A Study to Evaluate the Efficacy and Safety of Polatuzuma... | NCT04236141

Label	Type	Description	Intervention Names
Polatuzumab Vedotin plus BR	Experimental		Drug: Polatuzumab Vedotin Drug: Bendamustine Drug: Rituximab
Placebo plus BR	Active Comparator		Drug: Bendamustine Drug: Rituximab Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Polatuzumab Vedotin	Drug	Participants will receive a total of 6 cycles (a cycle being 21 days) of 1.8mg/kg Polatuzumab Vedotin (IV infusion) on Day 2 of Cycle 1 and Day 1 of Cycles 2-6.

Measure	Description	Time Frame
Percentage of Participants With Complete Response (CR) at the End of Treatment (EOT) Assessment Based on Positron Emission Tomography-Computed Tomography (PET-CT) Assessed by Independent Review Committee (IRC)	CR was determined by IRC according to the Lugano Response Criteria (LRC) for Malignant Lymphoma. Per LRC , CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment.	Up to approximately 23 weeks

Measure	Description	Time Frame
Percentage of Participants With CR at the EOT Assessment Based on PET-CT as Assessed by Investigator	CR was determined by investigator according to the LRC for Malignant Lymphoma. Per LRC, CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5PS, where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment. Percentages have been rounded off to the first decimal point.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to comply with the study protocol and procedures, in the investigator's judgement.
Transplant ineligible participants with R/R DLBCL.
Confirmed DLBCL diagnosis.
For participants who have received prior bendamustine, a response duration > 1 year (for participants who have relapsed disease after a prior regimen).
At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or magnetic resonance imaging (MRI).
Availability of archival or freshly collected tumor tissue before study enrolment.
Life expectancy of at least 24 weeks.
ECOG Performance Status of 0, 1 or 2.
Adequate haematologic function.
Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
For men who are not surgically sterile: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm.
Residence in the People's Republic of China.

Exclusion Criteria:

History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (MAbs) or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products.
Contraindication to bendamustine or rituximab.
History of sensitivity to mannitol (mannitol is an excipient in bendamustine).
Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 5 half-lives or 4 weeks, whichever is longer, before Cycle 1, Day 1.
Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1, Day 1.
Ongoing corticosteroid use > 30 mg/day prednisone or equivalent, for purposes other than lymphoma symptom control.
Completion of autologous SCT within 100 days prior to Cycle 1, Day 1.
Prior allogeneic Stem Cell Transplantation (SCT).
Prior treatment with Chimeric Antigen Receptor (CAR) T-cell therapy.
Eligibility for autologous SCT.
Grade 3b Follicular Lymphoma (FL).
History of transformation of indolent disease to DLBCL.
Primary or secondary CNS lymphoma.
Current Grade > 1 peripheral neuropathy.
History of other malignancy that could affect compliance with the protocol or interpretation of results.
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular or pulmonary disease.
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1.
Participants with suspected or latent tuberculosis.
Positive Chronic Hepatitis B (HBV) infection or Hepatitis C (HCV) infection.
Known history of HIV infection.
Known infection human T-cell leukemia virus 1 virus.
Vaccination with a live vaccine within 28 days prior to treatment.
Recent major surgery (within 6 weeks before the start of Cycle 1, Day 1) other than for diagnosis.
Pregnant or breastfeeding or intending to become pregnant during the study or within 12 months after the final dose of study treatment.
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Cancer Hospital		Beijing		100142	China
West China Hospital, Sichuan University

ID	Title	Description
FG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 milligrams per kilogram (mg/kg), as intravenous (IV) infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 milligrams per square meter (mg/m^2), as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 12, 2020	Jul 7, 2022

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

Percentage of Participants With Complete Response (CR) at the End of Treatment (EOT) Assessment Based on Positron Emission Tomography-Computed Tomography (PET-CT) Assessed by Independent Review Committee (IRC)

CR was determined by IRC according to the Lugano Response Criteria (LRC) for Malignant Lymphoma. Per LRC , CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Up to approximately 23 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.
OG001	Placebo Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin matching placebo by IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with placebo. Each cycle is 21 days.

