Study Of The Effectiveness & Safety Of Lenalidomide Versu... | NCT00910910

NCT00910910

ID	Type	Description	Link
2008-003079-32	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
1 - Lenalidomide	Experimental	1 - Lenalidomide	Drug: Lenalidomide
2- Chlorambucil	Active Comparator	2- Chlorambucil	Drug: Chlorambucil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lenalidomide	Drug	For patients with normal renal function (defined as CrCl ≥ 60 mL/min), 5 mg once daily on Days 1 through 28 of the first 28-day cycle, 10 mg once daily on Days 1 through 28 starting at the second cycle, 15 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first. For patients with moderate renal impairment (defined as CrCl ≥ 30 to < 60 mL/min), 2.5 mg once daily on Days 1 through 28 of the first 28-day cycle, 5 mg once daily on Days 1 through 28 starting at the second cycle, 7.5 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Kaplan-Meier Estimate of Progression Free Survival (PFS)	Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator's assessment or death due to any cause on study, whichever occurred first. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression	From first dose of study drug to date of data cut-off of 18 Feb 2013; up to approximately 39 months
Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off Date of 14 March 2014	Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator's assessment or death due to any cause on study, whichever occurred first. Progressive disease included lymphadenopathy, an appearance of any new lesion such as enlarged lymph nodes (> 1.5 cm), splenomegaly, hepatomegaly or other organ infiltrates, an increase by 50% or more in greatest determined diameter of any previous site or an increase by 50% or more in the sum of the product of diameters of multiple nodes. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.	From randomization to data cut off date of 31 March 2014; median follow up time for all participants was 12.6 months

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs)	AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. 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/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 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

Other Outcomes

Measure	Description	Time Frame
Number of Participants Deaths During the Treatment and Survival Follow-Up Phase	The number of study participants deaths during the treatment and follow-up phase	From the first dose of study drug up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months

Eligibility Module

Name	Affiliation	Role
Jeffrey Jones, MD	Celgene Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
California Cancer Associates for Research and Excellence cCARE		Escondido	California	92025	United States

PubMed Identifier	Type	Citation	Retractions
28140392	Result	Chanan-Khan A, Egyed M, Robak T, Martinelli de Oliveira FA, Echeveste MA, Dolan S, Desjardins P, Blonski JZ, Mei J, Golany N, Zhang J, Gribben JG. Randomized phase 3 study of lenalidomide versus chlorambucil as first-line therapy for older patients with chronic lymphocytic leukemia (the ORIGIN trial). Leukemia. 2017 May;31(5):1240-1243. doi: 10.1038/leu.2017.47. Epub 2017 Jan 31. No abstract available.

Label	URL
Related Info	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
BG001	Chlorambucil	Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
BG002	Total	Total of all reporting groups

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 Progression Free Survival (PFS)

Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator's assessment or death due to any cause on study, whichever occurred first. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression

This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The ITT population was defined as all participants who were randomized, independent of whether they received study treatment or not.

Posted

Median

95% Confidence Interval

months

From first dose of study drug to date of data cut-off of 18 Feb 2013; up to approximately 39 months

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
OG001	Chlorambucil	Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).

Units	Counts
Participants	OG000212 OG001215

Title

Denominators

Categories

Title	Measurements
	OG00030.8(18.7 to NA)Not Applicable = The upper boundary of confidence interval (CI) is not estimable because of censored participants. OG00123.0(19.3 to 29.2)

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	Stratification factors: Disease stage (Binet A or Binet B or Rai I or Rai II versus (VS) Binet C or Rai III or Rai IV); Presence of at least one of the co-morbidities Asparate transaminase (AST)/Alanine transaminase (ALT) ≥ 3.0 times Upper Limits of Normal (ULN,) Creatinine clearance ≥ 30 to < 60 mL/min, Yes VS No); Presence of at least one 11q deletion, 17p deletion, unmutated Immunoglobulin Heavy-chain Variable-region (IgVH) or Beta-2 Microglobulin (ß2M )> 4.0 mg/L (Yes versus No VS Unknown)	stratified log rank		0.323		Hazard Ratio (HR)	1.21			2-Sided	90	0.88	1.66			Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.

