A Study Evaluating Efficacy and Safety of Mosunetuzumab i... | NCT05171647

Label	Type	Description	Intervention Names
M+P (Arm A)	Experimental	Participants will receive subcutaneous (SC) mosunetuzumab plus intravenous (IV) polatuzumab vedotin (M+P). Mosunetuzumab will be administered on Days 1, 8, and 15 of Cycle 1, and thereafter on Day 1 of Cycles 2-8. Polatuzumab vedotin will be administered on Day 1 of each cycle up to Cycle 6. Cycle length = 21 days.	Drug: Mosunetuzumab Drug: Polatuzumab vedotin Drug: Tocilizumab
R-GemOx (Arm B)	Active Comparator	Participants will receive IV rituximab, IV gemcitabine, and IV oxaliplatin (R-GemOx) on Day 1 of each cycle for 8 cycles. Cycle length = 14 days.	Drug: Rituximab Drug: Gemcitabine Drug: Oxaliplatin

Name	Type	Description	Arm Group Labels	Other Names
Mosunetuzumab	Drug	Participants will receive SC mosunetuzumab on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-8 (cycle length = 21 days).	M+P (Arm A)

Measure	Description	Time Frame
Objective Response Rate (ORR) as Determined by the Independent Review Facility (IRF), According to Lugano Response Criteria 2014 (LRC) Using Positron Emission Tomography-computed Tomography (PET-CT) or CT Scans in Interim Analysis Population (IAP)	ORR was defined as the percentage of participants with complete response (CR)/partial response (PR), per IRF, per Lugano Response Criteria. Percentages have been rounded off.	Up to approximately 23.8 months
Progression-free Survival (PFS) as Determined by the IRF, According to LRC Using PET-CT or CT Scans	PFS was defined as the time from randomization to first occurrence of disease progression (PD) or death from any cause, whichever occurred first, per IRF, per Lugano Response Criteria.	Up to 32 months

Measure	Description	Time Frame
ORR as Determined by the IRF, According to LRC Using PET-CT or CT Scans in ITT Population	ORR was defined as the percentage of participants with complete response (CR)/partial response (PR), per IRF, per Lugano Response Criteria. Percentages have been rounded off.	Up to 32 months
ORR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans in ITT Population

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
CD20+ aggressive lymphoma as determined by the local hemopathology laboratory from the following diagnoses by 2016 World Health Organization classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS); high-grade B-cell lymphoma (NOS or double/triple hit); transformed follicular lymphoma; follicular lymphoma Grade 3b
Have disease relapsed or refractory to at least one prior systemic therapy for aggressive non-Hodgkin's lymphoma (aNHL)
Participants who have received only one prior line of therapy must be ineligible for autologous stem cell transplant (ASCT)
Measurable disease
Adequate hepatic, hematologic, and renal function
Estimated creatinine clearance (CrCl) ≥ 30 mL/min by Cockroft-Gault method or other institutional standard methods
Negative HIV test at screening. Participants with a positive HIV test at screening are eligible provided that, prior to enrollment, they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count of at least 200 microliters, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months

Exclusion Criteria:

