A Study Being Conducted at Multiple Locations to Compare... | NCT01358734

Label	Type	Description	Intervention Names
Lenalidomide in combination with azacitidine	Experimental	Repeated cycles of azacitidine 75 mg/m^2/day subcutaneous (SC) on Days 1-7 and lenalidomide 50 mg/day by mouth (PO) on Days 8-28 followed by a 14-day break plus best supportive care	Drug: Azacitidine Drug: Lenalidomide Other: Best Supportive Care (BSC)
Lenalidomide - single agent	Experimental	Lenalidomide 50 mg PO daily for 28 days for the first 2 cycles and lenalidomide 25 mg daily for 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg daily PO plus best supportive care	Drug: Lenalidomide Other: Best Supportive Care (BSC)
Azacitidine-single agent	Experimental	Repeated cycles of azacitidine 75mg/m^2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care	Drug: Azacitidine Other: Best Supportive Care (BSC)

Name	Type	Description	Arm Group Labels	Other Names
Azacitidine	Drug	Azacitidine at 75 mg/m^2/day subcutaneous on Days 1-7	Azacitidine-single agent Lenalidomide in combination with azacitidine

Measure	Description	Time Frame
Kaplan Meier Estimates for One Year Survival	One-year survival rate was defined as all deaths within one year from the date of randomization. All others censored at the at year 1 or date of discontinuation	Up to 24 months
Overall Survival	Overall Survival reported at the end of the study are for those participants who were alive at the end of the study	From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)

Measure	Description	Time Frame
Percentage of Participants With a Complete Response or Morphologic Incomplete Response.	Based on IWG response criteria for AML. Complete remission (CR), morphologic complete remission (CR) was defined as < 5% bone marrow blasts, an absolute neutrophil count ≥ 1 x 10^9/L, platelets ≥100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response. Morphologic CR with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC count may be <1 x 10^9/L and/or the platelet count may be <100 x 10^9/L. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Measure	Description	Time Frame
Percentage of Participants Alive at One Year	Defined as the percentage of participants who survived at one year	Up to 12 months

Name	Affiliation	Role
Robert Gale, MD	Celgene	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
(210) University of Arizona Cancer Center		Tucson	Arizona	85724	United States
(180) University of California, San Diego

PubMed Identifier	Type	Citation	Retractions
29097499	Derived	Medeiros BC, McCaul K, Kambhampati S, Pollyea DA, Kumar R, Silverman LR, Kew A, Saini L, Beach CL, Vij R, Wang X, Zhong J, Gale RP. Randomized study of continuous high-dose lenalidomide, sequential azacitidine and lenalidomide, or azacitidine in persons 65 years and over with newly-diagnosed acute myeloid leukemia. Haematologica. 2018 Jan;103(1):101-106. doi: 10.3324/haematol.2017.172353. Epub 2017 Nov 2.

ID	Title	Description
FG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
FG001

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

Kaplan Meier Estimates for One Year Survival

One-year survival rate was defined as all deaths within one year from the date of randomization. All others censored at the at year 1 or date of discontinuation

ITT included all randomized participants

Posted

Median

95% Confidence Interval

months

Up to 24 months

ID	Title	Description
OG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
OG001	Azacitidine Plus Lenalidomide	Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
OG002	Azacitidine	Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC

Units	Counts
Participants	OG00015 OG00139 OG00234

Title

Denominators

Categories

Title	Measurements
	OG0003.00(1.18 to 11.93) OG0019.61(3.18 to 19.31) OG00213.67(6.75 to NA)The Upper limit of the 95% Confidence Interval could not be estimated due to an insufficient number of participants with events.

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		0.119		Hazard Ratio (HR)	1.789			2-Sided	95	0.861	3.718					Superiority or Other
OG000 OG002		Log Rank		0.014

Secondary

Percentage of Participants With a Complete Response or Morphologic Incomplete Response.

Based on IWG response criteria for AML. Complete remission (CR), morphologic complete remission (CR) was defined as < 5% bone marrow blasts, an absolute neutrophil count ≥ 1 x 10^9/L, platelets ≥100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response.

Morphologic CR with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC count may be <1 x 10^9/L and/or the platelet count may be <100 x 10^9/L. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Posted

Complete Response or Morphologic Incomplete Response data not analyzed.

ID	Title	Description
OG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
OG001	Azacitidine Plus Lenalidomide	Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC

Secondary

Duration of Remission (DoR)

Duration of remission was defined as the time from the date of CR or CRi until relapse. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Posted

Duration of Remission (DoR) time frame not analyzed.

