Trial Outcomes & Findings for A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) (NCT NCT02763319)

NCT ID: NCT02763319

Last Updated: 2025-07-17

Results Overview

Progression-free survival was defined as the time from randomization to tumor progression or death from any cause.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 453 participants
• Primary outcome timeframe: up to 41.4 months
• Results posted on: 2025-07-17

Participant Flow

This study was conducted at 138 study centers in: Australia, Austria, Canada, Croatia, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Portugal, Romania, Serbia, South Korea, Spain, Singapore, Taiwan, Turkey, the United Kingdom, and the United States of America.

Participant milestones

Measure	Tafasitamab + Bendamustine Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Overall Study STARTED	226	227
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	226	227

Reasons for withdrawal

Measure	Tafasitamab + Bendamustine Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Overall Study Adverse Event	12	3
Overall Study Death	123	123
Overall Study Lost to Follow-up	6	7
Overall Study Noncompliance with Study Drug	2	0
Overall Study Captured as "Other" in Database	29	34
Overall Study Physician Decision	1	7
Overall Study Progressive Disease	24	27
Overall Study Completed the Maximum per Protocol Treatment Period	1	0
Overall Study Diagnosed with COVID-19 and/or Tested Positive for Coronavirus SARS-CoV-2	2	1
Overall Study Withdrawal by Subject	26	25

Baseline Characteristics

A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Baseline characteristics by cohort

Measure	Tafasitamab + Bendamustine n=226 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=227 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Total n=453 Participants Total of all reporting groups
Age, Continuous	70.9 years STANDARD_DEVIATION 10.36 • n=5 Participants	70.8 years STANDARD_DEVIATION 9.92 • n=7 Participants	70.9 years STANDARD_DEVIATION 10.13 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants	96 Participants n=7 Participants	192 Participants n=5 Participants
Sex: Female, Male Male	130 Participants n=5 Participants	131 Participants n=7 Participants	261 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	41 Participants n=5 Participants	45 Participants n=7 Participants	86 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	172 Participants n=5 Participants	171 Participants n=7 Participants	343 Participants n=5 Participants
Race/Ethnicity, Customized Not Applicable in Enrolled Country	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Captured as "Other" in Database	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Iraqi	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized European	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Eurasian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Captured as "Hispanic" in Database	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 41.4 months

Population: Full Analysis Set (FAS): all participants who were randomized to either treatment arm. Participants were analyzed according to the treatment and stratification factors they were assigned to during the randomization procedure. 95% confidence intervals (CIs) (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley.

Progression-free survival was defined as the time from randomization to tumor progression or death from any cause.

Outcome measures

Measure	Tafasitamab + Bendamustine n=226 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=227 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Overall Population	7.10 months Interval 5.8 to 8.5	8.30 months Interval 5.6 to 11.5

PRIMARY outcome

Timeframe: up to 46.5 months

Population: Natural Killer Cell Count-Low Full Analysis Set: participants in the FAS with ≤100 NK cells/µL at Baseline. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley.

Progression-free survival was defined as the time from randomization to tumor progression or death from any cause.

Outcome measures

Measure	Tafasitamab + Bendamustine n=88 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=74 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup	5.60 months Interval 4.4 to 8.6	5.60 months Interval 3.6 to 10.0

SECONDARY outcome

Timeframe: up to 77 months

Population: Full Analysis Set. A 2-sided 95% Clopper-Pearson exact method based on binomial distribution was used.

Best ORR was defined as the percentage of patients with complete response (CR) or partial response (PR) based on the best response achieved at any time during the study. Per International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites.

Outcome measures

Measure	Tafasitamab + Bendamustine n=226 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=227 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Best Objective Response Rate (ORR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population	65.5 percentage of participants Interval 58.9 to 71.67	61.7 percentage of participants Interval 55.01 to 68.03

SECONDARY outcome

Timeframe: up to 77 months

Population: Natural Killer Cell Count-Low Full Analysis Set. A 2-sided 95% Clopper-Pearson exact method based on binomial distribution was used.

