A Study Evaluating the Safety and Efficacy of Glofitamab... | NCT04313608

Label	Type	Description	Intervention Names
Arm A: Glofit-GemOx	Experimental	Participants will receive up to 8 cycles of Glofit-GemOx (glofitamab in combination with gemcitabine and oxaliplatin) administered in 21-day cycles, followed by up to 4 cycles of glofitamab monotherapy. A single dose of obinutuzumab will be administered 7 days prior to the first dose of glofitamab.	Drug: Glofitamab Drug: Gemcitabine Drug: Oxaliplatin Drug: Obinutuzumab Drug: Tocilizumab
Arm B: Mosun-GemOx	Experimental	Participants will receive up to 8 cycles of Mosun-GemOx (mosunetuzumab in combination with gemcitabine and oxaliplatin) administered in 21-day cycles.	Drug: Gemcitabine Drug: Oxaliplatin Drug: Mosunetuzumab Drug: Tocilizumab

Name	Type	Description	Arm Group Labels	Other Names
Glofitamab	Drug	Participants will receive intravenous (IV) glofitamab in combination with gemcitabine and oxaliplatin for up to 8 cycles, followed by up to 4 cycles of glofitamab monotherapy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Deaths Due to Adverse Events (AEs)	An adverse event 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 adverse event 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. Pre-existing conditions which worsen during a study are also considered as adverse events.	Baseline - 90 days after last dose of study treatment
Number of Treatment Discontinuations Due to AE	An adverse event 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 adverse event 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. Pre-existing conditions which worsen during a study are also considered as adverse events.	Baseline - 90 days after last dose of study treatment
Proportion of Participants With Serious Adverse Events (SAEs)	An adverse event 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 adverse event 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. Pre-existing conditions which worsen during a study are also considered as adverse events.	Baseline - 90 days after last dose of study treatment
Proportion of Participants With Cytokine Release Syndrome (CRS) by Grade of Severity

Secondary Outcomes

Measure	Description	Time Frame
Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs		Up to approximately 16 months
Complete Response (CR) Based on PET/CT as Determined by the Investigator According to the 2014 Lugano Response Criteria

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1, or 2
Histologically confirmed B-cell lymphoma, including one of the following diagnoses per the 2016 World Health Organization (WHO) classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS); HGBCL with MYC and BCL2 and/or BCL6 rearrangements; HGBCL, NOS
R/R disease, defined as follows: Relapse: disease that has recurred following a response that lasted >/=6 months after completion of last line of therapy; Refractory: disease that progressed during therapy or progressed within 6 months (<6 months) of prior therapy
At least one line of prior systemic therapy
At least one bi-dimensionally measurable nodal lesion or one bi-dimensionally measurable extranodal lesion, as measured on positron emission tomography-computed tomography (PET/CT) scan
Adequate hematologic function
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as follows: Women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the treatment period and for at least 18 months after the final dose of obinutuzumab, 6 months after the final dose of gemcitabine, 9 months after the final dose of oxaliplatin, 3 months after the final dose of mosunetuzumab, 3 months after the final dose of tocilizumab, and 2 months after the final dose of glofitamab. Women must refrain from donating eggs during this same period
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm, as follows: With a female partner of childbearing potential or pregnant female partners, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 2 months after the final dose of glofitamab, 2 months after the final dose of mosunetuzumab, 2 months after the final dose of tocilizumab (if applicable), 3 months after the final dose of obinutuzumab, and 6 months after the final dose of oxaliplatin or gemcitabine to avoid exposing the embryo. Men must refrain from donating sperm during this same period.

Exclusion Criteria

Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
Contraindication to obinutuzumab, gemcitabine, oxaliplatin, or tocilizumab
Prior treatment with a bispecific antibody targeting both CD20 and CD3, including glofitamab and mosunetuzumab
Grade >1 peripheral neuropathy
Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to the first study treatment
Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
History of other malignancy that could affect compliance with the protocol or interpretation of results
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular 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 (as evaluated by the investigator) within 4 weeks prior to first study treatment
Suspected or latent tuberculosis
Positive test results for chronic hepatitis B virus (HBV) infection
Positive test results for hepatitis C virus (HCV) antibody
Known HIV-seropositive status
Known or suspected chronic active Epstein-Barr virus infection
Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
History of progressive multifocal leukoencephalopathy
Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia)
Administration of a live, attenuated vaccine within 4 weeks prior to the first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
Prior solid organ transplantation
Prior allogenic stem cell transplant
Active autoimmune disease requiring treatment
Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 4 weeks prior to the first dose of study treatment
Corticosteroid therapy within 2 weeks prior to first dose of study treatment, with exceptions defined by the study protocol
Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
Clinically significant history of liver disease, including cirrhosis

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital; Haematology		Randwick	New South Wales	2031	Australia
Monash Health Monash Medical Centre

ID	Title	Description
FG000	Arm A: Glofit-GemOx	Participants received a single IV dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days)
FG001

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	May 2, 2020

ID	Title	Description
BG000	Arm A: Glofit-GemOx	Participants received a single IV dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days)
BG001	Arm B: Mosun-GemOx	Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00017 BG0016 BG00223

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

Number of Deaths Due to Adverse Events (AEs)

An adverse event 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 adverse event 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. Pre-existing conditions which worsen during a study are also considered as adverse events.

Posted

Number

Participants

Baseline - 90 days after last dose of study treatment

ID	Title	Description
OG000	Arm A: Glofit-GemOx	Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
OG001	Arm B: Mosun-GemOx	Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)

Units	Counts
Participants	OG00017 OG0016

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0010

Secondary

Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs

Posted

Number

percentage of participants

Up to approximately 16 months

ID	Title	Description
OG000	Arm A: Glofit-GemOx	Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
OG001	Arm B: Mosun-GemOx	Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)

Units	Counts
Participants	OG000

Secondary

Complete Response (CR) Based on PET/CT as Determined by the Investigator According to the 2014 Lugano Response Criteria

Per the 2014 Lugano Response Criteria for malignant lymphoma a CR = complete metabolic response with a score of 1, 2, or 3 on a 5-point scale (5PS), with higher scores indicating more extensive disease.

Posted

Number

95% Confidence Interval

percentage

Up to approximately 16 months

ID	Title	Description
OG000	Arm A: Glofit-GemOx	Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
OG001	Arm B: Mosun-GemOx	Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)

Units	Counts
Participants	OG000

Secondary

Objective Response Rate (ORR), Defined as the Proportion of Participants With a Best Overall Response of Partial Response (PR) or CR, as Determined by the Investigator According to the 2014 Lugano Response Criteria

Per the 2014 Lugano Response Criteria for malignant lymphoma a CR = complete metabolic response with a score of 1, 2, or 3 on a 5-point scale (5PS), while a PR = partial metabolic response with a score of 4 or 5 on 5PS with higher scores indicating more extensive disease.

Posted

Number

Proportion expressed as percentage

Up to approximately 16 months

ID	Title	Description
OG000	Arm A: Glofit-GemOx	Participants received a single IV dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days)
OG001	Arm B: Mosun-GemOx	Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)

Units	Counts
Participants

Secondary

Maximum Serum Concentration (Cmax) of Glofitamab

The pharmacokinetic population consisted of all participants that received at least one dose of glofitamab or mosunetuzumab and who had data from at least one post-dose sample.

Posted

Median

Full Range

ug/mL

Cycle 1 Day 8 and Cycle 2 Day 1

ID	Title	Description
OG000	Arm A: Glofit-GemOx	Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).

Units	Counts
Participants	OG000

Primary

Number of Treatment Discontinuations Due to AE

Posted

Number

Participants

Baseline - 90 days after last dose of study treatment

ID	Title	Description
OG000	Arm A: Glofit-GemOx	Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
OG001	Arm B: Mosun-GemOx	Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)

Units	Counts

Primary

Proportion of Participants With Serious Adverse Events (SAEs)

Posted

Number

Proportion expressed as percentage

Baseline - 90 days after last dose of study treatment

ID	Title	Description
OG000	Arm A: Glofit-GemOx	Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
OG001	Arm B: Mosun-GemOx	Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)

Units	Counts

Primary

Proportion of Participants With Cytokine Release Syndrome (CRS) by Grade of Severity

Severity of CRS was determined according to the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Criteria, in which Grade 1 as fever (≥38.0°C) with or without other symptoms; Grade 2 as fever with hypotension not requiring vasopressors and/or hypoxia requiring the use of oxygen (low-flow); and Grade 3 as fever with hypotension requiring one vasopressor with or without vasopressin and/or hypoxia requiring the use of oxygen (high-flow).

Posted

Number

Proportion expressed as percentage

Baseline - 90 days after last dose of study treatment

ID	Title	Description
OG000	Arm A: Glofit-GemOx	Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
OG001	Arm B: Mosun-GemOx	Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected6 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Colitis	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected6 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0011 events1 affected6 at risk
Vomiting	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Asthenia	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Pyrexia	General disorders	MedDRA v24.0	Systematic Assessment	EG0006 events6 affected17 at risk EG0011 events1 affected6 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Cytokine release syndrome	Immune system disorders	MedDRA v24.0	Systematic Assessment	EG0004 events2 affected17 at risk EG0011 events1 affected6 at risk
Cellulitis	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Neutropenic sepsis	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Sepsis	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0010 events0 affected6 at risk
Urinary tract infection	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0012 events1 affected6 at risk
Wound infection	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected6 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Immune effector cell-associated neurotoxicity syndrome	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Orthostatic hypotension	Vascular disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v24.0	Systematic Assessment	EG00015 events6 affected17 at risk EG0015 events3 affected6 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v24.0	Systematic Assessment	EG0005 events4 affected17 at risk EG0018 events1 affected6 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v24.0	Systematic Assessment	EG0006 events4 affected17 at risk EG0014 events2 affected6 at risk
Tachycardia	Cardiac disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Blepharitis	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Eye pain	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Vision blurred	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected6 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected6 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Colitis	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Constipation	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0004 events4 affected17 at risk EG0014 events3 affected6 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0006 events6 affected17 at risk EG00110 events5 affected6 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected6 at risk
Nausea	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0005 events4 affected17 at risk EG0015 events4 affected6 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected6 at risk
Vomiting	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected6 at risk
Chest pain	General disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Fatigue	General disorders	MedDRA v24.0	Systematic Assessment	EG0004 events4 affected17 at risk EG0014 events4 affected6 at risk
Oedema peripheral	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0013 events2 affected6 at risk
Performance status decreased	General disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Cytokine release syndrome	Immune system disorders	MedDRA v24.0	Systematic Assessment	EG00014 events7 affected17 at risk EG0010 events0 affected6 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Seasonal allergy	Immune system disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Candida infection	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0014 events2 affected6 at risk
Cellulitis	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Clostridium difficile infection	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
External ear cellulitis	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Oral candidiasis	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0011 events1 affected6 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Urinary tract infection	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0015 events3 affected6 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected6 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected6 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected6 at risk
Injury	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Alanine aminotransferase increased	Investigations	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0012 events2 affected6 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0012 events2 affected6 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected6 at risk
Blood creatinine increased	Investigations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Liver function test abnormal	Investigations	MedDRA v24.0	Systematic Assessment	EG0005 events4 affected17 at risk EG0010 events0 affected6 at risk
Neutrophil count decreased	Investigations	MedDRA v24.0	Systematic Assessment	EG0004 events3 affected17 at risk EG0010 events0 affected6 at risk
Platelet count decreased	Investigations	MedDRA v24.0	Systematic Assessment	EG0007 events4 affected17 at risk EG0010 events0 affected6 at risk
Weight decreased	Investigations	MedDRA v24.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0010 events0 affected6 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected6 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected6 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0013 events2 affected6 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0009 events6 affected17 at risk EG0015 events4 affected6 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0004 events4 affected17 at risk EG0019 events4 affected6 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0010 events0 affected6 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected6 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0003 events2 affected17 at risk EG0010 events0 affected6 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Dizziness	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected6 at risk
Headache	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0011 events1 affected6 at risk
Intention tremor	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Lethargy	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0010 events0 affected6 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0007 events6 affected17 at risk EG0011 events1 affected6 at risk
Paraesthesia	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected6 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0004 events3 affected17 at risk EG0013 events3 affected6 at risk
Depression	Psychiatric disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Dysuria	Renal and urinary disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0011 events1 affected6 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected6 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected6 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected6 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected6 at risk
Flushing	Vascular disorders	MedDRA v24.0	Systematic Assessment	EG0005 events2 affected17 at risk EG0011 events1 affected6 at risk
Hypertension	Vascular disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected6 at risk
Hypotension	Vascular disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Orthostatic hypotension	Vascular disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected6 at risk
Superficial vein thrombosis	Vascular disorders	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0012 events1 affected6 at risk
Thrombophlebitis	Vascular disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected6 at risk
Thrombosis	Vascular disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk
Vasospasm	Vascular disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected6 at risk

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
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	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: Glofit-GemOx	Participants received a single IV dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days)	1	17	12	17	17	17
EG001	Arm B: Mosun-GemOx	Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)	0	6	4	6	6	6

ID	Term
C000720108	glofitamab
D000093542	Gemcitabine
D000077150	Oxaliplatin
C543332	obinutuzumab
C502936	tocilizumab