Lenalidomide Plus Rituximab Followed by Lenalidomide Vers... | NCT01996865

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Lenalidomide + rituximab followed by lenalidomide	Experimental	Induction Period (12 cycles): Lenalidomide 20mg (10 mg if creatinine clearance ≥ 30 mL/min but < 60mL/min) by mouth (PO) daily (QD) on Days 1 to 21 of every 28-day cycle during cycles 1 through 12 and rituximab 375mg/m^2 intraveneously (IV) every week in Cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period (lasting 18 Cycles) that includes Lenalidomide 10 mg PO QD on Days 1 to 21 of every 28-day cycle during cycles 13 to 30 and rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29 followed by an optional Maintenance Period (up to Progressive Disease) receiving Lenalidomide 10mg PO QD on Days 1 through 21 of every 28 day cycle until the disease progresses	Drug: Lenalidomide Drug: Rituximab
Arm B: Lenalidomide + rituximab followed by rituximab	Active Comparator	Induction Period (12 Cycles): Lenalidomide 20 mg PO QD (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) on Days 1 to 21 of every 28-day cycle during cycles 1 to 12 and rituximab 375 mg/m^2 IV every week in cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period for 18 Cycles that includes: Rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29	Drug: Lenalidomide Drug: Rituximab

Name	Type	Description	Arm Group Labels	Other Names
Lenalidomide	Drug		Arm A: Lenalidomide + rituximab followed by lenalidomide Arm B: Lenalidomide + rituximab followed by rituximab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	Progression free survival (PFS) is defined as the time from the date of first dose of maintenance therapy to the date of the first objective documentation of tumor progression or death due to any cause. Analysis was based on Kaplan Meier estimates. The PFS events were determined using a modification of the IWG 1999 criteria.	From the first dose date of maintenance therapy to objective disease progression or death from any cause, whichever occurs first (up to approximately 432 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	Overall Survival (OS) is defined as the time between the first dose date of maintenance therapy and death from any cause. Participants who complete the study and are still alive at the time of the clinical data cutoff date will be censored at the last visit date or the last contact date, whichever is later. Participants who were lost to follow-up prior to the clinical data cut-off date will also be censored at the time of the last contact. Analysis was based on Kaplan Meier estimates and Hazard Ratio (HR).

Eligibility Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 055		Tucson	Arizona	85710	United States
Local Institution - 077

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30897038	Background	Leonard JP, Trneny M, Izutsu K, Fowler NH, Hong X, Zhu J, Zhang H, Offner F, Scheliga A, Nowakowski GS, Pinto A, Re F, Fogliatto LM, Scheinberg P, Flinn IW, Moreira C, Cabecadas J, Liu D, Kalambakas S, Fustier P, Wu C, Gribben JG; AUGMENT Trial Investigators. AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2019 May 10;37(14):1188-1199. doi: 10.1200/JCO.19.00010. Epub 2019 Mar 21.
30919940

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Induction Period: Lenalidomide + Rituximab	Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 11, 2022

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000
Between 18 and 65 years	BG000209
>=65 years	BG000

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000215
Male	BG000288

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00033
Not Hispanic or Latino	BG000463

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001
Asian	BG0004

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival (PFS)

Progression free survival (PFS) is defined as the time from the date of first dose of maintenance therapy to the date of the first objective documentation of tumor progression or death due to any cause. Analysis was based on Kaplan Meier estimates. The PFS events were determined using a modification of the IWG 1999 criteria.

All randomized participants in Arm A and Arm B, as prespecified in the protocol

Posted

Median

95% Confidence Interval

Weeks

From the first dose date of maintenance therapy to objective disease progression or death from any cause, whichever occurs first (up to approximately 432 weeks)

ID	Title	Description
OG000	Arm A: Lenalidomide + Rituximab	Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
OG001	Arm B: Rituximab	Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29

Units	Counts
Participants	OG000135 OG001132

Title

Denominators

Categories

Title	Measurements
	OG000263.1(166.1 to NA)Upper limit not calculated due to insufficient number of events. OG001229.1(173.7 to NA)Upper limit not calculated due to insufficient number of events.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Cox		0.3296		Hazard Ratio (HR)	0.8			2-Sided	95	0.6	1.2					Other

Secondary

Overall Survival (OS)

Overall Survival (OS) is defined as the time between the first dose date of maintenance therapy and death from any cause. Participants who complete the study and are still alive at the time of the clinical data cutoff date will be censored at the last visit date or the last contact date, whichever is later. Participants who were lost to follow-up prior to the clinical data cut-off date will also be censored at the time of the last contact. Analysis was based on Kaplan Meier estimates and Hazard Ratio (HR).

