A Study of Polatuzumab Vedotin (DCDS4501A) in Combination... | NCT02257567

NCT02257567

ID	Type	Description	Link
2014-001361-28	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A (Phase II Randomization): Polatuzumab+BR in FL	Experimental	Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with FL.	Drug: Bendamustine Drug: Polatuzumab vedotin (Liquid) Drug: Rituximab
Arm B (Phase II Randomization): BR in FL	Active Comparator	Bendamustine and rituximab will be administered alone (that is, without polatuzumab vedotin) as a control arm in participants with FL.	Drug: Bendamustine Drug: Rituximab
Arm C (Phase II Randomization): Polatuzumab+BR in DLBCL	Experimental	Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with DLBCL.	Drug: Bendamustine Drug: Polatuzumab vedotin (Liquid) Drug: Rituximab
Arm D (Phase II Randomization): BR in DLBCL	Active Comparator	Bendamustine and rituximab will be administered alone (that is, without polatuzumab vedotin) as a control arm in participants with DLBCL.	Drug: Bendamustine Drug: Rituximab
Arm E (Phase II Expansion): Polatuzumab+BG in FL	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bendamustine	Drug	Bendamustine 90 milligrams per meter-squared (mg/m^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phase Ib: Percentage of Participants With Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0).	From the study start up to the end of the study (up to approximately 84 months)
Arm G+H (Phase II NF Cohort): Percentage of Participants With AEs	An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, v4.0. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.	From Month 37 to Month 84 (up to approximately 47 months)
Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin	The number of participants with positive results for ADA against pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 titer unit (t.u.) greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.

Secondary Outcomes

Measure	Description	Time Frame
Phase II: Percentage of Participants With AEs	An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, v4.0. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed relapsed or refractory FL (Grades 1, 2, or 3a) or relapsed or refractory DLBCL
If the participant has received prior bendamustine, response duration must have been greater than (>) 1 year (for participants who have relapse disease after a prior regimen)
At least one bi-dimensionally measurable lesion on imaging scan defined as >1.5 centimeters (cm) in its longest dimension
Confirmed availability of archival or freshly collected tumor tissue
The Phase II NF Cohorts (Arms G and H) will be required to submit tissue and pathology report for central pathology review.
Life expectancy of at least 24 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Adequate hematological function unless inadequate function is due to underlying disease

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, rituximab, or obinutuzumab
Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 4 weeks or 5 half-lives 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 per day prednisone or equivalent, for purposes other than lymphoma symptom control
Completion of autologous stem cell transplant (SCT) within 100 days prior to Cycle 1 Day 1
Prior allogeneic SCT
Eligibility for autologous SCT
Grade 3b FL
History of transformation of indolent disease to DLBCL
Primary or secondary CNS lymphoma
Current Grade >1 peripheral neuropathy
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
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 within 4 weeks prior to Cycle 1 Day 1
Suspected or latent tuberculosis
Positive test results for chronic hepatitis B virus (HBV) infection or for hepatitis C virus (HCV) antibody
Known history of human immunodeficiency virus (HIV) seropositive status or known infection with human T-cell leukemia virus 1 (HTLV-1) virus
Women who are pregnant or lactating or who intend to become pregnant within a year of the last dose of study treatment in the rituximab cohort or within 18 months of last dose in the obinutuzumab cohort
Evidence of laboratory abnormalities in standard renal, hepatic, or coagulation function tests
Treatment with chimeric antigen receptor T-cell therapy within 100 days prior to Cycle 1, Day 1

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294-3300	United States
Clearview Cancer Institute

PubMed Identifier	Type	Citation	Retractions
38843483	Derived	Jemaa S, Ounadjela S, Wang X, El-Galaly TC, Kostakoglu L, Knapp A, Ku G, Musick L, Sahin D, Wei MC, Yin S, Bengtsson T, De Crespigny A, Carano RAD. Automated Lugano Metabolic Response Assessment in 18F-Fluorodeoxyglucose-Avid Non-Hodgkin Lymphoma With Deep Learning on 18F-Fluorodeoxyglucose-Positron Emission Tomography. J Clin Oncol. 2024 Sep 1;42(25):2966-2977. doi: 10.1200/JCO.23.01978. Epub 2024 Jun 6.
37981564

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 milligrams per kilogram (mg/kg), as intravenous (IV) infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 milligrams per meter-squared (mg/m^2), as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

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	Mar 23, 2020

Arm/Group Information

ID	Title	Description
BG000	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
BG001	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
BG002	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
BG003	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
BG004	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
BG005	Arm B (Phase II Randomization): BR in FL	Participants with FL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.
BG006	Arm C (Phase II Randomization): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
BG007	Arm D (Phase II Randomization): BR in DLBCL	Participants with DLBCL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.
BG008	Arm E (Phase II Expansion): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
BG009	Arm F (Phase II Expansion): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
BG010	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
BG011	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Phase Ib: Percentage of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0).

Safety population consisted of all ITT participants from Phase Ib who received at least one dose of study medication.