Primary

Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off Date of 14 March 2014

Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator's assessment or death due to any cause on study, whichever occurred first. Progressive disease included lymphadenopathy, an appearance of any new lesion such as enlarged lymph nodes (> 1.5 cm), splenomegaly, hepatomegaly or other organ infiltrates, an increase by 50% or more in greatest determined diameter of any previous site or an increase by 50% or more in the sum of the product of diameters of multiple nodes. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.

The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.

Posted

Median

95% Confidence Interval

months

From randomization to data cut off date of 31 March 2014; median follow up time for all participants was 12.6 months

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.

Secondary

Number of Participants With Adverse Events (AEs)

AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. 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/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 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

This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil) as of the data cut off date of 18 Feb 2013

Posted

Number

participants

From randomization up to data cut-off of 18 Feb 2013; Up to approximately 39 months; maximum duration of exposure for Lenalidomide was 1086 days and 406 days for Chlorambucil

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.

Secondary

Number of Participants With Adverse Events With a Later Cut-off Date of 31 March 2014

The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil).

Posted

Number

participants

From randomization to the data cut-off date of 31 March 2014; Up to 53 months; maximum duration of exposure for Lenalidomide was 1140 days and 406 days for Chlorambucil

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.

Secondary

Percentage of Participants With the Best Overall Response Based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines

A best overall response rate is a CR, CRi, nPR or PR and is defined as:

Complete Remission (CR):

No lymphadenopathy
No hepatomegaly or splenomegaly
Absence of constitutional symptoms
Polymorphonuclear leukocytes ≥ 1500/ul
No circulating clonal B-lymphocytes
Platelets > 100,000/ul
Hemoglobin > 11.0 g/dl
Normocellular <30% lymphocytes, no B-lymphoid nodules;

Incomplete Clinical Response (CRi):

• CR without bone marrow biopsy confirmation.

Nodular Partial Response (nPR):

• CR with the presence of residual clonal nodules.

Partial Response (PR) requires:

≥ 50% decrease in peripheral blood lymphocyte count
≥ 50% reduction in lymphadenopathy
≥ 50% reduction in size of liver and/or spleen
1 or more of the following:
Polymorphonuclear leukocytes ≥ 1500/ul
Platelets >100,000/ul

This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.

Posted

Number

percentage of participants

Up to data cut-off date of 18 Feb 2013; approximately 39 months

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.

Secondary

Percentage of Participants With a Best Overall Response Based on IWCLL Guidelines With a Later Cut-off Date of 31 March 2014

A best overall response rate is a CR, CRi, nPR or PR and is defined as:

Complete Remission (CR):

No lymphadenopathy
No hepatomegaly or splenomegaly
Absence of constitutional symptoms
Polymorphonuclear leukocytes ≥ 1500/ul
No circulating clonal B-lymphocytes
Platelets > 100,000/ul
Hemoglobin > 11.0 g/dl
Normocellular <30% lymphocytes, no B-lymphoid nodules;

Incomplete Clinical Response (CRi):

• CR without bone marrow biopsy confirmation.

Nodular Partial Response:

• CR with the presence of residual clonal nodules.

Partial Response requires:

≥ 50% decrease in peripheral blood lymphocyte count
≥ 50% reduction in lymphadenopathy
≥ 50% reduction in size of liver and/or spleen
1 or more of the following:
Polymorphonuclear leukocytes ≥ 1500/ul
Platelets >100,000/ul

The Intent-to-Treat population was defined as all participants who were randomized, independent of whether they received study treatment or not

Posted

Number

percentage of participants with response

Up to data cut-off of 31 March 2014; approximately 53 months

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.

