Study Comparing Carfilzomib, Lenalidomide, and Dexamethas... | NCT01080391

Label	Type	Description	Intervention Names
Lenalidomide and Dexamethasone (Rd)	Active Comparator	Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22.	Drug: Dexamethasone Drug: Lenalidomide
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)	Experimental	Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, escalating to 27 mg/m² on days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 from cycle 1 through cycle 18 and from cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 from cycle 1 through cycle 18 and from cycle 19 and higher.	Drug: Dexamethasone Drug: Lenalidomide Drug: Carfilzomib

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	40 mg orally or IV on days 1, 8, 15, 22	Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Lenalidomide and Dexamethasone (Rd)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).	From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier.	From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic multiple myeloma
Measurable disease, as defined by one or more of the following (assessed within 21 days prior to randomization):
- Serum M-protein ≥ 0.5 g/dL
- Urine Bence-Jones protein ≥ 200 mg/24 hours
- For immunoglobulin A (IgA) patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL)
Prior treatment with at least one, but no more than three, regimens for multiple myeloma
Documented relapse or progressive disease on or after any regimen
Achieved a response to at least one prior regimen
Age ≥ 18 years
Life expectancy ≥ 3 months
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate hepatic function, with serum alanine aminotransferase (ALT) ≤ 3.5 times the upper limit of normal and serum direct bilirubin ≤ 2 mg/dL (34 µmol/L) within 21 days prior to randomization
Absolute neutrophil count ≥ 1.0 × 10^9/L within 21 days prior to randomization
Hemoglobin ≥ 8 g/dL (80 g/L) within 21 days prior to randomization
Platelet count ≥ 50 × 10^9/L (≥ 30 × 10^9/L if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization
Creatinine clearance (CrCl) ≥ 50 mL/minute within 21 days prior to randomization
Written informed consent in accordance with federal, local, and institutional guidelines
Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception
Male subjects must agree to practice contraception

Exclusion Criteria:

If previously treated with bortezomib (alone or in combination), progression during treatment
If previously treated with a lenalidomide and dexamethasone (len/dex) combination:
- Progression during the first 3 months of initiating treatment
- Any progression during treatment if the len/dex combination was the subject's most recent line of therapy
Discontinuation of previous lenalidomide or dexamethasone due to intolerance; subjects intolerant to bortezomib are not excluded
Prior carfilzomib treatment
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Waldenström's macroglobulinemia or IgM myeloma
Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
Chemotherapy or investigational agent within 3 weeks prior to randomization or antibody therapy within 6 weeks prior to randomization
Radiotherapy to multiple sites or immunotherapy/antibody therapy within 28 days prior to randomization; localized radiotherapy to a single site within 7 days prior to randomization
Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization
Pregnant or lactating females
Major surgery within 21 days prior to randomization
Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomization
Known human immunodeficiency virus infection
Active hepatitis B or C infection
Myocardial infarction within 4 months prior to randomization, New York Hear Association (NYHA) Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization
Other malignancy, including myelodysplastic syndromes (MDS), within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to randomization
Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
Ongoing graft-vs-host disease
Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization
Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Scottsdale	Arizona	85259	United States
Providence St. Joseph Medical Center

PubMed Identifier	Type	Citation	Retractions
29615082	Background	Dimopoulos M, Wang M, Maisnar V, Minarik J, Bensinger W, Mateos MV, Obreja M, Blaedel J, Moreau P. Response and progression-free survival according to planned treatment duration in patients with relapsed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) in the phase III ASPIRE study. J Hematol Oncol. 2018 Apr 4;11(1):49. doi: 10.1186/s13045-018-0583-7.
27439911

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lenalidomide and Dexamethasone (Rd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-free Survival (PFS)

Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).

ITT analysis set comprised of all randomized participants

Posted

Median

95% Confidence Interval

months

From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.

ID	Title	Description
OG000	Lenalidomide and Dexamethasone (Rd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
OG001	Carfilzomib, Lenalidomide, and Dexamethasone (CRd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.

Units	Counts
Participants	OG000396 OG001396

Title

Denominators

Categories

Title	Measurements
	OG00017.6(15.0 to 20.6) OG00126.3(23.3 to 30.5)

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		Log Rank	The stopping boundary for this analysis was 0.0127 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).	< 0.0001	Analysis was stratified by β2 microglobulin levels (< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes)	Hazard Ratio (HR)	0.690			2-Sided	95	0.570	0.834					Superiority or Other (legacy)

Secondary

Overall Survival

Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier.