Best ORR was defined as the percentage of patients with CR or PR based on the best response achieved at any time during the study. Per International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites.

Outcome measures

Measure	Tafasitamab + Bendamustine n=88 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=74 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Best ORR by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup	64.8 percentage of participants Interval 53.86 to 74.66	59.5 percentage of participants Interval 47.41 to 70.73

SECONDARY outcome

Timeframe: up to 40.2 months

Population: Full Analysis Set. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley. Only participants with CR or PR were analyzed.

Duration of response was defined as the elapsed time (in months) between the date of the first documented response (CR or PR) and the following date of an event defined as the first documented progression (any new lesion or an increase by ≥50% of previously involved sites from nadir) or death. Per International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites.

Outcome measures

Measure	Tafasitamab + Bendamustine n=148 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=140 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Overall Population	7.40 months Interval 5.8 to 12.1	12.10 months Interval 10.0 to 23.3

SECONDARY outcome

Timeframe: up to 44.7 months

Population: Natural Killer Cell Count-Low Full Analysis Set. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley. Only participants with CR or PR were analyzed.

Duration of response was defined as the elapsed time (in months) between the date of the first documented response (CR or PR) and the following date of an event defined as the first documented progression (any new lesion or an increase by ≥50% of previously involved sites from nadir) or death. Per International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites.

Outcome measures

Measure	Tafasitamab + Bendamustine n=57 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=44 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup	6.70 months Interval 3.7 to 12.7	10.30 months Interval 4.9 to 37.5

SECONDARY outcome

Timeframe: up to 50.0 months

Population: Full Analysis Set. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley.

Overall survival was defined as the time (in months) from randomization until death from any cause.

Outcome measures

Measure	Tafasitamab + Bendamustine n=226 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=227 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Kaplan-Meier Estimate of Overall Survival in the Overall Population	14.60 months Interval 11.6 to 23.4	20.20 months Interval 13.4 to 24.3

SECONDARY outcome

Timeframe: up to 50.6 months

Population: Natural Killer Cell Count-Low Full Analysis Set. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley.

Overall survival was defined as the time (in months) from randomization until death from any cause.

Outcome measures

Measure	Tafasitamab + Bendamustine n=88 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=74 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Kaplan-Meier Estimate of Overall Survival in the Natural Killer Cell Count-Low Subgroup	10.60 months Interval 8.3 to 19.7	12.50 months Interval 8.3 to 32.3

SECONDARY outcome

Timeframe: up to 77 months

Population: Full Analysis Set. A 2-sided 95% Clopper-Pearson exact method based on binomial distribution was used.

DCR was defined as the percentage of participants with a CR, PR, or stable disease (SD) based on the best response achieved at any time during the study. Per the International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites; SD: failure to attain CR/PR or progressive disease (PD; any new lesion or an increase by ≥50% of previously involved sites from nadir).

Outcome measures

Measure	Tafasitamab + Bendamustine n=226 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=227 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Disease Control Rate (DCR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population	76.1 percentage of participants Interval 70.0 to 81.51	71.8 percentage of participants Interval 65.47 to 77.56

SECONDARY outcome

Timeframe: up to 77 months

Population: Natural Killer Cell Count-Low Full Analysis Set. A 2-sided 95% Clopper-Pearson exact method based on binomial distribution was used.

DCR was defined as the percentage of participants with a CR, PR, or SD based on the best response achieved at any time during the study. Per the International Working Group response criteria: CR: the disappearance of all evidence of disease; PR: regression of measurable disease and no new sites; SD: failure to attain CR/PR or PD (any new lesion or an increase by ≥50% of previously involved sites from nadir).