Posted

Number

percentage of participants

From the study start up to the end of the study (up to approximately 84 months)

ID	Title	Description
OG000	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG002	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
OG003	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG000100 OG001100 OG002100 OG003

Primary

Arm G+H (Phase II NF Cohort): Percentage of Participants With AEs

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, v4.0. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

Safety population consisted of all ITT participants from Arms G+H (Phase II NF Cohort) who received at least one dose of study medication.

Posted

Number

percentage of participants

From Month 37 to Month 84 (up to approximately 47 months)

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Primary

Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin

The number of participants with positive results for ADA against pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 titer unit (t.u.) greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.

Safety population consisted of all ITT participants from Cohort 1a (Phase Ib) who received at least one dose of study medication.

Posted

Number

percentage of participants

Baseline up to approximately Month 24

ID	Title	Description
OG000	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Primary

Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab

The number of participants with positive results for ADA against pola and obinutuzumab at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.

Safety population consisted of all ITT participants from Cohort 1b (Phase Ib) who received at least one dose of study medication. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point.

Posted

Number

percentage of participants

Baseline up to approximately Month 24

ID	Title	Description
OG000	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Primary

Arms G+H: (Phase II NF Cohorts): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin (Lyophilized)

The number of participants with positive results for ADA against lyophilized pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.

Safety population consisted of all ITT participants from Arm G+H (Phase II NF cohort) who received at least one dose of study medication. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Posted

Number

percentage of participants

From Month 37 to Month 84 (up to approximately 47 months)

ID	Title	Description
OG000	Arm G (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Primary

Phase II Randomized and NF Cohorts: Percentage of Participants With Complete Response (CR) at Primary Response Assessment (PRA) Based on Positron Emission Tomography (PET)-Computed Tomography (CT) Scan as Determined by Independent Review Committee (IRC)

CR was assessed by IRC at PRA according to Modified Lugano Response Criteria (MLRC). Per MLRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites (ELS) 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 evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, immunohistochemistry (IHC) negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.

ITT population included all randomized participants in Phase II Randomized and NF cohorts irrespective of whether or not they received the study treatment.

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Primary

Arm H (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC

CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS 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 evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.

ITT population included all randomized participants in Arm H (Phase II NF Cohort) irrespective of whether or not they received the study treatment.

Posted

Number

95% Confidence Interval

percentage of participants

6-8 weeks after Cycle 6, Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

ID	Title	Description
OG000	Arm H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Primary

Arm G (Phase II NF Cohort): Area Under Concentration-Time Curve (AUC) of Polatuzumab Vedotin (Lyophilized)

Pharmacokinetic (PK) of three pola-related analytes: antibody conjugated monomethyl auristatin E (acMMAE), total antibody, and unconjugated MMAE were measured. The unit of measure for AUC is nanograms*day per milliliters.

PK population included all ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*day/mL

Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks

ID	Title	Description
OG000	Arm G (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Units	Counts

Primary

Arm G (Phase II NF Cohort): Maximum Concentration (Cmax) of Polatuzumab Vedotin (Lyophilized)

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

PK evaluable population included all the ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanograms per milliliters (ng/mL)

Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4,(cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

ID	Title	Description
OG000	Arm G (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Units	Counts
Participants

Primary

Arm G (Phase II NF Cohort): Systemic Clearance (CL) of Polatuzumab Vedotin (Lyophilized)

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured. Unit of measure for CL is milliliters per day per kilograms (mL/day/kg)

As pre-specified in the protocol the analysis of this outcome measure (OM) was based on sponsor's discretion however, sponsor opted to not collect data for this OM.

Posted

Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

ID	Title	Description
OG000	Arm G (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Units	Counts
Participants	OG000

Primary

Arm G (Phase II NF Cohort): Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin (Lyophilized)

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM.

Posted

Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, Day (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

ID	Title	Description
OG000	Arm G (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Units	Counts
Participants	OG000

Secondary

Phase II: Percentage of Participants With AEs

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, v4.0. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

Safety population consisted of all ITT participants from Phase II who received at least one dose of study medication.

Posted

Number

percentage of participants

From the study start up to the end of the study (up to approximately 84 months)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Arm B (Phase II Randomization): BR in FL

Secondary

Arms A and C (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin

The number of participants with positive results for ADA against pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.

Safety population consisted of all ITT participants from Arms A and C (Phase II) who received at least one dose of study medication. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Posted

Number

percentage of participants

Baseline to approximately Month 24

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Arms E and F (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab

Safety population consisted of all ITT participants from Arms E and F (Phase II) who received at least one dose of study medication. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Posted

Number

percentage of participants

Baseline to approximately Month 24

ID	Title	Description
OG000	Arm E (Phase II Expansion): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Phase II: Percentage of Participants With CR at PRA Based on PET-CT as Determined by the Investigator

CR was assessed by investigator at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS 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 evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment.

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Phase II Expansion Cohorts and Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC

CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS 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 evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.

ITT population included all randomized participants in Phase II Expansion Cohorts and Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment.

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

ID	Title	Description
OG000	Arm E (Phase II Expansion): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Phase II: Percentage of Participants With Objective Response (OR) at PRA Based on PET-CT as Determined by Investigator

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator according to MLRC. Per MLRC, CR based on PET-CT complete MR in lymph nodes and ELS 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, normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).

ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Phase II: Percentage of Participants With OR at PRA Based on PET-CT as Determined by IRC

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC according to MLRC. Per MLRC, CR based on PET-CT= complete MR in lymph nodes and ELS 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. Bone marrow normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Phase II: Percentage of Participants With CR at PRA Based on CT Only as Determined by Investigator

CR was determined by investigator at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 centimetres (cm) in in longest transverse diameter (LDi) and no ELS of disease 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 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts). As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment.

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001

Secondary

Phase II: Percentage of Participants With CR at PRA Based on CT Only as Determined by IRC

CR was determined by IRC a at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease 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 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts). As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment.

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Arm B (Phase II Randomization): BR in FL

Secondary

Phase II: Percentage of Participants With OR at PRA Based on CT Only as Determined by Investigator

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in sum of the products of greatest diameters (SPD) of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts).

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Phase II: Percentage of Participants With OR at PRA Based on CT Only as Determined by IRC

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts).

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Phase II: Percentage of Participants With Best Objective Response (BOR) Based on PET-CT or CT Only as Determined by the Investigator

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

Posted

Number

95% Confidence Interval

percentage of participants

Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

DLBCL Cohorts: Percentage of Participants With BOR Based PET-CT or CT Only as Determined by IRC

ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

Posted

Number

95% Confidence Interval

percentage of participants

Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months)

ID	Title	Description
OG000	Arm C (Phase II Randomization): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

DLBCL Cohorts: Duration of Response (DOR) Based on PET-CT or CT Only as Determined by the Investigator

DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per investigator per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT> background; 2=UT≤mediastinum;3=UT>mediastinum but ≤liver;4=UT moderately>liver;5=UT>than liver &/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL & residual mass of any size at interim for LN & ELS;residual UT>UT in normal bone marrow but\

ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis.

Posted

Median

95% Confidence Interval

months

From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (up to approximately 84 months)

ID	Title	Description
OG000	Arm C (Phase II Randomization): Pola+BR in DLBCL

Secondary

DLBCL Cohorts: DOR Based on PET-CT or CT Only as Determined by the IRC

DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per IRC per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT> background; 2=UT≤mediastinum;3=UT>mediastinum but ≤liver;4=UT moderately>liver;5=UT>than liver &/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL & residual mass of any size at interim for LN & ELS;residual UT>UT in normal bone marrow but\

ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis.

Posted

Median

95% Confidence Interval

months

From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (up to approximately 84 months)

ID	Title	Description
OG000	Arm C (Phase II Randomization): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

DLBCL Cohorts: Progression Free Survival (PFS) Based on PET-CT or CT Only as Determined by the Investigator

PFS was defined as the time randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the investigators assessment. As pre-specified in the protocol data reported is combined for Arms G and H.

ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment.

Posted

Median

95% Confidence Interval

months

From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (up to approximately 84 months)

ID	Title	Description
OG000	Arm C (Phase II Randomization): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Arm D (Phase II Randomization): BR in DLBCL	Participants with DLBCL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.

Secondary

DLBCL Cohorts: PFS Based on PET-CT or CT Only as Determined by the IRC

PFS was defined as the time randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the IRC assessment. As pre-specified in the protocol data reported is combined for Arms G and H.

ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment.

Posted

Median

95% Confidence Interval

months

From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (up to approximately 84 months)

ID	Title	Description
OG000	Arm C (Phase II Randomization): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Arm D (Phase II Randomization): BR in DLBCL	Participants with DLBCL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.

Secondary

Phase II NF Cohort: Percentage of Participants With CR at PRA Based on PET-CT as Determined by the Investigator

CR was assessed by Investigator at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS 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 evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.

ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Phase II NF Cohort: Percentage of Participants With OR at PRA Based on PET-CT as Determined by Investigator

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator according to MLRC. Per MLRC, CR based on PET-CT= complete MR in lymph nodes and ELS 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, normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).

ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Phase II NF Cohort: Percentage of Participants With OR at PRA Based on PET-CT as Determined by IRC

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC according to MLRC. Per MLRC, CR based on PET-CT= complete MR in lymph nodes and ELS 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, bone marrow normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Phase II NF Cohorts: Percentage of Participants With BOR Based on PET-CT or CT Only as Determined by the Investigator

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

Posted

Number

95% Confidence Interval

percentage of participants

Up to every 6 months until disease progression, withdrawal or study completion (from Month 37 to Month 84 [up to approximately 47 months])

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Phase II NF Cohorts: Percentage of Participants With BOR Based on PET-CT or CT Only as Determined by the IRC

Posted

Number

95% Confidence Interval

percentage of participants

Up to every 6 months until disease progression, withdrawal or study completion (from Month 37 to Month 84 [up to approximately 47 months])

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Phase II NF Cohort: DOR Based on PET-CT or CT Only as Determined by the Investigator

ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis.

Posted

Median

95% Confidence Interval

months

From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (from Month 37 to Month 84 [up to approximately 47 months])

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL

Secondary

Phase II NF Cohort: DOR Based on PET-CT or CT Only as Determined by the IRC

ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis.

Posted

Median

95% Confidence Interval

months

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL

Secondary

Phase II NF Cohort: PFS Based on PET-CT or CT Only as Determined by the Investigator

PFS was defined as the time from randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the investigators assessment. As pre-specified in the protocol data reported is combined for Arms G and H.

ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.

Posted

Median

95% Confidence Interval

months

From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (from Month 37 to Month 84 [up to approximately 47 months])

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Units	Counts
Participants

Secondary

Phase II NF Cohort: PFS Based on PET-CT or CT Only as Determined by the IRC

PFS was defined as the time from randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the IRC assessment. As pre-specified in the protocol data reported is combined for Arms G and H.

ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.

Posted

Median

95% Confidence Interval

months

From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (from Month 37 to Month 84 [up to approximately 47 months])

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Units	Counts
Participants

Secondary

Phase II NF Cohort: Event-Free Survival (EFS) Based on PET-CT or CT Only, as Determined by the Investigator

EFS was defined as time from randomization to disease progression or relapse, as assessed by the investigator or death from any cause. As pre-specified in the protocol data reported is combined for Arms G and H.

ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.

Posted

Median

95% Confidence Interval

months

From Month 37 to Month 84 (up to approximately 47 months)

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Units	Counts
Participants	OG000

Secondary

Phase II NF Cohorts: Overall Survival (OS)

OS was defined as the time from the date of randomization or first treatment (for obinutuzumab arms) to the date of death from any cause. As pre-specified in the protocol data reported is combined for Arms G and H.

ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.

Posted

Median

95% Confidence Interval

months

From Month 37 to Month 84 (up to approximately 47 months)

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Units	Counts
Participants	OG000

Secondary

Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC

CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS 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 evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.

ITT population included all randomized participants in Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment.

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

ID	Title	Description
OG000	Arm G (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on CT Only as Determined by Investigator

CR was determined by Investigator at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease 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 (each cycle is 21 days for DLBCL cohorts). Values have been rounded off to the nearest whole number.

ITT population included all randomized participants in Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment.

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

ID	Title	Description
OG000	Arm G (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on CT Only as Determined by IRC

CR was determined by IRC at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease 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 (each cycle is 21 days for DLBCL cohorts). Values have been rounded off to the nearest whole number.

ITT population included all randomized participants in Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment.

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

ID	Title	Description
OG000	Arm G (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Units

Secondary

Arm G (Phase II NF Cohort): Percentage of Participants With OR at PRA Based on CT Only as Determined by Investigator

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts).

ITT population included all randomized participants in Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment. Values have been rounded off to the nearest whole number.

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to 23 weeks)

ID	Title	Description
OG000	Arm G (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Arm G (Phase II NF Cohort): Percentage of Participants With OR at PRA Based on CT Only as Determined by IRC

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts).

Posted

Number

95% Confidence Interval

percentage of participants

6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to 23 weeks)

ID	Title	Description
OG000	Arm G (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE

PK of pola-related analyte acMMAE was measured. Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.

PK evaluable population included all the ITT participants in Phase Ib and Phase II who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 1 Day 2: pre-dose and 30 minutes (min) post dose; Cycle 1 Days 8 and 15; Cycle 2 and 4 Day 1: pre-dose and 30 min post dose; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)

ID	Title	Description
OG000	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Arm G+H (Phase II NF Cohorts): Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE

PK of one pola-related analytes: acMMAE was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.

PK evaluable population included all the ITT participants in Arm G+H (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Posted

Mean

Standard Deviation

ng/mL

Cycle 1 Day 2: post dose; Cycle 2 and 4 Day 1: pre-dose and post dose

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Units	Counts
Participants

Secondary

Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab

PK of pola-related analyte Total Ab was measured. Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.

PK evaluable population included all the ITT participants Phase Ib and Phase II who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Posted

Geometric Mean

Geometric Coefficient of Variation

grams per milliliters (g/mL)

Cycle 1 Days 2: pre-dose & 30 min post dose; Cycle 1 Days 8 & 15; Cycle 2 and 4 Day 1 and unscheduled visits: pre-dose & 30 min post dose; Follow up at Day 1: Months 3, 6, 12, 18 & 24; study treatment completion visit (up to approx. 84 months)

ID	Title	Description
OG000	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Total Ab

PK of pola-related analyte: Total Ab was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.

Posted

Mean

Standard Deviation

ng/mL

Cycle 1 Day 2: post dose; Cycle 2 and 4 Day 1: pre-dose and post dose

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Units	Counts
Participants

Secondary

Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE

PK of pola-related analytes unconjugated MMAE was measured. Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 1 Day 2: pre-dose and 30 min post dose, Cycle 1 Days 8 and 15; Cycles 2 and 4: pre-dose and 30 min post dose; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)

ID	Title	Description
OG000	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE

PK of one pola-related analytes: Unconjugated MMAE was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.

PK evaluable population included all the ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Posted

Mean

Standard Deviation

ng/mL

Cycle 1 Day 2: post dose; Cycle 1 and 3 Day 8 and 15; Cycle 2, 3 and 4 Day 1: pre-dose and post dose

ID	Title	Description
OG000	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Units	Counts
Participants

Secondary

Plasma Concentration of Bendamustine

Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts. As pre specified in the protocol plasma concentration of bendamustine was not assessed in the Phase II NF Cohort (Arm G+H).