All randomized participants in Arm A and Arm B, as prespecified in the protocol

Posted

Median

95% Confidence Interval

Weeks

From the first dose date of maintenance therapy to death from any cause (up to approximately 480 weeks)

ID	Title	Description
OG000	Arm A: Lenalidomide + Rituximab	Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
OG001	Arm B: Rituximab	Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29

Secondary

Improvement of Response (IOR)

Improvement of Response (IOR) is the percentage of participants with improved tumor response during the maintenance phase (converted from partial response at end of induction to complete response or complete response unconfirmed as best response) and participants who converted from stable disease at the end of induction period to partial response or better as best response during maintenance phase.

All randomized participants in Arm A and Arm B, as prespecified in the protocol

Posted

Number

95% Confidence Interval

Percentage of participants

From the first dose date of maintenance therapy to death from any cause (up to approximately 432 weeks)

ID	Title	Description
OG000	Arm A: Lenalidomide + Rituximab	Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
OG001	Arm B: Rituximab	Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29

Secondary

Overall Response Rate (ORR)

The overall response rate (ORR) is defined as the percentage of participants with a best response of at least partial response (including complete response, complete response unconfirmed and partial response) after the first dose date of maintenance therapy and prior to any treatment change.

All randomized participants in Arm A and Arm B, as prespecified in the protocol

Posted

Number

95% Confidence Interval

Percentage of participants

From the first dose date of maintenance therapy up to CR, CRu, PR, or treatment change (up to approximately 432 weeks)

ID	Title	Description
OG000	Arm A: Lenalidomide + Rituximab	Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
OG001	Arm B: Rituximab	Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29

Secondary

Complete Response Rate (CRR)

Best Complete Response Rate (CRR), defined as the proportion of participants with a best response of at least CRu (including CR and CRu) after the first dose date of maintenance therapy and prior to any treatment change.

All randomized participants in Arm A and Arm B, as prespecified in the protocol

Posted

Number

95% Confidence Interval

Percentage of participants

From the first dose date of maintenance therapy up to CR or CRu (up to approximately 432 weeks)

ID	Title	Description
OG000	Arm A: Lenalidomide + Rituximab	Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
OG001	Arm B: Rituximab	Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29

Units	Counts

Secondary

Duration of Response (DOR)

DOR is from initial response (at least CRu) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death. Participants who have not progressed or died at the time of the clinical data cutoff date will be censored at the last assessment showing no progression. Participants who change treatment without evidence of disease progression will be censored at the last assessment showing no progression prior to treatment change. Analysis was based on Kaplan Meier estimates.

The analysis is only performed for participants who have achieved PR or better after the first dose date of maintenance therapy and prior to any treatment change.

Arm B includes 3 additional participants who achieved CR/CRu/PR in the follow-up period.

Posted

Median

95% Confidence Interval

Weeks

From the initial response (at least PR) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death, whichever occurs first (up to approximately 432 weeks)

ID	Title	Description
OG000	Arm A: Lenalidomide + Rituximab	Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
OG001

Secondary

Time to Next Anti-lymphoma Treatment

Time to next anti-lymphoma treatment is defined as the time from the first dose date of maintenance therapy to the time of first documented administration of new anti-lymphoma therapy. Participants without new treatment therapy will be censored at the last visit. Analysis was based on Kaplan Meier estimates.

All randomized participants in Arm A and Arm B, as prespecified in the protocol

Posted

Median

95% Confidence Interval

Weeks

From the first dose date of maintenance therapy to the time of first documented administration of new anti-lymphoma therapy (up to approximately 300 weeks)

ID	Title	Description
OG000	Arm A: Lenalidomide + Rituximab	Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
OG001	Arm B: Rituximab	Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29

Secondary

Time to Histological Transformation

Time to histological transformation is defined as from the first dose date of maintenance therapy to the time of histological transformation as measured based on documentation of histological transformation (as assessed by the investigator). Analysis was based on Kaplan Meier estimates.