Outcome measures

Measure	Tafasitamab + Bendamustine n=88 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=74 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
DCR by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup	75.0 percentage of participants Interval 64.63 to 83.62	70.3 percentage of participants Interval 58.52 to 80.34

SECONDARY outcome

Timeframe: up to 25.8 months

Population: Full Analysis Set. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley. Only participants with progression/death as a result of lymphoma were analyzed.

Time to progression was defined as the time (in months) from randomization until documented diffuse large B-call lymphoma (DLBCL) progression or death as a result of lymphoma. Death from other causes than lymphoma was not considered in relation to the TTP evaluation.

Outcome measures

Measure	Tafasitamab + Bendamustine n=117 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=111 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Kaplan-Meier Estimate of Time to Progression by Independent Radiology/Clinical Review Committee Assessment in the Overall Population	8.20 months Interval 6.2 to 9.3	11.10 months Interval 8.1 to 18.3

SECONDARY outcome

Timeframe: up to 40.6 months

Population: Natural Killer Cell Count-Low Full Analysis Set. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley. Only participants with progression/death as a result of lymphoma were analyzed.

Time to progression was defined as the time (in months) from randomization until documented diffuse large B-call lymphoma (DLBCL) progression or death as a result of lymphoma. Death from other causes than lymphoma was not considered in relation to the TTP evaluation.

Outcome measures

Measure	Tafasitamab + Bendamustine n=50 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=36 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Kaplan-Meier Estimate of Time to Progression by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup	8.00 months Interval 5.4 to 9.2	10.00 months Interval 3.8 to 39.4

SECONDARY outcome

Timeframe: up to 59.4 months

Population: Full Analysis Set. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley.

Time to next treatment was defined as the time (in months) from randomization to the institution of the next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity, and participant preference) or death due to any cause, whatever came first.

Outcome measures

Measure	Tafasitamab + Bendamustine n=226 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=227 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Kaplan-Meier Estimate of Time to Next Treatment in the Overall Population	8.80 months Interval 7.5 to 10.9	8.70 months Interval 6.8 to 11.5

SECONDARY outcome

Timeframe: up to 70.1 months

Population: Natural Killer Cell Count-Low Full Analysis Set. 95% CIs (Greenwood formula) for the median and the 25th and 75th percentiles were calculated using the method of Brookmeyer and Crowley.

Time to next treatment was defined as the time (in months) from randomization to the institution of the next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity, and participant preference) or death due to any cause, whatever came first.

Outcome measures

Measure	Tafasitamab + Bendamustine n=88 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=74 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Kaplan-Meier Estimate of Time to Next Treatment in the Natural Killer Cell Count-Low Subgroup	7.20 months Interval 5.8 to 9.5	6.30 months Interval 4.3 to 9.0

SECONDARY outcome

Timeframe: up to 77 months

Population: Safety Analysis Set: all participants who received at least one dose of tafasitamab, bendamustine, or rituximab. Analyses were based on the actual treatment received.

An adverse event was defined as any untoward medical occurrence in a participant administered a medicinal product, which did not necessarily have a causal relationship to this treatment. An AE could therefore have been any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it was considered related to that study drug. TEAEs were defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.

Outcome measures

Measure	Tafasitamab + Bendamustine n=219 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=225 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	215 participants	215 participants

SECONDARY outcome

Timeframe: up to 77 months

Population: Safety Analysis Set

AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (or higher). Grade 1: mild; asymptomatic or mild symptoms. Grade 2: moderate. Grade 3: severe or medically significant but not immediately life threatening. Grade 4: life-threatening consequences. Grade 5: death. TEAEs were defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.

Outcome measures

Measure	Tafasitamab + Bendamustine n=219 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=225 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Number of Participants With Any Grade 3 or Higher TEAE	191 participants	159 participants

SECONDARY outcome

Timeframe: Baseline; End of Treatment (EOT) (up to 77 months)

Population: Full Analysis Set. Only participants with available data were analyzed.

