An Open-Label, Multicenter Clinical Trial With Nivolumab... | NCT02409368

NCT02409368

ID	Type	Description	Link
2014-001285-10	EudraCT Number

Status Module

Name	Class
PPD Development, LP	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Cohort A: Treatment - Nivolumab	Experimental	Nivolumab IV infusion	Drug: Nivolumab

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Drug		Cohort A: Treatment - Nivolumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events	The total number of participants with high grade treatment related select adverse events.	From first dose to time of analysis of primary endpoint (approximately up to 34 months)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With High Grade Select Adverse Events	The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0002		Wels	Upper Austria	4600	Austria
Local Institution - 0003

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32028209	Derived	Felip E, Ardizzoni A, Ciuleanu T, Cobo M, Laktionov K, Szilasi M, Califano R, Carcereny E, Griffiths R, Paz-Ares L, Duchnowska R, Garcia MA, Isla D, Jassem J, Appel W, Milanowski J, Van Meerbeeck JP, Wolf J, Li A, Acevedo A, Popat S. CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations. Eur J Cancer. 2020 Mar;127:160-172. doi: 10.1016/j.ejca.2019.11.019. Epub 2020 Feb 3.

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ECOG (PS0)	ECOG Performance Status 0 Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
FG001	ECOG (PS1)	ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 10, 2018	Mar 31, 2021

Arm/Group Information

ID	Title	Description
BG000	ECOG (PS0)	ECOG Performance Status 0 Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
BG001	ECOG (PS1)	ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
BG002	ECOG Performance Status 2	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
BG003	ECOG (PS3)	ECOG Performance Status 3 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
BG004	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
	BG00063.6± 8.28 BG00166.1± 8.27 BG00267.9± 7.29 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00037 BG001111 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00013 BG00137 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events

The total number of participants with high grade treatment related select adverse events.

All Treated participants

Posted

Count of Participants

Participants

From first dose to time of analysis of primary endpoint (approximately up to 34 months)

ID	Title	Description
OG000	ECOG (PS0)	ECOG Performance Status 0 Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
OG001	ECOG (PS1)	ECOG Performance Status 1 Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
OG002	ECOG Performance Status 2	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks

Units	Counts
Participants	OG000173 OG001534 OG002103

Title

Denominators

Categories

Skin

Title	Measurements
	OG0001 OG0017 OG0020

Gastrointestinal

Secondary

Number of Participants With High Grade Select Adverse Events

The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.

All treated participants with ECOG PS Grade 0-2

Posted

Count of Participants

Participants

From first dose up to 100 days post last dose (up to 76 months)

ID	Title	Description
OG000	ECOG (PS0)	ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
OG001	ECOG (PS1)	ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
OG002	ECOG Performance Status 2	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks

Secondary

Median Time to Onset of Any Grade Select Adverse Events

Median Time to onset of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.

All treated participants with ECOG PS Grade 0-2

Posted

Median

Full Range

Weeks

From first dose up to 100 days post last dose (up to approximately 65 months)

ID	Title	Description
OG000	ECOG (PS0)	ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
OG001	ECOG (PS1)	ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
OG002	ECOG Performance Status 2	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks

Secondary

Median Time to Resolution of Any Grade Select Adverse Events

Median time to resolution of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.

All treated participants with ECOG PS Grade 0-2

Posted

Median

95% Confidence Interval

Weeks

From first dose to up to 100 days post last dose (up to approximately 45 months)

ID	Title	Description
OG000	ECOG (PS0)	ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
OG001	ECOG (PS1)	ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
OG002	ECOG Performance Status 2	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks

Secondary

Overall Survival

Overall Survival (OS) is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug.

All treated participants with ECOG PS Grade 0-2

Posted

Median

95% Confidence Interval

Months

From the first dosing up to the date of death (up to approximately 76 months)

ID	Title	Description
OG000	ECOG (PS0)	ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
OG001	ECOG (PS1)	ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
OG002	ECOG Performance Status 2	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks

Units	Counts
Participants

Secondary

Objective Response Rate (ORR)

ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions; PR is defined by at least a 30% decrease in the sum of the longest diameter of target lesions. ORR as assessed by the investigator will be reported.

