Safety and Efficacy of Pomalidomide, Bortezomib and Low-d... | NCT01734928

Label	Type	Description	Intervention Names
Pomalidomide, Bortezomib and Low Dose Dexamethasone	Experimental	4 mg of Pomalidomide will be taken orally on Days 1-14 of a 21-day cycle along with 1.3 mg/m2 of Bortezomib administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression, and Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2,8, 9 of 21 days for cycles 9 and onward until disease progression.	Drug: Pomalidomide Drug: Bortezomib Drug: Dexamethasone
Bortezomib and Low Dose Dexamethasone	Active Comparator	1.3 mg/m2 of Bortezomib will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression along with Dexamethasone 20 mg/day [≤ 75 years old]or 10 mg/day [> 75 years old] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.	Drug: Bortezomib Drug: Dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
Pomalidomide	Drug	Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.	Pomalidomide, Bortezomib and Low Dose Dexamethasone

Measure	Description	Time Frame
Progression Free Survival by Independent Response Adjudication Committee (IRAC)	Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death. Progressive Disease is defined as an Increase of ≥ 25% from nadir in: Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours) In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be > 100 mg/dL. Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.	From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months

Measure	Description	Time Frame
Overall Survival (OS)	Overall survival (OS) is calculated as the time from randomization to death from any cause.	From randomization to date of death, up to approximately 65 months
Overall Response Rate by Independent Response Adjudication Committee (IRAC)

Name	Affiliation	Role
Bristol Myers-Squibb	Bristol-Myers Squibb	Study Director
Amine Bensmaine, MD	Celgene Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Southern Cancer Center		Mobile	Alabama	36608	United States
Arizona Oncology

PubMed Identifier	Type	Citation	Retractions
31097405	Derived	Richardson PG, Oriol A, Beksac M, Liberati AM, Galli M, Schjesvold F, Lindsay J, Weisel K, White D, Facon T, San Miguel J, Sunami K, O'Gorman P, Sonneveld P, Robak P, Semochkin S, Schey S, Yu X, Doerr T, Bensmaine A, Biyukov T, Peluso T, Zaki M, Anderson K, Dimopoulos M; OPTIMISMM trial investigators. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):781-794. doi: 10.1016/S1470-2045(19)30152-4. Epub 2019 May 13.
28642620

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Treatment 1: POM+BTZ+LD-DEX	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.

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	Jun 14, 2017

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 by Independent Response Adjudication Committee (IRAC)

Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death.

Progressive Disease is defined as an Increase of ≥ 25% from nadir in:

Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g
Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours)
In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be > 100 mg/dL.
Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h
Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months

ID	Title	Description
OG000	Treatment 1: POM+BTZ+LD-DEX	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
OG001	Treatment 2: BTZ+LD-DEX	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.

Units	Counts
Participants	OG000281 OG001278

Title

Denominators

Categories

Title	Measurements
	OG00011.20(9.66 to 13.73) OG0017.10(5.88 to 8.48)

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		Based on Cox proportional hazards model		0.001		Hazard Ratio (HR)	0.61			2-Sided	95	0.49	0.77					Superiority

Secondary

Overall Survival (OS)

Overall survival (OS) is calculated as the time from randomization to death from any cause.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to date of death, up to approximately 65 months

ID	Title	Description
OG000	Treatment 1: POM+BTZ+LD-DEX	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
OG001	Treatment 2: BTZ+LD-DEX	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.

Secondary

Overall Response Rate by Independent Response Adjudication Committee (IRAC)

The ORR together with the relative proportions in each response category (ie, stringent CR [sCR], CR, very good PR [VGPR], PR, SD, and PD) by treatment using the IMWG criteria will be examined.

Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow

SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence

VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level < 100 mg per 24 hours

PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours

Progressive Disease: Please refer to Primary outcome measure for definition

SD: Not meeting criteria for CR, VGPR, PR, or progressive disease

All randomized participants

Posted

Count of Participants

Participants

From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months

ID	Title	Description
OG000	Treatment 1: POM+BTZ+LD-DEX	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.

Secondary

Duration of Response by Independent Response Adjudication Committee (IRAC)

Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first.

Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow

SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence

VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level < 100 mg per 24 hours

PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours

Progressive Disease: Please refer to Primary outcome measure for definition

SD: Not meeting criteria for CR, VGPR, PR, or progressive disease

All randomized participants with a response (sCR or CR or VGPR or PR)

Posted

Median

95% Confidence Interval

Months

From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months

ID	Title	Description
OG000	Treatment 1: POM+BTZ+LD-DEX	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.

