An Investigational Immuno-therapy Study of Nivolumab, Pom... | NCT02726581

NCT02726581

ID	Type	Description	Link
2015-005699-21	EudraCT Number

Status Module

Name	Class
AbbVie	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Investigational Arm	Experimental	Nivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm	Biological: Nivolumab Drug: Pomalidomide Drug: Dexamethasone
Control Arm	Active Comparator	Pomalidomide and Dexamethasone Enrollment is closed for this arm	Drug: Pomalidomide Drug: Dexamethasone
Exploratory Arm	Experimental	Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm	Biological: Nivolumab Biological: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological	Specified dose on specified days, IV (intravenous)	Exploratory Arm Investigational Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	Randomization to first documented tumor progression or death due to any cause, whichever occurred first. Participants who die without reported prior progression are considered to have progressed on date of their death. Participants who did not progress or die will be censored at their last efficacy assessment. Participants who did not have on study efficacy assessments and alive will be censored on randomization date. Participants who started subsequent anti-cancer therapy without prior reported progression will be censored at last efficacy assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), >/= 50% increase from nadir in SPD of > 1 lesion, or >/= 50% increase in the longest diameter of a previous lesion > 1 cm in short axis.	From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month)

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	The time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.	From randomization to the date of death due to any cause (up to approximately 64 months)
Objective Response Rate (ORR)

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0020		Birmingham	Alabama	35294-3300	United States
Local Institution - 0160

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source
FDA Safety Alerts and Recalls

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A: N-Pd	Nivolumab: Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Participants </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

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	Nov 12, 2018

Arm/Group Information

ID	Title	Description
BG000	Arm A: N-Pd	Nivolumab: Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Participants </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
BG001	Arm B: Pd	Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Participants </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
BG002	Arm C: NE-Pd	Nivolumab: Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Elotuzumab: Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle. Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle. Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle. Pomalidomide: 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Days 1, 8, 15, and 22 of each cycle. Participants </= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks. Participants > 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00065.9± 9.4 BG00165.5± 8.7 BG00266.2± 11.5 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00024 BG00125 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0014 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival (PFS)

Randomization to first documented tumor progression or death due to any cause, whichever occurred first. Participants who die without reported prior progression are considered to have progressed on date of their death. Participants who did not progress or die will be censored at their last efficacy assessment. Participants who did not have on study efficacy assessments and alive will be censored on randomization date. Participants who started subsequent anti-cancer therapy without prior reported progression will be censored at last efficacy assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), >/= 50% increase from nadir in SPD of > 1 lesion, or >/= 50% increase in the longest diameter of a previous lesion > 1 cm in short axis.

All randomized participants in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.

Posted

Median

95% Confidence Interval

Months

From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month)

ID	Title	Description
OG000	Arm A: N-Pd	Nivolumab: Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Participants </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
OG001	Arm B: Pd	Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Participants </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.

Units	Counts
Participants	OG00075 OG00171

Title

Denominators

Categories

Title	Measurements
	OG0008.38(5.78 to 12.06) OG0017.33(6.47 to 8.44)

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						Hazard Ratio (HR)	0.90			2-Sided	95	0.62	1.30					Superiority

Secondary

Overall Survival (OS)

The time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.

All randomized participants in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.

Posted

Median

95% Confidence Interval

Months

From randomization to the date of death due to any cause (up to approximately 64 months)

ID	Title	Description
OG000	Arm A: N-Pd	Nivolumab: Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Participants </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
OG001	Arm B: Pd	Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Participants </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.

Units	Counts

Secondary

Objective Response Rate (ORR)

The percentage of randomized participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using International Myeloma Working Group (IMWG) criteria.

sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry.

CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates.

VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h.

PR = >/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by >/= 90% or to < 200 mg per 24 h.

All randomized participants in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization up to approximately 64 months

ID	Title	Description
OG000	Arm A: N-Pd	Nivolumab: Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Participants </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
OG001	Arm B: Pd

Secondary

Time to Objective Response (TTR)

The time from the date of randomization to the date of the first stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).

sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry.

CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates.

VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h.

PR = >/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by >/= 90% or to < 200 mg per 24 h.

All responders (sCR, CR, VGPR, or PR) in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.

Posted

Mean

Standard Deviation

Months

From the date of randomization to the date of the first sCR, CR, VGPR, or PR (up to approximately 64 months)

ID	Title	Description
OG000	Arm A: N-Pd	Nivolumab: Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Participants </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
OG001	Arm B: Pd

Secondary

Duration of Objective Response (DOR)

The time between the date of first response to the date of the first objectively documented tumor progression as assessed by the investigator according to International Myeloma Working Group (IMWG) criteria or death due to any cause prior to subsequent anti-cancer therapy. Participants who neither progress nor die will be censored on the date of their last tumor assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), >/= 50% increase from nadir in SPD of > 1 lesion, or >/= 50% increase in the longest diameter of a previous lesion > 1 cm in short axis.

All responders (sCR, CR, VGPR, or PR) in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.

Posted

Median

95% Confidence Interval

Months

From randomization to the date of the first objectively documented tumor progression or death due to any cause prior to subsequent anti-cancer therapy (up to approximately 64 months)

ID	Title	Description
OG000	Arm A: N-Pd	Nivolumab: Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Participants </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: N-Pd	Nivolumab: Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Participants </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.	47	75	52	72	70	72
EG001	Arm B: Pd	Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Participants </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.	49	71	41	70	65	70
EG002	Arm C: NE-Pd	Nivolumab: Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Elotuzumab: Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle. Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle. Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle. Pomalidomide: 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Days 1, 8, 15, and 22 of each cycle. Participants </= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks. Participants > 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.	17	24	18	24	24	24
EG003	Arm B: NE-Pd Crossover	Participants who progressed on the Pd control arm and were allowed to crossover to the NE-Pd exploratory arm.	5	8	5	8	7	8

