Phase III Study of Lenalidomide and Dexamethasone With or... | NCT01239797

ID	Type	Description	Link
2010-020347-12	EudraCT Number

Name	Class
AbbVie	INDUSTRY

Label	Type	Description	Intervention Names
Lenalidomide + Dexamethasone	Active Comparator		Drug: Lenalidomide Drug: Dexamethasone
Lenalidomide + Dexamethasone +Elotuzumab	Experimental		Drug: Lenalidomide Drug: Dexamethasone (Oral) Drug: Dexamethasone (IV) Biological: Elotuzumab (BMS-901608; HuLuc63)

Name	Type	Description	Arm Group Labels	Other Names
Lenalidomide	Drug	Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug	Lenalidomide + Dexamethasone

Measure	Description	Time Frame
Median Progression Free Survival (PFS)	Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.	From randomization up to 326 events (up to approximately 38 months)
Objective Response Rate (ORR)	Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.	From randomization up to approximately 38 months

Measure	Description	Time Frame
Median Overall Survival (OS)	Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)	Randomization to the date of death from any cause (up to approximately 9 years)

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

Facility	Status	City	State	ZIP	Country	Contacts
Northwest Alabama Cancer Center, Pc		Muscle Shoals	Alabama	35661	United States
Acrc/Arizona Clinical Research Center, Inc.

PubMed Identifier	Type	Citation	Retractions
30204239	Derived	Dimopoulos MA, Lonial S, Betts KA, Chen C, Zichlin ML, Brun A, Signorovitch JE, Makenbaeva D, Mekan S, Sy O, Weisel K, Richardson PG. Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial. Cancer. 2018 Oct 15;124(20):4032-4043. doi: 10.1002/cncr.31680. Epub 2018 Sep 11.
28070715

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

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

Median Progression Free Survival (PFS)

Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization up to 326 events (up to approximately 38 months)

ID	Title	Description
OG000	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug
OG001	Lenalidomide + Dexamethasone	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

Units	Counts
Participants	OG000321 OG001325

Title

Denominators

Categories

Title	Measurements
	OG00019.35(16.62 to 22.18) OG00114.85(12.09 to 17.22)

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 of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone	Log Rank	2-sided p-value for stratified log rank test	0.0014		Hazard Ratio (HR)	0.73			2-Sided	95	0.60	0.89					Superiority

Post-Hoc

Median Progression Free Survival (PFS) - Extended Collection

The time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication based on Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria.

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. (Assessments were made until 06-Jul-2018)

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization up to to the date of first documented tumor progression or death (up to approximately 85 months)

ID	Title	Description
OG000	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

Primary

Objective Response Rate (ORR)

Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.

All randomized participants

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization up to approximately 38 months

ID	Title	Description
OG000	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

Secondary

Median Overall Survival (OS)

Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)

All randomized participants

Posted

Median

95% Confidence Interval

Months

Randomization to the date of death from any cause (up to approximately 9 years)

ID	Title	Description
OG000	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug
OG001	Lenalidomide + Dexamethasone

Secondary

Change From Baseline of Mean Score Pain Severity (BPI-SF)

The change from baseline of the mean score of pain severity at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.

All randomized participants with baseline and end of treatment scores

Posted

Mean

Standard Deviation

Score on a scale

From baseline up to approximately 38 months

ID	Title	Description
OG000	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

Secondary

Change From Baseline of Mean Score Pain Interference (BPI-SF)

The change from baseline of the mean score of pain interference at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.

