A Study of CC-5013 Plus Dexamethasone Versus Dexamethason... | NCT00424047

Label	Type	Description	Intervention Names
CC-5013 plus dexamethasone	Experimental	Arm A: Oral CC-5013 is initiated on Day 1 of Cycle 1 at a dose of 25 mg daily for 21 days every 28 days. Therefore, the subject will take a placebo identical in appearance to the CC-5013 capsule for week 4 of every 28 days. Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral CC-5013 placebo capsules will be administered for 28 days of every cycle.	Drug: CC-5013 plus dexamethasone
Dexamethasone plus placebo	Experimental	Arm B: Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.	Drug: Dexamethasone plus Placebo

Name	Type	Description	Arm Group Labels	Other Names
CC-5013 plus dexamethasone	Drug	25 mg daily for 21 days every 28 days.	CC-5013 plus dexamethasone

Measure	Description	Time Frame
Kaplan-Meier Estimate of Time to Tumor Progression (TTP)	Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.	From randomization up to cut-off date of 03 August 2005; up to 24 months
Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)	Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.	From randomization up to cut-off date of 02 March 2008; up to 51 months

Measure	Description	Time Frame
Kaplan-Meier Estimate of Overall Survival (OS)	OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.	Randomization to data cut off of 03 August 2005; up to 24 months

Name	Affiliation	Role
Robert Knight, MD	Celgene Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Royal Prince Alfred Hospital		Camperdown	New South Wales	2050	Australia
Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology

PubMed Identifier	Type	Citation	Retractions
18032762	Result	Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594.
21273172

Label	URL
Link to CSR synopsis	View source

ID	Title	Description
FG000	Lenalidomide Plus Dexamethasone (Len/Dex)	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

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 Estimate of Time to Tumor Progression (TTP)

Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.

Intent to treat included all participants who were randomized.

Posted

Median

95% Confidence Interval

weeks

From randomization up to cut-off date of 03 August 2005; up to 24 months

ID	Title	Description
OG000	Lenalidomide Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
OG001	Placebo Plus Dexamethasone	Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

Units	Counts
Participants	OG000176 OG001175

Title

Denominators

Categories

Title	Measurements
	OG00052.1(40.9 to NA)Unable to provide as data not yet estimable OG00120.1(16.6 to 20.7)

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 p-value is based on an unstratified log rank test of survival curve differences between the treatment groups	<0.001		Hazard Ratio (HR)	0.324			2-Sided	95	0.240	0.438			Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dex:Placebo/Dexamethasone)		Superiority or Other

Secondary

Kaplan-Meier Estimate of Overall Survival (OS)

OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.

Intent to Treat population includes all participants who were randomized.

Posted

Median

95% Confidence Interval

weeks

Randomization to data cut off of 03 August 2005; up to 24 months

ID	Title	Description
OG000	Lenalidomide Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
OG001	Placebo Plus Dexamethasone	Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

Secondary

Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)

Intent to Treat population includes all participants who were randomized.

Posted

Median

95% Confidence Interval

weeks

Randomization to data cut off of 02 March 2008; up to 51 months

ID	Title	Description
OG000	Lenalidomide Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
OG001	Placebo Plus Dexamethasone	Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.

Secondary

Summary of Myeloma Response Rates Based on Best Response Assessment

Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.

Intent to Treat Population includes all participants who were randomized

Posted

Number

percentage of participants

Randomization to 03 August 2005; up to 24 months

ID	Title	Description
OG000	Lenalidomide Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Secondary

Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)

Intent to Treat Population includes all participants who were randomized

Posted

Number

percentage of participants

Randomization to data cut-off of 02 Mar 2008; up to 51 months

ID	Title	Description
OG000	Lenalidomide Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Secondary

Number of Participants With Adverse Events (AE)

An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.

The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.

The safety population includes all participants who received at least one dose of study drug regimen

Posted

Number

participants

From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months

ID	Title	Description
OG000	Lenalidomide Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Secondary

Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)

Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone).

Analysis not performed due to an insufficient number of participants with SRE

Posted

Number

participants

Up to unblinding data cut off of 03 August 2005; up to 24 months

ID	Title	Description
OG000	Lenalidomide Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
OG001	Placebo Plus Dexamethasone	Placebo PO daily on Days 1 to 28 of each 28 day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

Units	Counts

Post-Hoc

Kaplan-Meier Estimate of Duration of Response

Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.