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 1 Day 2: pre-dose, 5 min, 1 hour (h); 2h, 3h and 4h post dose

ID	Title	Description
OG000	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Serum Concentration of Rituximab

Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts. As pre specified in the protocol serum concentration of rituximab was not assessed in the Phase II NF Cohort (Arm G+H).

PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) and Arms A-D (Phase II) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 1 Days 1: pre-dose and 30 min post dose; Cycle 2 and 4 Day 1: pre-dose; unscheduled visits: pre-dose and 30 min post dose (up to approximately 84 months)

ID	Title	Description
OG000	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Serum Concentration of Obinutuzumab

Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.

PK evaluable population included all the ITT participants who Cohort 1b (Phase 1b) and Arms E and F (Phase II) received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Posted

Geometric Mean

Geometric Coefficient of Variation

g/mL

Cycles 1 and 4 Days 1: pre-dose and 30 min post dose; Cycle 2 Day1: pre-dose; Follow up visits on Day 1: Months 3, 6, 12, 18 and 24; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)

ID	Title	Description
OG000	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
OG001	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Cmax was not evaluated for Bendamustine and Rituximab.

Posted

Mean

Standard Deviation

ng/mL

Cycles 1, 2 and 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

PK evaluable population included all the ITT participants Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Cmax was not evaluated for Bendamustine and Obinutuzumab.

Posted

Mean

Standard Deviation

ng/mL

Cycles 1, 2 and 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
OG001	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Phase II: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C

PK of three pola-related analytes: acMMAE, total antibody and unconjugated MMAE were measured.

PK evaluable population included all the ITT participants in Arms A and C who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints.

Posted

Mean

Standard Deviation

ng/mL

Cycle 1; Cycle 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Arm C (Phase II Randomization): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Phase II: Cmax of Bendamustine and Rituximab in Arms B and D

PK evaluable population included all the ITT participants in Arms B and D who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints.

Posted

Mean

Standard Deviation

ug/mL

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Arm B (Phase II Randomization): BR in FL	Participants with FL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.
OG001	Arm D (Phase II Randomization): BR in DLBCL	Participants with DLBCL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.

Units	Counts

Secondary

Phase II: Cmax of Polatuzumab Vedotin, Obinutuzumab and Bendamustine in Arms E and F

PK of three pola-related analytes: acMMAE, unconjugated MMAE and total antibody were measured.

PK evaluable population included all the ITT participants in Arms E and F who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints.

Posted

Mean

Standard Deviation

ug/mL

Cycle 1; Cycle 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Arm E (Phase II Expansion): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
OG001	Arm F (Phase II Expansion): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Arm H (Phase II NF Cohort): Cmax of Polatuzumab Vedotin (Lyophilized)

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM.

Posted

Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4,(cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

ID	Title	Description
OG000	Arm H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Units	Counts
Participants	OG000

Secondary

Phase Ib: AUC From Time Zero to Infinity (AUCinf) of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured. The unit of measure for AUC is day*micrograms per milliliter [day*ug/mL]).

PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for bendamustine and rituximab.

Posted

Geometric Mean

Geometric Coefficient of Variation

day*ug/mL

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Phase Ib: AUCinf of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for bendamustine and obinutuzumab.

Posted

Geometric Mean

Geometric Coefficient of Variation

day*ug/mL

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
OG001	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Phase II: AUCinf of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Arm C (Phase II Randomization): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Phase II: AUCinf of Bendamustine and Rituximab in Arms B and D

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Arm B (Phase II Randomization): BR in FL	Participants with FL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.
OG001	Arm D (Phase II Randomization): BR in DLBCL	Participants with DLBCL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.

Secondary

Phase II: AUCinf of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Arms E and F

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Arm E (Phase II Expansion): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
OG001	Arm F (Phase II Expansion): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Arm H (Phase II NF Cohort): AUC of Polatuzumab Vedotin (Lyophilized)

PK of three pola-related analytes: antibody acMMAE, total antibody, and unconjugated MMAE were measured.

As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM.

Posted

Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks

ID	Title	Description
OG000	Arm H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Units	Counts
Participants	OG000

Secondary

Phase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for bendamustine and rituximab.

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/day/kg

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Phase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for bendamustine and obinutuzumab.

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/day/kg

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
OG001	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Phase II: CL of Polatuzumab Vedotin, Bendamustine and Rituximab in Arms A and C

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

PK evaluable population included all the ITT participants in Arms A and B who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for pola and rituximab.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters per hour (L/h)

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Arm C (Phase II Randomization): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Phase II: CL of Bendamustine and Rituximab in Arms B and D

Posted

Geometric Mean

Geometric Coefficient of Variation

L/h

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Arm B (Phase II Randomization): BR in FL	Participants with FL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.
OG001	Arm D (Phase II Randomization): BR in DLBCL	Participants with DLBCL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.

Secondary

Phase II: CL of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and F

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Posted

Geometric Mean

Geometric Coefficient of Variation

L/h

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Arm E (Phase II Expansion): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
OG001	Arm F (Phase II Expansion): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Arm H (Phase II NF Cohort): CL of Polatuzumab Vedotin (Lyophilized)

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM.