Pregnant or breast feeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab, 9 months after the final dose of polatuzumab vedotin, 12 months after the final dose of rituximab, 6 months after the final dose of gemcitabine, 9 months after the final dose of oxaliplatin, and 3 months after the final dose of tocilizumab, as applicable
Inability to comply with protocol-mandated activity restrictions
Prior treatment with mosunetuzumab or other CD-20-directed bispecific antibodies, or R-GemOx or Gem-Ox
Prior treatment with polatuzumab vedotin, with the following exceptions: participants who have a documented response (partial response or complete response) to polatuzumab vedotin and an absence of PD within 12 months from the last dose of polatuzumab vedotin; participants who received up to 2 doses of a polatuzumab vedotin-containing regimen as bridging to CAR-T therapy, and either has a documented disease control (stable disease, partial response, or complete response), or were not assessed for response following treatment with polatuzumab vedotin
Contraindication to any component of the study treatment
Grade > 1 peripheral neuropathy
Participants with Grade > 1 persistent toxicity related to prior anti-lymphoma treatment (except for alopecia and anorexia, or other toxicities not considered a safety risk for the participant per investigator's judgment)
Received anti-lymphoma treatments with monoclonal antibodies, radio-immunoconjugates or antibody-drug conjugates (ADCs) within 4 weeks before the first dose of study treatment
Treatment with any chemotherapeutic agent, or treatment with any other anti-lymphoma agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of study treatment
Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
ASCT within 100 days prior to the first study treatment administration
Prior treatment with chimeric antigen receptor (CAR) T cell therapy within 30 days before the first study treatment administration
Prior allogenic stem cell transplant (SCT)
Have had a solid organ transplantation
Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
History of confirmed progressive multifocal leukoencephalopathy
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombination antibody-related fusion proteins)
History of other malignancy that could affect compliance with the protocol or interpretation of results, with the exception of malignancies with a negligible risk of metastasis or death
Currently have or have had a past history of central nervous system (CNS) involvement of lymphoma
Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator, or with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications, are allowed
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
Significant active pulmonary disease
Participants with active symptoms of interstitial lung disease and/or pneumonitis, or those with a history of interstitial lung disease and/or pneumonitis within 6 months prior to the first dose of study treatment
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of the nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to the first study treatment administration
Known or suspected chronic active Epstein-Barr virus (EBV) infection
Recent major surgery within 4 weeks prior to the first study treatment administration
Positive test results for chronic hepatitis B infection
Acute or chronic hepatitis C virus (HCV) infection
Have been administered a live, attenuated vaccine within 4 weeks before the first dose of study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
Participants who have positive SARS-CoV-2 test within 7 days prior to enrollment (rapid antigen test result is acceptable)
History of autoimmune disease
Received investigational therapy, whether or not intended for lymphoma treatment, within 7 days prior to initiation of study treatment
Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope Cancer Center		Duarte	California	91010	United States
St. Luke's Hospital

PubMed Identifier	Type	Citation	Retractions
42298056	Derived	Maruyama D, Goto H, Kumode T, Aizawa K, Fukuhara N, Westin JR, Kim WS, Mori C, Imaizumi T, Kato K. Efficacy and safety of subcutaneous mosunetuzumab plus polatuzumab vedotin in patients with relapsed/refractory large B-cell lymphoma: Japan subgroup analysis of the phase III SUNMO trial. Int J Clin Oncol. 2026 Jun 15. doi: 10.1007/s10147-026-03042-x. Online ahead of print.
42283231

ID	Title	Description
FG000	Arm A: Mosun-Pola	Participants received mosunetuzumab, 5 milligrams (mg), subcutaneously (SC), on Day 1 of Cycle 1, followed by 45 mg, SC, on Days 8 & 15 of Cycle 1 and thereafter on Day 1 of Cycles 2 to 8, in combination with polatuzumab vedotin, 1.8 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1 of Cycles 1 to 6 (1 Cycle=21 days).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 5, 2024	Feb 17, 2026

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

Secondary

ORR as Determined by the IRF, According to LRC Using PET-CT or CT Scans in ITT Population

ORR was defined as the percentage of participants with complete response (CR)/partial response (PR), per IRF, per Lugano Response Criteria. Percentages have been rounded off.

Not Posted

Up to 32 months

Participants

Secondary

ORR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans in ITT Population

ORR was defined as the percentage of participants with CR or PR, as determined by the investigator, per Lugano Response Criteria.

Not Posted

Up to approximately 58 months

Participants

Secondary

Duration of Response (DoR) as Determined by the IRF, According to LRC Using PET-CT or CT Scans

DoR was defined as the time from first occurrence of documented PET-CT and/or CT-based objective response (OR) (CR/PR) to PD, or death from any cause, whichever occurred first, per IRF, per Lugano Response Criteria.