ID	Title	Description
OG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
OG001	Azacitidine Plus Lenalidomide	Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
OG002	Azacitidine	Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC

Secondary

Cytogenetic Complete Remission Rate (CRc)

The CRc response category is comprised of the subset of participants who had abnormal cytogenetics at baseline and subsequently achieved CR during treatment in conjunction with a reversion to a normal karyotype. For the primary definition of CRc, a normal karyotype is defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) 1) CR criteria met AND 2) Abnormal karyotype present at baseline AND 3) Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Posted

Cytogenetic Complete Remission timeframe was not analyzed.

ID	Title	Description
OG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
OG001	Azacitidine Plus Lenalidomide	Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC

Secondary

Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)

Morphologic complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a one marrow aspirate with spicules and with at least 200 nucleated cells (there should be no blasts with auer rods) and ANC of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, no transfusions for 1 week prior to each assessment. No duration of these findings is required for confirmation of this response. Morphologic complete remission with incomplete blood count recovery was defined as a morphologic complete remission but the ANC may be < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Partial remission was defined as an ANC > 1 x 10^9/L and platelet count ≥ 100 x 10^9/L with a > 50% decrease in the percentage of bone marrow blasts to 5% to 25% (a blast count value of ≤ 5% may also be considered a partial remission if auer rods are present). Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Posted

Overall response rate time frame was not analyzed.

ID	Title	Description
OG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
OG001

Secondary

Progression-Free Survival (PFS)

PFS is defined as the time from randomization to the first observation of documented disease progression or death from any cause whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Posted

Progression-Free survival data and time frame was not analyzed.

ID	Title	Description
OG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
OG001	Azacitidine Plus Lenalidomide	Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
OG002	Azacitidine	Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC

Secondary

Event-Free Survival (EFS)

EFS was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after CR or CRi, or death from any cause, whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Posted

Event-Free survival time was not analyzed.

ID	Title	Description
OG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
OG001	Azacitidine Plus Lenalidomide	Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
OG002	Azacitidine	Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC

Secondary

Relapse-Free Survival (RFS)

RFS is defined only for subjects that achieve CR and CRi and is measured as the interval from that date to the date of disease relapse, death from any cause, whichever occurs first, censoring at the last visit date for subjects alive in continuous CR/CRi. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Posted

Relapse-Free survival time frame was not analyzed.

ID	Title	Description
OG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
OG001	Azacitidine Plus Lenalidomide	Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
OG002	Azacitidine	Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC

Secondary

Percentage of Participants With 30-Day Treatment-Related Mortality

30-day mortality rate was defined as death from any cause within 30 days after first dose.

ITT included all randomized participants.

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
OG001	Azacitidine Plus Lenalidomide	Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
OG002	Azacitidine	Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAE)

TEAEs were defined as those events that started on or after the first day of study drug up until 28 days after the last dose of study drug; Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; constitutes an important medical event. Severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); and according to the scale: Grade (Gr) 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death

Safety population includes all participants who have received at least 1 dose of Investigational Product.

Posted

Number

participants

From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018

ID	Title	Description
OG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
OG001	Azacitidine Plus Lenalidomide

Other Pre-specified

Percentage of Participants Alive at One Year

Defined as the percentage of participants who survived at one year

ITT population included participants who were randomized.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 12 months

ID	Title	Description
OG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
OG001	Azacitidine Plus Lenalidomide	Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
OG002	Azacitidine	Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC

Primary

Overall Survival

Overall Survival reported at the end of the study are for those participants who were alive at the end of the study

Participants who were still alive at the end of the study and in safety population.

Posted

Median

Full Range

months

From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)

ID	Title	Description
OG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
OG001	Azacitidine Plus Lenalidomide	Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
OG002	Azacitidine	Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC

Secondary

Number of Participants With a Second Primary Malignancy

Second primary malignancies were monitored as events of interest and reported as serious adverse events regardless of the treatment arm the participant was enrolled in.

Safety population includes all participants who received at least one dose of IP

Posted

Number

Participants

From randomization of the last participant up to a minimum of 4 years following discontinuation