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0003 affected72 at risk EG0011 affected70 at risk EG0021 affected24 at risk EG0030 affected8 at risk
Febrile neutropenia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0002 affected72 at risk EG0013 affected70 at risk EG0021 affected24 at risk EG003
Neutropenia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0002 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Atrial fibrillation	Cardiac disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0012 affected70 at risk EG0021 affected24 at risk EG003
Atrioventricular block complete	Cardiac disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Atrioventricular block first degree	Cardiac disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Cardiac arrest	Cardiac disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Cardiac failure	Cardiac disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0012 affected70 at risk EG0020 affected24 at risk EG003
Cardiac failure acute	Cardiac disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Cardiac failure congestive	Cardiac disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Myocardial infarction	Cardiac disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Sinus node dysfunction	Cardiac disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Vertigo	Ear and labyrinth disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Amaurosis fugax	Eye disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Colitis	Gastrointestinal disorders	24.1	Systematic Assessment	EG0003 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Diarrhoea	Gastrointestinal disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0021 affected24 at risk EG003
Food poisoning	Gastrointestinal disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Incarcerated inguinal hernia	Gastrointestinal disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Vomiting	Gastrointestinal disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Condition aggravated	General disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Fatigue	General disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Impaired healing	General disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Influenza like illness	General disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Localised oedema	General disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Non-cardiac chest pain	General disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Oedema peripheral	General disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Pyrexia	General disorders	24.1	Systematic Assessment	EG0005 affected72 at risk EG0014 affected70 at risk EG0021 affected24 at risk EG003
Sudden death	General disorders	24.1	Systematic Assessment	EG0002 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Cholecystitis	Hepatobiliary disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Hypersensitivity	Immune system disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Hypogammaglobulinaemia	Immune system disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Arthritis bacterial	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Atypical pneumonia	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Bacteraemia	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Bacterial infection	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Bronchitis	Infections and infestations	24.1	Systematic Assessment	EG0003 affected72 at risk EG0011 affected70 at risk EG0021 affected24 at risk EG003
Cellulitis	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0023 affected24 at risk EG003
Cytomegalovirus viraemia	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Diverticulitis	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Encephalitis	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Erysipelas	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Escherichia urinary tract infection	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Gastroenteritis	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Hand-foot-and-mouth disease	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Herpes simplex	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Infection	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Parainfluenzae virus infection	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Pneumococcal sepsis	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Pneumocystis jirovecii infection	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Pneumonia	Infections and infestations	24.1	Systematic Assessment	EG0009 affected72 at risk EG00117 affected70 at risk EG0026 affected24 at risk EG003
Pneumonia cytomegaloviral	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Pneumonia fungal	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Pneumonia legionella	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Pneumonia parainfluenzae viral	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Pneumonia respiratory syncytial viral	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Pneumonia staphylococcal	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Pulmonary sepsis	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Respiratory tract infection	Infections and infestations	24.1	Systematic Assessment	EG0003 affected72 at risk EG0013 affected70 at risk EG0020 affected24 at risk EG003
Rhinovirus infection	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Sepsis	Infections and infestations	24.1	Systematic Assessment	EG0008 affected72 at risk EG0013 affected70 at risk EG0023 affected24 at risk EG003
Septic shock	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0012 affected70 at risk EG0020 affected24 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Upper respiratory tract infection	Infections and infestations	24.1	Systematic Assessment	EG0002 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Urinary tract infection	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Vascular device infection	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Wound infection	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Fall	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0021 affected24 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0000 affected72 at risk EG0012 affected70 at risk EG0020 affected24 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Overdose	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Alanine aminotransferase increased	Investigations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Blood creatinine increased	Investigations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Blood glucose increased	Investigations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
C-reactive protein increased	Investigations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Platelet count decreased	Investigations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Dehydration	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Fluid retention	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0012 affected70 at risk EG0020 affected24 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Abdominal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0009 affected72 at risk EG0016 affected70 at risk EG0024 affected24 at risk EG003
Plasma cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected72 at risk EG0012 affected70 at risk EG0022 affected24 at risk EG003
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Refractory cytopenia with unilineage dysplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Cerebral thrombosis	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Dysarthria	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Encephalopathy	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Facial nerve disorder	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Haemorrhage intracranial	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Lacunar stroke	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Presyncope	Nervous system disorders	24.1	Systematic Assessment	EG0002 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Syncope	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0012 affected70 at risk EG0020 affected24 at risk EG003
Tremor	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Confusional state	Psychiatric disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0012 affected70 at risk EG0020 affected24 at risk EG003
Acute kidney injury	Renal and urinary disorders	24.1	Systematic Assessment	EG0005 affected72 at risk EG0013 affected70 at risk EG0024 affected24 at risk EG003
Hydronephrosis	Renal and urinary disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Renal failure	Renal and urinary disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0011 affected70 at risk EG0021 affected24 at risk EG003
Renal impairment	Renal and urinary disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0013 affected70 at risk EG0020 affected24 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0002 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0002 affected72 at risk EG0012 affected70 at risk EG0020 affected24 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0012 affected70 at risk EG0020 affected24 at risk EG003
Circulatory collapse	Vascular disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Deep vein thrombosis	Vascular disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Embolism	Vascular disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Haematoma	Vascular disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Hypovolaemic shock	Vascular disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG00026 affected72 at risk EG00120 affected70 at risk EG00211 affected24 at risk EG0032 affected8 at risk
Leukopenia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0004 affected72 at risk EG0012 affected70 at risk EG0022 affected24 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0021 affected24 at risk EG003
Neutropenia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG00024 affected72 at risk EG00122 affected70 at risk EG00210 affected24 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG00016 affected72 at risk EG00111 affected70 at risk EG0024 affected24 at risk EG003
Sinus bradycardia	Cardiac disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Hyperthyroidism	Endocrine disorders	24.1	Systematic Assessment	EG0002 affected72 at risk EG0011 affected70 at risk EG0022 affected24 at risk EG003
Hypothyroidism	Endocrine disorders	24.1	Systematic Assessment	EG0004 affected72 at risk EG0010 affected70 at risk EG0022 affected24 at risk EG003
Cataract	Eye disorders	24.1	Systematic Assessment	EG0004 affected72 at risk EG0014 affected70 at risk EG0020 affected24 at risk EG003
Vision blurred	Eye disorders	24.1	Systematic Assessment	EG00010 affected72 at risk EG0012 affected70 at risk EG0021 affected24 at risk EG003
Vitreous detachment	Eye disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Abdominal distension	Gastrointestinal disorders	24.1	Systematic Assessment	EG0002 affected72 at risk EG0015 affected70 at risk EG0021 affected24 at risk EG003
Abdominal pain	Gastrointestinal disorders	24.1	Systematic Assessment	EG0003 affected72 at risk EG0015 affected70 at risk EG0020 affected24 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	24.1	Systematic Assessment	EG0005 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Constipation	Gastrointestinal disorders	24.1	Systematic Assessment	EG00017 affected72 at risk EG00115 affected70 at risk EG0024 affected24 at risk EG003
Diarrhoea	Gastrointestinal disorders	24.1	Systematic Assessment	EG00022 affected72 at risk EG00117 affected70 at risk EG0025 affected24 at risk EG003
