An Open-Label, Randomized, Phase 3 Trial of Nivolumab Ver... | NCT02041533

NCT02041533

ID	Type	Description	Link
2012-004502-93	EudraCT Number

Status Module

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Nivolumab subjects	Experimental	Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure	Biological: Nivolumab
Arm B: Investigator's Choice Chemotherapy	Active Comparator	Investigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression, unacceptable toxicity or completion of the 6 cycles, whichever comes first Squamous subjects: Gemcitabine 1250 mg/mg(2) administered on Day 1 and Day 8 with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle; or Gemcitabine 1000 mg/mg(2) administered on Day 1 and Day 8 with Carboplatin (AUC 5) administered on Day 1 of each cycle; or Paclitaxel 200 mg/m(2) with Carboplatin (AUC 6) administered on Day 1 of each cycle Non-Squamous subjects: Pemetrexed 500 mg/m(2) with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle Pemetrexed 500 mg/m(2) Carboplatin (AUC 6) administered on Day 1 of each cycle Optional crossover: Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent or study closure	Biological: Nivolumab Drug: Gemcitabine Drug: Cisplatin Drug: Carboplatin Drug: Paclitaxel Drug: Pemetrexed

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological		Arm A: Nivolumab subjects Arm B: Investigator's Choice Chemotherapy	BMS-936558

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival in Participants With PD-L1 Expression >= 5%	Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.	From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)

Secondary Outcomes

Measure	Description	Time Frame
Progression-Free Survival in All Randomized Participants	Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Southern Cancer Center, Inc.		Mobile	Alabama	36608	United States
Banner MD Anderson Cancer Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38383458	Derived	Mason M, Lapuente-Santana O, Halkola AS, Wang W, Mall R, Xiao X, Kaufman J, Fu J, Pfeil J, Banerjee J, Chung V, Chang H, Chasalow SD, Lin HY, Chai R, Yu T, Finotello F, Mirtti T, Mayranpaa MI, Bao J, Verschuren EW, Ahmed EI, Ceccarelli M, Miller LD, Monaco G, Hendrickx WRL, Sherif S, Yang L, Tang M, Gu SS, Zhang W, Zhang Y, Zeng Z, Das Sahu A, Liu Y, Yang W, Bedognetti D, Tang J, Eduati F, Laajala TD, Geese WJ, Guinney J, Szustakowski JD, Vincent BG, Carbone DP. A community challenge to predict clinical outcomes after immune checkpoint blockade in non-small cell lung cancer. J Transl Med. 2024 Feb 21;22(1):190. doi: 10.1186/s12967-023-04705-3.
28636851

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nivolumab	Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
FG001	Investigator Choice of Chemotherapy	Administered in 3-week cycles for up to 6 cycles: Squamous: gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or paclitaxel (200 mg/m2) with carboplatin (AUC 6) Non-Squamous: pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Nivolumab	Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
BG001	Investigator Choice of Chemotherapy	Administered in 3-week cycles for up to 6 cycles: Squamous: gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or paclitaxel (200 mg/m2) with carboplatin (AUC 6) Non-Squamous: pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
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
	BG00062.8± 10.25 BG00163.4± 9.63 BG00263.1± 9.94

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00087 BG001122 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0013 BG002

Race/Ethnicity, Customized

Race

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000228 BG001242 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 in Participants With PD-L1 Expression >= 5%

Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.

All randomized participants with PD-L1 expression levels >= 5%

Posted

Median

95% Confidence Interval

Months

From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
OG001	Investigator Choice of Chemotherapy	Administered in 3-week cycles for up to 6 cycles: Squamous: gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or paclitaxel (200 mg/m2) with carboplatin (AUC 6) Non-Squamous: pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.

