A Study of Nivolumab and Ipilimumab in Untreated Particip... | NCT04026412

ID	Type	Description	Link
2019-001222-98	EudraCT Number

Label	Type	Description	Intervention Names
Arm A: nivolumab + CCRT + ipilimumab	Experimental	Concurrent chemoradiotherapy (CCRT)	Biological: nivolumab Biological: ipilimumab
Arm B: nivolumab + CCRT	Experimental	Concurrent chemoradiotherapy (CCRT)	Biological: nivolumab
Arm C: CCRT + durvalumab	Experimental	Concurrent chemoradiotherapy (CCRT)	Biological: durvalumab

Name	Type	Description	Arm Group Labels	Other Names
nivolumab	Biological	Specified dose on specified days	Arm A: nivolumab + CCRT + ipilimumab Arm B: nivolumab + CCRT

Measure	Description	Time Frame
Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR)	Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.	From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months)

Measure	Description	Time Frame
Overall Survival (OS)	Overall Survival (OS) for all randomized participants is the time between randomization and the date of death from any cause based on Kaplan-Meier estimates. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.	From randomization untill death (up to approximately 61 months)

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0119		La Jolla	California	92093	United States
Local Institution - 0207

PubMed Identifier	Type	Citation	Retractions
42129521	Derived	Peters S, Tan DSW, Gerber DE, Urbanic J, Ramalingam S, Yu J, Xing L, Rittmeyer A, Ciuleanu TE, de Menezes J, Kim HR, Rojas C, Syrigos K, Hayashi H, Haridass A, Cortinovis D, Bruno D, Kimmich M, Calles A, Nathani R, Pudussery G, Yang L, De Ruysscher D. Nivolumab plus chemoradiotherapy followed by nivolumab with or without ipilimumab for untreated locally advanced stage III NSCLC: a randomized phase 3 trial. Nat Cancer. 2026 May 13. doi: 10.1038/s43018-026-01161-y. Online ahead of print.
34489161

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.

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	Oct 30, 2023

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

Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR)

Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participant in Arm A and C were only considered in the analysis.

Posted

Median

95% Confidence Interval

months

From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months)

ID	Title	Description
OG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
OG001	Arm C: CCRT/Durva	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.

Units	Counts
Participants	OG000287 OG001318

Title

Denominators

Categories

Title	Measurements
	OG00016.69(12.58 to 21.98) OG00115.64(13.67 to 19.75)

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		Cox proportional hazards model		0.6460		Hazard Ratio (HR)	0.95			2-Sided	96	0.77	1.19					Superiority

Secondary

Overall Survival (OS)

Overall Survival (OS) for all randomized participants is the time between randomization and the date of death from any cause based on Kaplan-Meier estimates. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.

All enrolled participants who are randomized to any treatment arm in the study.

Posted

Median

95% Confidence Interval

months

From randomization untill death (up to approximately 61 months)

ID	Title	Description
OG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
OG001	Arm B: Nivo + CCRT/Nivo	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.

Secondary

Arm B Vs Arm C and Arm A Vs Arm B- Progression-Free Survival (Irrespective of Subsequent Therapy) by RECIST 1.1 Per Blinded Independent Central Review (BICR)

Progression-Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.

Posted

Median

95% Confidence Interval

months

From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

ID	Title	Description
OG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
OG001	Arm B: Nivo + CCRT/Nivo

Secondary

Objective Response Rate (ORR) by BICR

Objective Response Rate (ORR) is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1.

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

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.

Posted

Number

95% Confidence Interval

percentage of participants

From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

ID	Title	Description
OG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.

Secondary

Duration of Response (DoR) by RECIST 1.1 Per BICR

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

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

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.

Posted

Median

Full Range

months

From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

ID	Title	Description
OG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.

Secondary

Time to Response (TTR) by RECIST 1.1 Per BICR

Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per BICR.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

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

Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.

Posted

Median

Full Range

months

From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

ID	Title	Description
OG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.

Secondary

Progression Free Survival (PFS) by RECIST 1.1 Per Investigator Assessment

Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on Investigator assessments (per RECIST v1.1), or death due to any cause, whichever occurs first Calculated using Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.