All response evaluable participants

Posted

Number

95% Confidence Interval

Percentage

From first dose up to last dose (up to approximately 76 months)

ID	Title	Description
OG000	ECOG (PS0)	ECOG Performance Status 0 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
OG001	ECOG (PS1)	ECOG Performance Status 1 nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
OG002	ECOG Performance Status 2	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks

Units	Counts

Post-Hoc

Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection

The total number of participants with high grade treatment related select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4 or 5. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.

Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.

All treated participants with ECOG PS Grade 0-2

Posted

Count of Participants

Participants

From first dose to up to 100 days post last dose (up to approximately 76 months)

ID	Title	Description
OG000	ECOG (PS0)	ECOG Performance Status 0 Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks
OG001	ECOG (PS1)	ECOG Performance Status 1 Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks

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	ECOG Performance Status 0	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks	131	172	115	172	149	172
EG001	ECOG Performance Status 1	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks	446	537	375	537	472	537
EG002	ECOG Performance Status 2	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks	90	102	84	102	86	102
EG003	ECOG Performance Status 3	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks	1	1	1	1	1	1

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0002 affected172 at risk EG0016 affected537 at risk EG0021 affected102 at risk EG0030 affected1 at risk
Thrombocytopenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Atrial fibrillation	Cardiac disorders	24.0	Systematic Assessment	EG0002 affected172 at risk EG0012 affected537 at risk EG0022 affected102 at risk EG003
Atrial flutter	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Cardiac arrest	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Cardiac failure	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0013 affected537 at risk EG0020 affected102 at risk EG003
Cardiac failure congestive	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Cardiac tamponade	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0021 affected102 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0013 affected537 at risk EG0021 affected102 at risk EG003
Cardiomegaly	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Intracardiac thrombus	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Left ventricular failure	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Mitral valve prolapse	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Myocardial infarction	Cardiac disorders	24.0	Systematic Assessment	EG0002 affected172 at risk EG0013 affected537 at risk EG0021 affected102 at risk EG003
Pericardial effusion	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0013 affected537 at risk EG0021 affected102 at risk EG003
Pericarditis	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0013 affected537 at risk EG0020 affected102 at risk EG003
Sinus tachycardia	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Adrenal insufficiency	Endocrine disorders	24.0	Systematic Assessment	EG0002 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Hypercalcaemia of malignancy	Endocrine disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Hyperthyroidism	Endocrine disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Hypophysitis	Endocrine disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Hypothyroidism	Endocrine disorders	24.0	Systematic Assessment	EG0002 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Thyroiditis	Endocrine disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Abdominal pain	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Anal fissure	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Ascites	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Autoimmune colitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Colitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0013 affected537 at risk EG0020 affected102 at risk EG003
Colitis microscopic	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Constipation	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Diarrhoea	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0017 affected537 at risk EG0021 affected102 at risk EG003
Dysphagia	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0014 affected537 at risk EG0021 affected102 at risk EG003
Gastric ulcer	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Gastritis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Inguinal hernia	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Nausea	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Oesophageal rupture	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0013 affected537 at risk EG0020 affected102 at risk EG003
Stomatitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Vomiting	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Asthenia	General disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Chest pain	General disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Death	General disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0021 affected102 at risk EG003
Fatigue	General disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
General physical health deterioration	General disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0014 affected537 at risk EG0021 affected102 at risk EG003
Hernia obstructive	General disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Non-cardiac chest pain	General disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0014 affected537 at risk EG0021 affected102 at risk EG003
Oedema peripheral	General disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0021 affected102 at risk EG003
Pain	General disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Pyrexia	General disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0018 affected537 at risk EG0020 affected102 at risk EG003
Sudden cardiac death	General disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0021 affected102 at risk EG003