Dry mouth	Gastrointestinal disorders	24.1	Systematic Assessment	EG0003 affected72 at risk EG0015 affected70 at risk EG0021 affected24 at risk EG003
Dyspepsia	Gastrointestinal disorders	24.1	Systematic Assessment	EG0005 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Dysphagia	Gastrointestinal disorders	24.1	Systematic Assessment	EG0002 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Nausea	Gastrointestinal disorders	24.1	Systematic Assessment	EG00014 affected72 at risk EG00111 affected70 at risk EG0024 affected24 at risk EG003
Vomiting	Gastrointestinal disorders	24.1	Systematic Assessment	EG0005 affected72 at risk EG0016 affected70 at risk EG0022 affected24 at risk EG003
Asthenia	General disorders	24.1	Systematic Assessment	EG00015 affected72 at risk EG00112 affected70 at risk EG0024 affected24 at risk EG003
Chest pain	General disorders	24.1	Systematic Assessment	EG0003 affected72 at risk EG0014 affected70 at risk EG0020 affected24 at risk EG003
Chills	General disorders	24.1	Systematic Assessment	EG0002 affected72 at risk EG0014 affected70 at risk EG0020 affected24 at risk EG003
Fatigue	General disorders	24.1	Systematic Assessment	EG00034 affected72 at risk EG00124 affected70 at risk EG00210 affected24 at risk EG003
Non-cardiac chest pain	General disorders	24.1	Systematic Assessment	EG0005 affected72 at risk EG0014 affected70 at risk EG0020 affected24 at risk EG003
Oedema peripheral	General disorders	24.1	Systematic Assessment	EG00014 affected72 at risk EG00115 affected70 at risk EG0027 affected24 at risk EG003
Pain	General disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0016 affected70 at risk EG0021 affected24 at risk EG003
Pyrexia	General disorders	24.1	Systematic Assessment	EG00010 affected72 at risk EG0019 affected70 at risk EG00214 affected24 at risk EG003
Hypersensitivity	Immune system disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0022 affected24 at risk EG003
Bronchitis	Infections and infestations	24.1	Systematic Assessment	EG0008 affected72 at risk EG0015 affected70 at risk EG0021 affected24 at risk EG003
Candida infection	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Escherichia urinary tract infection	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Influenza	Infections and infestations	24.1	Systematic Assessment	EG0003 affected72 at risk EG0013 affected70 at risk EG0022 affected24 at risk EG003
Nasopharyngitis	Infections and infestations	24.1	Systematic Assessment	EG0005 affected72 at risk EG00112 affected70 at risk EG0020 affected24 at risk EG003
Oral infection	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Oropharyngeal candidiasis	Infections and infestations	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Pneumonia	Infections and infestations	24.1	Systematic Assessment	EG00010 affected72 at risk EG00112 affected70 at risk EG0025 affected24 at risk EG003
Respiratory tract infection	Infections and infestations	24.1	Systematic Assessment	EG0009 affected72 at risk EG0016 affected70 at risk EG0020 affected24 at risk EG003
Sinusitis	Infections and infestations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0012 affected70 at risk EG0024 affected24 at risk EG003
Upper respiratory tract infection	Infections and infestations	24.1	Systematic Assessment	EG00014 affected72 at risk EG00122 affected70 at risk EG0023 affected24 at risk EG003
Urinary tract infection	Infections and infestations	24.1	Systematic Assessment	EG0007 affected72 at risk EG0015 affected70 at risk EG0021 affected24 at risk EG003
Fall	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0003 affected72 at risk EG0013 affected70 at risk EG0024 affected24 at risk EG003
Alanine aminotransferase increased	Investigations	24.1	Systematic Assessment	EG0002 affected72 at risk EG0012 affected70 at risk EG0022 affected24 at risk EG003
Aspartate aminotransferase increased	Investigations	24.1	Systematic Assessment	EG0001 affected72 at risk EG0012 affected70 at risk EG0022 affected24 at risk EG003
Blood creatinine increased	Investigations	24.1	Systematic Assessment	EG0008 affected72 at risk EG0014 affected70 at risk EG0023 affected24 at risk EG003
Lymphocyte count decreased	Investigations	24.1	Systematic Assessment	EG0007 affected72 at risk EG0016 affected70 at risk EG0021 affected24 at risk EG003
Neutrophil count decreased	Investigations	24.1	Systematic Assessment	EG0007 affected72 at risk EG0016 affected70 at risk EG0023 affected24 at risk EG003
Platelet count decreased	Investigations	24.1	Systematic Assessment	EG0005 affected72 at risk EG0017 affected70 at risk EG0024 affected24 at risk EG003
Weight decreased	Investigations	24.1	Systematic Assessment	EG0004 affected72 at risk EG0010 affected70 at risk EG0023 affected24 at risk EG003
White blood cell count decreased	Investigations	24.1	Systematic Assessment	EG0006 affected72 at risk EG0017 affected70 at risk EG0022 affected24 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG00012 affected72 at risk EG00110 affected70 at risk EG0022 affected24 at risk EG003
Dehydration	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0004 affected72 at risk EG0011 affected70 at risk EG0022 affected24 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0007 affected72 at risk EG0013 affected70 at risk EG0020 affected24 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0003 affected72 at risk EG00110 affected70 at risk EG0024 affected24 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0002 affected72 at risk EG0013 affected70 at risk EG0021 affected24 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0013 affected70 at risk EG0022 affected24 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0005 affected72 at risk EG0013 affected70 at risk EG0023 affected24 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0005 affected72 at risk EG0016 affected70 at risk EG0024 affected24 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0009 affected72 at risk EG0017 affected70 at risk EG0025 affected24 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0003 affected72 at risk EG0012 affected70 at risk EG0023 affected24 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0004 affected72 at risk EG0014 affected70 at risk EG0021 affected24 at risk EG003