Units	Counts
Participants	OG000211 OG001212

Title

Denominators

Categories

Title	Measurements
	OG0004.21(2.96 to 5.55) OG0015.88(5.42 to 6.93)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Log-rank test stratified by histology (squamous vs. non-squamous) as entered into the IVRS.	0.2511		Hazard Ratio (HR)	1.15			2-Sided	95	0.91	1.45			Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.		Superiority or Other (legacy)

Secondary

Progression-Free Survival in All Randomized Participants

All randomized participants

Posted

Median

95% Confidence Interval

Months

From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
OG001	Investigator Choice of Chemotherapy	Administered in 3-week cycles for up to 6 cycles: Squamous: gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or paclitaxel (200 mg/m2) with carboplatin (AUC 6) Non-Squamous: pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.

Secondary

Overall Survival in Participants With PD-L1 Expression >= 5%

Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.

All randomized participants with PD-L1 expression >= 5%

Posted

Median

95% Confidence Interval

Months

From date of randomization to date of death (up to approximately 89 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
OG001	Investigator Choice of Chemotherapy	Administered in 3-week cycles for up to 6 cycles: Squamous: gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or paclitaxel (200 mg/m2) with carboplatin (AUC 6) Non-Squamous: pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.

Secondary

Overall Survival in All Randomized Participants

All randomized participants

Posted

Median

95% Confidence Interval

Months

From date of randomization to date of death (up to approximately 89 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
OG001	Investigator Choice of Chemotherapy	Administered in 3-week cycles for up to 6 cycles: Squamous: gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or paclitaxel (200 mg/m2) with carboplatin (AUC 6) Non-Squamous: pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.

Secondary

Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%

ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.

All randomized participants with PD-L1 expression >= 5%

Posted

Number

95% Confidence Interval

Percentage of participants

From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
OG001	Investigator Choice of Chemotherapy

Secondary

Disease-related Symptom Improvement Rate by Week 12

The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.

All randomized participants

Posted

Number

95% Confidence Interval

Percentage of participants

From date of randomization to week 12

ID	Title	Description
OG000	Nivolumab	Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
OG001	Investigator Choice of Chemotherapy	Administered in 3-week cycles for up to 6 cycles: Squamous: gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or paclitaxel (200 mg/m2) with carboplatin (AUC 6) Non-Squamous: pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.

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	Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity	233	271	195	267	245	267
EG001	Investigator Choice of Chemotherapy	Administered in 3-week cycles for up to 6 cycles: Squamous: gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or paclitaxel (200 mg/m2) with carboplatin (AUC 6) Non-Squamous: pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.	92	270	203	263	252	263
EG002	Post Chemotherapy Optional Nivolumab	Participants from the Investigator Choice Arm who progressed during Post-Chemotherapy Phase could receive crossover nivolumab treatment after disease progression. These participants received Nivolumab 3 mg/kg IV infusion every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.	136	159	110	159	137	159