Intent to Treat population includes all participants who were randomized to study drug.

Posted

Median

95% Confidence Interval

weeks

Up to data cut off of 03 August 2005; up to 24 months

ID	Title	Description
OG000	Lenalidomide Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
OG001	Placebo Plus Dexamethasone	Placebo PO daily on Days 1 to 28 of each 28 day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

Primary

Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)

Intent to treat included all participants who were randomized.

Posted

Median

95% Confidence Interval

weeks

From randomization up to cut-off date of 02 March 2008; up to 51 months

ID	Title	Description
OG000	Lenalidomide Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
OG001	Placebo Plus Dexamethasone	Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.

Secondary

Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale

The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.

Intent to Treat includes all participants who were randomized to study drug; a total of six ECOG scores were missing at the time of the Aug 2005 cut-off.

Posted

Median

95% Confidence Interval

weeks

Randomization to cut off date of 03 August 2005; up to 24 months

ID	Title	Description
OG000	Lenalidomide Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
OG001	Placebo Plus Dexamethasone	Placebo PO daily on Days 1 to 28 of each 28 day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

Secondary

Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)

Intent to Treat includes all participants who were randomized to study drug; six ECOG scores were missing at the March 2008 cut-off.

Posted

Median

95% Confidence Interval

weeks

Randomization to cut off date of 02 March 2008; up to 51 months

ID	Title	Description
OG000	Lenalidomide Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
OG001	Placebo Plus Dexamethasone	Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.

Post-Hoc

Kaplan-Meier Estimate of Duration of Response (Cut-off at a Later Date of 03 March 2008)

Intent to Treat population includes all participants who were randomized to study drug.