The European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) contains 30 items and measures 5 functional dimensions (i.e., physical, role, emotional, cognitive, and social), 3 symptom items (i.e., fatigue, nausea/vomiting, and pain), 6 single items (i.e., dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and quality of life scale. For each scale and single item, a linear transformation was applied to standardize the scores between 0 (worst) and 100 (best) as described in the EORTC QLQ-C30 Scoring Manual.

Outcome measures

Measure	Tafasitamab + Bendamustine n=226 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=227 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT; Role Functioning	-14.84 scores on a scale Standard Deviation 33.87	-10.88 scores on a scale Standard Deviation 32.35
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT; Emotional Functioning	-5.60 scores on a scale Standard Deviation 24.88	-2.41 scores on a scale Standard Deviation 24.83
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT; Cognitive Functioning	-7.29 scores on a scale Standard Deviation 23.37	-4.71 scores on a scale Standard Deviation 24.67
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT; Social Functioning	-14.32 scores on a scale Standard Deviation 31.56	-4.98 scores on a scale Standard Deviation 27.03
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT, Fatigue	11.89 scores on a scale Standard Deviation 31.49	10.24 scores on a scale Standard Deviation 24.30
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT, Nausea and Vomiting	5.47 scores on a scale Standard Deviation 18.37	3.10 scores on a scale Standard Deviation 25.00
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT, Pain	6.33 scores on a scale Standard Deviation 30.42	7.93 scores on a scale Standard Deviation 33.11
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT, Dyspnoea	9.11 scores on a scale Standard Deviation 34.93	8.05 scores on a scale Standard Deviation 28.40
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT, Insomnia	1.30 scores on a scale Standard Deviation 36.80	2.28 scores on a scale Standard Deviation 33.37
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT, Loss of Appetite	16.15 scores on a scale Standard Deviation 38.33	9.36 scores on a scale Standard Deviation 31.98
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT, Constipation	5.21 scores on a scale Standard Deviation 33.58	1.60 scores on a scale Standard Deviation 28.05
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT, Diarrhoea	7.03 scores on a scale Standard Deviation 28.26	1.38 scores on a scale Standard Deviation 28.02
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT, Financial Impact	2.08 scores on a scale Standard Deviation 22.04	1.17 scores on a scale Standard Deviation 25.24
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline; Global Health Status/QoL Scale	59.19 scores on a scale Standard Deviation 22.94	59.89 scores on a scale Standard Deviation 23.75
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline; Physical Functioning	71.68 scores on a scale Standard Deviation 23.05	69.39 scores on a scale Standard Deviation 24.60
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline; Role Functioning	68.91 scores on a scale Standard Deviation 30.84	69.53 scores on a scale Standard Deviation 31.48
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline; Emotional Functioning	76.63 scores on a scale Standard Deviation 22.24	74.79 scores on a scale Standard Deviation 25.05
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline; Cognitive Functioning	82.81 scores on a scale Standard Deviation 18.61	81.41 scores on a scale Standard Deviation 22.74
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline; Social Functioning	74.74 scores on a scale Standard Deviation 27.53	73.93 scores on a scale Standard Deviation 29.45
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline, Fatigue	37.74 scores on a scale Standard Deviation 26.69	36.64 scores on a scale Standard Deviation 27.28
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline, Nausea and Vomiting	6.20 scores on a scale Standard Deviation 15.26	9.69 scores on a scale Standard Deviation 21.25
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline, Pain	28.25 scores on a scale Standard Deviation 31.02	27.36 scores on a scale Standard Deviation 30.18
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline, Dyspnoea	19.43 scores on a scale Standard Deviation 25.13	18.06 scores on a scale Standard Deviation 25.70
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline, Insomnia	30.64 scores on a scale Standard Deviation 32.77	29.22 scores on a scale Standard Deviation 31.87
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline, Loss of Appetite	20.27 scores on a scale Standard Deviation 28.44	22.17 scores on a scale Standard Deviation 31.87
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline, Constipation	15.25 scores on a scale Standard Deviation 24.85	14.83 scores on a scale Standard Deviation 24.30
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline, Diarrhoea	8.07 scores on a scale Standard Deviation 17.46	8.74 scores on a scale Standard Deviation 21.07
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population Baseline, Financial Impact	14.20 scores on a scale Standard Deviation 24.97	21.78 scores on a scale Standard Deviation 28.26
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT; Baseline; Global Health Status/QoL Scale	-7.23 scores on a scale Standard Deviation 22.56	-7.99 scores on a scale Standard Deviation 22.71
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population CFB at EOT; Baseline; Physical Functioning	-13.59 scores on a scale Standard Deviation 25.48	-7.51 scores on a scale Standard Deviation 22.95