Units	Counts
Participants	OG00028 OG00114

Title

Denominators

Categories

Title	Measurements
	OG00025.0(10.69 to 44.87) OG00114.3(1.78 to 42.81)

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						Difference in Response Rates	10.71			2-Sided	95	-19.00	40.43					Superiority

Secondary

Percentage of Participants With CR at the EOT Assessment Based on PET-CT as Assessed by Investigator

CR was determined by investigator according to the LRC for Malignant Lymphoma. Per LRC, CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5PS, where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment. Percentages have been rounded off to the first decimal point.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Up to approximately to 23 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.
OG001

Secondary

Percentage of Participants With Objective Response (OR) at EOT Based on PET-CT as Assessed by Investigator

OR was defined as CR or partial response (PR) at the end of treatment assessment based on PET-CT, as determined by the investigator according to the LRC. CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass on 5PS, where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. PR based on PET-CT was defined as partial MR in lymph nodes and extralymphatic sites with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size; no new lesions and residual uptake higher than uptake in normal bone marrow but reduced compared with baseline. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Up to approximately 23 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.

Secondary

Percentage of Participants With OR at EOT Based on PET-CT as Assessed by IRC

OR was defined as CR or PR at the end of treatment assessment based on PET-CT, as determined by the IRC according to the LRC. CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass on 5PS, where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. PR per PET-CT was defined as partial MR in lymph nodes and extralymphatic sites with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size; no new lesions and residual uptake higher than uptake in normal marrow but reduced compared with baseline. The analysis was done 6-8 weeks after Cycle 6, Day 1(1 cycle= 21 days) or after final dose of study treatment.Percentages have been rounded off to the first decimal point.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Up to approximately 23 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.

Secondary

Percentage of Participants With CR at EOT Based on Computed Tomography (CT) as Assessed by Investigator

CR was determined by the investigator according to the LRC. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, immunohistochemistry (IHC) negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Up to approximately 23 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.
OG001	Placebo Plus Bendamustine and Rituximab

Secondary

Percentage of Participants With CR at EOT Based on CT as Assessed by IRC

CR was determined by the IRC according to the LRC. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Up to approximately 23 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.
OG001	Placebo Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin matching placebo by IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with placebo. Each cycle is 21 days.

Secondary

Percentage of Participants With OR at EOT Assessment Based on CT as Assessed by Investigator

OR was defined as CR or PR, at the EOT assessment based on CT only, as determined by the investigator according to the LRC. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. Per LRC, PR was defined as ≥ 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target nodes and extranodal sites; non-measured lesion is absent/normal, regressed, but no increase; spleen must have regressed by >50 % in length beyond normal; and no new lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment. Percentages have been rounded off to the first decimal point.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Up to approximately 23 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.

Secondary

Percentage of Participants With OR at EOT Assessment Based on CT as Assessed by IRC

OR was defined as percentage of participants with CR or PR, at EOT assessment based on CT only, as determined by IRC according to the LRC. Per LRC, CR based on CT was defined as complete radiologic response with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi. PR is ≥ 50% decrease in SPD of up to 6 target nodes and extranodal sites. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Up to approximately 23 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.
OG001	Placebo Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin matching placebo by IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with placebo. Each cycle is 21 days.

Secondary

Percentage of Participants With Best Overall Response (BOR) Based on PET-CT or CT Only as Assessed by Investigator

BOR=CR/PR per PET-CT/CT by investigator per LRC.CR perPET-CT=complete MR in lymph nodes & extralymphatic sites(ELS),score=1,2,3 with/without residual mass on5PS,1=no uptake(UT)above background;2=UT≤mediastinum;3=UT>mediastinum but ≤liver;4=UT moderately>liver;5=UT markedly higher than liver and/or new lesions; no new lesions & FDG-avid disease absent in bone marrow.CR perCT=complete radiologic response with target nodes/nodal masses regressedto≤1.5 cm in LDi&no ELS of disease;absence of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow morphology=normal,if indeterminate,IHC negative.PR per PET-CT=partial MR in lymph nodes&ELS,score=4or5,reduced UT than baseline(BL)&residual masses=any size;no new lesions&residual UT >UT in normal marrow,reduced than BL.PR per CT by LCR=≥50% decrease in SPD of up to 6 target nodes & extranodal sites;non-measured lesion=absent/normal,regressed,no increase;spleen=regressed by>50%in length beyond normal;no new lesions.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks)

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.