Posted

Median

95% Confidence Interval

weeks

Up to data cut off of 03 Mar 2008; up to 51 months

ID	Title	Description
OG000	Lenalidomide Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
OG001	Placebo Plus Dexamethasone	Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
PNEUMONIA NOS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00011 affected176 at risk EG0017 affected175 at risk
RESPIRATORY TRACT INFECTION NOS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0004 affected176 at risk EG0017 affected175 at risk
SEPSIS NOS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 affected176 at risk EG0013 affected175 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0012 affected175 at risk
UPPER RESPIRATORY TRACT INFECTION NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0004 affected176 at risk EG0010 affected175 at risk
BRONCHOPNEUMONIA NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0003 affected176 at risk EG0010 affected175 at risk
CELLULITIS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0012 affected175 at risk
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
BRONCHITIS ACUTE NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
HERPES ZOSTER	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
HERPES ZOSTER OPHTHALMIC	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
LOBAR PNEUMONIA NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
PNEUMOCYSTIS CARINII PNEUMONIA	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
PNEUMONIA PNEUMOCOCCAL	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
URINARY TRACT INFECTION NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
UROSEPSIS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
BACTERAEMIA	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
BACTERIAL SEPSIS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
BRONCHITIS CHRONIC NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
BURSITIS INFECTIVE NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
CENTRAL LINE INFECTION	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
CLOSTRIDIUM DIFFICILE SEPSIS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
GASTROINTESTINAL INFECTION NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
LOWER RESPIRATORY TRACT INFECTION NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
LUNG INFECTION NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
MENINGITIS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
MENINGITIS PNEUMOCOCCAL	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
NECROTISING FASCIITIS NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
OTITIS MEDIA NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
PNEUMONIA BACTERIAL NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
PNEUMONIA LEGIONELLA	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
PYELONEPHRITIS ACUTE NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
RESPIRATORY TRACT INFECTION VIRAL NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
SALMONELLA INFECTION NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
SINUSITIS NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
STREPTOCOCCAL SEPSIS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
URINARY TRACT INFECTION BACTERIAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
PYREXIA	General disorders	MedDRA (15.1)	Systematic Assessment	EG0006 affected176 at risk EG0017 affected175 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA (15.1)	Systematic Assessment	EG0004 affected176 at risk EG0011 affected175 at risk
ASTHENIA	General disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0011 affected175 at risk
DIFFICULTY IN WALKING	General disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
MULTI-ORGAN FAILURE	General disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
PERFORMANCE STATUS DECREASED	General disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
CATHETER SITE INFLAMMATION	General disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
GRANULOMA NOS	General disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
NECROSIS NOS	General disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
PAIN NOS	General disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
SUDDEN DEATH	General disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0005 affected176 at risk EG0011 affected175 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0005 affected176 at risk EG0010 affected175 at risk
MUSCLE WEAKNESS NOS	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0013 affected175 at risk
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected176 at risk EG0011 affected175 at risk
PATHOLOGICAL FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0012 affected175 at risk
PAIN IN LIMB	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
CHEST WALL PAIN	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
JOINT SWELLING	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
MYOPATHY	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
MYOPATHY STEROID	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
OSTEOPOROSIS NOS	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
PAIN IN JAW	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
SPONDYLITIS NOS	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0008 affected176 at risk EG0016 affected175 at risk
HYPOTENSION NOS	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0012 affected175 at risk
PHLEBITIS NOS	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0012 affected175 at risk
VENOUS THROMBOSIS NOS LIMB	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0011 affected175 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
PHLEBITIS SUPERFICIAL	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0007 affected176 at risk EG0012 affected175 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
BRONCHITIS NOS	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
BRONCHOSPASM NOS	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
BRONCHOPNEUMOPATHY	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
DYSPNOEA NOS	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
LUNG CONSOLIDATION	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
MAXILLARY SINUSITIS	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
PULMONARY CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
DIARRHOEA NOS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0012 affected175 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
MELAENA	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0012 affected175 at risk
OESOPHAGEAL VARICES HAEMORRHAGE	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
OESOPHAGITIS NOS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0012 affected175 at risk
ABDOMINAL PAIN NOS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
CAECITIS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
COLOVESICAL FISTULA	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
DIVERTICULITIS INTESTINAL	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
DIVERTICULITIS NOS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
GASTRITIS NOS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
GASTROENTERITIS NOS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
GASTROINTESTINAL HAEMORRHAGE NOS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
OESOPHAGITIS ULCERATIVE	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
PEPTIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
VOMITING NOS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected176 at risk EG0012 affected175 at risk
MEMORY IMPAIRMENT	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
SPINAL CORD COMPRESSION NOS	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
ATAXIA	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
BRAIN OEDEMA	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
ENCEPHALITIS NOS	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
EPIDURITIS	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
INTRACRANIAL PRESSURE INCREASED NOS	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
LEUKOENCEPHALOPATHY	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
PERIPHERAL MOTOR NEUROPATHY	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
PERIPHERAL NEUROPATHY NOS	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
POLYNEUROPATHY NOS	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
SUBDURAL HAEMATOMA	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
TREMOR	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
ANAEMIA NOS	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG0004 affected176 at risk EG0011 affected175 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0013 affected175 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected176 at risk EG0011 affected175 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG0004 affected176 at risk EG0010 affected175 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0012 affected175 at risk
HYPERVISCOSITY SYNDROME	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
THROMBOTIC THROMBOCYTOPENIC PURPURA	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0004 affected176 at risk EG0013 affected175 at risk
RENAL FAILURE NOS	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected176 at risk EG0014 affected175 at risk
RENAL IMPAIRMENT NOS	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0012 affected175 at risk
FANCONI SYNDROME ACQUIRED	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
OLIGURIA	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
RENAL COLIC	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
RENAL FAILURE ACUTE ON CHRONIC	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
PULMONARY OEDEMA NOS	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0013 affected175 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0011 affected175 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0012 affected175 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
CARDIAC FAILURE NOS	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
VENTRICULAR BIGEMINY	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
HYPERGLYCAEMIA NOS	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected176 at risk EG0012 affected175 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
ELECTROLYTE IMBALANCE	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0013 affected175 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
DIABETES MELLITUS INADEQUATE CONTROL	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
DIABETES MELLITUS NOS	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
DEPRESSION	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected176 at risk EG0011 affected175 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
BIPOLAR DISORDER	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
DELIRIUM	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
INSOMNIA	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
MANIA	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
MENTAL DISORDER NOS	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0011 affected175 at risk
BREAST CANCER IN SITU	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
GLIOBLASTOMA MULTIFORME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
LUNG ADENOCARCINOMA NOS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
NEOPLASM NOS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
PROSTATE CANCER NOS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
POST PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
POST PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
SPINAL FRACTURE NOS	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
BODY TEMPERATURE INCREASED	Investigations	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
INTERNATIONAL NORMALISED RATIO DECREASED	Investigations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
WEIGHT DECREASED	Investigations	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected176 at risk EG0010 affected175 at risk
CHOLECYSTITIS ACUTE NOS	Hepatobiliary disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
ACQUIRED HYPOTHYROIDISM	Endocrine disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
ADRENAL INSUFFICIENCY NOS	Endocrine disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
CORNEAL ULCER	Eye disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
EXOPHTHALMOS NOS	Eye disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
BREAST MICROCALCIFICATION	Reproductive system and breast disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
LUNG SQUAMOUS CELL CARCINOMA, STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
LEUKOPLAKIA NOS	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
PHLEBOTHROMBOSIS	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG00071 affected176 at risk EG00117 affected175 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG00052 affected176 at risk EG00149 affected175 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG00033 affected176 at risk EG00119 affected175 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG00021 affected176 at risk EG00111 affected175 at risk
LYMPHOPENIA	Blood and lymphatic system disorders	MedDRA (15.1)	Systematic Assessment	EG00017 affected176 at risk EG0019 affected175 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA (15.1)	Systematic Assessment	EG00012 affected176 at risk EG0018 affected175 at risk
CUSHINGOID	Endocrine disorders	MedDRA (15.1)	Systematic Assessment	EG0009 affected176 at risk EG0014 affected175 at risk
VISION BLURRED	Eye disorders	MedDRA (15.1)	Systematic Assessment	EG00013 affected176 at risk EG00113 affected175 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG00071 affected176 at risk EG00141 affected175 at risk
DIARRHOEA NOS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG00067 affected176 at risk EG00145 affected175 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG00040 affected176 at risk EG00120 affected175 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG00023 affected176 at risk EG00123 affected175 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG00022 affected176 at risk EG00111 affected175 at risk
VOMITING NOS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG00020 affected176 at risk EG00112 affected175 at risk
ABDOMINAL PAIN NO	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG00016 affected176 at risk EG00110 affected175 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG00011 affected176 at risk EG0016 affected175 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG00010 affected176 at risk EG0015 affected175 at risk
GASTRITIS NOS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0009 affected176 at risk EG0014 affected175 at risk
GASTROENTERITIS NOS	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0009 affected176 at risk EG0015 affected175 at risk