SECONDARY outcome

Timeframe: Baseline; End of Treatment (EOT) (up to 77 months)

Population: Natural Killer Cell Count-Low Full Analysis Set. Only participants with available data were analyzed.

The European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) contains 30 items and measures 5 functional dimensions (i.e., physical, role, emotional, cognitive, and social), 3 symptom items (i.e., fatigue, nausea/vomiting, and pain), 6 single items (i.e., dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and quality of life scale. For each scale and single item, a linear transformation was applied to standardize the scores between 0 (worst) and 100 (best) as described in the EORTC QLQ-C30 Scoring Manual.

Outcome measures

Measure	Tafasitamab + Bendamustine n=88 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=74 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline; Global Health Status/QoL Scale	57.66 scores on a scale Standard Deviation 22.37	52.59 scores on a scale Standard Deviation 24.13
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline; Physical Functioning	68.60 scores on a scale Standard Deviation 24.73	64.30 scores on a scale Standard Deviation 26.46
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline; Role Functioning	65.89 scores on a scale Standard Deviation 31.61	60.59 scores on a scale Standard Deviation 33.63
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline; Emotional Functioning	76.10 scores on a scale Standard Deviation 22.32	67.61 scores on a scale Standard Deviation 28.71
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline; Cognitive Functioning	84.88 scores on a scale Standard Deviation 18.72	77.03 scores on a scale Standard Deviation 23.84
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline; Social Functioning	73.84 scores on a scale Standard Deviation 27.00	67.34 scores on a scale Standard Deviation 31.87
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Fatigue	39.02 scores on a scale Standard Deviation 26.61	43.62 scores on a scale Standard Deviation 28.01
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Nausea and Vomiting	6.20 scores on a scale Standard Deviation 14.24	15.77 scores on a scale Standard Deviation 26.44
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Pain	28.88 scores on a scale Standard Deviation 32.38	34.68 scores on a scale Standard Deviation 32.50
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Dyspnoea	21.32 scores on a scale Standard Deviation 25.52	21.62 scores on a scale Standard Deviation 28.37
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Insomnia	31.78 scores on a scale Standard Deviation 30.64	36.49 scores on a scale Standard Deviation 33.64
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Loss of Appetite	21.32 scores on a scale Standard Deviation 27.49	29.73 scores on a scale Standard Deviation 36.00
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Constipation	17.83 scores on a scale Standard Deviation 26.91	16.67 scores on a scale Standard Deviation 27.72
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Diarrhoea	7.75 scores on a scale Standard Deviation 16.71	9.01 scores on a scale Standard Deviation 22.95
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Financial Impact	13.57 scores on a scale Standard Deviation 25.25	24.32 scores on a scale Standard Deviation 32.78
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT; Baseline; Global Health Status/QoL Scale	-6.57 scores on a scale Standard Deviation 23.70	-7.54 scores on a scale Standard Deviation 30.84
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT; Baseline; Physical Functioning	-15.29 scores on a scale Standard Deviation 25.83	-11.83 scores on a scale Standard Deviation 33.60
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT; Role Functioning	-19.61 scores on a scale Standard Deviation 37.07	-15.45 scores on a scale Standard Deviation 41.06
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT; Emotional Functioning	-4.81 scores on a scale Standard Deviation 28.02	0.27 scores on a scale Standard Deviation 33.98
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT; Cognitive Functioning	-7.69 scores on a scale Standard Deviation 22.01	-5.95 scores on a scale Standard Deviation 30.54
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT; Social Functioning	-16.67 scores on a scale Standard Deviation 27.42	-2.44 scores on a scale Standard Deviation 32.18
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Fatigue	13.51 scores on a scale Standard Deviation 31.69	13.10 scores on a scale Standard Deviation 33.19
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Nausea and Vomiting	5.66 scores on a scale Standard Deviation 14.78	-3.66 scores on a scale Standard Deviation 34.86
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Pain	8.65 scores on a scale Standard Deviation 33.09	7.94 scores on a scale Standard Deviation 42.97
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Dyspnoea	9.15 scores on a scale Standard Deviation 37.17	7.94 scores on a scale Standard Deviation 32.77
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Insomnia	5.88 scores on a scale Standard Deviation 35.09	-1.59 scores on a scale Standard Deviation 41.62
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Loss of Appetite	20.26 scores on a scale Standard Deviation 41.14	10.32 scores on a scale Standard Deviation 42.60
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Constipation	5.88 scores on a scale Standard Deviation 32.46	0.79 scores on a scale Standard Deviation 30.79
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Diarrhoea	5.77 scores on a scale Standard Deviation 21.61	5.56 scores on a scale Standard Deviation 30.28
Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Financial Impact	2.56 scores on a scale Standard Deviation 17.27	7.32 scores on a scale Standard Deviation 26.37