Secondary

Percentage of Participants With Best Overall Response (BOR) Based on PET-CT or CT Only as Assessed by IRC

BOR=CR/PR per PET-CT/CT by IRC per LRC. CR per PET-CT=complete MR in lymph nodes& ELS, score=1, 2,3 with/without residual mass on 5PS, 1=no UT above background; 2=UT≤mediastinum; 3=UT>mediastinum but ≤liver; 4=UT moderately>liver; 5=UT markedly higher than liver and/or new lesions; no new lesions & FDG-avid disease absent in bone marrow.CR per CT=complete radiologic response with target nodes/nodal masses regressed to≤1.5 cm in LDi and no ELS of disease; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; bone marrow morphology=normal, if indeterminate, IHC negative. PR per PET-CT=partial MR in lymph nodes & ELS, score =4 or 5,reduced UT than baseline(BL)&residual masses=any size; no new lesions &residual UT >UT in normal marrow, reduced than BL.PR per CT by LCR=≥50% decrease in SPD of up to 6 target nodes& extranodal sites; non-measured lesion=absent/normal, regressed, no increase; spleen=regressed by>50% in length beyond normal; no new lesions.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks)

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.

Secondary

Duration Of Response (DOR) Based on PET-CT/CT Only as Assessed by Investigator

DOR was defined as time from first occurrence of a documented objective response to disease progression, relapse or death from any cause, as determined by the investigator according to the LRC

ITT population included all participants randomized, whether or not the participants received the assigned treatment. Overall number of participants analyzed are the number of BOR responders as assessed by investigator.

Posted

Median

95% Confidence Interval

months

Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks)

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.
OG001	Placebo Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin matching placebo by IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with placebo. Each cycle is 21 days.

Secondary

DOR Based on PET-CT/CT Only as Assessed by IRC

DOR was defined as time from first occurrence of a documented objective response to disease progression, relapse or death from any cause, as determined by IRC according to the LRC.

Posted

Median

95% Confidence Interval

months

Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks)

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.
OG001	Placebo Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin matching placebo by IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with placebo. Each cycle is 21 days.

Secondary

Progression-Free Survival (PFS) Based on PET-CT/CT Only as Assessed by Investigator

PFS was defined as the period from date of randomization until the date of disease progression, relapse, or death from any cause based on PET-CT or CT only, as determined by the investigator according to the LRC.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Median

95% Confidence Interval

months

Up to approximately 82 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.
OG001	Placebo Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin matching placebo by IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with placebo. Each cycle is 21 days.

Secondary

PFS Based on PET-CT/CT Only as Assessed by IRC

PFS was defined as the period from date of randomization until the date of disease progression, relapse, or death from any cause based on PET-CT or CT only, as determined by IRC according to the LRC.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Median

95% Confidence Interval

months

Up to approximately 82 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.
OG001	Placebo Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin matching placebo by IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with placebo. Each cycle is 21 days.

Secondary

Event-Free Survival (EFS) Based on PET-CT or CT Assessed by Investigator

EFS was defined as the time from date of randomization to any treatment failure including disease progression, relapse, initiation of new anti-lymphoma treatment (NALT), or death based on PET-CT or CT only, as determined by the investigator according to the LRC.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Median

95% Confidence Interval

months

Up to approximately 82 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.
OG001	Placebo Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin matching placebo by IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with placebo. Each cycle is 21 days.

Secondary

Overall Survival (OS)

OS was defined as the time from date of randomization until the date of death from any cause.

ITT population included all participants randomized, whether or not the participants received the assigned treatment.

Posted

Median

95% Confidence Interval

months

Up to approximately 82 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.
OG001	Placebo Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin matching placebo by IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with placebo. Each cycle is 21 days.

Secondary

Percentage of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition), recurrence of an intermittent medical condition not present at baseline, any deterioration in a laboratory value or other clinical test that is associated with symptoms or leads to a change in study treatment or concomitant treatment or discontinuation from study drug or adverse events that are related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment.

Safety population included all randomized participants who received at least one dose of the study drug.

Posted

Number

percentage of participants

Up to approximately 82 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.

Secondary

Serum Concentration of Total Antibody at Specified Timepoints

PK of polatuzumab vedodtin-related analyte- total antibody was measured

PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Number analyzed is the number of participants with data available for analysis at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms per milliliter (μg/mL)

Predose & post dose on Day 2 of Cycle 1,& post dose on Days 8 & 15 of Cycles 1& 3; predose & post dose on Day 1 of Cycles 2, 3 & 4; treatment completion/early discontinuation visit; follow-up visits at Months 3 &6 (1 cycle=21 days) up to approx. 46 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.