All randomized participants with baseline and end of treatment scores

Posted

Mean

Standard Deviation

Score on a scale

From baseline up to approximately 38 months

ID	Title	Description
OG000	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG00011 affected318 at risk EG0018 affected317 at risk
Bone marrow failure	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Eosinophilia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Febrile neutropenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0005 affected318 at risk EG0014 affected317 at risk
Microangiopathic haemolytic anaemia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Neutropenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0014 affected317 at risk
Pancytopenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Splenic infarction	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Thrombocytopenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0005 affected318 at risk EG0012 affected317 at risk
Acute coronary syndrome	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0012 affected317 at risk
Acute left ventricular failure	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Acute myocardial infarction	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0012 affected317 at risk
Angina pectoris	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Angina unstable	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Arrhythmia	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Atrial fibrillation	Cardiac disorders	24.0	Systematic Assessment	EG0006 affected318 at risk EG0019 affected317 at risk
Atrioventricular block complete	Cardiac disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Brugada syndrome	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Cardiac aneurysm	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Cardiac arrest	Cardiac disorders	24.0	Systematic Assessment	EG0003 affected318 at risk EG0011 affected317 at risk
Cardiac failure	Cardiac disorders	24.0	Systematic Assessment	EG0003 affected318 at risk EG0013 affected317 at risk
Cardiac failure congestive	Cardiac disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0011 affected317 at risk
Cardio-respiratory arrest	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Cardiogenic shock	Cardiac disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Left ventricular failure	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Myocardial infarction	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0013 affected317 at risk
Myocardial ischaemia	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0012 affected317 at risk
Pericarditis	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Sinus node dysfunction	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Supraventricular tachycardia	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Hypothyroidism	Endocrine disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Cataract	Eye disorders	24.0	Systematic Assessment	EG0006 affected318 at risk EG0016 affected317 at risk
Cataract nuclear	Eye disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Visual impairment	Eye disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Abdominal pain	Gastrointestinal disorders	24.0	Systematic Assessment	EG0003 affected318 at risk EG0010 affected317 at risk
Abdominal pain upper	Gastrointestinal disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Colitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0012 affected317 at risk
Constipation	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0012 affected317 at risk
Diarrhoea	Gastrointestinal disorders	24.0	Systematic Assessment	EG0007 affected318 at risk EG00112 affected317 at risk
Diverticulum	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Enteritis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Enterocolitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Enterocutaneous fistula	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Gastric haemorrhage	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Gastric ulcer	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0011 affected317 at risk
Haemorrhoids	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Hiatus hernia	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Ileus	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Ileus paralytic	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Inguinal hernia	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Intestinal haemorrhage	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Intestinal ischaemia	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Intestinal obstruction	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Irritable bowel syndrome	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Large intestinal ulcer	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Large intestine perforation	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Mouth haemorrhage	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Nausea	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Pancreatitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Pancreatitis acute	Gastrointestinal disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Rectal haemorrhage	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Subileus	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Vomiting	Gastrointestinal disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0014 affected317 at risk
Asthenia	General disorders	24.0	Systematic Assessment	EG0004 affected318 at risk EG0010 affected317 at risk
Chest pain	General disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Chills	General disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Death	General disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Disease progression	General disorders	24.0	Systematic Assessment	EG00015 affected318 at risk EG00110 affected317 at risk
Fatigue	General disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
General physical health deterioration	General disorders	24.0	Systematic Assessment	EG0005 affected318 at risk EG0014 affected317 at risk
Hernia	General disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Malaise	General disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Multiple organ dysfunction syndrome	General disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Pain	General disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Pyrexia	General disorders	24.0	Systematic Assessment	EG00025 affected318 at risk EG00117 affected317 at risk