Sudden death	General disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0014 affected537 at risk EG0020 affected102 at risk EG003
Systemic inflammatory response syndrome	General disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0022 affected102 at risk EG003
Biliary tract disorder	Hepatobiliary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Cholangitis	Hepatobiliary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Hepatic failure	Hepatobiliary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Jaundice	Hepatobiliary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Liver injury	Hepatobiliary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Drug hypersensitivity	Immune system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Abscess	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0021 affected102 at risk EG003
Anal abscess	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Bacteraemia	Infections and infestations	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Bacterial diarrhoea	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0021 affected102 at risk EG003
Bacterial infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0021 affected102 at risk EG003
Biliary sepsis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Bronchitis	Infections and infestations	24.0	Systematic Assessment	EG0004 affected172 at risk EG0019 affected537 at risk EG0021 affected102 at risk EG003
Bronchitis bacterial	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
COVID-19	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
COVID-19 pneumonia	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Cellulitis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Clostridium colitis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Cystitis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0022 affected102 at risk EG003
H1N1 influenza	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected172 at risk EG0012 affected537 at risk EG0021 affected102 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0013 affected537 at risk EG0020 affected102 at risk EG003
Lower respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG0005 affected172 at risk EG00121 affected537 at risk EG0025 affected102 at risk EG003
Mediastinitis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0021 affected102 at risk EG003
Meningitis aseptic	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Neutropenic sepsis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Parainfluenzae virus infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Pneumonia	Infections and infestations	24.0	Systematic Assessment	EG00020 affected172 at risk EG00141 affected537 at risk EG00210 affected102 at risk EG003
Pneumonia bacterial	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Pneumonia cytomegaloviral	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Pneumonia fungal	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Pneumonia pneumococcal	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Pulmonary sepsis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected172 at risk EG0013 affected537 at risk EG0020 affected102 at risk EG003
Pulmonary tuberculosis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG00011 affected172 at risk EG00125 affected537 at risk EG0023 affected102 at risk EG003
Sepsis	Infections and infestations	24.0	Systematic Assessment	EG0003 affected172 at risk EG0017 affected537 at risk EG0020 affected102 at risk EG003
Septic shock	Infections and infestations	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Staphylococcal infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Streptococcal infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Tracheobronchitis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Upper respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected172 at risk EG0013 affected537 at risk EG0021 affected102 at risk EG003
Urinary tract infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected172 at risk EG0015 affected537 at risk EG0021 affected102 at risk EG003
Vulval abscess	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Concussion	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Fall	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0022 affected102 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0021 affected102 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected172 at risk EG0011 affected537 at risk EG0021 affected102 at risk EG003
Overdose	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0022 affected102 at risk EG003
Radiation oesophagitis	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Skull fractured base	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Splenic rupture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Tracheal obstruction	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Alanine aminotransferase increased	Investigations	24.0	Systematic Assessment	EG0001 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Aspartate aminotransferase increased	Investigations	24.0	Systematic Assessment	EG0001 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Gamma-glutamyltransferase increased	Investigations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Liver function test increased	Investigations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Cachexia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Dehydration	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0002 affected172 at risk EG0012 affected537 at risk EG0021 affected102 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Diabetic metabolic decompensation	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG00112 affected537 at risk EG0023 affected102 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0002 affected172 at risk EG0013 affected537 at risk EG0022 affected102 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0021 affected102 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0003 affected172 at risk EG0012 affected537 at risk EG0021 affected102 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Follicular thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0021 affected102 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG00059 affected172 at risk EG001206 affected537 at risk EG00258 affected102 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected172 at risk EG0013 affected537 at risk EG0020 affected102 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0021 affected102 at risk EG003