Secondary

Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)

Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.

All Treated Participants

Posted

Count of Participants

Participants

From first dose to 28 days after the last dose (up to approximately 44 months

ID	Title	Description
OG000	Treatment 1: POM+BTZ+LD-DEX	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
OG001	Treatment 2: BTZ+LD-DEX	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.

Secondary

Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)

Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.

All Treated Participants

Posted

Count of Participants

Participants

From first dose to 28 days after the last dose (up to approximately 44 months

ID	Title	Description
OG000	Treatment 1: POM+BTZ+LD-DEX	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
OG001	Treatment 2: BTZ+LD-DEX	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	20.0	Systematic Assessment	EG0004 affected278 at risk EG0015 affected270 at risk
Febrile neutropenia	Blood and lymphatic system disorders	20.0	Systematic Assessment	EG0005 affected278 at risk EG0011 affected270 at risk
Hyperviscosity syndrome	Blood and lymphatic system disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0013 affected270 at risk
Lymphopenia	Blood and lymphatic system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Neutropenia	Blood and lymphatic system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Thrombocytopenia	Blood and lymphatic system disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0013 affected270 at risk
Acute coronary syndrome	Cardiac disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Acute myocardial infarction	Cardiac disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Angina pectoris	Cardiac disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Angina unstable	Cardiac disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Atrial fibrillation	Cardiac disorders	20.0	Systematic Assessment	EG0009 affected278 at risk EG0012 affected270 at risk
Atrial flutter	Cardiac disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0011 affected270 at risk
Atrial thrombosis	Cardiac disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Atrioventricular block complete	Cardiac disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Atrioventricular block second degree	Cardiac disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Bradycardia	Cardiac disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Bundle branch block left	Cardiac disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Cardiac arrest	Cardiac disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Cardiac failure	Cardiac disorders	20.0	Systematic Assessment	EG0003 affected278 at risk EG0012 affected270 at risk
Cardiac failure congestive	Cardiac disorders	20.0	Systematic Assessment	EG0003 affected278 at risk EG0012 affected270 at risk
Cardio-respiratory arrest	Cardiac disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Coronary artery disease	Cardiac disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Left ventricular dysfunction	Cardiac disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Left ventricular failure	Cardiac disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Myocardial infarction	Cardiac disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Pericardial effusion	Cardiac disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Pericarditis	Cardiac disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Restrictive cardiomyopathy	Cardiac disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Sinus bradycardia	Cardiac disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Sinus node dysfunction	Cardiac disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Supraventricular tachycardia	Cardiac disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Vertigo	Ear and labyrinth disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Hyperthyroidism	Endocrine disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Cataract	Eye disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Retinal detachment	Eye disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Retinal vein thrombosis	Eye disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Abdominal pain	Gastrointestinal disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0011 affected270 at risk
Abdominal pain upper	Gastrointestinal disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Colonic fistula	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Constipation	Gastrointestinal disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0012 affected270 at risk
Diarrhoea	Gastrointestinal disorders	20.0	Systematic Assessment	EG0005 affected278 at risk EG0016 affected270 at risk
Enterocolitis	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Food poisoning	Gastrointestinal disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Gastric haemorrhage	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Gastric volvulus	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Ileus	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Intestinal obstruction	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Nausea	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0013 affected270 at risk
Pancreatitis acute	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Parotid gland enlargement	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Umbilical hernia	Gastrointestinal disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Vomiting	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0013 affected270 at risk
Death	General disorders	20.0	Systematic Assessment	EG0004 affected278 at risk EG0010 affected270 at risk
Fatigue	General disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Gait disturbance	General disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0012 affected270 at risk
General physical health deterioration	General disorders	20.0	Systematic Assessment	EG0005 affected278 at risk EG0019 affected270 at risk
Influenza like illness	General disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Malaise	General disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0012 affected270 at risk