ITT analysis set comprised of all randomized participants

Posted

Median

95% Confidence Interval

months

From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.

ID	Title	Description
OG000	Lenalidomide and Dexamethasone (Rd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
OG001	Carfilzomib, Lenalidomide, and Dexamethasone (CRd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.

Secondary

Overall Response Rate

Overall response rate is defined as the percentage of participants who achieved either a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).

ITT analysis set comprised of all randomized participants

Posted

Number

95% Confidence Interval

percentage of participants

From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.

ID	Title	Description
OG000	Lenalidomide and Dexamethasone (Rd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
OG001	Carfilzomib, Lenalidomide, and Dexamethasone (CRd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.

Secondary

Disease Control Rate

Disease control rate was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).

ITT analysis set comprised of all randomized participants

Posted

Number

95% Confidence Interval

percentage of participants

From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.

ID	Title	Description
OG000	Lenalidomide and Dexamethasone (Rd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
OG001	Carfilzomib, Lenalidomide, and Dexamethasone (CRd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.

Secondary

Duration of Response

Duration of response (DOR) was calculated for participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.

The Intent to treat (ITT) population with participantant who achieved a best overall response of PR or better.

Posted

Median

95% Confidence Interval

months

From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.

ID	Title	Description
OG000	Lenalidomide and Dexamethasone (Rd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
OG001	Carfilzomib, Lenalidomide, and Dexamethasone (CRd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.

Secondary

Duration of Disease Control

Duration of disease control (DDC) was calculated for participants who achieved disease control. DDC was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.

The Intent to treat (ITT) population with participantants who achieved disease control.

Posted

Median

95% Confidence Interval

months

From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.

ID	Title	Description
OG000	Lenalidomide and Dexamethasone (Rd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
OG001	Carfilzomib, Lenalidomide, and Dexamethasone (CRd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.

Secondary

Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores

Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.

ITT analysis set participants with a baseline value.