Cholangitis	Hepatobiliary disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Cholecystitis	Hepatobiliary disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Cholecystitis acute	Hepatobiliary disorders	24.0	Systematic Assessment	EG0004 affected318 at risk EG0010 affected317 at risk
Cholecystitis chronic	Hepatobiliary disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Cholelithiasis	Hepatobiliary disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Hepatic failure	Hepatobiliary disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Hepatic function abnormal	Hepatobiliary disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Hepatitis	Hepatobiliary disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Abdominal abscess	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Abscess oral	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Acute sinusitis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Appendicitis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Arthritis bacterial	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0012 affected317 at risk
Atypical pneumonia	Infections and infestations	24.0	Systematic Assessment	EG0003 affected318 at risk EG0010 affected317 at risk
Bacteraemia	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Bacterial sepsis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Biliary sepsis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Brain abscess	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Bronchitis	Infections and infestations	24.0	Systematic Assessment	EG0008 affected318 at risk EG0018 affected317 at risk
Bronchopulmonary aspergillosis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Bursitis infective	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Campylobacter gastroenteritis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Catheter site abscess	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Cellulitis	Infections and infestations	24.0	Systematic Assessment	EG0008 affected318 at risk EG0011 affected317 at risk
Cerebral aspergillosis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Clostridium colitis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Clostridium difficile colitis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Clostridium difficile infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Cytomegalovirus chorioretinitis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Cytomegalovirus infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Device related infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Device related sepsis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Diverticulitis	Infections and infestations	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Endocarditis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0012 affected317 at risk
Enteritis infectious	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Enterocolitis viral	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Epididymitis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Escherichia urinary tract infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Febrile infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Gastroenteritis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0012 affected317 at risk
Gastroenteritis clostridial	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Gastroenteritis norovirus	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Gastroenteritis viral	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0014 affected317 at risk
Genital abscess	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
H1N1 influenza	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Hepatitis B	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Herpes zoster	Infections and infestations	24.0	Systematic Assessment	EG0004 affected318 at risk EG0011 affected317 at risk
Herpes zoster reactivation	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Infection	Infections and infestations	24.0	Systematic Assessment	EG0003 affected318 at risk EG0011 affected317 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Influenza	Infections and infestations	24.0	Systematic Assessment	EG0003 affected318 at risk EG0014 affected317 at risk
Intervertebral discitis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Large intestine infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Listeriosis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Localised infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Lower respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG0008 affected318 at risk EG0014 affected317 at risk
Lung abscess	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Meningitis staphylococcal	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Metapneumovirus infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Neutropenic sepsis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Ophthalmic herpes zoster	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Osteomyelitis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Otitis media chronic	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Parvovirus B19 infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Periodontitis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Peritonitis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Pharyngitis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0012 affected317 at risk
Pneumococcal sepsis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	24.0	Systematic Assessment	EG0002 affected318 at risk EG0011 affected317 at risk
Pneumonia	Infections and infestations	24.0	Systematic Assessment	EG00056 affected318 at risk EG00140 affected317 at risk
Pneumonia bacterial	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Pneumonia fungal	Infections and infestations	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Pneumonia influenzal	Infections and infestations	24.0	Systematic Assessment	EG0002 affected318 at risk EG0012 affected317 at risk
Pneumonia pneumococcal	Infections and infestations	24.0	Systematic Assessment	EG0003 affected318 at risk EG0011 affected317 at risk
Post procedural infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Pseudomonal sepsis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Pseudomonas infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Pulmonary sepsis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Pyelonephritis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Pyelonephritis acute	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Respiratory syncytial virus infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG00011 affected318 at risk EG0014 affected317 at risk
