doublet Chemotherapy	Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles. Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle. Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
OG001	Arm B: Nivolumab Plus Ipilimumab	Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.

Secondary

Objective Response Rate (ORR) by Blinded Independent Centralized Review (BICR)

ORR is number of randomized participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using RECIST v1.1 criteria by BICR assessment.

BOR is the best response designation, between randomization and objectively documented progression per RECIST v1.1 criteria by BICR or the date of subsequent anti-cancer therapy, whichever occurs first.

PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to <10 mm (whether target or non-target).

Radiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy.

CR+PR, confidence interval based on the Clopper and Pearson method.

All randomized participants

Posted

Number

95% Confidence Interval

Percent of Participants

From randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (up to approximately 67 months)

ID	Title	Description
OG000	Arm A: Nivolumab Plus Platinum-doublet Chemotherapy	Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles. Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle. Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.

Secondary

Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)

DOR is the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not included), whichever occurred first.

Participants who neither progress nor die were censored on the date of their last assessment.

Median computed using Kaplan-Meier method

Randomized participants with CR or PR

Posted

Median

95% Confidence Interval

Months

From randomization to the date of first documented disease progression or death due to any cause (approximately 67 months)

ID	Title	Description
OG000	Arm A: Nivolumab Plus Platinum-doublet Chemotherapy	Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles. Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle. Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.

Secondary

9 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)

The PFSR at 9 months is defined as the percent of treated participants remaining progression free and surviving at 9 months since the first dosing date. Progression is the appearance of one or more new lesions.

Point estimates are derived from Kaplan-Meier analyses.

All randomized participants

Posted

Number

95% Confidence Interval

Percent of Participants

9 months after first treatment dose

ID	Title	Description
OG000	Arm A: Nivolumab Plus Platinum-doublet Chemotherapy	Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles. Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle. Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
OG001	Arm B: Nivolumab Plus Ipilimumab

Secondary

12 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)

The PFSR at 12 months is defined as the percent of treated participants remaining progression free and surviving at 12 months since the first dosing date. Progression is the appearance of one or more new lesions. Point estimates are derived from Kaplan-Meier analyses.

All randomized participants

Posted

Number

95% Confidence Interval

Percent of Participants

12 Months after first treatment dose

ID	Title	Description
OG000	Arm A: Nivolumab Plus Platinum-doublet Chemotherapy	Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles. Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle. Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.
OG001	Arm B: Nivolumab Plus Ipilimumab

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	Arm A: Nivolumab Plus Platinum-doublet Chemotherapy	Nivolumab was administered IV every 3 weeks with platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) IV for a maximum of 4 cycles. Treatment administered was either Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Nivolumab 360 mg IV, followed by pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle. Following completion of the fourth cycle of nivolumab/chemotherapy, all participants who did not experience disease progression should have continued nivolumab 360 mg IV and pemetrexed (500 mg/m2) every 3 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, or study closure, whichever comes first. Nivolumab should only be administered for a maximum of 24 months (96 weeks) from the first study treatment.	92	144	77	141	136	141
EG001	Arm B: Nivolumab Plus Ipilimumab	Nivolumab 3 mg/kg IV was administered every 2 weeks and ipilimumab 1 mg/kg IV was administered every 6 weeks until the progression of disease, discontinuation due to toxicity, withdrawal of consent, a maximum of 24 months (96 weeks) from the first study treatment, or study closure.	55	73	46	71	62	71
EG002	Arm C: Platinum Doublet Chemotherapy	Platinum-doublet chemotherapy (investigator's choice of cisplatin or carboplatin) was administered IV in 3-week cycles for up to a maximum of 4 cycles. Participants received either Pemetrexed (500 mg/m2) with cisplatin (75 mg/m2) administered on Day 1 of each cycle OR Pemetrexed (500 mg/m2) with carboplatin (AUC 5 or 6) administered on Day 1 of each cycle. Platinum-doublet chemotherapy continued until disease progression, unacceptable toxicity, or completion of the 4 cycles, whichever came first. Participants who had stable disease or response after 4 cycles of pemetrexed with cisplatin or carboplatin should have continued pemetrexed alone as maintenance therapy until disease progression, or unacceptable toxicity.	105	150	55	143	140	143