Secondary

Kaplan-Meier Estimate for Duration of Response

Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) participants who had not progressed at the time of analysis; 2) participants who had withdrawn consent or were lost to follow-up prior to documentation of progression

Intent to Treat population with an objective response as of 18 Feb 2013; includes responders

Posted

Median

95% Confidence Interval

weeks

Up to data cut-off of 18 Feb 2013; up to approximately 39 months

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
OG001	Chlorambucil

Secondary

Kaplan-Meier Estimate for Duration of Response With a Later Cut-off Date of 31 March 2014

Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) patients who had not progressed at the time of analysis; 2) patients who had withdrawn consent or were lost to follow-up prior to documentation of progression

Intent to Treat population with an objective response as of 31 March 2014; includes responders.

Posted

Median

95% Confidence Interval

weeks

Up to data cut-off of 31 March 2014; up to approximately 53 months

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
OG001	Chlorambucil

Secondary

Time to Response

Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines

ITT participants with an objective response as of 18 February 2013

Posted

Median

Full Range

weeks

Up to data cut-off of 18 Feb 2013; up to approximately 39 months

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
OG001	Chlorambucil	Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).

Secondary

Time to Response for a Later Cut-off Date of 31 March 2014

Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines

ITT participants who had not progressed at the time of analysis; or those who had withdrawn consent or were lost to follow-up prior to documentation of progression.

Posted

Median

Full Range

weeks

Up to data cut-off of 31 March 2014; up to approximately 53 months

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
OG001	Chlorambucil	Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).

Secondary

Kaplan Meier Estimate of Overall Survival

Overall Survival is defined as the time between randomization and death from any cause.

The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.

Posted

Median

95% Confidence Interval

Months

Up to data cut off of 31 March 2014; median follow-up for all participants was 18.8 months

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
OG001	Chlorambucil	Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).

Secondary

Kaplan Meier Estimate for Overall Survival at the Final Analysis

Overall Survival is defined as the time between randomization and death from any cause. Overall survival was censored at the last date that the subject was known to be alive for participants who were alive as of the data cutoff date and for participants who were lost to follow-up before death was documented.

The ITT population was defined as all participants who were randomized, independent of whether they received study treatment.

Posted

Median

95% Confidence Interval

Months

Up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
OG001	Chlorambucil

Secondary

Functional Assessment of Cancer Therapy-General to Create the FACT-Leukemia (FACT-Leu) Quality of Life Instrument

The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease. The FACT-Leu is described as including 27 items that assess 17 physical symptoms (fevers, bleeding, general pain, stomach pain, chills, night sweats, bruising, lymph node swelling, weakness, tiredness, weight loss, appetite, shortness of breath, functional ability, diarrhea, concentration, and mouth sores) and 10 emotional/social concerns (frustration with activity limitation, discouraged by illness, future planning, uncertainty, worry about illness, emotional lability, isolation, infertility concern, family worry, and worry about infections).

No data were collected for the FACT-Leu QOL assessment. Analysis was not conducted due to the discontinuation of the lenalidomide arm.

Posted

Day 1 and once every 8 weeks

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.

Secondary

Euro Quality of Life Five Dimension (EQ-5D) Questionnaire

The standardized extended version of EQ-5D was designed for the collection of health state values using a visual analogue scale (VAS) rating scale - a vertical 20 cm visual analogue scale with the end points labeled best imaginable health state at the top and worst imaginable health state at the bottom having numeric values of 100 and 0 respectively. The participant is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.

No data were collected for the EQ-5D QOL assessment. The EQ-5D analysis was not conducted due to the discontinuation of the lenalidomide arm.

Posted

Day 1 and once every 8 weeks

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
OG001

Secondary

Number of Participants and Types of Subsequent Anti-cancer Therapies Received Post Treatment

Subsequent anti-cancer therapies administered to participants following the discontinuation of study drug (either Lenalidomide or Chlorambucil)

The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil).

Posted

Number

participants

Up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
OG001	Chlorambucil	Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).