Retinitis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Rotavirus infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Sepsis	Infections and infestations	24.0	Systematic Assessment	EG0005 affected318 at risk EG0018 affected317 at risk
Septic shock	Infections and infestations	24.0	Systematic Assessment	EG0002 affected318 at risk EG0015 affected317 at risk
Sinusitis	Infections and infestations	24.0	Systematic Assessment	EG0002 affected318 at risk EG0011 affected317 at risk
Skin infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Staphylococcal bacteraemia	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Staphylococcal sepsis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Streptococcal bacteraemia	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Systemic infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Tooth abscess	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Upper respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG0002 affected318 at risk EG0011 affected317 at risk
Urinary tract infection	Infections and infestations	24.0	Systematic Assessment	EG0003 affected318 at risk EG0015 affected317 at risk
Urinary tract infection enterococcal	Infections and infestations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Urosepsis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Varicella zoster virus infection	Infections and infestations	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Viral diarrhoea	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Viral infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Wound infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Accidental overdose	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Ankle fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Chemical burn	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Compression fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0012 affected317 at risk
Fall	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Femur fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Hip fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0002 affected318 at risk EG0012 affected317 at risk
Humerus fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Ilium fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Joint dislocation	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Limb injury	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Lip injury	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0002 affected318 at risk EG0011 affected317 at risk
Overdose	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Pelvic fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected318 at risk EG0012 affected317 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0012 affected317 at risk
Procedural pain	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Rib fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Road traffic accident	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Seroma	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Skin laceration	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Soft tissue injury	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0003 affected318 at risk EG0011 affected317 at risk
Spinal fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Stenosis of vesicourethral anastomosis	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Subdural haematoma	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Tendon rupture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Traumatic fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected318 at risk EG0012 affected317 at risk
Upper limb fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Blood creatinine increased	Investigations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Clostridium test positive	Investigations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Escherichia test positive	Investigations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
General physical condition abnormal	Investigations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Haemoglobin decreased	Investigations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Hepatic enzyme increased	Investigations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Influenza A virus test positive	Investigations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Influenza B virus test positive	Investigations	24.0	Systematic Assessment	EG0002 affected318 at risk EG0011 affected317 at risk
International normalised ratio increased	Investigations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Liver function test abnormal	Investigations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Polymerase chain reaction positive	Investigations	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Viral test positive	Investigations	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Decreased appetite	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0011 affected317 at risk
Dehydration	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0011 affected317 at risk
Diabetes mellitus	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Failure to thrive	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Fluid retention	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Hypercalcaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0003 affected318 at risk EG0012 affected317 at risk
Hyperglycaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0003 affected318 at risk EG0011 affected317 at risk
Hypocalcaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Hypoglycaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Hypokalaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0003 affected318 at risk EG0012 affected317 at risk
Hyponatraemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Ketoacidosis	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0012 affected317 at risk
Arthritis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Back pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0007 affected318 at risk EG0015 affected317 at risk
Bone cyst	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Bone lesion	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Bone pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0003 affected318 at risk EG0010 affected317 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Exostosis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Muscle mass	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0016 affected317 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0013 affected317 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Acute erythroid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Atypical fibroxanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG00010 affected318 at risk EG0014 affected317 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