SECONDARY outcome

Timeframe: Baseline; End of Treatment (EOT) (up to 77 months)

Population: Full Analysis Set. Only participants with available data were analyzed.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 [worst overall health] to 100 [best overall health]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health.

Outcome measures

Measure	Tafasitamab + Bendamustine n=226 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=227 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Overall Population Baseline, Mobility Level	1.83 scores on a scale Standard Deviation 0.969	1.94 scores on a scale Standard Deviation 1.054
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Overall Population Baseline, Self-care Level	1.37 scores on a scale Standard Deviation 0.771	1.44 scores on a scale Standard Deviation 0.861
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Overall Population Baseline, Usual Activities	1.97 scores on a scale Standard Deviation 1.086	1.92 scores on a scale Standard Deviation 1.063
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Overall Population Baseline, Pain/Discomfort	2.04 scores on a scale Standard Deviation 1.045	2.08 scores on a scale Standard Deviation 1.027
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Overall Population Baseline, Anxiety/Depression	1.67 scores on a scale Standard Deviation 0.844	1.73 scores on a scale Standard Deviation 0.907
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Overall Population CFB at EOT, Mobility Level	0.47 scores on a scale Standard Deviation 1.076	0.25 scores on a scale Standard Deviation 1.094
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Overall Population CFB at EOT, Self-care Level	0.48 scores on a scale Standard Deviation 1.052	0.23 scores on a scale Standard Deviation 0.946
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Overall Population CFB at EOT, Usual Activities	0.42 scores on a scale Standard Deviation 1.410	0.31 scores on a scale Standard Deviation 1.066
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Overall Population CFB at EOT, Pain/Discomfort	0.29 scores on a scale Standard Deviation 1.102	0.09 scores on a scale Standard Deviation 1.173
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Overall Population CFB at EOT, Anxiety/Depression	0.33 scores on a scale Standard Deviation 1.071	0.21 scores on a scale Standard Deviation 1.030

SECONDARY outcome

Timeframe: Baseline; End of Treatment (EOT) (up to 77 months)

Population: Full Analysis Set. Only participants with available data were analyzed.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 [worst overall health] to 100 [best overall health]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health.