Multiple organ dysfunction syndrome	General disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Non-cardiac chest pain	General disorders	20.0	Systematic Assessment	EG0003 affected278 at risk EG0012 affected270 at risk
Pain	General disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Pyrexia	General disorders	20.0	Systematic Assessment	EG00012 affected278 at risk EG0015 affected270 at risk
Systemic inflammatory response syndrome	General disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Cholecystitis	Hepatobiliary disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Cholecystitis acute	Hepatobiliary disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Cholecystitis chronic	Hepatobiliary disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Hepatitis acute	Hepatobiliary disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Hepatotoxicity	Hepatobiliary disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Abscess limb	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Acute hepatitis B	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Atypical pneumonia	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Bacterial sepsis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Bronchiolitis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Bronchitis	Infections and infestations	20.0	Systematic Assessment	EG0003 affected278 at risk EG0012 affected270 at risk
Bronchitis bacterial	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Bronchitis pneumococcal	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Bronchopulmonary aspergillosis	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Catheter site infection	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Cellulitis	Infections and infestations	20.0	Systematic Assessment	EG0002 affected278 at risk EG0011 affected270 at risk
Clostridium difficile colitis	Infections and infestations	20.0	Systematic Assessment	EG0004 affected278 at risk EG0010 affected270 at risk
Clostridium difficile infection	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Device related infection	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Diverticulitis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Endocarditis	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Enterobacter pneumonia	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Enterococcal sepsis	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Epididymitis	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Erysipelas	Infections and infestations	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Escherichia bacteraemia	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Escherichia sepsis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Escherichia urinary tract infection	Infections and infestations	20.0	Systematic Assessment	EG0003 affected278 at risk EG0011 affected270 at risk
Gastroenteritis	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Gastroenteritis salmonella	Infections and infestations	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
H1N1 influenza	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Haemophilus infection	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Herpes oesophagitis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Herpes zoster	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Hordeolum	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Infection	Infections and infestations	20.0	Systematic Assessment	EG0003 affected278 at risk EG0011 affected270 at risk
Influenza	Infections and infestations	20.0	Systematic Assessment	EG00010 affected278 at risk EG0014 affected270 at risk
Leishmaniasis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Localised infection	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Lower respiratory tract infection	Infections and infestations	20.0	Systematic Assessment	EG00010 affected278 at risk EG0015 affected270 at risk
Lung infection	Infections and infestations	20.0	Systematic Assessment	EG0002 affected278 at risk EG0012 affected270 at risk
Mastoiditis	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Meningitis listeria	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Meningococcal infection	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Muscle abscess	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Neutropenic sepsis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Oesophageal candidiasis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Osteomyelitis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Periorbital cellulitis	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Pharyngitis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Pharyngotonsillitis	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Pneumococcal sepsis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Pneumonia	Infections and infestations	20.0	Systematic Assessment	EG00034 affected278 at risk EG00117 affected270 at risk
Pneumonia bacterial	Infections and infestations	20.0	Systematic Assessment	EG0002 affected278 at risk EG0011 affected270 at risk
Pneumonia haemophilus	Infections and infestations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Pneumonia influenzal	Infections and infestations	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Pneumonia legionella	Infections and infestations	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Pneumonia moraxella	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Pneumonia parainfluenzae viral	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Pneumonia pneumococcal	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0012 affected270 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Pneumonia staphylococcal	Infections and infestations	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Pneumonia streptococcal	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0012 affected270 at risk
Pulmonary sepsis	Infections and infestations	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Respiratory syncytial virus infection	Infections and infestations	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Respiratory tract infection	Infections and infestations	20.0	Systematic Assessment	EG0005 affected278 at risk EG0010 affected270 at risk