Not Posted

Up to 32 months

Participants

Secondary

DoR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans

DoR=time from first occurrence of documented PET-CT and/or CT-based objective response (OR) (CR/PR) to PD, or death from any cause, whichever occurred first, per investigator, per Lugano Response Criteria.

Not Posted

Up to approximately 58 months

Participants

Secondary

Overall Survival (OS)

OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS.

Not Posted

Up to 32 months

Participants

Secondary

PFS as Determined by the Investigator, According to LRC Using PET-CT or CT Scans

PFS was defined as the time from randomization to first occurrence of PD or death from any cause, whichever occurred first, as determined by the investigator, per Lugano Response Criteria.

Not Posted

Up to approximately 58 months

Participants

Primary

Objective Response Rate (ORR) as Determined by the Independent Review Facility (IRF), According to Lugano Response Criteria 2014 (LRC) Using Positron Emission Tomography-computed Tomography (PET-CT) or CT Scans in Interim Analysis Population (IAP)

ORR was defined as the percentage of participants with complete response (CR)/partial response (PR), per IRF, per Lugano Response Criteria. Percentages have been rounded off.

IAP population included the first 178 randomized participants, with participants grouped according to their assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Up to approximately 23.8 months

ID	Title	Description
OG000	Arm A: Mosun-Pola	Participants received mosunetuzumab, 5 mg, SC, on Day 1 of Cycle 1, followed by 45 mg, SC, on Days 8 & 15 of Cycle 1 and thereafter on Day 1 of Cycles 2 to 8, in combination with polatuzumab vedotin, 1.8 mg/kg, IV, on Day 1 of Cycles 1 to 6 (1 Cycle=21 days).
OG001	Arm B: R-GemOx	Participants received rituximab, 375 milligrams per square meter (mg/m^2), IV, in combination with gemcitabine, 1000 mg/m^2, and oxaliplatin, 100 mg/m^2, IV, on Day 1 of Cycles 1 to 8 (1 Cycle=14-21 days).

Units

Primary

Progression-free Survival (PFS) as Determined by the IRF, According to LRC Using PET-CT or CT Scans

PFS was defined as the time from randomization to first occurrence of disease progression (PD) or death from any cause, whichever occurred first, per IRF, per Lugano Response Criteria.

Intent-to-treat (ITT) population included all randomized participants, with participants grouped according to their assigned treatment.

Posted

Median

95% Confidence Interval

months

Up to 32 months

ID	Title	Description
OG000	Arm A: Mosun-Pola	Participants received mosunetuzumab, 5 mg, SC, on Day 1 of Cycle 1, followed by 45 mg, SC, on Days 8 & 15 of Cycle 1 and thereafter on Day 1 of Cycles 2 to 8, in combination with polatuzumab vedotin, 1.8 mg/kg, IV, on Day 1 of Cycles 1 to 6 (1 Cycle=21 days).
OG001	Arm B: R-GemOx	Participants received rituximab, 375 milligrams per square meter (mg/m^2), IV, in combination with gemcitabine, 1000 mg/m^2, and oxaliplatin, 100 mg/m^2, IV, on Day 1 of Cycles 1 to 8 (1 Cycle=14-21 days).

Units	Counts
Participants

Secondary

Complete Response Rate (CRR) as Determined by the IRF, According to LRC Using PET-CT or CT Scans

CRR was defined as the percentage of participants in whom CR was observed at any time during the study, based on PET-CT and/or CT scans, as determined by the IRF, per Lugano Response Criteria.

Not Posted

Up to approximately 58 months

Participants

Secondary

CRR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans

CRR was defined as the percentage of participants in whom CR was observed at any time during the study, based on PET-CT and/or CT scans, as determined by the investigator, per Lugano Response Criteria.

Not Posted

Up to approximately 58 months

Participants

Secondary

Duration of Complete Response (DOCR) as Determined by the IRF, According to LRC Using PET-CT or CT Scans

DOCR was defined as the time from first occurrence of a documented CR to PD, per IRF, per Lugano Response Criteria.