Posted

Median

95% Confidence Interval

months

From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

ID	Title	Description
OG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
OG001	Arm B: Nivo + CCRT/Nivo

Secondary

Objective Response Rate (ORR) by RECIST 1.1 Per Investigator Assessment

ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by investigator assessment per response evaluation criteria in solid tumors (RECIST) v1.1.

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

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.

Posted

Number

95% Confidence Interval

percentage of participants

From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

ID	Title	Description
OG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.

Secondary

Duration of Response (DOR) by RECIST 1.1 Per Investigator Assessment

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

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

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.

Posted

Median

Full Range

months

From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

ID	Title	Description
OG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.

Secondary

Time to Response (TTR) by RECIST 1.1 Per Investigator Assessment

Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per investigator assessment.

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

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.

Posted

Median

Full Range

months

From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

ID	Title	Description
OG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.

Secondary

Time to Death or Distant Metastases (TDDM)

Time to Death or Distant Metastases (TDDM) is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis based on Kaplan-Meier estimates. Distant metastasis is defined as any new lesion that is outside of the thorax (except for heart) according to RECIST 1.1, as assessed by the Investigator.

Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.

Posted

Median

95% Confidence Interval

months

From randomization until metastases or death, whichever occurs first (up to approximately 61 months)

ID	Title	Description
OG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
OG001	Arm B: Nivo + CCRT/Nivo	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.

Secondary

Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs

An Adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.

All treated participants

Posted

Count of Participants

Participants

From first dose (Day 1) till 30 days after the last dose (up to approximately 19 months)

ID	Title	Description
OG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
OG001

Secondary

Change From Baseline in Non-small Cell Lung Cancer (NSCLC)-Symptom Assessment Questionnaire (SAQ) Total Score at Week 48

The NSCLC-SAQ is a questionnaire used in clinical trials to understand how non-small cell lung cancer (NSCLC) affects your daily life and well-being. It has 7 questions that ask about your symptoms over the past 7 days, including cough, pain, shortness of breath, fatigue, and appetite loss. The total scores from the questionnaire range from 0 to 20. A higher score means you have more severe symptoms and are feeling worse, which is a bad outcome. A lower score means you have fewer symptoms and are feeling better, which is a good outcome.

All randomized participants. Only participants with data available at the specified timepoint are included in the analysis.