In case of clinical suspicion of transformation, including rapid disease progression, unexpected changes in "B" symptoms or rapidly increasing LDH, a biopsy should be performed. In this clinical trial, histological transformation will be considered disease progression. This endpoint will not be calculated for participants randomized with transformed Follicular Lymphoma (tFL).

All randomized participants in Arm A and Arm B without transformed Follicular Lymphoma (tFL)

Posted

Median

95% Confidence Interval

Weeks

From the first dose date of maintenance therapy to the time of histological transformation (up to approximately 432 weeks)

ID	Title	Description
OG000	Arm A: Lenalidomide + Rituximab	Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
OG001	Arm B: Rituximab

Secondary

Duration of Complete Response (DOCR)

Duration of complete response (DOCR) is calculated as the time from the initial response (CR or CRu) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death. Analysis was based on Kaplan Meier estimates. Participants who have not progressed or died at the time of the clinical data cutoff date will be censored at the last assessment showing no progression. Participants who change treatment without evidence of disease progression will be censored at the last assessment showing no progression prior to treatment change.

The analysis is only performed for participants who have achieved CR or CRu after the first dose date of maintenance therapy and prior to any treatment change.

Posted

Median

95% Confidence Interval

Weeks

From the initial CR/CRu after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death, whichever occurs first (up to approximately 432 weeks)

ID	Title	Description
OG000	Arm A: Lenalidomide + Rituximab	Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
OG001	Arm B: Rituximab

Secondary

Participants Experiencing Treatment Emergent Adverse Events (TEAEs)

Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment.

All treated participants

Posted

Count of Participants

Participants

From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)

ID	Title	Description
OG000	Induction Period: Lenalidomide + Rituximab	Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11
OG001	Arm A: Lenalidomide + Rituximab

Secondary

Participants Experiencing Adverse Events Related to Vital Signs

The number of participants who experienced adverse events related to vital sign measurements

All treated participants

Posted

Count of Participants

Participants

From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)

ID	Title	Description
OG000	Induction Period: Lenalidomide + Rituximab	Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11
OG001	Arm A: Lenalidomide + Rituximab	Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
OG002	Arm B: Rituximab

Secondary

Participants With Grade 3 or Grade 4 Hematology Parameters

Clinical laboratory values in induction period include any laboratory values that are taken after the first dose date of induction therapy through 28 days after the last dose date of induction therapy or before the first dose date of maintenance therapy, whichever is earlier. Graded according to the NCI CTCAE version 4.03, except for tumor flare reaction, which is accessed using NCI CTCAE version 3.0. Participants with zero maximum grade are excluded.

All treated participants

Posted

Count of Participants

Participants

From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)

ID	Title	Description
OG000	Induction Period: Lenalidomide + Rituximab	Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11
OG001	Arm A: Lenalidomide + Rituximab	Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.

Secondary

Participants With Grade 3 or Grade 4 Serum Chemistry Parameters

Clinical laboratory values in induction period include any laboratory values that are taken after the first dose date of induction therapy through 28 days after the last dose date of therapy. Graded according to the NCI CTCAE version 4.03, except for tumor flare reaction, which is accessed using NCI CTCAE version 3.0. Participants with zero maximum grade are excluded.

All treated participants

Posted

Count of Participants

Participants

From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)

ID	Title	Description
OG000	Induction Period: Lenalidomide + Rituximab	Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11
OG001	Arm A: Lenalidomide + Rituximab	Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.

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	Induction Period: Lenalidomide + Rituximab	Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11.	112	500	172	500	491	500
EG001	Arm A: Lenalidomide + Rituximab	Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.	26	134	57	134	129	134
EG002	Arm B: Rituximab	Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29	32	132	22	132	106	132