Posted

Mean

Standard Deviation

scores on a scale

Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18

ID	Title	Description
OG000	Lenalidomide and Dexamethasone (Rd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
OG001	Carfilzomib, Lenalidomide, and Dexamethasone (CRd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00010 affected389 at risk EG0018 affected392 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0018 affected392 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected389 at risk EG0014 affected392 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Platelet disorder	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0015 affected392 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0015 affected392 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0012 affected392 at risk
Angina unstable	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Arrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0008 affected389 at risk EG0019 affected392 at risk
Atrial flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Cardiac arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0012 affected392 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0015 affected392 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0015 affected392 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0016 affected392 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Pericardial effusion	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0010 affected392 at risk
Hypothyroidism	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Cataract	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0015 affected392 at risk
Cataract nuclear	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Cataract subcapsular	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Retinal vein occlusion	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0014 affected392 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Colitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Dental caries	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0009 affected389 at risk EG0017 affected392 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Diverticulum oesophageal	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Duodenal stenosis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Enteritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0010 affected392 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0010 affected392 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Death	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0012 affected392 at risk
Disease progression	General disorders	MedDRA 20.0	Systematic Assessment	EG0008 affected389 at risk EG0014 affected392 at risk
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
General physical health deterioration	General disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0010 affected392 at risk
Influenza like illness	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Malaise	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Mucosal inflammation	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Multi-organ failure	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0012 affected392 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0009 affected389 at risk EG00114 affected392 at risk
Sudden death	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0010 affected392 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0014 affected392 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0012 affected392 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Cytokine release syndrome	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Abdominal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Bacterial infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Bronchiolitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00011 affected389 at risk EG0019 affected392 at risk
Bronchitis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Bronchopneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0007 affected389 at risk EG0015 affected392 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Catheter site cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0011 affected392 at risk
Cholangitis suppurative	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Chronic hepatitis C	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Clostridial infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0014 affected392 at risk
Cystitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Device related infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0013 affected392 at risk
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Endocarditis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Enterocolitis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Erysipelas	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Escherichia sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0005 affected389 at risk EG0015 affected392 at risk
Genitourinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Gingivitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Hepatic infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Herpes zoster disseminated	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Incision site infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0013 affected392 at risk
Laryngitis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Listeria sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Liver abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Lobar pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0012 affected392 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0012 affected392 at risk
Lower respiratory tract infection viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Lung infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0013 affected392 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Peritonitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00052 affected389 at risk EG00167 affected392 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0010 affected392 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Pneumonia viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Postoperative abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0008 affected389 at risk EG00116 affected392 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0011 affected392 at risk
Salmonella sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0005 affected389 at risk EG0017 affected392 at risk
Sepsis syndrome	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Septic shock	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0013 affected392 at risk
Sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0014 affected392 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Testicular abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Tonsillitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Tooth abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Tracheobronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Tuberculosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0014 affected392 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0014 affected392 at risk
Urosepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0011 affected392 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0011 affected392 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0015 affected392 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Gallbladder injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0011 affected392 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0011 affected392 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Splenic injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Alanine aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Blood creatinine increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Cardiac stress test abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
General physical condition abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Haemoglobin decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Influenza A virus test positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Intraocular pressure increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Monoclonal immunoglobulin present	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Respiratory syncytial virus test positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Streptococcus test positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Viral test positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Weight decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Gout	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0010 affected392 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0013 affected392 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0012 affected392 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0011 affected392 at risk
Mineral deficiency	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0013 affected392 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0012 affected392 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Fracture pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0010 affected392 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0012 affected392 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0012 affected392 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0012 affected392 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0015 affected392 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Leukaemia plasmacytic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Malignant neoplasm of pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0010 affected392 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0011 affected392 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0012 affected392 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0012 affected392 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0012 affected392 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Cerebral cyst	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00010 affected389 at risk EG0014 affected392 at risk
Cognitive disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Coma	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Convulsion	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0010 affected392 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Hydrocephalus	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Loss of consciousness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Myxoedema coma	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Neuralgia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Paraparesis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Polyneuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Spinal cord compression	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0012 affected392 at risk
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0013 affected392 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0010 affected392 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Completed suicide	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Confusional state	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Disorientation	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Mental status changes	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Personality change	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Psychiatric decompensation	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Haematuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Nephropathy	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Prerenal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Renal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0016 affected392 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Renal impairment	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Urinary retention	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0014 affected392 at risk
Alveolitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0010 affected392 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0013 affected392 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0014 affected392 at risk