Oncologic complication	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Small intestine adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Tumour compression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected172 at risk EG0015 affected537 at risk EG0022 affected102 at risk EG003
Brain oedema	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Cerebral haemorrhage	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Cerebral infarction	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Cerebrovascular accident	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0012 affected537 at risk EG0021 affected102 at risk EG003
Coma	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Dizziness	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Epilepsy	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Intracranial pressure increased	Nervous system disorders	24.0	Systematic Assessment	EG0002 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Lacunar infarction	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Loss of consciousness	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Monoparesis	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Motor dysfunction	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Neuropathy peripheral	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Seizure	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0013 affected537 at risk EG0020 affected102 at risk EG003
Spinal cord compression	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Status epilepticus	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0021 affected102 at risk EG003
Syncope	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0023 affected102 at risk EG003
Transient ischaemic attack	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Tremor	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Agitation	Psychiatric disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Confusional state	Psychiatric disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Delirium	Psychiatric disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Mania	Psychiatric disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Acute kidney injury	Renal and urinary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0014 affected537 at risk EG0021 affected102 at risk EG003
Calculus urinary	Renal and urinary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Leukocyturia	Renal and urinary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0021 affected102 at risk EG003
Nephrolithiasis	Renal and urinary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Renal failure	Renal and urinary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0014 affected537 at risk EG0020 affected102 at risk EG003
Urinary retention	Renal and urinary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0021 affected102 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0022 affected102 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0021 affected102 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0017 affected537 at risk EG0025 affected102 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0009 affected172 at risk EG00128 affected537 at risk EG00210 affected102 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0007 affected172 at risk EG00111 affected537 at risk EG0023 affected102 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Lung consolidation	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0021 affected102 at risk EG003
Oesophagobronchial fistula	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0003 affected172 at risk EG00110 affected537 at risk EG0022 affected102 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0004 affected172 at risk EG00115 affected537 at risk EG0020 affected102 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0021 affected102 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0003 affected172 at risk EG0016 affected537 at risk EG0020 affected102 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0012 affected537 at risk EG0021 affected102 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0003 affected172 at risk EG00110 affected537 at risk EG0021 affected102 at risk EG003
Respiratory tract haemorrhage	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Deep vein thrombosis	Vascular disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0021 affected102 at risk EG003
Embolism	Vascular disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Hypertension	Vascular disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Hypotension	Vascular disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Peripheral ischaemia	Vascular disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Superior vena cava occlusion	Vascular disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Superior vena cava syndrome	Vascular disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0014 affected537 at risk EG0020 affected102 at risk EG003
Venous thrombosis limb	Vascular disorders	24.0	Systematic Assessment	EG0001 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG00023 affected172 at risk EG00197 affected537 at risk EG00221 affected102 at risk EG0031 affected1 at risk
Hypothyroidism	Endocrine disorders	24.0	Systematic Assessment	EG00025 affected172 at risk EG00137 affected537 at risk EG0026 affected102 at risk EG003
Constipation	Gastrointestinal disorders	24.0	Systematic Assessment	EG00018 affected172 at risk EG00180 affected537 at risk EG00216 affected102 at risk EG003
Diarrhoea	Gastrointestinal disorders	24.0	Systematic Assessment	EG00026 affected172 at risk EG001100 affected537 at risk EG00216 affected102 at risk EG003
Nausea	Gastrointestinal disorders	24.0	Systematic Assessment	EG00020 affected172 at risk EG00171 affected537 at risk EG00216 affected102 at risk EG003
Vomiting	Gastrointestinal disorders	24.0	Systematic Assessment	EG0009 affected172 at risk EG00134 affected537 at risk EG0029 affected102 at risk EG003
Asthenia	General disorders	24.0	Systematic Assessment	EG00030 affected172 at risk EG001131 affected537 at risk EG00215 affected102 at risk EG003
Fatigue	General disorders	24.0	Systematic Assessment	EG00040 affected172 at risk EG001121 affected537 at risk EG00225 affected102 at risk EG003