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00018 affected500 at risk EG0018 affected134 at risk EG0021 affected132 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0008 affected500 at risk EG00110 affected134 at risk EG0025 affected132 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0008 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00014 affected500 at risk EG0011 affected134 at risk EG0021 affected132 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00015 affected500 at risk EG0013 affected134 at risk EG0020 affected132 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0006 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Angina pectoris	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0009 affected500 at risk EG0013 affected134 at risk EG0020 affected132 at risk
Atrial flutter	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Atrioventricular block	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Bradycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Extrasystoles	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Trifascicular block	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Ear canal stenosis	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Angle closure glaucoma	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Visual impairment	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Colitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0012 affected134 at risk EG0020 affected132 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Epiploic appendagitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Volvulus of small bowel	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0012 affected134 at risk EG0020 affected132 at risk
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Death	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Disease progression	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Face oedema	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Generalised oedema	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Impaired healing	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Malaise	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Non-cardiac chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0013 affected134 at risk EG0022 affected132 at risk
Sudden death	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0012 affected134 at risk EG0021 affected132 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Hepatic haematoma	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Jaundice	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Contrast media allergy	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Contrast media reaction	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Appendicitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Aspergillus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Atypical pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Bacteraemia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Bronchitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0013 affected134 at risk EG0020 affected132 at risk
Catheter site infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Cellulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0005 affected500 at risk EG0013 affected134 at risk EG0020 affected132 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Coronavirus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Device related infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Disseminated varicella zoster virus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Diverticulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Epididymitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Groin abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Hepatitis C	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Herpes zoster	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Histoplasmosis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Influenza	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Joint abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Localised infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Osteomyelitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Otitis media	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0012 affected134 at risk EG0020 affected132 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Pneumonia viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Progressive multifocal leukoencephalopathy	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Pseudomonas infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Psoas abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0007 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Sinusitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Skin infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0012 affected134 at risk EG0020 affected132 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0013 affected134 at risk EG0020 affected132 at risk
Urosepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Varicella	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Viral infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0012 affected134 at risk EG0020 affected132 at risk
Heat exhaustion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Ilium fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Post concussion syndrome	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Blood bilirubin increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Lipase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Troponin increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
White blood cell count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0008 affected500 at risk EG0011 affected134 at risk EG0021 affected132 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0005 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0021 affected132 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0004 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0012 affected134 at risk EG0020 affected132 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Sacral pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0013 affected134 at risk EG0020 affected132 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Central nervous system lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Diffuse large B-cell lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Large granular lymphocytosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Lip squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Sebaceous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG00010 affected500 at risk EG0015 affected134 at risk EG0021 affected132 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Ataxia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Bell's palsy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Encephalopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Lethargy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Seizure	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Somnolence	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Syncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Transient global amnesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Device occlusion	Product Issues	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Delirium	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Depression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Mental status changes	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Suicide attempt	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0009 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Renal failure	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Urinary tract disorder	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Granulomatous pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0008 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected500 at risk EG0011 affected134 at risk EG0020 affected132 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00077 affected500 at risk EG00112 affected134 at risk EG0028 affected132 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00067 affected500 at risk EG00113 affected134 at risk EG0029 affected132 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00033 affected500 at risk EG0015 affected134 at risk EG0023 affected132 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG000217 affected500 at risk EG00154 affected134 at risk EG00222 affected132 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00074 affected500 at risk EG0019 affected134 at risk EG0025 affected132 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0005 affected500 at risk EG0017 affected134 at risk EG0023 affected132 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG00014 affected500 at risk EG0017 affected134 at risk EG0024 affected132 at risk