Posted

Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

ID	Title	Description
OG000	Arm H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Units	Counts
Participants	OG000

Secondary

Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1a

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for bendamustine and rituximab.

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/kg

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for bendamustine and obinutuzumab.

Posted

Mean

Standard Deviation

mL/kg

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
OG001	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Phase II: Vss of Polatuzumab Vedotin, Bendamustine and Rituximab in Arms A and C

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Posted

Geometric Mean

Geometric Coefficient of Variation

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
OG001	Arm C (Phase II Randomization): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Secondary

Phase II: Vss of Bendamustine and Rituximab in Arms B and D

Posted

Geometric Mean

Geometric Coefficient of Variation

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Arm B (Phase II Randomization): BR in FL	Participants with FL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.
OG001	Arm D (Phase II Randomization): BR in DLBCL	Participants with DLBCL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.

Secondary

Phase II: Vss of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and F

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Posted

Geometric Mean

Geometric Coefficient of Variation

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

ID	Title	Description
OG000	Arm E (Phase II Expansion): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
OG001	Arm F (Phase II Expansion): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Secondary

Arm H (Phase II NF Cohort): Vss of Polatuzumab Vedotin (Lyophilized)

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM.

Posted

Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, Day (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

ID	Title	Description
OG000	Arm H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Units	Counts
Participants	OG000

Secondary

Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F

The TINAS is an 11-item questionnaire that assesses the severity of neuropathy-related symptoms in the last 24 hours. The 11 items assessed were: hot/burning sensations in hands/feet, sensations pins and needles arms/legs, numbness or tingling in hands/feet, sensations of electric shock, pain when touching cold things, cramps in hands/feet, discomfort when touching things, discomfort skin contact with something, trouble grasping small objects, trouble walking loss feeling legs/feet, difficulty balance loss feeling leg/feet. Each item was scored on a 0-10 scale, with 0 being the symptom is not present, and 10 being the symptom is as bad as the participant can imagine. Higher scores indicate more severe disease. Scores were averaged at each week.

ITT population included all randomized participants in Arms A-F (Phase II) irrespective of whether or not they received the study treatment. 'Overall Number Analysed' =number of participants with data available for analysis. 'Number of Participants Analyzed'=number of participants evaluable for this outcome measure. Participants from Arm F did not answer a sufficient number of questions at both baseline and end of treatment visit therefore the average score could not be calculated.

Posted

Mean

Standard Deviation

Points on scale

Every week during treatment (up to 24 weeks) and for the first 2 months after treatment, thereafter every month for 10 months or until withdrawal (up to 18 months overall)

ID	Title	Description
OG000	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

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	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	2	6	2	6	6	6
EG001	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	2	6	4	6	6	6
EG002	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	2	6	4	6	6	6
EG003	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	4	6	5	6	6	6
EG004	Arm A (Phase II Randomization): Pola+BR in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	16	39	25	38	38	38
EG005	Arm B (Phase II Randomization): BR in FL	Participants with FL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.	11	41	12	41	39	41
EG006	Arm C (Phase II Randomization): Pola+BR in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	26	40	24	39	36	39
EG007	Arm D (Phase II Randomization): BR in DLBCL	Participants with DLBCL received bendamustine 90 mg/m^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6.	30	40	27	39	37	39
EG008	Arm E (Phase II Expansion): Pola+BG in FL	Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	3	20	8	20	20	20
EG009	Arm F (Phase II Expansion): Pola+BG in DLBCL	Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	18	21	13	20	19	20
EG010	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 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 to 6 and rituximab, 375 mg/m^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	65	106	57	106	103	106