Posted

Mean

Standard Deviation

Score on a Scale

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
OG001	Arm B: Nivo + CCRT/Nivo	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0006 affected282 at risk EG0013 affected318 at risk EG0029 affected317 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Febrile neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0006 affected282 at risk EG0015 affected318 at risk EG0024 affected317 at risk
Leukopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Lymphopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Myelosuppression	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0012 affected318 at risk EG0021 affected317 at risk
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0012 affected318 at risk EG0022 affected317 at risk
Pancytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0012 affected318 at risk EG0021 affected317 at risk
Thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0003 affected282 at risk EG0014 affected318 at risk EG0022 affected317 at risk
Acute coronary syndrome	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Acute myocardial infarction	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Angina pectoris	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Arrhythmia	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Atrial fibrillation	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0013 affected318 at risk EG0022 affected317 at risk
Atrial flutter	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0023 affected317 at risk
Cardiac arrest	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Cardiac failure	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Cardio-respiratory arrest	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0012 affected318 at risk EG0020 affected317 at risk
Coronary artery disease	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Myocardial infarction	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Myocarditis	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Myopericarditis	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Pericardial effusion	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Pericarditis	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Stress cardiomyopathy	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Adrenal insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Hypophysitis	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Immune-mediated hypophysitis	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Steroid withdrawal syndrome	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Eye pain	Eye disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Pterygium	Eye disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Abdominal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0012 affected318 at risk EG0020 affected317 at risk
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Colitis ischaemic	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Colitis ulcerative	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0007 affected282 at risk EG0010 affected318 at risk EG0022 affected317 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Dyspepsia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Dysphagia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0013 affected318 at risk EG0023 affected317 at risk
Enterocolitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Gastritis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Gastrointestinal perforation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Haematemesis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Inguinal hernia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Mesenteric artery embolism	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0012 affected318 at risk EG0022 affected317 at risk
Odynophagia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Oesophageal disorder	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Oesophageal stenosis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Oesophagitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0018 affected318 at risk EG0024 affected317 at risk
Pancreatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Small intestinal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0012 affected318 at risk EG0020 affected317 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0010 affected318 at risk EG0023 affected317 at risk
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Asthenia	General disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0022 affected317 at risk
Chest pain	General disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Chills	General disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Death	General disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0012 affected318 at risk EG0020 affected317 at risk
Fatigue	General disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0023 affected317 at risk
General physical health deterioration	General disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Hyperthermia	General disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Malaise	General disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Medical device site fistula	General disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Mucosal inflammation	General disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Multiple organ dysfunction syndrome	General disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Non-cardiac chest pain	General disorders	27.1	Systematic Assessment	EG0003 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Pain	General disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Pyrexia	General disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0025 affected317 at risk
Sudden death	General disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Systemic inflammatory response syndrome	General disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Autoimmune hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Biliary obstruction	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Cholangitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Drug-induced liver injury	Hepatobiliary disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0012 affected318 at risk EG0020 affected317 at risk
Hepatic function abnormal	Hepatobiliary disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0010 affected318 at risk EG0022 affected317 at risk
Hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Hepatotoxicity	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Immune-mediated hepatic disorder	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0003 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Liver disorder	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Anaphylactic reaction	Immune system disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Contrast media allergy	Immune system disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Cytokine release syndrome	Immune system disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Drug hypersensitivity	Immune system disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Aspergillus infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Atypical pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Bacterial disease carrier	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Bacterial infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Bronchiolitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Bronchitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Bronchopulmonary aspergillosis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