ID	Title	Description
OG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
OG001	Azacitidine Plus Lenalidomide	Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC
OG002	Azacitidine	Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected14 at risk EG00116 affected38 at risk EG0028 affected32 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0012 affected38 at risk EG0022 affected32 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 affected14 at risk EG0014 affected38 at risk EG0027 affected32 at risk
Sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected38 at risk EG0022 affected32 at risk
Cellulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0021 affected32 at risk
Septic shock	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Breast abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Enterobacter bacteraemia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Herpes zoster	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Lobar pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Lung infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Osteomyelitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Pneumonia fungal	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Postoperative wound infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Pseudomonas infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Scrotal abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Soft tissue infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Non-cardiac chest pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Asthenia	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Malaise	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Oedema peripheral	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Performance status decreased	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0013 affected38 at risk EG0021 affected32 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Angina unstable	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Atrial flutter	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Cardiac arrest	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Cardiac failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Syncope	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Central nervous system lesion	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Status epilepticus	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Blast cell count increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Blood bilirubin increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Bone marrow myelogram abnormal	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Megakaryocytes decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Renal failure	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Urinary retention	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Leukaemic infiltration extramedullary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Vulval cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Middle ear inflammation	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected14 at risk EG00124 affected38 at risk EG00217 affected32 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected14 at risk EG00119 affected38 at risk EG00222 affected32 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0005 affected14 at risk EG00119 affected38 at risk EG0028 affected32 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected14 at risk EG0017 affected38 at risk EG00212 affected32 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0015 affected38 at risk EG0026 affected32 at risk
Oral disorder	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected14 at risk EG0013 affected38 at risk EG0021 affected32 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0014 affected38 at risk EG0023 affected32 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0015 affected38 at risk EG0021 affected32 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0023 affected32 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0021 affected32 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0022 affected32 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Oral pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0022 affected32 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Toothache	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Flatulence	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Tongue coated	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG0008 affected14 at risk EG00115 affected38 at risk EG00214 affected32 at risk
Oedema peripheral	General disorders	MedDRA 19.0	Systematic Assessment	EG0006 affected14 at risk EG0017 affected38 at risk EG0027 affected32 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected14 at risk EG0019 affected38 at risk EG0028 affected32 at risk
Asthenia	General disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected14 at risk EG0017 affected38 at risk EG0023 affected32 at risk
Chills	General disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected14 at risk EG0015 affected38 at risk EG0022 affected32 at risk
Injection site erythema	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0014 affected38 at risk EG0026 affected32 at risk
Injection site reaction	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0026 affected32 at risk
Injection site pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0017 affected38 at risk EG0021 affected32 at risk
Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0014 affected38 at risk EG0023 affected32 at risk
Mucosal inflammation	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0014 affected38 at risk EG0021 affected32 at risk
Device occlusion	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0022 affected32 at risk
Injection site bruising	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0023 affected32 at risk
Injection site irritation	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0022 affected32 at risk
Non-cardiac chest pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0022 affected32 at risk
Catheter site pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Face oedema	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Facial pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Gait disturbance	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Generalised oedema	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Injection site discomfort	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Localised oedema	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Malaise	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Mucosal haemorrhage	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Oedema	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Feeling abnormal	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Local swelling	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected14 at risk EG00112 affected38 at risk EG0028 affected32 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected14 at risk EG00116 affected38 at risk EG0024 affected32 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0016 affected38 at risk EG0026 affected32 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0017 affected38 at risk EG0022 affected32 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0025 affected32 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0023 affected32 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0014 affected38 at risk EG0021 affected32 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0022 affected32 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0014 affected38 at risk EG0020 affected32 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0014 affected38 at risk EG0020 affected32 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0021 affected32 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0023 affected32 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0020 affected32 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0020 affected32 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Weight decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0005 affected14 at risk EG00115 affected38 at risk EG00210 affected32 at risk
Neutrophil count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0015 affected38 at risk EG0024 affected32 at risk
White blood cell count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0014 affected38 at risk EG0025 affected32 at risk
Platelet count decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0016 affected38 at risk EG0022 affected32 at risk
Alanine aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0015 affected38 at risk EG0020 affected32 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0015 affected38 at risk EG0021 affected32 at risk
Blood magnesium decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0014 affected38 at risk EG0020 affected32 at risk
Blood creatinine increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Cardiac murmur	Investigations	MedDRA 19.0	Systematic Assessment	EG0003 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
International normalised ratio increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0013 affected38 at risk EG0020 affected32 at risk
Lymphocyte count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Blood bilirubin increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Transaminases increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Weight increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Oxygen saturation decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Staphylococcus test positive	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Vitamin D decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Activated partial thromboplastin time abnormal	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Clostridium test positive	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG0014 affected38 at risk EG0024 affected32 at risk
Cellulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0015 affected38 at risk EG0024 affected32 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0013 affected38 at risk EG0026 affected32 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0016 affected38 at risk EG0023 affected32 at risk
Herpes simplex	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0014 affected38 at risk EG0021 affected32 at risk
Oral candidiasis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0012 affected38 at risk EG0023 affected32 at risk
Herpes zoster	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0023 affected32 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0022 affected32 at risk
Respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0014 affected38 at risk EG0020 affected32 at risk
Sinusitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0021 affected32 at risk
Fungal infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Furuncle	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0020 affected32 at risk
Hordeolum	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Oral herpes	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0022 affected32 at risk
Rash pustular	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Tooth abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0022 affected32 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Ear infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Mucosal infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Osteomyelitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Tooth infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Body tinea	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected14 at risk EG00118 affected38 at risk EG00210 affected32 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0007 affected14 at risk EG00112 affected38 at risk EG0028 affected32 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0018 affected38 at risk EG0022 affected32 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0015 affected38 at risk EG0022 affected32 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0012 affected38 at risk EG0024 affected32 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected14 at risk EG0013 affected38 at risk EG0020 affected32 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0024 affected32 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0015 affected38 at risk EG0021 affected32 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0020 affected32 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0022 affected32 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Vitamin K deficiency	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0006 affected14 at risk EG00111 affected38 at risk EG00210 affected32 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG00111 affected38 at risk EG00211 affected32 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected14 at risk EG0016 affected38 at risk EG0029 affected32 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0016 affected38 at risk EG0022 affected32 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Spleen disorder	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Splenic lesion	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected14 at risk EG00114 affected38 at risk EG0022 affected32 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected14 at risk EG00110 affected38 at risk EG0026 affected32 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0017 affected38 at risk EG0022 affected32 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected14 at risk EG0014 affected38 at risk EG0021 affected32 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0014 affected38 at risk EG0022 affected32 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0014 affected38 at risk EG0022 affected32 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0021 affected32 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected14 at risk EG0018 affected38 at risk EG00211 affected32 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0013 affected38 at risk EG0029 affected32 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0017 affected38 at risk EG0023 affected32 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0017 affected38 at risk EG0020 affected32 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0013 affected38 at risk EG0022 affected32 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0024 affected32 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0013 affected38 at risk EG0020 affected32 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0023 affected32 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0021 affected32 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Dizziness	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected14 at risk EG00112 affected38 at risk EG0026 affected32 at risk
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0019 affected38 at risk EG0024 affected32 at risk
Dysgeusia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0016 affected38 at risk EG0023 affected32 at risk
Syncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0012 affected38 at risk EG0023 affected32 at risk
Tremor	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0014 affected38 at risk EG0020 affected32 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Balance disorder	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Paraesthesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Presyncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Insomnia	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected14 at risk EG0018 affected38 at risk EG0022 affected32 at risk
Anxiety	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG00110 affected38 at risk EG0023 affected32 at risk
Depression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0014 affected38 at risk EG0024 affected32 at risk
Confusional state	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0014 affected38 at risk EG0022 affected32 at risk
Agitation	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0022 affected32 at risk
Mental status changes	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0022 affected32 at risk
Delirium	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0020 affected32 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected14 at risk EG0015 affected38 at risk EG0021 affected32 at risk
Tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0025 affected32 at risk
Angina pectoris	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Bradycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected14 at risk EG0014 affected38 at risk EG0020 affected32 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0022 affected32 at risk
Atrial flutter	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Cardiac disorder	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected14 at risk EG0016 affected38 at risk EG0021 affected32 at risk
Hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0013 affected38 at risk EG0022 affected32 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0022 affected32 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0021 affected32 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Phlebitis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0015 affected38 at risk EG0026 affected32 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0013 affected38 at risk EG0021 affected32 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0022 affected32 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0011 affected38 at risk EG0022 affected32 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Cartilage injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Dysuria	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0013 affected38 at risk EG0024 affected32 at risk
Haematuria	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0015 affected38 at risk EG0020 affected32 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0022 affected32 at risk
Urinary retention	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0021 affected32 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Renal cyst	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Renal failure	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0011 affected38 at risk EG0020 affected32 at risk
Azotaemia	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Renal disorder	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Ear congestion	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected14 at risk EG0010 affected38 at risk EG0022 affected32 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Vision blurred	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected14 at risk EG0012 affected38 at risk EG0021 affected32 at risk
Erythema of eyelid	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Eye inflammation	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Lacrimation increased	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0012 affected38 at risk EG0020 affected32 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected14 at risk EG0010 affected38 at risk EG0020 affected32 at risk

ID	Title	Description
BG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.
BG001	Azacitidine + Lenalidomide	Participants received azacitidine 75 mg/m^2/ daily SC on Days 1 through 7 and lenalidomide 50 mg daily PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care
BG002	Azacitidine	Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
BG003	Total	Total of all reporting groups

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D010881	Piperidones
D010880	Piperidines
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lenalidomide	Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.	7	14	13	14	14	14
EG001	Azacitidine Plus Lenalidomide	Participants received azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC	34	38	29	38	38	38
EG002	Azacitidine	Participants received azacitidine 75mg/m^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC	29	32	25	32	32	32