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG00116 affected263 at risk EG0022 affected159 at risk
Anaemia of malignant disease	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Febrile neutropenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0003 affected267 at risk EG0017 affected263 at risk EG0021 affected159 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Leukopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Neutropenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0014 affected263 at risk EG0021 affected159 at risk
Pancytopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0013 affected263 at risk EG0020 affected159 at risk
Thrombocytopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0016 affected263 at risk EG0020 affected159 at risk
Acute coronary syndrome	Cardiac disorders	25.0	Systematic Assessment	EG0003 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Acute left ventricular failure	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Atrial fibrillation	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0016 affected263 at risk EG0023 affected159 at risk
Atrial flutter	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0013 affected263 at risk EG0022 affected159 at risk
Atrial tachycardia	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Bradycardia	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Cardiac arrest	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Cardiac failure	Cardiac disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0014 affected263 at risk EG0023 affected159 at risk
Cardiac failure acute	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Cardiac failure congestive	Cardiac disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Cardiac tamponade	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Cardiovascular disorder	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Myocardial infarction	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0017 affected263 at risk EG0024 affected159 at risk
Myocardial ischaemia	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Pericardial effusion	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Pericarditis constrictive	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Sinus bradycardia	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Sinus tachycardia	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Tornwaldt cyst	Congenital, familial and genetic disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Adrenal insufficiency	Endocrine disorders	25.0	Systematic Assessment	EG0004 affected267 at risk EG0014 affected263 at risk EG0022 affected159 at risk
Hypothyroidism	Endocrine disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0022 affected159 at risk
Angle closure glaucoma	Eye disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Cataract	Eye disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Exophthalmos	Eye disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Glaucoma	Eye disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Ophthalmic vein thrombosis	Eye disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Optic nerve disorder	Eye disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Abdominal pain	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0014 affected263 at risk EG0021 affected159 at risk
Ascites	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Colitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0004 affected267 at risk EG0013 affected263 at risk EG0023 affected159 at risk
Constipation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Diarrhoea	Gastrointestinal disorders	25.0	Systematic Assessment	EG0007 affected267 at risk EG0016 affected263 at risk EG0024 affected159 at risk
Dysphagia	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Enteritis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Gastritis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Ileus	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0013 affected263 at risk EG0020 affected159 at risk
Large intestinal obstruction	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Large intestine perforation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Nausea	Gastrointestinal disorders	25.0	Systematic Assessment	EG0004 affected267 at risk EG0015 affected263 at risk EG0021 affected159 at risk
Oesophagitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Small intestinal obstruction	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Vomiting	Gastrointestinal disorders	25.0	Systematic Assessment	EG0004 affected267 at risk EG0015 affected263 at risk EG0021 affected159 at risk
Asthenia	General disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Catheter site pain	General disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Chest pain	General disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0012 affected263 at risk EG0020 affected159 at risk
Death	General disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Fatigue	General disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0018 affected263 at risk EG0023 affected159 at risk
General physical health deterioration	General disorders	25.0	Systematic Assessment	EG0004 affected267 at risk EG0016 affected263 at risk EG0024 affected159 at risk
Illness	General disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Localised oedema	General disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Multiple organ dysfunction syndrome	General disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Oedema peripheral	General disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Pain	General disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0013 affected263 at risk EG0021 affected159 at risk
Performance status decreased	General disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0020 affected159 at risk
Pyrexia	General disorders	25.0	Systematic Assessment	EG0007 affected267 at risk EG0019 affected263 at risk EG0026 affected159 at risk