Other Pre-specified

Number of Participants Deaths During the Treatment and Survival Follow-Up Phase

The number of study participants deaths during the treatment and follow-up phase

ITT population includes all participants who were randomized, independent of whether they received study treatment or not

Posted

Number

Participants

From the first dose of study drug up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months

ID	Title	Description
OG000	Lenalidomide	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
OG001	Chlorambucil	Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).

Arm/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	For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide was administered by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.	100	224	148	224	204	224
EG001	Chlorambucil	Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months	93	223	90	223	184	223

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
AGRANULOCYTOSIS	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00018 affected224 at risk EG00110 affected223 at risk
AUTOIMMUNE HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected224 at risk EG0014 affected223 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0007 affected224 at risk EG0013 affected223 at risk
HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
IDIOPATHIC THROMBOCYTOPENIC PURPURA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
LYMPHOPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00054 affected224 at risk EG00133 affected223 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
SPLENIC HAEMORRHAGE	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00019 affected224 at risk EG00113 affected223 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected224 at risk EG0011 affected223 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
BRADYCARDIA	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected224 at risk EG0010 affected223 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0011 affected223 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected224 at risk EG0010 affected223 at risk
CARDIOPULMONARY FAILURE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected224 at risk EG0010 affected223 at risk
CONGESTIVE CARDIOMYOPATHY	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
SICK SINUS SYNDROME	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0010 affected223 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
DIPLOPIA	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
MACULOPATHY	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0012 affected223 at risk
COLITIS	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
FEMORAL HERNIA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0012 affected223 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0012 affected223 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
VOMITING	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0013 affected223 at risk
ASTHENIA	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0013 affected223 at risk
FATIGUE	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0012 affected223 at risk
MULTI-ORGAN FAILURE	General disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected224 at risk EG0010 affected223 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0010 affected223 at risk
PAIN	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
PYREXIA	General disorders	MedDRA 16.1	Systematic Assessment	EG00010 affected224 at risk EG0016 affected223 at risk
SUDDEN CARDIAC DEATH	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0011 affected223 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0010 affected223 at risk
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0012 affected223 at risk
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
ANAL ABSCESS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
ARTHRITIS INFECTIVE	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
BRONCHITIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0011 affected223 at risk
BRONCHITIS BACTERIAL	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
BRONCHOPNEUMONIA	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0011 affected223 at risk
CELLULITIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0013 affected223 at risk
CELLULITIS STAPHYLOCOCCAL	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
DIARRHOEA INFECTIOUS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
ENTEROBACTER SEPSIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
ERYSIPELAS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0011 affected223 at risk
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 affected224 at risk EG0011 affected223 at risk
LUNG INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0010 affected223 at risk
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
PELVIC INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
PNEUMOCOCCAL SEPSIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
PNEUMONIA	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00024 affected224 at risk EG0016 affected223 at risk
PNEUMONIA PNEUMOCOCCAL	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
SEPSIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0014 affected223 at risk
SEPSIS SYNDROME	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
TONSILLITIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 affected224 at risk EG0011 affected223 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0011 affected223 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0011 affected223 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0010 affected223 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
BLOOD UREA INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0013 affected223 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0012 affected223 at risk
GOUT	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0011 affected223 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0011 affected223 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0013 affected223 at risk
TUMOUR LYSIS SYNDROME	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0010 affected223 at risk
ARTHROPATHY	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0010 affected223 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
ADENOCARCINOMA PANCREAS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0005 affected224 at risk EG0018 affected223 at risk
BASOSQUAMOUS CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0011 affected223 at risk
BOWEN'S DISEASE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
CHRONIC LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
COLON ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
HEPATIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
HODGKIN'S DISEASE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
LUNG SQUAMOUS CELL CARCINOMA STAGE II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
METASTASES TO LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0011 affected223 at risk
METASTATIC MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