Units	Counts
Participants

Secondary

Plasma Concentration of Antibody-Conjugated Monomethyl Auristatin E (acMMAE) at Specified Timepoints

PK of polatuzumab vedodtin-related analyte- acMMAE was measured.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanograms per milliliter (ng/mL)

Predose and post dose on Day 2 of Cycle 1, and post dose on Days 8 and 15 of Cycles 1 and 3; predose and post dose on Day 1 of Cycles 2, 3 and 4; treatment completion/early discontinuation visit (each cycle = 21 days) up to approximately 19 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.

Units	Counts
Participants

Secondary

Plasma Concentration of Unconjugated Monomethyl Auristatin E (MMAE) at Specified Timepoints

PK of polatuzumab vedodtin-related analyte- unconjugated MMAE was measured.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.

Units	Counts
Participants

Secondary

Number of Participants With Positive Treatment Emergent Anti-Drug Antibodies (ADA) to Polatuzumab Vedotin

Treatment Emergent ADA is (a) negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result, OR (b) positive ADA result at baseline and one or more post-baseline titer results that are at least 0.60 titer unit (t.u.) greater than the baseline titer result.

Immunogenicity-evaluable population (Post-Baseline Evaluable) included all participants with at least one evaluable post-baseline anti-drug antibody (ADA) sample.