External ear neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Haemangioma of bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Lip squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0004 affected318 at risk EG0010 affected317 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0005 affected318 at risk EG0014 affected317 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0002 affected318 at risk EG0013 affected317 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0006 affected318 at risk EG0015 affected317 at risk
Plasma cell myeloma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0002 affected318 at risk EG0013 affected317 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0012 affected317 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0002 affected318 at risk EG0013 affected317 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG00012 affected318 at risk EG0013 affected317 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Cerebral haemorrhage	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Cerebral infarction	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Cerebral ischaemia	Nervous system disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0011 affected317 at risk
Cerebrospinal fluid leakage	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Cerebrovascular accident	Nervous system disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0013 affected317 at risk
Dementia	Nervous system disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Dizziness	Nervous system disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Encephalopathy	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0012 affected317 at risk
Hemiparesis	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Hepatic encephalopathy	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Hypoaesthesia	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Ischaemic stroke	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Nervous system disorder	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Neuropathy peripheral	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Optic neuritis	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Paraesthesia	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Paraparesis	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Presyncope	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Sciatica	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Seizure	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Somnolence	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Spinal cord compression	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0012 affected317 at risk
Spinal cord disorder	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Status epilepticus	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Syncope	Nervous system disorders	24.0	Systematic Assessment	EG0003 affected318 at risk EG0012 affected317 at risk
Transient ischaemic attack	Nervous system disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0011 affected317 at risk
Device dislocation	Product Issues	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Completed suicide	Psychiatric disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Confusional state	Psychiatric disorders	24.0	Systematic Assessment	EG0004 affected318 at risk EG0011 affected317 at risk
Delirium	Psychiatric disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Depression	Psychiatric disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Mental status changes	Psychiatric disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Acute kidney injury	Renal and urinary disorders	24.0	Systematic Assessment	EG00011 affected318 at risk EG0018 affected317 at risk
Haematuria	Renal and urinary disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Haemorrhage urinary tract	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Myeloma cast nephropathy	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Nephrolithiasis	Renal and urinary disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Neurogenic bladder	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Prerenal failure	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Renal failure	Renal and urinary disorders	24.0	Systematic Assessment	EG0004 affected318 at risk EG0015 affected317 at risk
Renal impairment	Renal and urinary disorders	24.0	Systematic Assessment	EG0003 affected318 at risk EG0010 affected317 at risk
Renal tubular acidosis	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Urinary retention	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0013 affected317 at risk
Urinary tract obstruction	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Ovarian cyst	Reproductive system and breast disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Bronchial disorder	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0005 affected318 at risk EG0013 affected317 at risk
Cough	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0004 affected318 at risk EG0014 affected317 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0013 affected317 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0004 affected318 at risk EG0011 affected317 at risk
Obliterative bronchiolitis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0010 affected317 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0011 affected317 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0012 affected317 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00011 affected318 at risk EG0018 affected317 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 affected318 at risk EG0011 affected317 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Pustular psoriasis	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Skin haemorrhage	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Hip arthroplasty	Surgical and medical procedures	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Aortic aneurysm rupture	Vascular disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Deep vein thrombosis	Vascular disorders	24.0	Systematic Assessment	EG00010 affected318 at risk EG0014 affected317 at risk
Embolism	Vascular disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Hypotension	Vascular disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0011 affected317 at risk