Respiratory tract infection bacterial	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Respiratory tract infection viral	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Rhinovirus infection	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Sepsis	Infections and infestations	20.0	Systematic Assessment	EG0005 affected278 at risk EG0011 affected270 at risk
Septic shock	Infections and infestations	20.0	Systematic Assessment	EG0006 affected278 at risk EG0010 affected270 at risk
Sinusitis	Infections and infestations	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Skin infection	Infections and infestations	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Staphylococcal bacteraemia	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Staphylococcal sepsis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Streptococcal sepsis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Upper respiratory tract infection	Infections and infestations	20.0	Systematic Assessment	EG0003 affected278 at risk EG0013 affected270 at risk
Urinary tract infection	Infections and infestations	20.0	Systematic Assessment	EG0003 affected278 at risk EG0010 affected270 at risk
Urinary tract infection bacterial	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Urinary tract infection staphylococcal	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Urosepsis	Infections and infestations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0012 affected270 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Femur fracture	Injury, poisoning and procedural complications	20.0	Systematic Assessment	EG0001 affected278 at risk EG0013 affected270 at risk
Head injury	Injury, poisoning and procedural complications	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Humerus fracture	Injury, poisoning and procedural complications	20.0	Systematic Assessment	EG0002 affected278 at risk EG0011 affected270 at risk
Infusion related reaction	Injury, poisoning and procedural complications	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Overdose	Injury, poisoning and procedural complications	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Rib fracture	Injury, poisoning and procedural complications	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Spinal fracture	Injury, poisoning and procedural complications	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Alanine aminotransferase increased	Investigations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Aspartate aminotransferase increased	Investigations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Blood alkaline phosphatase increased	Investigations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Blood creatinine increased	Investigations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Chest X-ray abnormal	Investigations	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Coronavirus test positive	Investigations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
General physical condition abnormal	Investigations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
International normalised ratio increased	Investigations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Neutrophil count decreased	Investigations	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Dehydration	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG0003 affected278 at risk EG0012 affected270 at risk
Diabetes mellitus	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Hypercalcaemia	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Hyperglycaemia	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG0003 affected278 at risk EG0011 affected270 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Hyponatraemia	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Hypovolaemia	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Malnutrition	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Metabolic acidosis	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Arthritis	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Back pain	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG0003 affected278 at risk EG0011 affected270 at risk
Bone pain	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Osteorrhagia	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0012 affected270 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0006 affected278 at risk EG0011 affected270 at risk
Basosquamous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Plasma cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Porocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Scrotal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	20.0	Systematic Assessment	EG0004 affected278 at risk EG0012 affected270 at risk
Altered state of consciousness	Nervous system disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Amnesia	Nervous system disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Aphasia	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Cerebral haemorrhage	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Cerebrovascular accident	Nervous system disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0010 affected270 at risk
Cognitive disorder	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Depressed level of consciousness	Nervous system disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Disturbance in attention	Nervous system disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Dizziness	Nervous system disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Encephalopathy	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Epilepsy	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Generalised tonic-clonic seizure	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Guillain-Barre syndrome	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Hepatic encephalopathy	Nervous system disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Ischaemic cerebral infarction	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Ischaemic stroke	Nervous system disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Loss of consciousness	Nervous system disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Lumbar radiculopathy	Nervous system disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Motor dysfunction	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Nerve root compression	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Paraparesis	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Paraplegia	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Peripheral motor neuropathy	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Peripheral sensory neuropathy	Nervous system disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Presyncope	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Spinal cord compression	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0012 affected270 at risk