Not Posted

Up to 32 months

Participants

Secondary

DOCR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans

DOCR=time from first occurrence of documented CR to PD, as determined by the investigator, per Lugano Response Criteria.

Not Posted

Up to approximately 58 months

Participants

Secondary

Time to Deterioration in Physical Functioning (PF), as Measured by the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire-Core 30 (EORTC QLQ-C30)

Time to deterioration in PF was defined as time from randomization to the first documentation of 10-point or more decrease, from baseline. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), global health status (GHS)/quality of life (QoL), & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). Functioning scales were scored on a 4-point scale, ranging from 1=Not at all to 4=Very much. All EORTC scales & single-item measures were linearly transformed to a score range of 0-100. High score for a functioning scale indicated high/healthy level of functioning.

Not Posted

Up to approximately 58 months

Participants

Secondary

Time to Deterioration in Fatigue Scale, as Measured by the EORTC QLQ-C30

Time to deterioration in fatigue was defined as time from randomization to the first documentation of 10-point or more decrease, from baseline. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), global health status (GHS)/quality of life (QoL), & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). Fatigue scale was scored on a 4-point scale, ranging from 1=Not at all to 4=Very much. All EORTC scales & single-item measures were linearly transformed to a score range of 0-100. High score for a fatigue scale indicated a high level of symptom severity.

Not Posted

Up to approximately 58 months

Participants

Secondary

Time to Deterioration in Lymphoma Symptoms, as Measured by Functional Assessment of Cancer Therapy- Lymphoma Questionnaire (FACT- Lym LymS)

Time to deterioration in lymphoma-specific symptoms was defined as the time from randomization to the first documentation of a 3-point or more decrease, from baseline. FACT-Lym is a cancer-specific scale used to assess health-related QoL aspects relevant to participants with lymphoma. The full measure consists of the FACT-G physical, social/family, emotional, and functional well-being scales (27 items), as well as lymphoma-specific symptoms subscale (LymS). The FACT-Lym Lyms consists of 15 items scored from 0-4, where 0="Not at all" and 4="very much". Scale score ranges from 0 to 60, where a high score indicated a better QoL.

Not Posted

Up to approximately 58 months

Participants

Secondary

Number of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.

Not Posted

Up to approximately 58 months

Participants

Secondary

Number of Participants With Cytokine Release Syndrome (CRS) With Severity Determined by the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Scale

CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction. Severity of CRS was determined per ASTCT Consensus Grading Criteria, which categorizes CRS into 5 grades- Grade 1: Fever (≥38◦Celsius), with/without constitutional symptoms, in absence of hypotension & hypoxia; Grade 2: Fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; Grade 3: Fever with hypotension requiring one vasopressor, with/without vasopressin, and/or hypoxia requiring high-flow oxygen; Grade 4: Fever accompanied by hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive-pressure ventilation; Grade 5: death due to CRS.

Not Posted

Up to approximately 58 months

Participants

Secondary

Number of Participants With Dose Interruptions, Dose Reductions and Study Treatment Discontinuation Due to AEs

Not Posted

Up to approximately 58 months

Participants

Secondary

Dose Intensity of Mosunetuzumab

Not Posted

Up to approximately 58 months

Participants

Secondary

Change From Baseline in Peripheral Neuropathy (PN), as Measured by the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx)

The FACT/GOG-Ntx is an 11-item patient-reported outcome that measures polatuzumab vedotin-induced PN. The scale contains 4 subscales to assess sensory neuropathy (4 items), hearing neuropathy (2 items), motor neuropathy (3 items), and dysfunction associated with neuropathy (2 items), which can be summed to create a total score. Each item is scored on a 5-point response scale that ranges from 0=not at all to 4=very much. The possible range for the scores is 0-44, with higher scores indicating more extreme neuropathy.

Not Posted

Up to approximately 58 months

Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected64 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG0003 events3 affected135 at risk EG0010 events0 affected64 at risk
Cardiac arrest	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected64 at risk
Cardiac failure acute	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected64 at risk
Tachycardia	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected64 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected64 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Asthenia	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected64 at risk
Fatigue	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected64 at risk
Malaise	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected64 at risk
Pyrexia	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected64 at risk
Cholangitis	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Cytokine release syndrome	Immune system disorders	MedDRA Version 27.1	Systematic Assessment	EG0008 events7 affected135 at risk EG0010 events0 affected64 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected64 at risk
COVID-19	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0007 events6 affected135 at risk EG0011 events1 affected64 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0005 events5 affected135 at risk EG0011 events1 affected64 at risk
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Device related infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Escherichia sepsis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected64 at risk
Haematological infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Hepatitis B reactivation	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Influenza	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Pneumonia	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected135 at risk EG0014 events4 affected64 at risk
Pneumonia parainfluenzae viral	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected64 at risk
Salmonella sepsis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected64 at risk
Sepsis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0002 events1 affected135 at risk EG0012 events2 affected64 at risk
Septic shock	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected64 at risk
Skin infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected64 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0004 events4 affected135 at risk EG0010 events0 affected64 at risk
Craniofacial fracture	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected135 at risk EG0011 events1 affected64 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Alanine aminotransferase increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Aspartate aminotransferase increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected64 at risk
CD4 lymphocytes decreased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Platelet count decreased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected64 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0013 events2 affected64 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Leukaemic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Tumour compression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected64 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Headache	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Device occlusion	Product Issues	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected64 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0003 events3 affected135 at risk EG0010 events0 affected64 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected64 at risk
Embolism	Vascular disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected64 at risk
Thrombophlebitis	Vascular disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected64 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG00050 events41 affected135 at risk EG00133 events27 affected64 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG00013 events9 affected135 at risk EG0012 events2 affected64 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG00017 events11 affected135 at risk EG0018 events5 affected64 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG00078 events44 affected135 at risk EG00128 events18 affected64 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 27.1	Systematic Assessment	EG0009 events5 affected135 at risk EG00128 events22 affected64 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0009 events7 affected135 at risk EG0013 events2 affected64 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00020 events18 affected135 at risk EG00112 events10 affected64 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00015 events14 affected135 at risk EG00119 events15 affected64 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00018 events17 affected135 at risk EG00128 events17 affected64 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00011 events9 affected135 at risk EG00111 events11 affected64 at risk
Fatigue	General disorders	MedDRA Version 27.1	Systematic Assessment	EG00028 events21 affected135 at risk EG00114 events12 affected64 at risk
Infusion site extravasation	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected135 at risk EG0014 events4 affected64 at risk
Injection site reaction	General disorders	MedDRA Version 27.1	Systematic Assessment	EG000140 events71 affected135 at risk EG0010 events0 affected64 at risk
Pyrexia	General disorders	MedDRA Version 27.1	Systematic Assessment	EG00017 events14 affected135 at risk EG0019 events7 affected64 at risk
Cytokine release syndrome	Immune system disorders	MedDRA Version 27.1	Systematic Assessment	EG00037 events29 affected135 at risk EG0010 events0 affected64 at risk
COVID-19	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG00010 events9 affected135 at risk EG0010 events0 affected64 at risk
Herpes zoster	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0007 events7 affected135 at risk EG0010 events0 affected64 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG00015 events13 affected135 at risk EG0012 events2 affected64 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG00013 events9 affected135 at risk EG0012 events2 affected64 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0009 events8 affected135 at risk EG00115 events13 affected64 at risk
Alanine aminotransferase increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG00022 events19 affected135 at risk EG00113 events10 affected64 at risk
Aspartate aminotransferase increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG00024 events17 affected135 at risk EG00119 events11 affected64 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0008 events6 affected135 at risk EG0019 events6 affected64 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0004 events4 affected135 at risk EG0014 events4 affected64 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0009 events8 affected135 at risk EG0015 events4 affected64 at risk
Lymphocyte count decreased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG00011 events7 affected135 at risk EG00110 events3 affected64 at risk
Neutrophil count decreased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG00035 events19 affected135 at risk EG00134 events18 affected64 at risk
Platelet count decreased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG0009 events7 affected135 at risk EG00139 events21 affected64 at risk
White blood cell count decreased	Investigations	MedDRA Version 27.1	Systematic Assessment	EG00012 events12 affected135 at risk EG00122 events10 affected64 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG00010 events10 affected135 at risk EG0015 events5 affected64 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0004 events4 affected135 at risk EG0014 events4 affected64 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG00014 events12 affected135 at risk EG00110 events8 affected64 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0009 events8 affected135 at risk EG0013 events3 affected64 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0004 events3 affected135 at risk EG0015 events5 affected64 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00012 events9 affected135 at risk EG0010 events0 affected64 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0009 events9 affected135 at risk EG0012 events2 affected64 at risk
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG00010 events7 affected135 at risk EG0010 events0 affected64 at risk
Dizziness	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0008 events8 affected135 at risk EG0012 events2 affected64 at risk
Headache	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG00017 events11 affected135 at risk EG0010 events0 affected64 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 events1 affected135 at risk EG0015 events4 affected64 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG00016 events14 affected135 at risk EG00113 events13 affected64 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0009 events8 affected135 at risk EG0015 events4 affected64 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0008 events8 affected135 at risk EG0018 events7 affected64 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG00013 events12 affected135 at risk EG0011 events1 affected64 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00010 events8 affected135 at risk EG0011 events1 affected64 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00010 events8 affected135 at risk EG0012 events2 affected64 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00011 events9 affected135 at risk EG0011 events1 affected64 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG00023 events17 affected135 at risk EG0010 events0 affected64 at risk
Hypotension	Vascular disorders	MedDRA Version 27.1	Systematic Assessment	EG0008 events8 affected135 at risk EG0013 events3 affected64 at risk