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0011 affected71 at risk EG0023 affected143 at risk
Febrile neutropenia	Blood and lymphatic system disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0011 affected71 at risk EG0021 affected143 at risk
Leukocytosis	Blood and lymphatic system disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Myelosuppression	Blood and lymphatic system disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Neutropenia	Blood and lymphatic system disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Pancytopenia	Blood and lymphatic system disorders	25.1	Systematic Assessment	EG0002 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Acute myocardial infarction	Cardiac disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Atrial fibrillation	Cardiac disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Cardiac tamponade	Cardiac disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Cardio-respiratory arrest	Cardiac disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Immune-mediated myocarditis	Cardiac disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Pericardial effusion	Cardiac disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0012 affected71 at risk EG0020 affected143 at risk
Pericarditis	Cardiac disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Prinzmetal angina	Cardiac disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Sinus bradycardia	Cardiac disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Hypopituitarism	Endocrine disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Thyroiditis subacute	Endocrine disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Cataract	Eye disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Ascites	Gastrointestinal disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Colitis	Gastrointestinal disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0012 affected71 at risk EG0020 affected143 at risk
Diarrhoea	Gastrointestinal disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0012 affected71 at risk EG0020 affected143 at risk
Enteritis	Gastrointestinal disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Inguinal hernia	Gastrointestinal disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Nausea	Gastrointestinal disorders	25.1	Systematic Assessment	EG0003 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Pancreatitis acute	Gastrointestinal disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Vomiting	Gastrointestinal disorders	25.1	Systematic Assessment	EG0004 affected141 at risk EG0012 affected71 at risk EG0021 affected143 at risk
Asthenia	General disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Catheter site oedema	General disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Fatigue	General disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Non-cardiac chest pain	General disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Pain	General disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Pyrexia	General disorders	25.1	Systematic Assessment	EG0003 affected141 at risk EG0012 affected71 at risk EG0021 affected143 at risk
Sudden death	General disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Swelling	General disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Hepatic function abnormal	Hepatobiliary disorders	25.1	Systematic Assessment	EG0003 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0012 affected71 at risk EG0020 affected143 at risk
Atypical pneumonia	Infections and infestations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0021 affected143 at risk
Breast cellulitis	Infections and infestations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Carbuncle	Infections and infestations	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Cellulitis	Infections and infestations	25.1	Systematic Assessment	EG0003 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Clostridium difficile colitis	Infections and infestations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Device related infection	Infections and infestations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Gastroenteritis viral	Infections and infestations	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Herpes zoster	Infections and infestations	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Infection	Infections and infestations	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Influenza	Infections and infestations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0012 affected71 at risk EG0020 affected143 at risk
Meningitis	Infections and infestations	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Pneumonia	Infections and infestations	25.1	Systematic Assessment	EG00010 affected141 at risk EG0014 affected71 at risk EG0027 affected143 at risk
Pneumonia aspiration	Infections and infestations	25.1	Systematic Assessment	EG0002 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Pneumonia influenzal	Infections and infestations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Pneumonia klebsiella	Infections and infestations	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Post procedural infection	Infections and infestations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Staphylococcal sepsis	Infections and infestations	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Tuberculosis	Infections and infestations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Urinary tract infection	Infections and infestations	25.1	Systematic Assessment	EG0001 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Vestibular neuronitis	Infections and infestations	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Fall	Injury, poisoning and procedural complications	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Hip fracture	Injury, poisoning and procedural complications	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Post procedural discharge	Injury, poisoning and procedural complications	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Spinal fracture	Injury, poisoning and procedural complications	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Wrist fracture	Injury, poisoning and procedural complications	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Alanine aminotransferase increased	Investigations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Aspartate aminotransferase increased	Investigations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Blood alkaline phosphatase increased	Investigations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Blood bilirubin increased	Investigations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Blood creatine increased	Investigations	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Blood creatinine increased	Investigations	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Gamma-glutamyltransferase increased	Investigations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Liver function test increased	Investigations	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Neutrophil count decreased	Investigations	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0022 affected143 at risk
Platelet count decreased	Investigations	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Decreased appetite	Metabolism and nutrition disorders	25.1	Systematic Assessment	EG0004 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Diabetes mellitus	Metabolism and nutrition disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Hyperkalaemia	Metabolism and nutrition disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Arthritis	Musculoskeletal and connective tissue disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Flank pain	Musculoskeletal and connective tissue disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Immune-mediated myositis	Musculoskeletal and connective tissue disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Myositis	Musculoskeletal and connective tissue disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0002 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Lymphangiosis carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Malignant ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG00025 affected141 at risk EG00120 affected71 at risk EG00222 affected143 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0022 affected143 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0001 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0022 affected143 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0002 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Cerebral infarction	Nervous system disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Cervical cord compression	Nervous system disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Hydrocephalus	Nervous system disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Intracranial pressure increased	Nervous system disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Ischaemic stroke	Nervous system disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Optic neuritis	Nervous system disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Delirium	Psychiatric disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Depression	Psychiatric disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Insomnia	Psychiatric disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Acute kidney injury	Renal and urinary disorders	25.1	Systematic Assessment	EG0002 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Nephrolithiasis	Renal and urinary disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Pyelocaliectasis	Renal and urinary disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0015 affected71 at risk EG0022 affected143 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0023 affected143 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	25.1	Systematic Assessment	EG0005 affected141 at risk EG0011 affected71 at risk EG0021 affected143 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0021 affected143 at risk
Drug eruption	Skin and subcutaneous tissue disorders	25.1	Systematic Assessment	EG0001 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Rash	Skin and subcutaneous tissue disorders	25.1	Systematic Assessment	EG0002 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0011 affected71 at risk EG0020 affected143 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	25.1	Systematic Assessment	EG0002 affected141 at risk EG0010 affected71 at risk EG0020 affected143 at risk
Urticarial vasculitis	Skin and subcutaneous tissue disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Deep vein thrombosis	Vascular disorders	25.1	Systematic Assessment	EG0003 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk
Peripheral venous disease	Vascular disorders	25.1	Systematic Assessment	EG0000 affected141 at risk EG0010 affected71 at risk EG0021 affected143 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	25.1	Systematic Assessment	EG00066 affected141 at risk EG0017 affected71 at risk EG00258 affected143 at risk
Neutropenia	Blood and lymphatic system disorders	25.1	Systematic Assessment	EG00022 affected141 at risk EG0013 affected71 at risk EG0026 affected143 at risk
Thrombocytopenia	Blood and lymphatic system disorders	25.1	Systematic Assessment	EG00010 affected141 at risk EG0011 affected71 at risk EG0026 affected143 at risk
Hyperthyroidism	Endocrine disorders	25.1	Systematic Assessment	EG0007 affected141 at risk EG0018 affected71 at risk EG0020 affected143 at risk
Hypothyroidism	Endocrine disorders	25.1	Systematic Assessment	EG00015 affected141 at risk EG00112 affected71 at risk EG0020 affected143 at risk
Abdominal pain	Gastrointestinal disorders	25.1	Systematic Assessment	EG0003 affected141 at risk EG0015 affected71 at risk EG00211 affected143 at risk
Abdominal pain upper	Gastrointestinal disorders	25.1	Systematic Assessment	EG0003 affected141 at risk EG0014 affected71 at risk EG0024 affected143 at risk
Constipation	Gastrointestinal disorders	25.1	Systematic Assessment	EG00052 affected141 at risk EG00121 affected71 at risk EG00257 affected143 at risk
Diarrhoea	Gastrointestinal disorders	25.1	Systematic Assessment	EG00018 affected141 at risk EG00117 affected71 at risk EG00217 affected143 at risk
Nausea	Gastrointestinal disorders	25.1	Systematic Assessment	EG00063 affected141 at risk EG00112 affected71 at risk EG00260 affected143 at risk
Stomatitis	Gastrointestinal disorders	25.1	Systematic Assessment	EG00012 affected141 at risk EG0014 affected71 at risk EG00210 affected143 at risk
Vomiting	Gastrointestinal disorders	25.1	Systematic Assessment	EG00035 affected141 at risk EG0017 affected71 at risk EG00221 affected143 at risk
Asthenia	General disorders	25.1	Systematic Assessment	EG00012 affected141 at risk EG0013 affected71 at risk EG00210 affected143 at risk
Face oedema	General disorders	25.1	Systematic Assessment	EG0008 affected141 at risk EG0010 affected71 at risk EG0029 affected143 at risk
Fatigue	General disorders	25.1	Systematic Assessment	EG00030 affected141 at risk EG00115 affected71 at risk EG00219 affected143 at risk
Malaise	General disorders	25.1	Systematic Assessment	EG00018 affected141 at risk EG0015 affected71 at risk EG00221 affected143 at risk
Non-cardiac chest pain	General disorders	25.1	Systematic Assessment	EG00010 affected141 at risk EG0017 affected71 at risk EG0028 affected143 at risk
Oedema peripheral	General disorders	25.1	Systematic Assessment	EG00026 affected141 at risk EG0018 affected71 at risk EG00218 affected143 at risk
Pyrexia	General disorders	25.1	Systematic Assessment	EG00029 affected141 at risk EG00114 affected71 at risk EG00217 affected143 at risk
Conjunctivitis	Infections and infestations	25.1	Systematic Assessment	EG00010 affected141 at risk EG0012 affected71 at risk EG0022 affected143 at risk
Nasopharyngitis	Infections and infestations	25.1	Systematic Assessment	EG0008 affected141 at risk EG0011 affected71 at risk EG0021 affected143 at risk
Paronychia	Infections and infestations	25.1	Systematic Assessment	EG0006 affected141 at risk EG0014 affected71 at risk EG0021 affected143 at risk
Pneumonia	Infections and infestations	25.1	Systematic Assessment	EG0007 affected141 at risk EG0015 affected71 at risk EG0027 affected143 at risk
Upper respiratory tract infection	Infections and infestations	25.1	Systematic Assessment	EG0009 affected141 at risk EG0016 affected71 at risk EG0029 affected143 at risk
Urinary tract infection	Infections and infestations	25.1	Systematic Assessment	EG0005 affected141 at risk EG0014 affected71 at risk EG0023 affected143 at risk
Alanine aminotransferase increased	Investigations	25.1	Systematic Assessment	EG00035 affected141 at risk EG00112 affected71 at risk EG00226 affected143 at risk
Amylase increased	Investigations	25.1	Systematic Assessment	EG00013 affected141 at risk EG0013 affected71 at risk EG0029 affected143 at risk
Aspartate aminotransferase increased	Investigations	25.1	Systematic Assessment	EG00035 affected141 at risk EG00111 affected71 at risk EG00227 affected143 at risk