Vision blurred	Eye disorders	MedDRA 26.1	Systematic Assessment	EG00018 affected500 at risk EG0019 affected134 at risk EG0020 affected132 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00057 affected500 at risk EG00113 affected134 at risk EG0028 affected132 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000146 affected500 at risk EG00112 affected134 at risk EG0022 affected132 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000176 affected500 at risk EG00156 affected134 at risk EG00211 affected132 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00031 affected500 at risk EG0010 affected134 at risk EG0021 affected132 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00035 affected500 at risk EG0014 affected134 at risk EG0020 affected132 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000150 affected500 at risk EG00115 affected134 at risk EG0026 affected132 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00037 affected500 at risk EG0013 affected134 at risk EG0023 affected132 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00054 affected500 at risk EG00110 affected134 at risk EG0024 affected132 at risk
Chills	General disorders	MedDRA 26.1	Systematic Assessment	EG00043 affected500 at risk EG0015 affected134 at risk EG0025 affected132 at risk
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG000225 affected500 at risk EG00127 affected134 at risk EG00215 affected132 at risk
Influenza like illness	General disorders	MedDRA 26.1	Systematic Assessment	EG00014 affected500 at risk EG0017 affected134 at risk EG0021 affected132 at risk
Oedema peripheral	General disorders	MedDRA 26.1	Systematic Assessment	EG00081 affected500 at risk EG00114 affected134 at risk EG0023 affected132 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG00050 affected500 at risk EG00114 affected134 at risk EG0025 affected132 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0008 affected500 at risk EG0017 affected134 at risk EG0022 affected132 at risk
Bronchitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00023 affected500 at risk EG00112 affected134 at risk EG0025 affected132 at risk
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected500 at risk EG0018 affected134 at risk EG0020 affected132 at risk
Nasopharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00026 affected500 at risk EG0015 affected134 at risk EG0023 affected132 at risk
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00035 affected500 at risk EG00117 affected134 at risk EG0025 affected132 at risk
Sinusitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00043 affected500 at risk EG00116 affected134 at risk EG00211 affected132 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00065 affected500 at risk EG00122 affected134 at risk EG00214 affected132 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00041 affected500 at risk EG00111 affected134 at risk EG0024 affected132 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG00024 affected500 at risk EG00113 affected134 at risk EG0027 affected132 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG00053 affected500 at risk EG0010 affected134 at risk EG0020 affected132 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00030 affected500 at risk EG0015 affected134 at risk EG0022 affected132 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00022 affected500 at risk EG0017 affected134 at risk EG0024 affected132 at risk
Blood creatinine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00022 affected500 at risk EG00112 affected134 at risk EG0024 affected132 at risk
Lymphocyte count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00011 affected500 at risk EG0017 affected134 at risk EG0023 affected132 at risk
Weight decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00034 affected500 at risk EG00114 affected134 at risk EG0024 affected132 at risk
White blood cell count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00020 affected500 at risk EG00110 affected134 at risk EG0021 affected132 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00069 affected500 at risk EG0018 affected134 at risk EG0023 affected132 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00024 affected500 at risk EG0018 affected134 at risk EG0023 affected132 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00017 affected500 at risk EG0018 affected134 at risk EG0027 affected132 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00063 affected500 at risk EG00116 affected134 at risk EG0028 affected132 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00027 affected500 at risk EG0016 affected134 at risk EG0027 affected132 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00068 affected500 at risk EG00123 affected134 at risk EG00218 affected132 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00057 affected500 at risk EG0019 affected134 at risk EG0024 affected132 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00064 affected500 at risk EG00111 affected134 at risk EG0023 affected132 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00031 affected500 at risk EG0018 affected134 at risk EG0022 affected132 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00025 affected500 at risk EG00110 affected134 at risk EG0022 affected132 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00037 affected500 at risk EG00111 affected134 at risk EG0029 affected132 at risk
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00068 affected500 at risk EG00114 affected134 at risk EG0027 affected132 at risk
Dysgeusia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00030 affected500 at risk EG0013 affected134 at risk EG0020 affected132 at risk
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00066 affected500 at risk EG00115 affected134 at risk EG00211 affected132 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00056 affected500 at risk EG00114 affected134 at risk EG0026 affected132 at risk
Anxiety	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG00031 affected500 at risk EG0018 affected134 at risk EG0023 affected132 at risk
Insomnia	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG00050 affected500 at risk EG0017 affected134 at risk EG0025 affected132 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG000103 affected500 at risk EG00141 affected134 at risk EG00220 affected132 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00073 affected500 at risk EG00118 affected134 at risk EG0022 affected132 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00023 affected500 at risk EG00110 affected134 at risk EG0022 affected132 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00037 affected500 at risk EG0019 affected134 at risk EG0022 affected132 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected500 at risk EG0018 affected134 at risk EG0021 affected132 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00019 affected500 at risk EG0017 affected134 at risk EG0021 affected132 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00021 affected500 at risk EG00110 affected134 at risk EG0024 affected132 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00041 affected500 at risk EG0014 affected134 at risk EG0022 affected132 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00039 affected500 at risk EG0018 affected134 at risk EG0026 affected132 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00096 affected500 at risk EG0012 affected134 at risk EG0023 affected132 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00033 affected500 at risk EG0010 affected134 at risk EG0022 affected132 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00082 affected500 at risk EG0016 affected134 at risk EG0021 affected132 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00030 affected500 at risk EG0016 affected134 at risk EG0022 affected132 at risk
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG00034 affected500 at risk EG0019 affected134 at risk EG0026 affected132 at risk

Ancestor Terms

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
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D020522	Lymphoma, Mantle-Cell
D008224	Lymphoma, Follicular
D018442	Lymphoma, B-Cell, Marginal Zone

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D016393	Lymphoma, B-Cell