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
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
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D056831	Coordination Complexes
D009930	Organic Chemicals

ID	Title	Description
BG000	Arm A: Mosun-Pola	Participants received mosunetuzumab, 5 mg, SC, on Day 1 of Cycle 1, followed by 45 mg, SC, on Days 8 & 15 of Cycle 1 and thereafter on Day 1 of Cycles 2 to 8, in combination with polatuzumab vedotin, 1.8 mg/kg, IV, on Day 1 of Cycles 1 to 6 (1 Cycle=21 days).
BG001	Arm B: R-GemOx	Participants received rituximab, 375 milligrams per square meter (mg/m^2), IV, in combination with gemcitabine, 1000 mg/m^2, and oxaliplatin, 100 mg/m^2, IV, on Day 1 of Cycles 1 to 8 (1 Cycle=14-21 days).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: Mosun-Pola	Participants received mosunetuzumab, 5 mg, SC, on Day 1 of Cycle 1, followed by 45 mg, SC, on Days 8 & 15 of Cycle 1 and thereafter on Day 1 of Cycles 2 to 8, in combination with polatuzumab vedotin, 1.8 mg/kg, IV, on Day 1 of Cycles 1 to 6 (1 Cycle=21 days).	66	135	45	135	129	135
EG001	Arm B: R-GemOx	Participants received rituximab, 375 milligrams per square meter (mg/m^2), IV, in combination with gemcitabine, 1000 mg/m^2, and oxaliplatin, 100 mg/m^2, IV, on Day 1 of Cycles 1 to 8 (1 Cycle=14-21 days).	35	64	16	64	60	64

ID	Term
C000600736	polatuzumab vedotin
C502936	tocilizumab
D000069283	Rituximab
D000093542	Gemcitabine
D000077150	Oxaliplatin