Syncope	Nervous system disorders	20.0	Systematic Assessment	EG0006 affected278 at risk EG0015 affected270 at risk
Transient ischaemic attack	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Trigeminal neuralgia	Nervous system disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Anxiety	Psychiatric disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Confusional state	Psychiatric disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Depression	Psychiatric disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Mental status changes	Psychiatric disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Acute kidney injury	Renal and urinary disorders	20.0	Systematic Assessment	EG0008 affected278 at risk EG0016 affected270 at risk
Anuria	Renal and urinary disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Chronic kidney disease	Renal and urinary disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Nephrolithiasis	Renal and urinary disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Renal colic	Renal and urinary disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Urinary retention	Renal and urinary disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0003 affected278 at risk EG0010 affected270 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0004 affected278 at risk EG0011 affected270 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0011 affected270 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0003 affected278 at risk EG0013 affected270 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0009 affected278 at risk EG0011 affected270 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Respiratory alkalosis	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG0002 affected278 at risk EG0012 affected270 at risk
Rash	Skin and subcutaneous tissue disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Skin disorder	Skin and subcutaneous tissue disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Circulatory collapse	Vascular disorders	20.0	Systematic Assessment	EG0000 affected278 at risk EG0011 affected270 at risk
Deep vein thrombosis	Vascular disorders	20.0	Systematic Assessment	EG0004 affected278 at risk EG0014 affected270 at risk
Hypertension	Vascular disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk
Hypotension	Vascular disorders	20.0	Systematic Assessment	EG0003 affected278 at risk EG0011 affected270 at risk
Orthostatic hypotension	Vascular disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0011 affected270 at risk
Peripheral arterial occlusive disease	Vascular disorders	20.0	Systematic Assessment	EG0001 affected278 at risk EG0010 affected270 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	20.0	Systematic Assessment	EG00087 affected278 at risk EG00172 affected270 at risk
Leukopenia	Blood and lymphatic system disorders	20.0	Systematic Assessment	EG00037 affected278 at risk EG0019 affected270 at risk
Lymphopenia	Blood and lymphatic system disorders	20.0	Systematic Assessment	EG00014 affected278 at risk EG0019 affected270 at risk
Neutropenia	Blood and lymphatic system disorders	20.0	Systematic Assessment	EG000150 affected278 at risk EG00129 affected270 at risk
Thrombocytopenia	Blood and lymphatic system disorders	20.0	Systematic Assessment	EG000110 affected278 at risk EG001105 affected270 at risk
Atrial fibrillation	Cardiac disorders	20.0	Systematic Assessment	EG00026 affected278 at risk EG0015 affected270 at risk
Cataract	Eye disorders	20.0	Systematic Assessment	EG00022 affected278 at risk EG0013 affected270 at risk
Vision blurred	Eye disorders	20.0	Systematic Assessment	EG00014 affected278 at risk EG0019 affected270 at risk
Abdominal distension	Gastrointestinal disorders	20.0	Systematic Assessment	EG00017 affected278 at risk EG0016 affected270 at risk
Abdominal pain	Gastrointestinal disorders	20.0	Systematic Assessment	EG00030 affected278 at risk EG00119 affected270 at risk
Abdominal pain upper	Gastrointestinal disorders	20.0	Systematic Assessment	EG00023 affected278 at risk EG00116 affected270 at risk
Constipation	Gastrointestinal disorders	20.0	Systematic Assessment	EG000106 affected278 at risk EG00165 affected270 at risk
Diarrhoea	Gastrointestinal disorders	20.0	Systematic Assessment	EG000102 affected278 at risk EG00182 affected270 at risk
Dry mouth	Gastrointestinal disorders	20.0	Systematic Assessment	EG00019 affected278 at risk EG00111 affected270 at risk
Dyspepsia	Gastrointestinal disorders	20.0	Systematic Assessment	EG00022 affected278 at risk EG00125 affected270 at risk
Nausea	Gastrointestinal disorders	20.0	Systematic Assessment	EG00052 affected278 at risk EG00156 affected270 at risk
Stomatitis	Gastrointestinal disorders	20.0	Systematic Assessment	EG00017 affected278 at risk EG0011 affected270 at risk
Vomiting	Gastrointestinal disorders	20.0	Systematic Assessment	EG00035 affected278 at risk EG00127 affected270 at risk
Asthenia	General disorders	20.0	Systematic Assessment	EG00052 affected278 at risk EG00148 affected270 at risk
Fatigue	General disorders	20.0	Systematic Assessment	EG000107 affected278 at risk EG00172 affected270 at risk
Influenza like illness	General disorders	20.0	Systematic Assessment	EG00015 affected278 at risk EG0019 affected270 at risk
Oedema peripheral	General disorders	20.0	Systematic Assessment	EG000101 affected278 at risk EG00154 affected270 at risk
Pyrexia	General disorders	20.0	Systematic Assessment	EG00072 affected278 at risk EG00133 affected270 at risk
Bronchitis	Infections and infestations	20.0	Systematic Assessment	EG00043 affected278 at risk EG00120 affected270 at risk