Sudden death	General disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Bile duct stenosis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Cholecystitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Cholecystitis acute	Hepatobiliary disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Cholelithiasis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Cholestasis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Drug-induced liver injury	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Gallbladder obstruction	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Hepatic failure	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Hepatitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Hepatitis acute	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Hypertransaminasaemia	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Jaundice	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Hypersensitivity	Immune system disorders	25.0	Systematic Assessment	EG0003 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Appendicitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Appendicitis perforated	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Bronchitis	Infections and infestations	25.0	Systematic Assessment	EG0002 affected267 at risk EG0013 affected263 at risk EG0021 affected159 at risk
Cellulitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Diverticulitis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Erysipelas	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Gastroenteritis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Herpes virus infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Influenza	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Localised infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Lower respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG0002 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Nasopharyngitis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Norovirus infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Oral candidiasis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Peritonitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Pleural infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Pneumonia	Infections and infestations	25.0	Systematic Assessment	EG00021 affected267 at risk EG00126 affected263 at risk EG0028 affected159 at risk
Pneumonia aspiration	Infections and infestations	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Pneumonia bacterial	Infections and infestations	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Post procedural infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Pulmonary sepsis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Sepsis	Infections and infestations	25.0	Systematic Assessment	EG0005 affected267 at risk EG0015 affected263 at risk EG0023 affected159 at risk
Septic shock	Infections and infestations	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Skin infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0020 affected159 at risk
Subcutaneous abscess	Infections and infestations	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Upper respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Urinary tract infection	Infections and infestations	25.0	Systematic Assessment	EG0003 affected267 at risk EG0012 affected263 at risk EG0022 affected159 at risk
Vascular device infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Wound infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Compression fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Fall	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Femur fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0020 affected159 at risk
Hip fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0002 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Infusion related reaction	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0002 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Joint dislocation	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Kyphosis postoperative	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Radiation necrosis	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Road traffic accident	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Upper limb fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Vascular procedure complication	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Alanine aminotransferase increased	Investigations	25.0	Systematic Assessment	EG0005 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Aspartate aminotransferase increased	Investigations	25.0	Systematic Assessment	EG0006 affected267 at risk EG0012 affected263 at risk EG0022 affected159 at risk
Blood alkaline phosphatase increased	Investigations	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Blood bilirubin increased	Investigations	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Blood creatine phosphokinase increased	Investigations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Blood creatinine increased	Investigations	25.0	Systematic Assessment	EG0002 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
C-reactive protein increased	Investigations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Gamma-glutamyltransferase increased	Investigations	25.0	Systematic Assessment	EG0002 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
General physical condition abnormal	Investigations	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Haemoglobin decreased	Investigations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Transaminases increased	Investigations	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Dehydration	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0004 affected267 at risk EG0015 affected263 at risk EG0023 affected159 at risk
Diabetes mellitus	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Hypercalcaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0003 affected267 at risk EG0013 affected263 at risk EG0023 affected159 at risk
Hyperglycaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0012 affected263 at risk EG0022 affected159 at risk
Hypoglycaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Hypokalaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Hyponatraemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0005 affected267 at risk EG0014 affected263 at risk EG0022 affected159 at risk
Metabolic acidosis	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Back pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0013 affected263 at risk EG0021 affected159 at risk