ASTHENIA	General disorders	MedDRA (15.1)	Systematic Assessment	EG00064 affected176 at risk EG00146 affected175 at risk
FATIGUE	General disorders	MedDRA (15.1)	Systematic Assessment	EG00051 affected176 at risk EG00141 affected175 at risk
PYREXIA	General disorders	MedDRA (15.1)	Systematic Assessment	EG00050 affected176 at risk EG00140 affected175 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA (15.1)	Systematic Assessment	EG00042 affected176 at risk EG00134 affected175 at risk
OEDEMA NOS	General disorders	MedDRA (15.1)	Systematic Assessment	EG00022 affected176 at risk EG00115 affected175 at risk
LETHARGY	General disorders	MedDRA (15.1)	Systematic Assessment	EG00015 affected176 at risk EG0014 affected175 at risk
CHEST PAIN	General disorders	MedDRA (15.1)	Systematic Assessment	EG00011 affected176 at risk EG0017 affected175 at risk
UPPER RESPIRATORY TRACT INFECTION NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG00029 affected176 at risk EG00116 affected175 at risk
URINARY TRACT INFECTION NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG00015 affected176 at risk EG00113 affected175 at risk
INFLUENZA	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG00010 affected176 at risk EG0018 affected175 at risk
ORAL CANDIDIASIS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG00010 affected176 at risk EG0019 affected175 at risk
LOWER RESPIRATORY TRACT INFECTION NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0009 affected176 at risk EG00111 affected175 at risk
RESPIRATORY TRACT INFECTION NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0009 affected176 at risk EG0016 affected175 at risk
HERPES SIMPLEX	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0008 affected176 at risk EG00112 affected175 at risk
SINUSITIS NOS	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0006 affected176 at risk EG0019 affected175 at risk
WEIGHT DECREASED	Investigations	MedDRA (15.1)	Systematic Assessment	EG00049 affected176 at risk EG00146 affected175 at risk
WEIGHT INCREASED	Investigations	MedDRA (15.1)	Systematic Assessment	EG00017 affected176 at risk EG00124 affected175 at risk
ANOREXIA	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG00025 affected176 at risk EG00114 affected175 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG00020 affected176 at risk EG00110 affected175 at risk
HYPERGLYCAEMIA NOS	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG00019 affected176 at risk EG00122 affected175 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG00016 affected176 at risk EG0015 affected175 at risk
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG00011 affected176 at risk EG0012 affected175 at risk
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0004 affected176 at risk EG00110 affected175 at risk
MUSCLE CRAMP	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG00056 affected176 at risk EG00136 affected175 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG00045 affected176 at risk EG00129 affected175 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG00034 affected176 at risk EG00124 affected175 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG00033 affected176 at risk EG00128 affected175 at risk
MUSCLE WEAKNESS NOS	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG00030 affected176 at risk EG00128 affected175 at risk
PAIN IN LIMB	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG00027 affected176 at risk EG00120 affected175 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG00018 affected176 at risk EG00116 affected175 at risk
CHEST WALL PAIN	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG00011 affected176 at risk EG00114 affected175 at risk
HEADACHE	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG00041 affected176 at risk EG00135 affected175 at risk
TREMOR	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG00039 affected176 at risk EG00114 affected175 at risk
DIZZINESS	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG00036 affected176 at risk EG00116 affected175 at risk
PARAESTHESIA	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG00029 affected176 at risk EG00129 affected175 at risk
DYSGEUSIA	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG00020 affected176 at risk EG00116 affected175 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG00015 affected176 at risk EG0017 affected175 at risk
SOMNOLENCE	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0008 affected176 at risk EG00110 affected175 at risk
INSOMNIA	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG00051 affected176 at risk EG00163 affected175 at risk
DEPRESSION	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG00019 affected176 at risk EG00118 affected175 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG00014 affected176 at risk EG00110 affected175 at risk
ANXIETY	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG00011 affected176 at risk EG00114 affected175 at risk
MOOD ALTERATION NOS	Psychiatric disorders	MedDRA (15.1)	Systematic Assessment	EG0005 affected176 at risk EG00110 affected175 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG00041 affected176 at risk EG00141 affected175 at risk
DYSPNOEA NOS	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG00036 affected176 at risk EG00122 affected175 at risk
NASOPHARYNGITIS	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG00035 affected176 at risk EG00123 affected175 at risk
BRONCHITIS NOS	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG00027 affected176 at risk EG00126 affected175 at risk
PHARYNGITIS	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG00027 affected176 at risk EG00116 affected175 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG00012 affected176 at risk EG00117 affected175 at risk
HICCUPS	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG00010 affected176 at risk EG0018 affected175 at risk
RHINITIS NOS	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0005 affected176 at risk EG0019 affected175 at risk
RASH NOS	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Systematic Assessment	EG00024 affected176 at risk EG0019 affected175 at risk
SWEATING INCREASED	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Systematic Assessment	EG00017 affected176 at risk EG00116 affected175 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Systematic Assessment	EG00016 affected176 at risk EG0016 affected175 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Systematic Assessment	EG00011 affected176 at risk EG0019 affected175 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0008 affected176 at risk EG00113 affected175 at risk
HYPERTENSION NOS	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG00017 affected176 at risk EG00111 affected175 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
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

ID	Title	Description
BG000	Lenalidomide Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
BG001	Placebo Plus Dexamethasone	Placebo PO daily on Days 1 to 28 of each 28 day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.
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 Plus Dexamethasone	Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.			105	176	175	176
EG001	Placebo Plus Dexamethasone	Placebo PO daily on Days 1 to 28 of each 28 day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.			79	175	173	175