Blood creatinine increased	Investigations	25.1	Systematic Assessment	EG00019 affected141 at risk EG0011 affected71 at risk EG00215 affected143 at risk
Neutrophil count decreased	Investigations	25.1	Systematic Assessment	EG00042 affected141 at risk EG0014 affected71 at risk EG00245 affected143 at risk
Platelet count decreased	Investigations	25.1	Systematic Assessment	EG00019 affected141 at risk EG0016 affected71 at risk EG00228 affected143 at risk
Weight decreased	Investigations	25.1	Systematic Assessment	EG0009 affected141 at risk EG0017 affected71 at risk EG0026 affected143 at risk
White blood cell count decreased	Investigations	25.1	Systematic Assessment	EG00038 affected141 at risk EG0013 affected71 at risk EG00235 affected143 at risk
Decreased appetite	Metabolism and nutrition disorders	25.1	Systematic Assessment	EG00042 affected141 at risk EG00116 affected71 at risk EG00252 affected143 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	25.1	Systematic Assessment	EG0009 affected141 at risk EG0012 affected71 at risk EG0026 affected143 at risk
Hypokalaemia	Metabolism and nutrition disorders	25.1	Systematic Assessment	EG00011 affected141 at risk EG0016 affected71 at risk EG0026 affected143 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	25.1	Systematic Assessment	EG00015 affected141 at risk EG0019 affected71 at risk EG00210 affected143 at risk
Back pain	Musculoskeletal and connective tissue disorders	25.1	Systematic Assessment	EG00021 affected141 at risk EG0015 affected71 at risk EG00212 affected143 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	25.1	Systematic Assessment	EG0007 affected141 at risk EG0014 affected71 at risk EG0023 affected143 at risk
Myalgia	Musculoskeletal and connective tissue disorders	25.1	Systematic Assessment	EG0006 affected141 at risk EG0016 affected71 at risk EG0024 affected143 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	25.1	Systematic Assessment	EG0006 affected141 at risk EG0015 affected71 at risk EG0023 affected143 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0009 affected141 at risk EG0015 affected71 at risk EG0029 affected143 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0001 affected141 at risk EG0014 affected71 at risk EG0021 affected143 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.1	Systematic Assessment	EG0004 affected141 at risk EG0017 affected71 at risk EG0023 affected143 at risk
Dizziness	Nervous system disorders	25.1	Systematic Assessment	EG00015 affected141 at risk EG0017 affected71 at risk EG00214 affected143 at risk
Dysgeusia	Nervous system disorders	25.1	Systematic Assessment	EG0009 affected141 at risk EG0011 affected71 at risk EG00210 affected143 at risk
Headache	Nervous system disorders	25.1	Systematic Assessment	EG00022 affected141 at risk EG0015 affected71 at risk EG00219 affected143 at risk
Anxiety	Psychiatric disorders	25.1	Systematic Assessment	EG0006 affected141 at risk EG0014 affected71 at risk EG0023 affected143 at risk
Insomnia	Psychiatric disorders	25.1	Systematic Assessment	EG00017 affected141 at risk EG0016 affected71 at risk EG00222 affected143 at risk
Cough	Respiratory, thoracic and mediastinal disorders	25.1	Systematic Assessment	EG00016 affected141 at risk EG00116 affected71 at risk EG00218 affected143 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	25.1	Systematic Assessment	EG00015 affected141 at risk EG00114 affected71 at risk EG00212 affected143 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	25.1	Systematic Assessment	EG0009 affected141 at risk EG0014 affected71 at risk EG0029 affected143 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	25.1	Systematic Assessment	EG00012 affected141 at risk EG0012 affected71 at risk EG0028 affected143 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	25.1	Systematic Assessment	EG0009 affected141 at risk EG0018 affected71 at risk EG00211 affected143 at risk
Alopecia	Skin and subcutaneous tissue disorders	25.1	Systematic Assessment	EG0006 affected141 at risk EG0014 affected71 at risk EG0028 affected143 at risk
Eczema	Skin and subcutaneous tissue disorders	25.1	Systematic Assessment	EG0002 affected141 at risk EG0015 affected71 at risk EG0021 affected143 at risk
Pruritus	Skin and subcutaneous tissue disorders	25.1	Systematic Assessment	EG00017 affected141 at risk EG00118 affected71 at risk EG0028 affected143 at risk
Rash	Skin and subcutaneous tissue disorders	25.1	Systematic Assessment	EG0002 affected141 at risk EG0019 affected71 at risk EG0020 affected143 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	25.1	Systematic Assessment	EG0009 affected141 at risk EG0012 affected71 at risk EG0024 affected143 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	25.1	Systematic Assessment	EG00012 affected141 at risk EG0019 affected71 at risk EG0021 affected143 at risk
Hypertension	Vascular disorders	25.1	Systematic Assessment	EG0009 affected141 at risk EG0015 affected71 at risk EG0024 affected143 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
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

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