Non-cardiac chest pain	General disorders	24.0	Systematic Assessment	EG0006 affected172 at risk EG00134 affected537 at risk EG0025 affected102 at risk EG003
Oedema peripheral	General disorders	24.0	Systematic Assessment	EG0007 affected172 at risk EG00130 affected537 at risk EG00214 affected102 at risk EG003
Pyrexia	General disorders	24.0	Systematic Assessment	EG0009 affected172 at risk EG00149 affected537 at risk EG0028 affected102 at risk EG003
Lower respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG00018 affected172 at risk EG00151 affected537 at risk EG0027 affected102 at risk EG003
Respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG00010 affected172 at risk EG00137 affected537 at risk EG0026 affected102 at risk EG003
Upper respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG00010 affected172 at risk EG00129 affected537 at risk EG0022 affected102 at risk EG003
Alanine aminotransferase increased	Investigations	24.0	Systematic Assessment	EG00012 affected172 at risk EG00130 affected537 at risk EG0025 affected102 at risk EG003
Aspartate aminotransferase increased	Investigations	24.0	Systematic Assessment	EG00015 affected172 at risk EG00128 affected537 at risk EG0025 affected102 at risk EG003
Blood creatinine increased	Investigations	24.0	Systematic Assessment	EG0009 affected172 at risk EG00134 affected537 at risk EG0025 affected102 at risk EG003
Weight decreased	Investigations	24.0	Systematic Assessment	EG0008 affected172 at risk EG00142 affected537 at risk EG0027 affected102 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG00024 affected172 at risk EG001147 affected537 at risk EG00224 affected102 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0006 affected172 at risk EG00139 affected537 at risk EG0026 affected102 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG00011 affected172 at risk EG00127 affected537 at risk EG0025 affected102 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00024 affected172 at risk EG00152 affected537 at risk EG0027 affected102 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00011 affected172 at risk EG00146 affected537 at risk EG0027 affected102 at risk EG003
Headache	Nervous system disorders	24.0	Systematic Assessment	EG00010 affected172 at risk EG00136 affected537 at risk EG0023 affected102 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00044 affected172 at risk EG001134 affected537 at risk EG00219 affected102 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00044 affected172 at risk EG001167 affected537 at risk EG00228 affected102 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00011 affected172 at risk EG00147 affected537 at risk EG00210 affected102 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0009 affected172 at risk EG00158 affected537 at risk EG00210 affected102 at risk EG003
Rash	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG00010 affected172 at risk EG00139 affected537 at risk EG0025 affected102 at risk EG003
Hyperthyroidism	Endocrine disorders	24.0	Systematic Assessment	EG00013 affected172 at risk EG00118 affected537 at risk EG0021 affected102 at risk EG003
Lacrimation increased	Eye disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Abdominal pain	Gastrointestinal disorders	24.0	Systematic Assessment	EG0002 affected172 at risk EG00128 affected537 at risk EG0023 affected102 at risk EG003
Stomatitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0005 affected172 at risk EG00114 affected537 at risk EG0027 affected102 at risk EG003
Chest pain	General disorders	24.0	Systematic Assessment	EG00010 affected172 at risk EG00124 affected537 at risk EG0021 affected102 at risk EG003
Influenza like illness	General disorders	24.0	Systematic Assessment	EG0003 affected172 at risk EG0014 affected537 at risk EG0022 affected102 at risk EG003
Peripheral swelling	General disorders	24.0	Systematic Assessment	EG0002 affected172 at risk EG0018 affected537 at risk EG0022 affected102 at risk EG003
Catheter site infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0010 affected537 at risk EG0020 affected102 at risk EG003
Nasopharyngitis	Infections and infestations	24.0	Systematic Assessment	EG00011 affected172 at risk EG00115 affected537 at risk EG0021 affected102 at risk EG003
Oral candidiasis	Infections and infestations	24.0	Systematic Assessment	EG0004 affected172 at risk EG00126 affected537 at risk EG0023 affected102 at risk EG003
Oral fungal infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Pneumonia	Infections and infestations	24.0	Systematic Assessment	EG00011 affected172 at risk EG00124 affected537 at risk EG0025 affected102 at risk EG003
Tooth infection	Infections and infestations	24.0	Systematic Assessment	EG0002 affected172 at risk EG0011 affected537 at risk EG0020 affected102 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0007 affected172 at risk EG00120 affected537 at risk EG0026 affected102 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0007 affected172 at risk EG00124 affected537 at risk EG0027 affected102 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0004 affected172 at risk EG00125 affected537 at risk EG0026 affected102 at risk EG003
Dizziness	Nervous system disorders	24.0	Systematic Assessment	EG0003 affected172 at risk EG00128 affected537 at risk EG0028 affected102 at risk EG003
Seizure	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected172 at risk EG0012 affected537 at risk EG0020 affected102 at risk EG003
Anxiety	Psychiatric disorders	24.0	Systematic Assessment	EG0009 affected172 at risk EG00112 affected537 at risk EG0021 affected102 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 affected172 at risk EG0016 affected537 at risk EG0021 affected102 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00010 affected172 at risk EG00122 affected537 at risk EG0022 affected102 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0003 affected172 at risk EG00126 affected537 at risk EG0026 affected102 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0007 affected172 at risk EG00126 affected537 at risk EG0026 affected102 at risk EG003
Hypertension	Vascular disorders	24.0	Systematic Assessment	EG00012 affected172 at risk EG00119 affected537 at risk EG0020 affected102 at risk EG003

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