Bone pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0012 affected263 at risk EG0020 affected159 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0008 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Follicular lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Haemangioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Intestinal metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0022 affected159 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG00069 affected267 at risk EG00195 affected263 at risk EG00255 affected159 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0004 affected267 at risk EG0015 affected263 at risk EG0023 affected159 at risk
Mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0002 affected267 at risk EG0018 affected263 at risk EG0026 affected159 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0003 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected267 at risk EG0012 affected263 at risk EG0020 affected159 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0002 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Pericardial effusion malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0005 affected267 at risk EG0012 affected263 at risk EG0020 affected159 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0004 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Aphasia	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Ataxia	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Cerebral infarction	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Cerebrovascular accident	Nervous system disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Cubital tunnel syndrome	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Depressed level of consciousness	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Epilepsy	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Headache	Nervous system disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
IIIrd nerve paresis	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Ischaemic stroke	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Loss of consciousness	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Malignant spinal cord compression	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Muscle spasticity	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Nervous system disorder	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Peripheral motor neuropathy	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Presyncope	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Seizure	Nervous system disorders	25.0	Systematic Assessment	EG0004 affected267 at risk EG0013 affected263 at risk EG0021 affected159 at risk
Spinal cord compression	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Syncope	Nervous system disorders	25.0	Systematic Assessment	EG0004 affected267 at risk EG0013 affected263 at risk EG0020 affected159 at risk
VIth nerve paresis	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Vocal cord paralysis	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Device occlusion	Product Issues	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Confusional state	Psychiatric disorders	25.0	Systematic Assessment	EG0003 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Disorientation	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Mental status changes	Psychiatric disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Organic brain syndrome	Psychiatric disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Psychotic disorder	Psychiatric disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Suicide attempt	Psychiatric disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Acute kidney injury	Renal and urinary disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Haematuria	Renal and urinary disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Hydronephrosis	Renal and urinary disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Oliguria	Renal and urinary disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Renal failure	Renal and urinary disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Renal infarct	Renal and urinary disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0003 affected267 at risk EG0017 affected263 at risk EG0021 affected159 at risk
Cough	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0006 affected267 at risk EG0019 affected263 at risk EG0025 affected159 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Eosinophilic pneumonia	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Laryngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Mediastinal disorder	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0008 affected267 at risk EG0015 affected263 at risk EG0023 affected159 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0009 affected267 at risk EG0012 affected263 at risk EG0021 affected159 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0004 affected267 at risk EG0012 affected263 at risk EG0022 affected159 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0008 affected267 at risk EG00111 affected263 at risk EG0025 affected159 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Pulmonary microemboli	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0004 affected267 at risk EG0012 affected263 at risk EG0022 affected159 at risk
Rash	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Rash papular	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Air embolism	Vascular disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Aortic aneurysm rupture	Vascular disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Circulatory collapse	Vascular disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0013 affected263 at risk EG0021 affected159 at risk
Deep vein thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0003 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Embolism	Vascular disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0014 affected263 at risk EG0021 affected159 at risk
Extremity necrosis	Vascular disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Hypotension	Vascular disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Iliac artery occlusion	Vascular disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Jugular vein thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Leriche syndrome	Vascular disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Lymphoedema	Vascular disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0021 affected159 at risk