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG0030 events0 affected6 at risk EG0040 events0 affected38 at risk EG0050 events0 affected41 at risk EG0061 events1 affected39 at risk EG0072 events2 affected39 at risk EG0080 events0 affected20 at risk EG0090 events0 affected20 at risk EG0101 events1 affected106 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LYMPHOPENIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ATRIAL FLUTTER	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CARDIAC ARREST	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CARDIAC FAILURE	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CARDIOMYOPATHY	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
TACHYCARDIA	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ASCITES	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
COLITIS	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ENTERITIS	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
OBSTRUCTION GASTRIC	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PANCREATITIS	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ASTHENIA	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DEATH	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PYREXIA	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
SUDDEN DEATH	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HEPATIC CIRRHOSIS	Hepatobiliary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
HYPERTRANSAMINASAEMIA	Hepatobiliary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ISCHAEMIC HEPATITIS	Hepatobiliary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ABDOMINAL ABSCESS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ABDOMINAL INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BACTERAEMIA	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BACTERIAL INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CEREBRAL TOXOPLASMOSIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CLOSTRIDIAL SEPSIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CYTOMEGALOVIRUS CHORIORETINITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CYTOMEGALOVIRUS COLITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CYTOMEGALOVIRUS ENTERITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DEVICE RELATED INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DIVERTICULITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ENTEROCOLITIS VIRAL	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ESCHERICHIA BACTERAEMIA	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
GASTROINTESTINAL BACTERIAL INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
GIARDIASIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HEPATITIS E	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HERPES VIRUS INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HERPES ZOSTER	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HUMAN ANAPLASMOSIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
INFECTED LYMPHOCELE	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LARGE INTESTINE INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MENINGOENCEPHALITIS HERPETIC	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
OESOPHAGEAL CANDIDIASIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ORAL INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PARONYCHIA	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PLEURAL INFECTION BACTERIAL	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PNEUMOCYSTIS JIROVECII PNEUMONIA	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PNEUMONIA CYTOMEGALOVIRAL	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PNEUMONIA FUNGAL	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PNEUMONIA PNEUMOCOCCAL	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PNEUMONIA VIRAL	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
POST PROCEDURAL INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RESPIRATORY SYNCYTIAL VIRUS INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RHINOVIRUS INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SEPSIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0022 events2 affected6 at risk EG003
SEPTIC SHOCK	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
UROSEPSIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
POST PROCEDURAL FEVER	Injury, poisoning and procedural complications	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MORAXELLA TEST POSITIVE	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
TRANSAMINASES INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
TUMOUR LYSIS SYNDROME	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ADENOCARCINOMA GASTRIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ADENOCARCINOMA OF COLON	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ENDOMETRIAL ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ENDOMETRIAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
INTESTINAL ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MYELODYSPLASTIC SYNDROME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CAROTID ARTERY OCCLUSION	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CEREBRAL INFARCTION	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HYDROCEPHALUS	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LEUKOENCEPHALOPATHY	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SEIZURE	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
VOCAL CORD PARALYSIS	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BRONCHOPNEUMOPATHY	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPERVENTILATION	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
DRUG ERUPTION	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DISTRIBUTIVE SHOCK	Vascular disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPOTENSION	Vascular disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
THROMBOPHLEBITIS	Vascular disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ATRIAL THROMBOSIS	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ENTEROCOLITIS HAEMORRHAGIC	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
COVID-19 PNEUMONIA	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
VASCULAR ACCESS SITE CELLULITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
EPIGLOTTIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PANCREATIC CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RENAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BRAIN OEDEMA	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG0030 events0 affected6 at risk EG00424 events6 affected38 at risk EG0055 events5 affected41 at risk EG00613 events10 affected39 at risk EG00728 events19 affected39 at risk EG0087 events3 affected20 at risk EG0096 events5 affected20 at risk EG01035 events27 affected106 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LYMPHOPENIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0004 events2 affected6 at risk EG0010 events0 affected6 at risk EG0028 events2 affected6 at risk EG003
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0012 events2 affected6 at risk EG0021 events1 affected6 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
TACHYCARDIA	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
HYPOACUSIS	Ear and labyrinth disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
APHTHOUS ULCER	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0003 events3 affected6 at risk EG0011 events1 affected6 at risk EG0027 events4 affected6 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0008 events2 affected6 at risk EG0015 events2 affected6 at risk EG0027 events4 affected6 at risk EG003
DRY MOUTH	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0022 events2 affected6 at risk EG003
DYSPEPSIA	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
FLATULENCE	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0004 events3 affected6 at risk EG0014 events3 affected6 at risk EG0027 events5 affected6 at risk EG003
ODYNOPHAGIA	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
STOMATITIS	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0003 events2 affected6 at risk EG0012 events1 affected6 at risk EG0026 events5 affected6 at risk EG003
ASTHENIA	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
CHILLS	General disorders	MedDRA version 24.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0014 events1 affected6 at risk EG0025 events3 affected6 at risk EG003
DISCOMFORT	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
FATIGUE	General disorders	MedDRA version 24.1	Systematic Assessment	EG0004 events4 affected6 at risk EG0015 events4 affected6 at risk EG0023 events3 affected6 at risk EG003
MUCOSAL INFLAMMATION	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
OEDEMA	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
PAIN	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0022 events2 affected6 at risk EG003
PYREXIA	General disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0014 events2 affected6 at risk EG0024 events2 affected6 at risk EG003
HYPOGAMMAGLOBULINAEMIA	Immune system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0022 events2 affected6 at risk EG003
HERPES VIRUS INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HERPES ZOSTER	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ORAL HERPES	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SINUSITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected6 at risk EG0021 events1 affected6 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0022 events1 affected6 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HAEMOGLOBIN DECREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LIPASE INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LYMPHOCYTE COUNT DECREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PLATELET COUNT DECREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0012 events2 affected6 at risk EG0020 events0 affected6 at risk EG003
WEIGHT INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0003 events3 affected6 at risk EG0012 events2 affected6 at risk EG0022 events2 affected6 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0003 events2 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0013 events3 affected6 at risk EG0024 events2 affected6 at risk EG003
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0005 events1 affected6 at risk EG0012 events2 affected6 at risk EG0021 events1 affected6 at risk EG003