Conjunctivitis	Infections and infestations	20.0	Systematic Assessment	EG00026 affected278 at risk EG00116 affected270 at risk
Influenza	Infections and infestations	20.0	Systematic Assessment	EG00027 affected278 at risk EG00113 affected270 at risk
Lower respiratory tract infection	Infections and infestations	20.0	Systematic Assessment	EG00017 affected278 at risk EG0018 affected270 at risk
Pneumonia	Infections and infestations	20.0	Systematic Assessment	EG00026 affected278 at risk EG00121 affected270 at risk
Respiratory tract infection	Infections and infestations	20.0	Systematic Assessment	EG00021 affected278 at risk EG00116 affected270 at risk
Upper respiratory tract infection	Infections and infestations	20.0	Systematic Assessment	EG00071 affected278 at risk EG00151 affected270 at risk
Urinary tract infection	Infections and infestations	20.0	Systematic Assessment	EG00036 affected278 at risk EG00128 affected270 at risk
Viral upper respiratory tract infection	Infections and infestations	20.0	Systematic Assessment	EG00036 affected278 at risk EG00118 affected270 at risk
Accidental overdose	Injury, poisoning and procedural complications	20.0	Systematic Assessment	EG00035 affected278 at risk EG00111 affected270 at risk
Fall	Injury, poisoning and procedural complications	20.0	Systematic Assessment	EG00020 affected278 at risk EG00111 affected270 at risk
Alanine aminotransferase increased	Investigations	20.0	Systematic Assessment	EG00014 affected278 at risk EG0013 affected270 at risk
Weight decreased	Investigations	20.0	Systematic Assessment	EG00020 affected278 at risk EG00118 affected270 at risk
Weight increased	Investigations	20.0	Systematic Assessment	EG00019 affected278 at risk EG00119 affected270 at risk
Decreased appetite	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG00029 affected278 at risk EG00126 affected270 at risk
Hyperglycaemia	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG00043 affected278 at risk EG00128 affected270 at risk
Hypocalcaemia	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG00020 affected278 at risk EG00110 affected270 at risk
Hypokalaemia	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG00045 affected278 at risk EG00131 affected270 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG00020 affected278 at risk EG0017 affected270 at risk
Hypophosphataemia	Metabolism and nutrition disorders	20.0	Systematic Assessment	EG00020 affected278 at risk EG00110 affected270 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG00039 affected278 at risk EG00132 affected270 at risk
Back pain	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG00061 affected278 at risk EG00138 affected270 at risk
Bone pain	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG00025 affected278 at risk EG00114 affected270 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG00030 affected278 at risk EG00116 affected270 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG00041 affected278 at risk EG00112 affected270 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG00023 affected278 at risk EG00117 affected270 at risk
Myalgia	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG00015 affected278 at risk EG00111 affected270 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG00042 affected278 at risk EG00138 affected270 at risk
Dizziness	Nervous system disorders	20.0	Systematic Assessment	EG00049 affected278 at risk EG00129 affected270 at risk
Dysgeusia	Nervous system disorders	20.0	Systematic Assessment	EG00018 affected278 at risk EG0018 affected270 at risk
Headache	Nervous system disorders	20.0	Systematic Assessment	EG00035 affected278 at risk EG00125 affected270 at risk
Hypoaesthesia	Nervous system disorders	20.0	Systematic Assessment	EG0007 affected278 at risk EG00115 affected270 at risk
Paraesthesia	Nervous system disorders	20.0	Systematic Assessment	EG00018 affected278 at risk EG0015 affected270 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	20.0	Systematic Assessment	EG00018 affected278 at risk EG00112 affected270 at risk
Peripheral sensory neuropathy	Nervous system disorders	20.0	Systematic Assessment	EG000134 affected278 at risk EG001103 affected270 at risk
Syncope	Nervous system disorders	20.0	Systematic Assessment	EG00014 affected278 at risk EG0016 affected270 at risk
Tremor	Nervous system disorders	20.0	Systematic Assessment	EG00032 affected278 at risk EG0018 affected270 at risk
Anxiety	Psychiatric disorders	20.0	Systematic Assessment	EG00013 affected278 at risk EG00117 affected270 at risk
Depression	Psychiatric disorders	20.0	Systematic Assessment	EG00016 affected278 at risk EG0017 affected270 at risk
Insomnia	Psychiatric disorders	20.0	Systematic Assessment	EG00049 affected278 at risk EG00154 affected270 at risk
Cough	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG00066 affected278 at risk EG00145 affected270 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG00062 affected278 at risk EG00132 affected270 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG00017 affected278 at risk EG00116 affected270 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	20.0	Systematic Assessment	EG00017 affected278 at risk EG00113 affected270 at risk
Rash	Skin and subcutaneous tissue disorders	20.0	Systematic Assessment	EG00031 affected278 at risk EG00111 affected270 at risk
Hypertension	Vascular disorders	20.0	Systematic Assessment	EG00024 affected278 at risk EG00122 affected270 at risk
Hypotension	Vascular disorders	20.0	Systematic Assessment	EG00026 affected278 at risk EG00113 affected270 at risk

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

ID	Term
D001897	Boronic Acids
D000148	Acids, Noncarboxylic
D000143	Acids
D007287	Inorganic Chemicals
D001896	Boron Compounds
D009930	Organic Chemicals
D011719	Pyrazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

ID	Title	Description
BG000	Treatment 1: POM+BTZ+LD-DEX	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
BG001	Treatment 2: BTZ+LD-DEX	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
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	Treatment 1: POM + BTZ + LD-DEX	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.	197	281	177	278	276	278
EG001	Treatment 2: BTZ + LD-DEX	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.	193	278	119	270	260	270