Peripheral artery thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Peripheral ischaemia	Vascular disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Superior vena cava syndrome	Vascular disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0012 affected263 at risk EG0020 affected159 at risk
Vascular occlusion	Vascular disorders	25.0	Systematic Assessment	EG0000 affected267 at risk EG0011 affected263 at risk EG0020 affected159 at risk
Vein disorder	Vascular disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk
Venous thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG0010 affected263 at risk EG0020 affected159 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG00054 affected267 at risk EG001142 affected263 at risk EG00238 affected159 at risk
Leukopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected267 at risk EG00117 affected263 at risk EG0021 affected159 at risk
Neutropenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0005 affected267 at risk EG00154 affected263 at risk EG0024 affected159 at risk
Thrombocytopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0005 affected267 at risk EG00140 affected263 at risk EG0024 affected159 at risk
Hypothyroidism	Endocrine disorders	25.0	Systematic Assessment	EG00023 affected267 at risk EG00123 affected263 at risk EG00214 affected159 at risk
Lacrimation increased	Eye disorders	25.0	Systematic Assessment	EG0003 affected267 at risk EG00121 affected263 at risk EG0021 affected159 at risk
Abdominal pain	Gastrointestinal disorders	25.0	Systematic Assessment	EG00035 affected267 at risk EG00132 affected263 at risk EG00212 affected159 at risk
Abdominal pain upper	Gastrointestinal disorders	25.0	Systematic Assessment	EG00011 affected267 at risk EG00123 affected263 at risk EG0029 affected159 at risk
Constipation	Gastrointestinal disorders	25.0	Systematic Assessment	EG00065 affected267 at risk EG00184 affected263 at risk EG00224 affected159 at risk
Diarrhoea	Gastrointestinal disorders	25.0	Systematic Assessment	EG00084 affected267 at risk EG00182 affected263 at risk EG00229 affected159 at risk
Dry mouth	Gastrointestinal disorders	25.0	Systematic Assessment	EG00013 affected267 at risk EG00112 affected263 at risk EG0028 affected159 at risk
Dyspepsia	Gastrointestinal disorders	25.0	Systematic Assessment	EG00019 affected267 at risk EG00113 affected263 at risk EG0022 affected159 at risk
Nausea	Gastrointestinal disorders	25.0	Systematic Assessment	EG00086 affected267 at risk EG001149 affected263 at risk EG00236 affected159 at risk
Stomatitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG00013 affected267 at risk EG00120 affected263 at risk EG0025 affected159 at risk
Vomiting	Gastrointestinal disorders	25.0	Systematic Assessment	EG00059 affected267 at risk EG00177 affected263 at risk EG00216 affected159 at risk
Asthenia	General disorders	25.0	Systematic Assessment	EG00026 affected267 at risk EG00141 affected263 at risk EG00213 affected159 at risk
Chest pain	General disorders	25.0	Systematic Assessment	EG0009 affected267 at risk EG00125 affected263 at risk EG0029 affected159 at risk
Chills	General disorders	25.0	Systematic Assessment	EG00018 affected267 at risk EG00118 affected263 at risk EG0026 affected159 at risk
Fatigue	General disorders	25.0	Systematic Assessment	EG000108 affected267 at risk EG001134 affected263 at risk EG00247 affected159 at risk
Malaise	General disorders	25.0	Systematic Assessment	EG00015 affected267 at risk EG00114 affected263 at risk EG0025 affected159 at risk
Mucosal inflammation	General disorders	25.0	Systematic Assessment	EG0007 affected267 at risk EG00123 affected263 at risk EG0023 affected159 at risk
Non-cardiac chest pain	General disorders	25.0	Systematic Assessment	EG00025 affected267 at risk EG00121 affected263 at risk EG00211 affected159 at risk
Oedema peripheral	General disorders	25.0	Systematic Assessment	EG00035 affected267 at risk EG00167 affected263 at risk EG00221 affected159 at risk
Pain	General disorders	25.0	Systematic Assessment	EG00014 affected267 at risk EG00112 affected263 at risk EG0029 affected159 at risk
Pyrexia	General disorders	25.0	Systematic Assessment	EG00037 affected267 at risk EG00155 affected263 at risk EG00222 affected159 at risk
Bronchitis	Infections and infestations	25.0	Systematic Assessment	EG00013 affected267 at risk EG00119 affected263 at risk EG00210 affected159 at risk
Nasopharyngitis	Infections and infestations	25.0	Systematic Assessment	EG00019 affected267 at risk EG00120 affected263 at risk EG00210 affected159 at risk
Pneumonia	Infections and infestations	25.0	Systematic Assessment	EG00025 affected267 at risk EG00123 affected263 at risk EG0029 affected159 at risk
Upper respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG00024 affected267 at risk EG00124 affected263 at risk EG0029 affected159 at risk
Urinary tract infection	Infections and infestations	25.0	Systematic Assessment	EG00014 affected267 at risk EG00113 affected263 at risk EG0024 affected159 at risk
Fall	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG00015 affected267 at risk EG00111 affected263 at risk EG0025 affected159 at risk
Alanine aminotransferase increased	Investigations	25.0	Systematic Assessment	EG00031 affected267 at risk EG00130 affected263 at risk EG00213 affected159 at risk
Aspartate aminotransferase increased	Investigations	25.0	Systematic Assessment	EG00039 affected267 at risk EG00128 affected263 at risk EG00210 affected159 at risk
Blood alkaline phosphatase increased	Investigations	25.0	Systematic Assessment	EG00022 affected267 at risk EG00118 affected263 at risk EG0027 affected159 at risk
Blood creatinine increased	Investigations	25.0	Systematic Assessment	EG00013 affected267 at risk EG00134 affected263 at risk EG00217 affected159 at risk
Gamma-glutamyltransferase increased	Investigations	25.0	Systematic Assessment	EG00010 affected267 at risk EG00114 affected263 at risk EG0024 affected159 at risk
Lymphocyte count decreased	Investigations	25.0	Systematic Assessment	EG00018 affected267 at risk EG00118 affected263 at risk EG0025 affected159 at risk
Neutrophil count decreased	Investigations	25.0	Systematic Assessment	EG0009 affected267 at risk EG00143 affected263 at risk EG0024 affected159 at risk