Hypovolaemic shock	Vascular disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Orthostatic hypotension	Vascular disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Pelvic venous thrombosis	Vascular disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Peripheral artery thrombosis	Vascular disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Peripheral ischaemia	Vascular disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Subclavian vein thrombosis	Vascular disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk
Thrombophlebitis	Vascular disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0012 affected317 at risk
Thrombophlebitis superficial	Vascular disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Thrombosis	Vascular disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0011 affected317 at risk
Venous thrombosis	Vascular disorders	24.0	Systematic Assessment	EG0000 affected318 at risk EG0012 affected317 at risk
Venous thrombosis limb	Vascular disorders	24.0	Systematic Assessment	EG0001 affected318 at risk EG0010 affected317 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG000135 affected318 at risk EG001118 affected317 at risk
Leukopenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG00026 affected318 at risk EG00126 affected317 at risk
Lymphopenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG00041 affected318 at risk EG00123 affected317 at risk
Neutropenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG000114 affected318 at risk EG001137 affected317 at risk
Thrombocytopenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG00091 affected318 at risk EG00172 affected317 at risk
Cataract	Eye disorders	24.0	Systematic Assessment	EG00058 affected318 at risk EG00136 affected317 at risk
Vision blurred	Eye disorders	24.0	Systematic Assessment	EG00031 affected318 at risk EG00118 affected317 at risk
Abdominal pain	Gastrointestinal disorders	24.0	Systematic Assessment	EG00044 affected318 at risk EG00131 affected317 at risk
Abdominal pain upper	Gastrointestinal disorders	24.0	Systematic Assessment	EG00030 affected318 at risk EG00120 affected317 at risk
Constipation	Gastrointestinal disorders	24.0	Systematic Assessment	EG000115 affected318 at risk EG00189 affected317 at risk
Diarrhoea	Gastrointestinal disorders	24.0	Systematic Assessment	EG000159 affected318 at risk EG001122 affected317 at risk
Dry mouth	Gastrointestinal disorders	24.0	Systematic Assessment	EG00016 affected318 at risk EG00110 affected317 at risk
Dyspepsia	Gastrointestinal disorders	24.0	Systematic Assessment	EG00036 affected318 at risk EG00119 affected317 at risk
Nausea	Gastrointestinal disorders	24.0	Systematic Assessment	EG00082 affected318 at risk EG00173 affected317 at risk
Stomatitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG00030 affected318 at risk EG00114 affected317 at risk
Toothache	Gastrointestinal disorders	24.0	Systematic Assessment	EG00018 affected318 at risk EG00111 affected317 at risk
Vomiting	Gastrointestinal disorders	24.0	Systematic Assessment	EG00058 affected318 at risk EG00132 affected317 at risk
Asthenia	General disorders	24.0	Systematic Assessment	EG00080 affected318 at risk EG00154 affected317 at risk
Chest pain	General disorders	24.0	Systematic Assessment	EG00028 affected318 at risk EG00114 affected317 at risk
Chills	General disorders	24.0	Systematic Assessment	EG00031 affected318 at risk EG00112 affected317 at risk
Fatigue	General disorders	24.0	Systematic Assessment	EG000154 affected318 at risk EG001131 affected317 at risk
Influenza like illness	General disorders	24.0	Systematic Assessment	EG00027 affected318 at risk EG00116 affected317 at risk
Malaise	General disorders	24.0	Systematic Assessment	EG00019 affected318 at risk EG00112 affected317 at risk
Oedema peripheral	General disorders	24.0	Systematic Assessment	EG00097 affected318 at risk EG00178 affected317 at risk
Pain	General disorders	24.0	Systematic Assessment	EG00017 affected318 at risk EG0017 affected317 at risk
Pyrexia	General disorders	24.0	Systematic Assessment	EG000121 affected318 at risk EG00174 affected317 at risk
Bronchitis	Infections and infestations	24.0	Systematic Assessment	EG00066 affected318 at risk EG00152 affected317 at risk
Gastroenteritis	Infections and infestations	24.0	Systematic Assessment	EG00018 affected318 at risk EG0019 affected317 at risk
Herpes zoster	Infections and infestations	24.0	Systematic Assessment	EG00018 affected318 at risk EG0015 affected317 at risk
Influenza	Infections and infestations	24.0	Systematic Assessment	EG00025 affected318 at risk EG00117 affected317 at risk
Lower respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG00032 affected318 at risk EG00116 affected317 at risk
Nasopharyngitis	Infections and infestations	24.0	Systematic Assessment	EG00083 affected318 at risk EG00160 affected317 at risk
Oral herpes	Infections and infestations	24.0	Systematic Assessment	EG00020 affected318 at risk EG00113 affected317 at risk
Pharyngitis	Infections and infestations	24.0	Systematic Assessment	EG00017 affected318 at risk EG00116 affected317 at risk
Pneumonia	Infections and infestations	24.0	Systematic Assessment	EG00030 affected318 at risk EG00123 affected317 at risk
Respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG00036 affected318 at risk EG00132 affected317 at risk
Rhinitis	Infections and infestations	24.0	Systematic Assessment	EG00030 affected318 at risk EG00113 affected317 at risk
Sinusitis	Infections and infestations	24.0	Systematic Assessment	EG00023 affected318 at risk EG00115 affected317 at risk
Upper respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG00086 affected318 at risk EG00162 affected317 at risk
Urinary tract infection	Infections and infestations	24.0	Systematic Assessment	EG00036 affected318 at risk EG00131 affected317 at risk
Viral infection	Infections and infestations	24.0	Systematic Assessment	EG00018 affected318 at risk EG00110 affected317 at risk
Contusion	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG00044 affected318 at risk EG00128 affected317 at risk
Fall	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG00021 affected318 at risk EG00114 affected317 at risk
Alanine aminotransferase increased	Investigations	24.0	Systematic Assessment	EG00025 affected318 at risk EG00133 affected317 at risk
Aspartate aminotransferase increased	Investigations	24.0	Systematic Assessment	EG00021 affected318 at risk EG00131 affected317 at risk
Blood creatinine increased	Investigations	24.0	Systematic Assessment	EG00036 affected318 at risk EG00127 affected317 at risk
C-reactive protein increased	Investigations	24.0	Systematic Assessment	EG00013 affected318 at risk EG00116 affected317 at risk