Vitamin B1 deficiency	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG00011 affected72 at risk EG0018 affected70 at risk EG0020 affected24 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG00012 affected72 at risk EG00115 affected70 at risk EG0024 affected24 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0007 affected72 at risk EG0016 affected70 at risk EG0020 affected24 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0006 affected72 at risk EG00111 affected70 at risk EG0023 affected24 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0006 affected72 at risk EG0014 affected70 at risk EG0025 affected24 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0006 affected72 at risk EG0014 affected70 at risk EG0022 affected24 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0004 affected72 at risk EG0014 affected70 at risk EG0021 affected24 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0003 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0007 affected72 at risk EG0013 affected70 at risk EG0022 affected24 at risk EG003
Resorption bone increased	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Dizziness	Nervous system disorders	24.1	Systematic Assessment	EG0008 affected72 at risk EG00110 affected70 at risk EG0027 affected24 at risk EG003
Headache	Nervous system disorders	24.1	Systematic Assessment	EG0007 affected72 at risk EG0017 affected70 at risk EG0023 affected24 at risk EG003
Hypoaesthesia	Nervous system disorders	24.1	Systematic Assessment	EG0003 affected72 at risk EG0012 affected70 at risk EG0021 affected24 at risk EG003
Neuropathy peripheral	Nervous system disorders	24.1	Systematic Assessment	EG0002 affected72 at risk EG0016 affected70 at risk EG0022 affected24 at risk EG003
Paraesthesia	Nervous system disorders	24.1	Systematic Assessment	EG0003 affected72 at risk EG0014 affected70 at risk EG0020 affected24 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	24.1	Systematic Assessment	EG0005 affected72 at risk EG0011 affected70 at risk EG0021 affected24 at risk EG003
Tremor	Nervous system disorders	24.1	Systematic Assessment	EG0008 affected72 at risk EG0016 affected70 at risk EG0022 affected24 at risk EG003
Anxiety	Psychiatric disorders	24.1	Systematic Assessment	EG0002 affected72 at risk EG0014 affected70 at risk EG0022 affected24 at risk EG003
Confusional state	Psychiatric disorders	24.1	Systematic Assessment	EG0005 affected72 at risk EG0016 affected70 at risk EG0022 affected24 at risk EG003
Hallucination	Psychiatric disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Insomnia	Psychiatric disorders	24.1	Systematic Assessment	EG00011 affected72 at risk EG00111 affected70 at risk EG0021 affected24 at risk EG003
Chronic kidney disease	Renal and urinary disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0014 affected70 at risk EG0022 affected24 at risk EG003
Urinary incontinence	Renal and urinary disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0022 affected24 at risk EG003
Urinary retention	Renal and urinary disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG00011 affected72 at risk EG00112 affected70 at risk EG0026 affected24 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0014 affected70 at risk EG0021 affected24 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG00013 affected72 at risk EG00115 affected70 at risk EG0026 affected24 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0004 affected72 at risk EG0013 affected70 at risk EG0023 affected24 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0003 affected72 at risk EG0011 affected70 at risk EG0022 affected24 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0014 affected70 at risk EG0020 affected24 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0021 affected24 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0004 affected72 at risk EG0012 affected70 at risk EG0021 affected24 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0014 affected70 at risk EG0020 affected24 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	24.1	Systematic Assessment	EG0001 affected72 at risk EG0011 affected70 at risk EG0020 affected24 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	24.1	Systematic Assessment	EG0004 affected72 at risk EG0010 affected70 at risk EG0022 affected24 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	24.1	Systematic Assessment	EG0009 affected72 at risk EG0014 affected70 at risk EG0022 affected24 at risk EG003
Rash	Skin and subcutaneous tissue disorders	24.1	Systematic Assessment	EG00011 affected72 at risk EG0018 affected70 at risk EG0023 affected24 at risk EG003
Aortic stenosis	Vascular disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Embolism	Vascular disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0020 affected24 at risk EG003
Haematoma	Vascular disorders	24.1	Systematic Assessment	EG0000 affected72 at risk EG0010 affected70 at risk EG0022 affected24 at risk EG003
Hypertension	Vascular disorders	24.1	Systematic Assessment	EG0004 affected72 at risk EG0019 affected70 at risk EG0022 affected24 at risk EG003
Hypotension	Vascular disorders	24.1	Systematic Assessment	EG0003 affected72 at risk EG0011 affected70 at risk EG0023 affected24 at risk EG003

Certain Agreements

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

ID	Term
D000077594	Nivolumab
C546027	elotuzumab
C467566	pomalidomide
D003907	Dexamethasone