Eosinophilic pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0012 affected392 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Pleural fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0008 affected389 at risk EG00112 affected392 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0014 affected392 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0011 affected392 at risk
Acute generalised exanthematous pustulosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0014 affected392 at risk
Aortic aneurysm	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Circulatory collapse	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0006 affected389 at risk EG0019 affected392 at risk
Embolism	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Haematoma	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected389 at risk EG0012 affected392 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Thrombophlebitis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0013 affected392 at risk
Vasculitis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Venous thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Cardiac asthma	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Retinal detachment	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Disease progression	General disorders	MedDRA 20.0	Systematic Assessment	EG0008 affected389 at risk EG0015 affected392 at risk
Drowning	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
General physical health deterioration	General disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0012 affected392 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0012 affected392 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0013 affected392 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG00012 affected389 at risk EG00115 affected392 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Arthritis infective	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Atypical pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Cholangitis infective	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0012 affected392 at risk
Epididymitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Hepatitis B	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Osteomyelitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Osteomyelitis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Progressive multifocal leukoencephalopathy	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Staphylococcal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Stoma site abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Crystal arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0011 affected392 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
B precursor type acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Plasma cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0010 affected392 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0010 affected392 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected389 at risk EG0010 affected392 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected389 at risk EG0018 affected392 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Urethral prolapse	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Left ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected389 at risk EG0010 affected392 at risk
Postoperative wound infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected389 at risk EG0011 affected392 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG000154 affected389 at risk EG001166 affected392 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00022 affected389 at risk EG00133 affected392 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG000133 affected389 at risk EG001157 affected392 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00094 affected389 at risk EG001115 affected392 at risk
Cataract	Eye disorders	MedDRA 20.0	Systematic Assessment	EG00036 affected389 at risk EG00139 affected392 at risk
Vision blurred	Eye disorders	MedDRA 20.0	Systematic Assessment	EG00015 affected389 at risk EG00124 affected392 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00027 affected389 at risk EG00132 affected392 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00012 affected389 at risk EG00128 affected392 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00069 affected389 at risk EG00181 affected392 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG000143 affected389 at risk EG001170 affected392 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00022 affected389 at risk EG00124 affected392 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00057 affected389 at risk EG00182 affected392 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00034 affected389 at risk EG00149 affected392 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG00056 affected389 at risk EG00169 affected392 at risk
Chills	General disorders	MedDRA 20.0	Systematic Assessment	EG0009 affected389 at risk EG00125 affected392 at risk
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG000119 affected389 at risk EG001128 affected392 at risk
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG00075 affected389 at risk EG00185 affected392 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG00078 affected389 at risk EG001105 affected392 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00056 affected389 at risk EG00175 affected392 at risk
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00014 affected389 at risk EG00126 affected392 at risk
Nasopharyngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00065 affected389 at risk EG00187 affected392 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00029 affected389 at risk EG00145 affected392 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00039 affected389 at risk EG00141 affected392 at risk
Sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00018 affected389 at risk EG00124 affected392 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00081 affected389 at risk EG001115 affected392 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00021 affected389 at risk EG00136 affected392 at risk
Viral infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00011 affected389 at risk EG00128 affected392 at risk
Alanine aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG00015 affected389 at risk EG00121 affected392 at risk
Blood creatinine increased	Investigations	MedDRA 20.0	Systematic Assessment	EG00021 affected389 at risk EG00127 affected392 at risk
Neutrophil count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG00022 affected389 at risk EG00121 affected392 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00035 affected389 at risk EG00147 affected392 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00039 affected389 at risk EG00148 affected392 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00049 affected389 at risk EG00165 affected392 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00058 affected389 at risk EG001114 affected392 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00029 affected389 at risk EG00140 affected392 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00033 affected389 at risk EG00157 affected392 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00057 affected389 at risk EG00157 affected392 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00081 affected389 at risk EG00173 affected392 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00036 affected389 at risk EG00139 affected392 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00082 affected389 at risk EG001106 affected392 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00024 affected389 at risk EG00128 affected392 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00029 affected389 at risk EG00126 affected392 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00036 affected389 at risk EG00125 affected392 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00022 affected389 at risk EG00125 affected392 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00042 affected389 at risk EG00148 affected392 at risk
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00045 affected389 at risk EG00154 affected392 at risk
Dysgeusia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00021 affected389 at risk EG00114 affected392 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00032 affected389 at risk EG00156 affected392 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00028 affected389 at risk EG00134 affected392 at risk
Paraesthesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00023 affected389 at risk EG00127 affected392 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00027 affected389 at risk EG00125 affected392 at risk
Tremor	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00032 affected389 at risk EG00128 affected392 at risk
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG00017 affected389 at risk EG00133 affected392 at risk
Insomnia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG00065 affected389 at risk EG00181 affected392 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00070 affected389 at risk EG001116 affected392 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00059 affected389 at risk EG00176 affected392 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00019 affected389 at risk EG00123 affected392 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00022 affected389 at risk EG00128 affected392 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG00013 affected389 at risk EG00130 affected392 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG00018 affected389 at risk EG00128 affected392 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG00016 affected389 at risk EG00131 affected392 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG00059 affected389 at risk EG00150 affected392 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00011 affected389 at risk EG00121 affected392 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00030 affected389 at risk EG00162 affected392 at risk
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00022 affected389 at risk EG00126 affected392 at risk
Toothache	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00012 affected389 at risk EG00120 affected392 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG00057 affected389 at risk EG00172 affected392 at risk
Chills	General disorders	MedDRA 20.0	Systematic Assessment	EG0009 affected389 at risk EG00126 affected392 at risk
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG000124 affected389 at risk EG001132 affected392 at risk
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG00066 affected389 at risk EG00178 affected392 at risk
Peripheral swelling	General disorders	MedDRA 20.0	Systematic Assessment	EG00021 affected389 at risk EG00121 affected392 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG00080 affected389 at risk EG001110 affected392 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00068 affected389 at risk EG00180 affected392 at risk
Weight decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG00020 affected389 at risk EG00114 affected392 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00011 affected389 at risk EG00122 affected392 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00017 affected389 at risk EG00120 affected392 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00012 affected389 at risk EG00121 affected392 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
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
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

ID	Title	Description
BG000	Lenalidomide and Dexamethasone (Rd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
BG001	Carfilzomib, Lenalidomide, and Dexamethasone (CRd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every 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	Lenalidomide and Dexamethasone (Rd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.			221	389	358	389
EG001	Carfilzomib, Lenalidomide, and Dexamethasone (CRd)	Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.			256	392	370	392

ID	Term
D003907	Dexamethasone
D000077269	Lenalidomide
C524865	carfilzomib