RICHTER'S SYNDROME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
SKIN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0011 affected223 at risk
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0017 affected223 at risk
SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
TUMOUR FLARE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0008 affected224 at risk EG0010 affected223 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
CONVULSION	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
HEMIPARESIS	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
SCIATICA	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
SIMPLE PARTIAL SEIZURES	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
SYNCOPE	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected224 at risk EG0010 affected223 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected224 at risk EG0010 affected223 at risk
DEPRESSION	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
RENAL COLIC	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0010 affected223 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected224 at risk EG0010 affected223 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0011 affected223 at risk
BRONCHIECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0011 affected223 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected224 at risk EG0011 affected223 at risk
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0011 affected223 at risk
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected224 at risk EG0010 affected223 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
HEPATITIS TOXIC	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
LOBAR PNEUMONIA	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0010 affected223 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
SKULL FRACTURE	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
INTERNATIONAL NORMALISED RATIO INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
PULMONARY ALVEOLAR HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected224 at risk EG0011 affected223 at risk
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0010 affected223 at risk
SINUS CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
BLISTER	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
DRUG ERUPTION	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
EXFOLIATIVE RASH	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected224 at risk EG0010 affected223 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected224 at risk EG0011 affected223 at risk
RASH GENERALISED	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
STEVENS-JOHNSON SYNDROME	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected224 at risk EG0011 affected223 at risk
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected224 at risk EG0011 affected223 at risk
LERICHE SYNDROME	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
PERIPHERAL ARTERY ANEURYSM	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
SHOCK	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
THROMBOPHLEBITIS SUPERFICIAL	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk
VENOUS THROMBOSIS LIMB	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected224 at risk EG0010 affected223 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG000126 affected224 at risk EG00174 affected223 at risk
VOMITING	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00011 affected224 at risk EG00128 affected223 at risk
ASTHENIA	General disorders	MedDRA 16.1	Systematic Assessment	EG00019 affected224 at risk EG00110 affected223 at risk
PYREXIA	General disorders	MedDRA 16.1	Systematic Assessment	EG00037 affected224 at risk EG00118 affected223 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00012 affected224 at risk EG0013 affected223 at risk
PNEUMONIA	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00013 affected224 at risk EG0011 affected223 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG00030 affected224 at risk EG00113 affected223 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00016 affected224 at risk EG0014 affected223 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00021 affected224 at risk EG00112 affected223 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00069 affected224 at risk EG00146 affected223 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00072 affected224 at risk EG00150 affected223 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00030 affected224 at risk EG00110 affected223 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00028 affected224 at risk EG00117 affected223 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00066 affected224 at risk EG00132 affected223 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00033 affected224 at risk EG00163 affected223 at risk
FATIGUE	General disorders	MedDRA 16.1	Systematic Assessment	EG00066 affected224 at risk EG00153 affected223 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 16.1	Systematic Assessment	EG00043 affected224 at risk EG00116 affected223 at risk
BRONCHITIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00016 affected224 at risk EG0014 affected223 at risk
INFLUENZA	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00013 affected224 at risk EG0012 affected223 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00016 affected224 at risk EG00111 affected223 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG00014 affected224 at risk EG0017 affected223 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG00014 affected224 at risk EG0017 affected223 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG00022 affected224 at risk EG0017 affected223 at risk
WEIGHT DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG00034 affected224 at risk EG00123 affected223 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG00012 affected224 at risk EG0014 affected223 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00015 affected224 at risk EG00112 affected223 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00028 affected224 at risk EG00118 affected223 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00015 affected224 at risk EG0015 affected223 at risk
TUMOUR FLARE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG00085 affected224 at risk EG00111 affected223 at risk
DIZZINESS	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00016 affected224 at risk EG00112 affected223 at risk
HEADACHE	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00016 affected224 at risk EG00111 affected223 at risk
INSOMNIA	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG00014 affected224 at risk EG00111 affected223 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00038 affected224 at risk EG00121 affected223 at risk
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00024 affected224 at risk EG00114 affected223 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00018 affected224 at risk EG0017 affected223 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00041 affected224 at risk EG00119 affected223 at risk

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons