Trial Outcomes & Findings for A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma (NCT NCT05171647)

Last Updated: 2026-05-07

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

208 participants

Primary outcome timeframe

Up to approximately 23.8 months

Results posted on

2026-05-07

Participant Flow

A total of 208 participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL), and follicular lymphoma (FL) Grade 3B (FL3B), ineligible for autologous stem cell transplant (ASCT), took part in the study at 54 investigative sites across 13 countries. The study is still ongoing.

Participants were randomized in a 2:1 ratio to receive either mosunetuzumab in combination with polatuzumab vedotin (Mosun-Pola) (Arm A) or rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) (Arm B).

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	138	70
Overall Study Safety-evaluable (SE) Population	135	64
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	138	70

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).
Overall Study Death	64	32
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	8	11
Overall Study Physician Decision	1	0
Overall Study Reason not Specified	0	1
Overall Study Ongoing in Study	64	25

Baseline Characteristics

A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Mosun-Pola n=138 Participants 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).	Arm B: R-GemOx n=70 Participants 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).	Total n=208 Participants Total of all reporting groups
Age, Continuous	60.2 years STANDARD_DEVIATION 14.3 • n=54 Participants	61.7 years STANDARD_DEVIATION 12.7 • n=60 Participants	60.7 years STANDARD_DEVIATION 13.7 • n=114 Participants
Sex: Female, Male Female	62 Participants n=54 Participants	25 Participants n=60 Participants	87 Participants n=114 Participants
Sex: Female, Male Male	76 Participants n=54 Participants	45 Participants n=60 Participants	121 Participants n=114 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	47 Participants n=54 Participants	22 Participants n=60 Participants	69 Participants n=114 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=54 Participants	48 Participants n=60 Participants	136 Participants n=114 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=54 Participants	0 Participants n=60 Participants	3 Participants n=114 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=54 Participants	5 Participants n=60 Participants	14 Participants n=114 Participants
Race (NIH/OMB) Asian	56 Participants n=54 Participants	26 Participants n=60 Participants	82 Participants n=114 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=54 Participants	0 Participants n=60 Participants	1 Participants n=114 Participants
Race (NIH/OMB) Black or African American	4 Participants n=54 Participants	1 Participants n=60 Participants	5 Participants n=114 Participants
Race (NIH/OMB) White	61 Participants n=54 Participants	38 Participants n=60 Participants	99 Participants n=114 Participants
Race (NIH/OMB) More than one race	2 Participants n=54 Participants	0 Participants n=60 Participants	2 Participants n=114 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=54 Participants	0 Participants n=60 Participants	5 Participants n=114 Participants

PRIMARY outcome

Timeframe: Up to approximately 23.8 months

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

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.

Outcome measures

Outcome measures
Measure	Arm A: Mosun-Pola n=119 Participants 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).	Arm B: R-GemOx n=59 Participants 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).
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)	69.7 percentage of participants Interval 60.65 to 77.83	44.1 percentage of participants Interval 31.16 to 57.6

PRIMARY outcome

Timeframe: Up to 32 months

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

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.

Outcome measures

Outcome measures
Measure	Arm A: Mosun-Pola n=138 Participants 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).	Arm B: R-GemOx n=70 Participants 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).
Progression-free Survival (PFS) as Determined by the IRF, According to LRC Using PET-CT or CT Scans	11.5 months Interval 5.6 to 17.6	3.8 months Interval 2.9 to 4.1

SECONDARY outcome

Timeframe: Up to 32 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 32 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 32 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 32 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 58 months

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.

Outcome measures

Outcome data not reported

Adverse Events

Arm A: Mosun-Pola

Serious events: 45 serious events

Other events: 129 other events

Deaths: 66 deaths

Arm B: R-GemOx

Serious events: 16 serious events

Other events: 60 other events

Deaths: 35 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Arm A: Mosun-Pola n=135 participants at risk 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).	Arm B: R-GemOx n=64 participants at risk 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).
Blood and lymphatic system disorders Anaemia	0.00% 0/135 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Blood and lymphatic system disorders Febrile neutropenia	2.2% 3/135 • Number of events 3 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Cardiac disorders Cardiac arrest	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Cardiac disorders Cardiac failure acute	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Cardiac disorders Sinus node dysfunction	0.00% 0/135 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Cardiac disorders Tachycardia	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/135 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Gastrointestinal disorders Abdominal pain	0.74% 1/135 • Number of events 2 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
General disorders Asthenia	0.00% 0/135 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
General disorders Fatigue	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
General disorders Malaise	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
General disorders Pyrexia	1.5% 2/135 • Number of events 2 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Hepatobiliary disorders Cholangitis	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Immune system disorders Cytokine release syndrome	5.2% 7/135 • Number of events 8 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/135 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations COVID-19	4.4% 6/135 • Number of events 7 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations COVID-19 pneumonia	3.7% 5/135 • Number of events 5 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Cytomegalovirus infection reactivation	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Device related infection	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Escherichia sepsis	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Gastroenteritis	0.00% 0/135 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Haematological infection	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Hepatitis B reactivation	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Influenza	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Pneumonia	1.5% 2/135 • Number of events 2 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	6.2% 4/64 • Number of events 4 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Pneumonia parainfluenzae viral	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/135 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Salmonella sepsis	0.00% 0/135 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Sepsis	0.74% 1/135 • Number of events 2 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	3.1% 2/64 • Number of events 2 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Septic shock	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Skin infection	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Upper respiratory tract infection	0.00% 0/135 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Urinary tract infection	3.0% 4/135 • Number of events 4 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Injury, poisoning and procedural complications Craniofacial fracture	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Injury, poisoning and procedural complications Infusion related reaction	1.5% 2/135 • Number of events 2 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Injury, poisoning and procedural complications Subdural haematoma	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Investigations Alanine aminotransferase increased	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Investigations Aspartate aminotransferase increased	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	1.6% 1/64 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.

Other adverse events
Measure	Arm A: Mosun-Pola n=135 participants at risk 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).	Arm B: R-GemOx n=64 participants at risk 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).
Blood and lymphatic system disorders Anaemia	30.4% 41/135 • Number of events 50 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	42.2% 27/64 • Number of events 33 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Blood and lymphatic system disorders Leukopenia	6.7% 9/135 • Number of events 13 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	3.1% 2/64 • Number of events 2 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Blood and lymphatic system disorders Lymphopenia	8.1% 11/135 • Number of events 17 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	7.8% 5/64 • Number of events 8 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Blood and lymphatic system disorders Neutropenia	32.6% 44/135 • Number of events 78 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	28.1% 18/64 • Number of events 28 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Blood and lymphatic system disorders Thrombocytopenia	3.7% 5/135 • Number of events 9 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	34.4% 22/64 • Number of events 28 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Gastrointestinal disorders Abdominal pain	5.2% 7/135 • Number of events 9 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	3.1% 2/64 • Number of events 3 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Gastrointestinal disorders Constipation	13.3% 18/135 • Number of events 20 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	15.6% 10/64 • Number of events 12 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Gastrointestinal disorders Diarrhoea	10.4% 14/135 • Number of events 15 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	23.4% 15/64 • Number of events 19 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Gastrointestinal disorders Nausea	12.6% 17/135 • Number of events 18 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	26.6% 17/64 • Number of events 28 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Gastrointestinal disorders Vomiting	6.7% 9/135 • Number of events 11 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	17.2% 11/64 • Number of events 11 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
General disorders Fatigue	15.6% 21/135 • Number of events 28 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	18.8% 12/64 • Number of events 14 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
General disorders Infusion site extravasation	0.00% 0/135 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	6.2% 4/64 • Number of events 4 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
General disorders Injection site reaction	52.6% 71/135 • Number of events 140 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
General disorders Pyrexia	10.4% 14/135 • Number of events 17 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	10.9% 7/64 • Number of events 9 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Immune system disorders Cytokine release syndrome	21.5% 29/135 • Number of events 37 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations COVID-19	6.7% 9/135 • Number of events 10 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Herpes zoster	5.2% 7/135 • Number of events 7 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Upper respiratory tract infection	9.6% 13/135 • Number of events 15 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	3.1% 2/64 • Number of events 2 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Infections and infestations Urinary tract infection	6.7% 9/135 • Number of events 13 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	3.1% 2/64 • Number of events 2 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Injury, poisoning and procedural complications Infusion related reaction	5.9% 8/135 • Number of events 9 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	20.3% 13/64 • Number of events 15 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Investigations Alanine aminotransferase increased	14.1% 19/135 • Number of events 22 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	15.6% 10/64 • Number of events 13 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Investigations Aspartate aminotransferase increased	12.6% 17/135 • Number of events 24 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	17.2% 11/64 • Number of events 19 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Investigations Blood alkaline phosphatase increased	4.4% 6/135 • Number of events 8 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	9.4% 6/64 • Number of events 9 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Investigations Blood lactate dehydrogenase increased	3.0% 4/135 • Number of events 4 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	6.2% 4/64 • Number of events 4 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Investigations Gamma-glutamyltransferase increased	5.9% 8/135 • Number of events 9 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	6.2% 4/64 • Number of events 5 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Investigations Lymphocyte count decreased	5.2% 7/135 • Number of events 11 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	4.7% 3/64 • Number of events 10 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Investigations Neutrophil count decreased	14.1% 19/135 • Number of events 35 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	28.1% 18/64 • Number of events 34 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Investigations Platelet count decreased	5.2% 7/135 • Number of events 9 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	32.8% 21/64 • Number of events 39 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Investigations White blood cell count decreased	8.9% 12/135 • Number of events 12 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	15.6% 10/64 • Number of events 22 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Metabolism and nutrition disorders Decreased appetite	7.4% 10/135 • Number of events 10 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	7.8% 5/64 • Number of events 5 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Metabolism and nutrition disorders Hypocalcaemia	3.0% 4/135 • Number of events 4 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	6.2% 4/64 • Number of events 4 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Metabolism and nutrition disorders Hypokalaemia	8.9% 12/135 • Number of events 14 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	12.5% 8/64 • Number of events 10 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Metabolism and nutrition disorders Hypomagnesaemia	5.9% 8/135 • Number of events 9 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	4.7% 3/64 • Number of events 3 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Metabolism and nutrition disorders Hyponatraemia	2.2% 3/135 • Number of events 4 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	7.8% 5/64 • Number of events 5 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 9/135 • Number of events 12 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Musculoskeletal and connective tissue disorders Back pain	6.7% 9/135 • Number of events 9 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	3.1% 2/64 • Number of events 2 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	5.2% 7/135 • Number of events 10 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Nervous system disorders Dizziness	5.9% 8/135 • Number of events 8 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	3.1% 2/64 • Number of events 2 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Nervous system disorders Headache	8.1% 11/135 • Number of events 17 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	0.00% 0/64 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
Nervous system disorders Hypoaesthesia	0.74% 1/135 • Number of events 1 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.	6.2% 4/64 • Number of events 5 • From initiation of study drug up to approximately 33.7 months SE population included all randomized participants who received at least one dose of study treatment, with participants grouped according to their actual treatment received. Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.