Platelet count decreased	Investigations	24.0	Systematic Assessment	EG00016 affected318 at risk EG0015 affected317 at risk
Weight decreased	Investigations	24.0	Systematic Assessment	EG00052 affected318 at risk EG00120 affected317 at risk
Decreased appetite	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG00071 affected318 at risk EG00142 affected317 at risk
Hyperglycaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG00061 affected318 at risk EG00145 affected317 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG00017 affected318 at risk EG00111 affected317 at risk
Hypocalcaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG00048 affected318 at risk EG00128 affected317 at risk
Hypokalaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG00067 affected318 at risk EG00147 affected317 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG00022 affected318 at risk EG0015 affected317 at risk
Hyponatraemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG00018 affected318 at risk EG00110 affected317 at risk
Hypophosphataemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG00019 affected318 at risk EG00110 affected317 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00098 affected318 at risk EG00163 affected317 at risk
Back pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG000105 affected318 at risk EG00197 affected317 at risk
Bone pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00033 affected318 at risk EG00143 affected317 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00099 affected318 at risk EG00185 affected317 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00042 affected318 at risk EG00128 affected317 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00039 affected318 at risk EG00130 affected317 at risk
Myalgia	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00026 affected318 at risk EG00122 affected317 at risk
Neck pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00023 affected318 at risk EG00113 affected317 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00064 affected318 at risk EG00135 affected317 at risk
Dizziness	Nervous system disorders	24.0	Systematic Assessment	EG00048 affected318 at risk EG00138 affected317 at risk
Headache	Nervous system disorders	24.0	Systematic Assessment	EG00054 affected318 at risk EG00129 affected317 at risk
Hypoaesthesia	Nervous system disorders	24.0	Systematic Assessment	EG00028 affected318 at risk EG00112 affected317 at risk
Neuropathy peripheral	Nervous system disorders	24.0	Systematic Assessment	EG00051 affected318 at risk EG00131 affected317 at risk
Paraesthesia	Nervous system disorders	24.0	Systematic Assessment	EG00035 affected318 at risk EG00129 affected317 at risk
Peripheral sensory neuropathy	Nervous system disorders	24.0	Systematic Assessment	EG00033 affected318 at risk EG00139 affected317 at risk
Taste disorder	Nervous system disorders	24.0	Systematic Assessment	EG00018 affected318 at risk EG00114 affected317 at risk
Tremor	Nervous system disorders	24.0	Systematic Assessment	EG00030 affected318 at risk EG00129 affected317 at risk
Anxiety	Psychiatric disorders	24.0	Systematic Assessment	EG00026 affected318 at risk EG00124 affected317 at risk
Confusional state	Psychiatric disorders	24.0	Systematic Assessment	EG00018 affected318 at risk EG00110 affected317 at risk
Depression	Psychiatric disorders	24.0	Systematic Assessment	EG00018 affected318 at risk EG00114 affected317 at risk
Insomnia	Psychiatric disorders	24.0	Systematic Assessment	EG00079 affected318 at risk EG00183 affected317 at risk
Mood altered	Psychiatric disorders	24.0	Systematic Assessment	EG00023 affected318 at risk EG0018 affected317 at risk
Dysuria	Renal and urinary disorders	24.0	Systematic Assessment	EG00016 affected318 at risk EG0019 affected317 at risk
Cough	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG000109 affected318 at risk EG00162 affected317 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00025 affected318 at risk EG00132 affected317 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00072 affected318 at risk EG00160 affected317 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00020 affected318 at risk EG00115 affected317 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00022 affected318 at risk EG00119 affected317 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00032 affected318 at risk EG00115 affected317 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00025 affected318 at risk EG0015 affected317 at risk
Erythema	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG00026 affected318 at risk EG00116 affected317 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG00038 affected318 at risk EG00125 affected317 at risk
Night sweats	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG00024 affected318 at risk EG00110 affected317 at risk
Pruritus	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG00036 affected318 at risk EG00129 affected317 at risk
Rash	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG00063 affected318 at risk EG00158 affected317 at risk
Deep vein thrombosis	Vascular disorders	24.0	Systematic Assessment	EG00019 affected318 at risk EG00110 affected317 at risk
Flushing	Vascular disorders	24.0	Systematic Assessment	EG00016 affected318 at risk EG0016 affected317 at risk
Haematoma	Vascular disorders	24.0	Systematic Assessment	EG00017 affected318 at risk EG0018 affected317 at risk
Hypertension	Vascular disorders	24.0	Systematic Assessment	EG00040 affected318 at risk EG00123 affected317 at risk
Hypotension	Vascular disorders	24.0	Systematic Assessment	EG00033 affected318 at risk EG00112 affected317 at risk

ID	Term
D008223	Lymphoma
D009101	Multiple Myeloma

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D054219	Neoplasms, Plasma Cell
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006474	Hemorrhagic Disorders

ID	Term
D000077269	Lenalidomide
D003907	Dexamethasone
D002123	Calcium Dobesilate
C546027	elotuzumab

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D001190	Arylsulfonates
D017739	Arylsulfonic Acids
D013451	Sulfonic Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds

ID	Title	Description
BG000	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug
BG001	Lenalidomide + Dexamethasone	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lenalidomide + Dexamethasone + Elotuzumab	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	226	321	238	318	314	318
EG001	Lenalidomide + Dexamethasone	Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug	249	325	194	317	309	317