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0022 events2 affected6 at risk EG003
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected6 at risk EG0022 events2 affected6 at risk EG003
DYSGEUSIA	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected6 at risk EG0020 events0 affected6 at risk EG003
HEADACHE	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events1 affected6 at risk EG0022 events1 affected6 at risk EG003
HYPOAESTHESIA	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
PARAESTHESIA	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PERIPHERAL MOTOR NEUROPATHY	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0022 events1 affected6 at risk EG003
POST HERPETIC NEURALGIA	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA version 24.1	Systematic Assessment	EG0003 events3 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
DYSURIA	Renal and urinary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
POLLAKIURIA	Renal and urinary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
URINARY INCONTINENCE	Renal and urinary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected6 at risk EG0026 events3 affected6 at risk EG003
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0003 events2 affected6 at risk EG0010 events0 affected6 at risk EG0022 events2 affected6 at risk EG003
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected6 at risk EG0023 events2 affected6 at risk EG003
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
THROAT IRRITATION	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
UPPER-AIRWAY COUGH SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0003 events3 affected6 at risk EG0010 events0 affected6 at risk EG0023 events3 affected6 at risk EG003
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0022 events2 affected6 at risk EG003
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0003 events2 affected6 at risk EG0012 events2 affected6 at risk EG0020 events0 affected6 at risk EG003
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0022 events2 affected6 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
FLUSHING	Vascular disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected6 at risk EG0023 events1 affected6 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
HYPOTENSION	Vascular disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0022 events1 affected6 at risk EG003
COAGULOPATHY	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HAEMOLYSIS	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BUNDLE BRANCH BLOCK RIGHT	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SINUS TACHYCARDIA	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
EAR PAIN	Ear and labyrinth disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
EYE DISCHARGE	Eye disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
EYE PRURITUS	Eye disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
GLAUCOMA	Eye disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
OCULAR HYPERAEMIA	Eye disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
VISION BLURRED	Eye disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ABDOMINAL DISCOMFORT	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ANAL SPASM	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
COLITIS	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DEFAECATION URGENCY	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DIVERTICULUM	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DYSPHAGIA	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
GINGIVAL BLEEDING	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
GINGIVAL DISORDER	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
GINGIVAL PAIN	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HAEMATEMESIS	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HAEMATOCHEZIA	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LIP DRY	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
NONINFECTIVE GINGIVITIS	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
RECTAL DISCHARGE	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
CATHETER SITE PAIN	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
CATHETER SITE PRURITUS	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
CHEST DISCOMFORT	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CHEST PAIN	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
EARLY SATIETY	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
GAIT DISTURBANCE	General disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
PERIPHERAL SWELLING	General disorders	MedDRA version 24.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPERSENSITIVITY	Immune system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CANDIDA INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CELLULITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
CYSTITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CYTOMEGALOVIRUS VIRAEMIA	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
EAR INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
FOLLICULITIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ORAL CANDIDIASIS	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RASH PUSTULAR	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
SKIN INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ARTHROPOD BITE	Injury, poisoning and procedural complications	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
COMMINUTED FRACTURE	Injury, poisoning and procedural complications	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
WOUND	Injury, poisoning and procedural complications	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
AMYLASE INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BLOOD CALCIUM DECREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BLOOD MAGNESIUM DECREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BLOOD PHOSPHORUS DECREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HEPATIC ENZYME INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
NEUTROPHIL COUNT INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
TRANSAMINASES INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
TROPONIN I INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
TROPONIN INCREASED	Investigations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
HYPERPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
LACTIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
MALNUTRITION	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
VITAMIN D DEFICIENCY	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CERVICAL SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
GROIN PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
INTERVERTEBRAL DISC DEGENERATION	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MUSCLE TIGHTNESS	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MUSCULOSKELETAL STIFFNESS	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HODGKIN'S DISEASE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MYELODYSPLASTIC SYNDROME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
TUMOUR PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
AMNESIA	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DYSKINESIA	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
LETHARGY	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
NEURALGIA	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PERONEAL NERVE PALSY	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
POLYNEUROPATHY	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RESTLESS LEGS SYNDROME	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SCIATICA	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SINUS HEADACHE	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SOMNOLENCE	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
TASTE DISORDER	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
TREMOR	Nervous system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CONFUSIONAL STATE	Psychiatric disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
DELIRIUM	Psychiatric disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
IRRITABILITY	Psychiatric disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SUICIDAL IDEATION	Psychiatric disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ANURIA	Renal and urinary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
URINARY RETENTION	Renal and urinary disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ERECTILE DYSFUNCTION	Reproductive system and breast disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
TESTICULAR PAIN	Reproductive system and breast disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
TESTICULAR SWELLING	Reproductive system and breast disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
VAGINAL DISCHARGE	Reproductive system and breast disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
VAGINAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HICCUPS	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
NASAL DISCHARGE DISCOLOURATION	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
ORGANISING PNEUMONIA	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RHINITIS ALLERGIC	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SINUS CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SINUS PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
TACHYPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
RASH MACULAR	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SKIN DISCOLOURATION	Skin and subcutaneous tissue disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
EMBOLISM	Vascular disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PALLOR	Vascular disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PHLEBITIS SUPERFICIAL	Vascular disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
IMMUNE THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
VASCULAR ACCESS SITE INFECTION	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
ENDOMETRIAL ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 24.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003

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

ID	Term
D000069461	Bendamustine Hydrochloride
C543332	obinutuzumab
C000600736	polatuzumab vedotin
D005440	Fluid Therapy
D000069283	Rituximab

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
D004358	Drug Therapy
D013812	Therapeutics
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