Posted

Count of Participants

Participants

Baseline up to approximately 39 weeks

ID	Title	Description
OG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version: 24.0	Systematic Assessment	EG00028 events16 affected27 at risk EG0017 events5 affected14 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA version: 24.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0011 events1 affected14 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA version: 24.0	Systematic Assessment	EG0005 events3 affected27 at risk EG0010 events0 affected14 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA version: 24.0	Systematic Assessment	EG0004 events4 affected27 at risk EG0013 events3 affected14 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version: 24.0	Systematic Assessment	EG0003 events3 affected27 at risk EG0012 events2 affected14 at risk
Bradycardia	Cardiac disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Palpitations	Cardiac disorders	MedDRA version: 24.0	Systematic Assessment	EG0002 events1 affected27 at risk EG0011 events1 affected14 at risk
Sinus tachycardia	Cardiac disorders	MedDRA version: 24.0	Systematic Assessment	EG0003 events3 affected27 at risk EG0011 events1 affected14 at risk
Deafness	Ear and labyrinth disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA version: 24.0	Systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected14 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version: 24.0	Systematic Assessment	EG0003 events2 affected27 at risk EG0010 events0 affected14 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA version: 24.0	Systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected14 at risk
Constipation	Gastrointestinal disorders	MedDRA version: 24.0	Systematic Assessment	EG0005 events3 affected27 at risk EG0013 events2 affected14 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version: 24.0	Systematic Assessment	EG00011 events7 affected27 at risk EG0010 events0 affected14 at risk
Dry mouth	Gastrointestinal disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Nausea	Gastrointestinal disorders	MedDRA version: 24.0	Systematic Assessment	EG00021 events11 affected27 at risk EG0017 events4 affected14 at risk
Vomiting	Gastrointestinal disorders	MedDRA version: 24.0	Systematic Assessment	EG00019 events10 affected27 at risk EG0015 events4 affected14 at risk
Asthenia	General disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Chest discomfort	General disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0012 events2 affected14 at risk
Fatigue	General disorders	MedDRA version: 24.0	Systematic Assessment	EG00013 events9 affected27 at risk EG0015 events5 affected14 at risk
Malaise	General disorders	MedDRA version: 24.0	Systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected14 at risk
Oedema peripheral	General disorders	MedDRA version: 24.0	Systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected14 at risk
Pyrexia	General disorders	MedDRA version: 24.0	Systematic Assessment	EG00015 events10 affected27 at risk EG0011 events1 affected14 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Herpes zoster	Infections and infestations	MedDRA version: 24.0	Systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected14 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version: 24.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0012 events2 affected14 at risk
Alanine aminotransferase increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG00013 events8 affected27 at risk EG0011 events1 affected14 at risk
Aspartate aminotransferase increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG00013 events7 affected27 at risk EG0013 events1 affected14 at risk
Bilirubin conjugated increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0012 events2 affected14 at risk
Blood bilirubin decreased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Blood bilirubin increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0002 events2 affected27 at risk EG0011 events1 affected14 at risk
Blood creatinine increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0007 events5 affected27 at risk EG0012 events1 affected14 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0005 events5 affected27 at risk EG0010 events0 affected14 at risk
Blood potassium decreased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0003 events2 affected27 at risk EG0010 events0 affected14 at risk
Blood pressure increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Blood uric acid increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0003 events2 affected27 at risk EG0010 events0 affected14 at risk
C-reactive protein increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0003 events3 affected27 at risk EG0010 events0 affected14 at risk
Electrocardiogram high voltage	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0011 events1 affected14 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0004 events3 affected27 at risk EG0011 events1 affected14 at risk
Haemoglobin decreased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected14 at risk
Lymphocyte count decreased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG00013 events8 affected27 at risk EG00116 events10 affected14 at risk
Lymphocyte percentage decreased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0002 events1 affected27 at risk EG0011 events1 affected14 at risk
Mononuclear cell count increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0002 events1 affected27 at risk EG0011 events1 affected14 at risk
Neutrophil count decreased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG00051 events19 affected27 at risk EG00118 events7 affected14 at risk
Neutrophil count increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected14 at risk
Neutrophil percentage increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0002 events1 affected27 at risk EG0011 events1 affected14 at risk
Platelet count decreased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG00024 events15 affected27 at risk EG0019 events7 affected14 at risk
Protein urine present	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected14 at risk
Urine output decreased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Weight decreased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0005 events5 affected27 at risk EG0011 events1 affected14 at risk
White blood cell count decreased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG00056 events20 affected27 at risk EG00120 events9 affected14 at risk
White blood cell count increased	Investigations	MedDRA version: 24.0	Systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected14 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA version: 24.0	Systematic Assessment	EG00010 events6 affected27 at risk EG0012 events2 affected14 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA version: 24.0	Systematic Assessment	EG0007 events5 affected27 at risk EG0011 events1 affected14 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA version: 24.0	Systematic Assessment	EG0007 events3 affected27 at risk EG0012 events2 affected14 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA version: 24.0	Systematic Assessment	EG0004 events3 affected27 at risk EG0012 events2 affected14 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA version: 24.0	Systematic Assessment	EG0003 events2 affected27 at risk EG0011 events1 affected14 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version: 24.0	Systematic Assessment	EG00023 events12 affected27 at risk EG0015 events4 affected14 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version: 24.0	Systematic Assessment	EG0006 events4 affected27 at risk EG0012 events2 affected14 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0012 events2 affected14 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Dizziness	Nervous system disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Dysgeusia	Nervous system disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA version: 24.0	Systematic Assessment	EG0005 events5 affected27 at risk EG0011 events1 affected14 at risk
Paraesthesia	Nervous system disorders	MedDRA version: 24.0	Systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected14 at risk
Insomnia	Psychiatric disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.0	Systematic Assessment	EG0003 events3 affected27 at risk EG0011 events1 affected14 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version: 24.0	Systematic Assessment	EG0004 events3 affected27 at risk EG0011 events1 affected14 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA version: 24.0	Systematic Assessment	EG0003 events2 affected27 at risk EG0012 events2 affected14 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk
Hypertension	Vascular disorders	MedDRA version: 24.0	Systematic Assessment	EG0003 events3 affected27 at risk EG0010 events0 affected14 at risk
Hypotension	Vascular disorders	MedDRA version: 24.0	Systematic Assessment	EG0003 events3 affected27 at risk EG0010 events0 affected14 at risk
Venous thrombosis	Vascular disorders	MedDRA version: 24.0	Systematic Assessment	EG0003 events3 affected27 at risk EG0010 events0 affected14 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA version: 24.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected14 at risk

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
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

ID	Term
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
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	Title	Description
BG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days.
BG001	Placebo Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin matching placebo by IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with placebo. Each cycle is 21 days.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Polatuzumab Vedotin Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days	18	28	12	27	27	27
EG001	Placebo Plus Bendamustine and Rituximab	Participants received polatuzumab vedotin matching placebo by IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with placebo. Each cycle is 21 days.	10	14	3	14	14	14

ID	Term
C000600736	polatuzumab vedotin
D000069461	Bendamustine Hydrochloride
D000069283	Rituximab