Platelet count decreased	Investigations	25.0	Systematic Assessment	EG00012 affected267 at risk EG00138 affected263 at risk EG0021 affected159 at risk
Weight decreased	Investigations	25.0	Systematic Assessment	EG00042 affected267 at risk EG00137 affected263 at risk EG00212 affected159 at risk
White blood cell count decreased	Investigations	25.0	Systematic Assessment	EG0007 affected267 at risk EG00133 affected263 at risk EG0026 affected159 at risk
Decreased appetite	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00091 affected267 at risk EG001102 affected263 at risk EG00237 affected159 at risk
Dehydration	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00010 affected267 at risk EG00119 affected263 at risk EG0027 affected159 at risk
Hyperglycaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00019 affected267 at risk EG00118 affected263 at risk EG00210 affected159 at risk
Hyperkalaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00015 affected267 at risk EG00119 affected263 at risk EG00211 affected159 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00028 affected267 at risk EG00127 affected263 at risk EG00211 affected159 at risk
Hypokalaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00024 affected267 at risk EG00131 affected263 at risk EG00213 affected159 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00016 affected267 at risk EG00149 affected263 at risk EG00219 affected159 at risk
Hyponatraemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00028 affected267 at risk EG00137 affected263 at risk EG00213 affected159 at risk
Hypophosphataemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0006 affected267 at risk EG00117 affected263 at risk EG0026 affected159 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00053 affected267 at risk EG00147 affected263 at risk EG00229 affected159 at risk
Back pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00042 affected267 at risk EG00162 affected263 at risk EG00223 affected159 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0009 affected267 at risk EG00114 affected263 at risk EG00210 affected159 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00017 affected267 at risk EG00126 affected263 at risk EG0029 affected159 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00018 affected267 at risk EG00113 affected263 at risk EG0025 affected159 at risk
Myalgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00028 affected267 at risk EG00128 affected263 at risk EG00210 affected159 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00023 affected267 at risk EG00131 affected263 at risk EG00211 affected159 at risk
Dizziness	Nervous system disorders	25.0	Systematic Assessment	EG00030 affected267 at risk EG00141 affected263 at risk EG00221 affected159 at risk
Dysgeusia	Nervous system disorders	25.0	Systematic Assessment	EG00014 affected267 at risk EG00125 affected263 at risk EG0027 affected159 at risk
Headache	Nervous system disorders	25.0	Systematic Assessment	EG00030 affected267 at risk EG00150 affected263 at risk EG00219 affected159 at risk
Neuropathy peripheral	Nervous system disorders	25.0	Systematic Assessment	EG0005 affected267 at risk EG00115 affected263 at risk EG0028 affected159 at risk
Peripheral sensory neuropathy	Nervous system disorders	25.0	Systematic Assessment	EG0007 affected267 at risk EG00124 affected263 at risk EG0027 affected159 at risk
Anxiety	Psychiatric disorders	25.0	Systematic Assessment	EG00017 affected267 at risk EG00118 affected263 at risk EG00212 affected159 at risk
Depression	Psychiatric disorders	25.0	Systematic Assessment	EG00014 affected267 at risk EG00113 affected263 at risk EG0024 affected159 at risk
Insomnia	Psychiatric disorders	25.0	Systematic Assessment	EG00024 affected267 at risk EG00140 affected263 at risk EG00218 affected159 at risk
Cough	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00077 affected267 at risk EG00179 affected263 at risk EG00237 affected159 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00012 affected267 at risk EG00121 affected263 at risk EG0023 affected159 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00069 affected267 at risk EG00175 affected263 at risk EG00238 affected159 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0008 affected267 at risk EG00122 affected263 at risk EG0024 affected159 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00017 affected267 at risk EG00120 affected263 at risk EG0028 affected159 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0008 affected267 at risk EG00115 affected263 at risk EG0025 affected159 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0008 affected267 at risk EG00116 affected263 at risk EG0029 affected159 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00012 affected267 at risk EG00117 affected263 at risk EG00215 affected159 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00030 affected267 at risk EG00125 affected263 at risk EG0028 affected159 at risk
Alopecia	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0009 affected267 at risk EG00126 affected263 at risk EG0023 affected159 at risk
Dry skin	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00022 affected267 at risk EG00126 affected263 at risk EG00214 affected159 at risk
Pruritus	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00039 affected267 at risk EG00131 affected263 at risk EG00217 affected159 at risk
Rash	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00039 affected267 at risk EG00137 affected263 at risk EG00220 affected159 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00018 affected267 at risk EG00112 affected263 at risk EG0026 affected159 at risk
Hypertension	Vascular disorders	25.0	Systematic Assessment	EG00018 affected267 at risk EG00119 affected263 at risk EG0028 affected159 at risk
Hypotension	Vascular disorders	25.0	Systematic Assessment	EG0009 affected267 at risk EG00114 affected263 at risk EG0028 affected159 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
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000600	Amino Acids, Dicarboxylic

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
D000093542	Gemcitabine
D002945	Cisplatin
D016190	Carboplatin
D017239	Paclitaxel
D000068437	Pemetrexed