COVID-19	Infections and infestations	27.1	Systematic Assessment	EG0009 affected282 at risk EG00111 affected318 at risk EG0026 affected317 at risk
COVID-19 pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0002 affected282 at risk EG0014 affected318 at risk EG0025 affected317 at risk
Cellulitis	Infections and infestations	27.1	Systematic Assessment	EG0002 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Cholecystitis infective	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Clostridium difficile colitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0012 affected318 at risk EG0020 affected317 at risk
Cytomegalovirus enterocolitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Diverticulitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0022 affected317 at risk
Empyema	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Gastroenteritis rotavirus	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Gastroenteritis viral	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Haematological infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Helicobacter gastritis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Herpes zoster	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Infection	Infections and infestations	27.1	Systematic Assessment	EG0002 affected282 at risk EG0011 affected318 at risk EG0023 affected317 at risk
Infectious pleural effusion	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Influenza	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Lower respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0022 affected317 at risk
Lung abscess	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0022 affected317 at risk
Mucosal infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Neutropenic sepsis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Oesophageal candidiasis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Oral fungal infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Osteomyelitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Otitis media	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Pleural infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0003 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG00033 affected282 at risk EG00139 affected318 at risk EG00229 affected317 at risk
Pneumonia aspiration	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Pneumonia bacterial	Infections and infestations	27.1	Systematic Assessment	EG0003 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Pneumonia cytomegaloviral	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Pneumonia fungal	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Pneumonia pneumococcal	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Pneumonia staphylococcal	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Post-acute COVID-19 syndrome	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Pulmonary sepsis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0012 affected318 at risk EG0020 affected317 at risk
Pulmonary tuberculosis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0003 affected282 at risk EG0013 affected318 at risk EG0020 affected317 at risk
Sepsis	Infections and infestations	27.1	Systematic Assessment	EG0005 affected282 at risk EG0014 affected318 at risk EG0021 affected317 at risk
Septic shock	Infections and infestations	27.1	Systematic Assessment	EG0002 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Suspected COVID-19	Infections and infestations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Tuberculosis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Upper respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Urinary tract infection	Infections and infestations	27.1	Systematic Assessment	EG0002 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Viral infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Wound infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Accidental overdose	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0002 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Humerus fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected282 at risk EG0012 affected318 at risk EG0020 affected317 at risk
Infusion related reaction	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Procedural pain	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0005 affected282 at risk EG0014 affected318 at risk EG0024 affected317 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG00018 affected282 at risk EG00115 affected318 at risk EG00213 affected317 at risk
Road traffic accident	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Wound evisceration	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
General physical condition abnormal	Investigations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Granulocyte count decreased	Investigations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Imaging procedure abnormal	Investigations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Lymphocyte count decreased	Investigations	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0022 affected317 at risk
Neutrophil count decreased	Investigations	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0023 affected317 at risk
Platelet count decreased	Investigations	27.1	Systematic Assessment	EG0002 affected282 at risk EG0012 affected318 at risk EG0026 affected317 at risk
White blood cell count decreased	Investigations	27.1	Systematic Assessment	EG0002 affected282 at risk EG0011 affected318 at risk EG0023 affected317 at risk
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0012 affected318 at risk EG0021 affected317 at risk
Dehydration	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0011 affected318 at risk EG0023 affected317 at risk
Diabetes mellitus	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Hypercalcaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Hyperglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Hyperkalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0022 affected317 at risk
Hypokalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0012 affected318 at risk EG0022 affected317 at risk
Hypophagia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Malnutrition	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0012 affected318 at risk EG0021 affected317 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0022 affected317 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0012 affected318 at risk EG0020 affected317 at risk
Neck pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Appendix cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0022 affected317 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG00017 affected282 at risk EG00112 affected318 at risk EG00214 affected317 at risk
Metastases to adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected282 at risk EG0013 affected318 at risk EG0020 affected317 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Cerebral amyloid angiopathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Cerebral artery embolism	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Cerebral haemorrhage	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Cerebral ischaemia	Nervous system disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Cognitive disorder	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0012 affected318 at risk EG0020 affected317 at risk
Depressed level of consciousness	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Dizziness	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0012 affected318 at risk EG0020 affected317 at risk
Dysaesthesia	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Epilepsy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Guillain-Barre syndrome	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Haemorrhage intracranial	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0012 affected318 at risk EG0021 affected317 at risk
Headache	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Hemiparesis	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Intracranial aneurysm	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Intracranial pressure increased	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Neuralgia	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Seizure	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Spinal cord compression	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Subarachnoid haemorrhage	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Device dislocation	Product Issues	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Confusional state	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Disorientation	Psychiatric disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Acute kidney injury	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0014 affected318 at risk EG0020 affected317 at risk
Autoimmune nephritis	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Azotaemia	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Renal failure	Renal and urinary disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Urinary retention	Renal and urinary disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0012 affected318 at risk EG0021 affected317 at risk
Autoimmune lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Bronchial haemorrhage	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0023 affected317 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0024 affected317 at risk
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0009 affected282 at risk EG0019 affected318 at risk EG0024 affected317 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0004 affected282 at risk EG0015 affected318 at risk EG00210 affected317 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00013 affected282 at risk EG00110 affected318 at risk EG0022 affected317 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0004 affected282 at risk EG0012 affected318 at risk EG0021 affected317 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0004 affected282 at risk EG0010 affected318 at risk EG0022 affected317 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00032 affected282 at risk EG00132 affected318 at risk EG00211 affected317 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0006 affected282 at risk EG0011 affected318 at risk EG0021 affected317 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0006 affected282 at risk EG0015 affected318 at risk EG0023 affected317 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0012 affected318 at risk EG0021 affected317 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected318 at risk EG0023 affected317 at risk
Respiratory tract haemorrhage	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0012 affected318 at risk EG0020 affected317 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Angioedema	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Drug eruption	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk
Pemphigus	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Arterial thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Embolism	Vascular disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Hypotension	Vascular disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Hypovolaemic shock	Vascular disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Orthostatic hypotension	Vascular disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Peripheral embolism	Vascular disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Peripheral ischaemia	Vascular disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected318 at risk EG0021 affected317 at risk
Superior vena cava syndrome	Vascular disorders	27.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0002 affected282 at risk EG0010 affected318 at risk EG0020 affected317 at risk
Venous thrombosis limb	Vascular disorders	27.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected318 at risk EG0020 affected317 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG000124 affected282 at risk EG001132 affected318 at risk EG002134 affected317 at risk
Leukopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG00041 affected282 at risk EG00139 affected318 at risk EG00246 affected317 at risk
Lymphopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG00022 affected282 at risk EG00125 affected318 at risk EG00238 affected317 at risk
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG00057 affected282 at risk EG00162 affected318 at risk EG00244 affected317 at risk
Thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG00042 affected282 at risk EG00127 affected318 at risk EG00229 affected317 at risk
Hyperthyroidism	Endocrine disorders	27.1	Systematic Assessment	EG00022 affected282 at risk EG00116 affected318 at risk EG00216 affected317 at risk
Hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG00044 affected282 at risk EG00151 affected318 at risk EG00232 affected317 at risk
Abdominal pain	Gastrointestinal disorders	27.1	Systematic Assessment	EG00020 affected282 at risk EG00110 affected318 at risk EG00217 affected317 at risk
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG0008 affected282 at risk EG00117 affected318 at risk EG00213 affected317 at risk
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG00082 affected282 at risk EG00178 affected318 at risk EG00289 affected317 at risk
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG00064 affected282 at risk EG00162 affected318 at risk EG00252 affected317 at risk
Dyspepsia	Gastrointestinal disorders	27.1	Systematic Assessment	EG00024 affected282 at risk EG00121 affected318 at risk EG00213 affected317 at risk
Dysphagia	Gastrointestinal disorders	27.1	Systematic Assessment	EG00053 affected282 at risk EG00142 affected318 at risk EG00234 affected317 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	27.1	Systematic Assessment	EG00011 affected282 at risk EG0015 affected318 at risk EG00219 affected317 at risk
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG00098 affected282 at risk EG001104 affected318 at risk EG002108 affected317 at risk
Odynophagia	Gastrointestinal disorders	27.1	Systematic Assessment	EG00015 affected282 at risk EG00120 affected318 at risk EG00213 affected317 at risk
Oesophagitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG00074 affected282 at risk EG00181 affected318 at risk EG00269 affected317 at risk
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG00033 affected282 at risk EG00138 affected318 at risk EG00231 affected317 at risk
Asthenia	General disorders	27.1	Systematic Assessment	EG00060 affected282 at risk EG00150 affected318 at risk EG00254 affected317 at risk
Chest pain	General disorders	27.1	Systematic Assessment	EG00012 affected282 at risk EG00111 affected318 at risk EG00224 affected317 at risk
Fatigue	General disorders	27.1	Systematic Assessment	EG00060 affected282 at risk EG00161 affected318 at risk EG00277 affected317 at risk
Non-cardiac chest pain	General disorders	27.1	Systematic Assessment	EG00019 affected282 at risk EG00120 affected318 at risk EG00219 affected317 at risk
Oedema peripheral	General disorders	27.1	Systematic Assessment	EG00020 affected282 at risk EG00120 affected318 at risk EG00212 affected317 at risk
Pain	General disorders	27.1	Systematic Assessment	EG00011 affected282 at risk EG00113 affected318 at risk EG00218 affected317 at risk
Pyrexia	General disorders	27.1	Systematic Assessment	EG00059 affected282 at risk EG00146 affected318 at risk EG00241 affected317 at risk
COVID-19	Infections and infestations	27.1	Systematic Assessment	EG00029 affected282 at risk EG00141 affected318 at risk EG00239 affected317 at risk
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG00041 affected282 at risk EG00143 affected318 at risk EG00234 affected317 at risk
Upper respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG00011 affected282 at risk EG0019 affected318 at risk EG00217 affected317 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG00048 affected282 at risk EG00147 affected318 at risk EG00256 affected317 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG00041 affected282 at risk EG00152 affected318 at risk EG00248 affected317 at risk
Radiation skin injury	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG00035 affected282 at risk EG00146 affected318 at risk EG00232 affected317 at risk
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG00036 affected282 at risk EG00135 affected318 at risk EG00243 affected317 at risk
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG00026 affected282 at risk EG00129 affected318 at risk EG00237 affected317 at risk
Blood creatine phosphokinase increased	Investigations	27.1	Systematic Assessment	EG00014 affected282 at risk EG00120 affected318 at risk EG00225 affected317 at risk
Blood creatinine increased	Investigations	27.1	Systematic Assessment	EG00023 affected282 at risk EG00113 affected318 at risk EG00226 affected317 at risk
Blood thyroid stimulating hormone increased	Investigations	27.1	Systematic Assessment	EG0009 affected282 at risk EG00117 affected318 at risk EG00214 affected317 at risk
Lymphocyte count decreased	Investigations	27.1	Systematic Assessment	EG00026 affected282 at risk EG00142 affected318 at risk EG00223 affected317 at risk
Neutrophil count decreased	Investigations	27.1	Systematic Assessment	EG00054 affected282 at risk EG00169 affected318 at risk EG00257 affected317 at risk
Platelet count decreased	Investigations	27.1	Systematic Assessment	EG00047 affected282 at risk EG00155 affected318 at risk EG00248 affected317 at risk
Weight decreased	Investigations	27.1	Systematic Assessment	EG00025 affected282 at risk EG00124 affected318 at risk EG00217 affected317 at risk
White blood cell count decreased	Investigations	27.1	Systematic Assessment	EG00065 affected282 at risk EG00173 affected318 at risk EG00263 affected317 at risk
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00079 affected282 at risk EG00164 affected318 at risk EG00277 affected317 at risk
Hyperglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00017 affected282 at risk EG00121 affected318 at risk EG00221 affected317 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00024 affected282 at risk EG00126 affected318 at risk EG00223 affected317 at risk
Hypokalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00025 affected282 at risk EG00121 affected318 at risk EG00223 affected317 at risk
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00029 affected282 at risk EG00138 affected318 at risk EG00220 affected317 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00037 affected282 at risk EG00138 affected318 at risk EG00251 affected317 at risk
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00022 affected282 at risk EG00126 affected318 at risk EG00227 affected317 at risk
Myalgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00013 affected282 at risk EG00120 affected318 at risk EG00229 affected317 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00017 affected282 at risk EG00114 affected318 at risk EG00223 affected317 at risk
Dizziness	Nervous system disorders	27.1	Systematic Assessment	EG00014 affected282 at risk EG00118 affected318 at risk EG00212 affected317 at risk
Headache	Nervous system disorders	27.1	Systematic Assessment	EG00032 affected282 at risk EG00130 affected318 at risk EG00232 affected317 at risk
Neuropathy peripheral	Nervous system disorders	27.1	Systematic Assessment	EG00012 affected282 at risk EG00113 affected318 at risk EG00216 affected317 at risk
Insomnia	Psychiatric disorders	27.1	Systematic Assessment	EG00035 affected282 at risk EG00137 affected318 at risk EG00232 affected317 at risk
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00082 affected282 at risk EG00183 affected318 at risk EG00287 affected317 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00047 affected282 at risk EG00163 affected318 at risk EG00254 affected317 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00011 affected282 at risk EG00117 affected318 at risk EG00218 affected317 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00012 affected282 at risk EG00117 affected318 at risk EG00212 affected317 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00062 affected282 at risk EG00176 affected318 at risk EG00248 affected317 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00017 affected282 at risk EG00115 affected318 at risk EG00220 affected317 at risk
Alopecia	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00054 affected282 at risk EG00169 affected318 at risk EG00254 affected317 at risk
Dry skin	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00017 affected282 at risk EG00113 affected318 at risk EG00219 affected317 at risk
Pruritus	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00065 affected282 at risk EG00154 affected318 at risk EG00251 affected317 at risk
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00051 affected282 at risk EG00155 affected318 at risk EG00249 affected317 at risk

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
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

ID	Title	Description
BG000	Arm A:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
BG001	Arm B: Nivo + CCRT/Nivo	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.
BG002	Arm C: CCRT/Durva	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
BG003	Total	Total of all reporting 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:Nivo + CCRT/Nivo + Ipi	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.	132	287	180	282	273	282
EG001	Arm B: Nivo + CCRT/Nivo	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.	132	320	181	318	310	318
EG002	Arm C: CCRT/Durva	Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.	132	318	145	317	307	317