Outcome measures

Measure	Tafasitamab + Bendamustine n=226 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=227 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Change From Baseline (CFB) in EQ-5D-5L VAS Score at End of Treatment in the Overall Population Baseline	66.22 scores on a scale Standard Deviation 20.5	66.69 scores on a scale Standard Deviation 20.4
Change From Baseline (CFB) in EQ-5D-5L VAS Score at End of Treatment in the Overall Population Change from Baseline at End of Treatment	-8.10 scores on a scale Standard Deviation 21.1	-5.47 scores on a scale Standard Deviation 23.2

SECONDARY outcome

Timeframe: Baseline; End of Treatment (EOT) (up to 77 months)

Population: Natural Killer Cell Count-Low Full Analysis Set. Only participants with available data were analyzed.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 [worst overall health] to 100 [best overall health]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health.

Outcome measures

Measure	Tafasitamab + Bendamustine n=88 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=74 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Change From Baseline (CFB) in EQ-5D-5L VAS Score at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline	65.87 scores on a scale Standard Deviation 21.4	58.65 scores on a scale Standard Deviation 20.7
Change From Baseline (CFB) in EQ-5D-5L VAS Score at End of Treatment in the Natural Killer Cell Count-Low Subgroup Change from Baseline at End of Treatment	-10.75 scores on a scale Standard Deviation 21.0	-7.53 scores on a scale Standard Deviation 31.4

SECONDARY outcome

Timeframe: Baseline; End of Treatment (EOT) (up to 77 months)

Population: Natural Killer Cell Count-Low Full Analysis Set. Only participants with available data were analyzed.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 [worst overall health] to 100 [best overall health]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health.

Outcome measures

Measure	Tafasitamab + Bendamustine n=88 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=74 Participants Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Mobility Level	2.09 scores on a scale Standard Deviation 0.983	2.04 scores on a scale Standard Deviation 1.104
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Self-care Level	1.49 scores on a scale Standard Deviation 0.977	1.54 scores on a scale Standard Deviation 0.917
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Usual Activities	2.03 scores on a scale Standard Deviation 1.116	2.14 scores on a scale Standard Deviation 1.228
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Pain/Discomfort	2.08 scores on a scale Standard Deviation 1.054	2.26 scores on a scale Standard Deviation 1.060
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup Baseline, Anxiety/Depression	1.65 scores on a scale Standard Deviation 0.803	1.96 scores on a scale Standard Deviation 1.143
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Mobility Level	0.55 scores on a scale Standard Deviation 1.080	0.46 scores on a scale Standard Deviation 1.315
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Self-care Level	0.53 scores on a scale Standard Deviation 1.080	0.41 scores on a scale Standard Deviation 1.312
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Usual Activities	0.62 scores on a scale Standard Deviation 1.392	0.53 scores on a scale Standard Deviation 1.224
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Pain/Discomfort	0.40 scores on a scale Standard Deviation 1.173	0.05 scores on a scale Standard Deviation 1.469
Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup CFB at EOT, Anxiety/Depression	0.30 scores on a scale Standard Deviation 1.250	0.24 scores on a scale Standard Deviation 1.324

SECONDARY outcome

Timeframe: pre-dose: Cycle 1 Days 1, 2, 3, 4, 15; Cycle 2 Days 1, 15; Cycle 3 Days 1, 15, Cycles 4, 5, 6, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35 Day 1. 1 hour post-dose: Cycle 1 Days 1, 4, 15; Cycle 2 Days 1, 15; Cycle 3 Days 1, 15

Population: Pharmacokinetic (PK) Analysis Set: all participants who received at least one dose of tafasitamab and had at least one quantifiable serum tafasitamab concentration

Blood samples were collected for the assessment of serum concentrations of tafasitamab.

Outcome measures

Measure	Tafasitamab + Bendamustine n=219 Participants Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Tafasitamab Serum Concentrations Cycle 1 Day 1, pre-dose	0.00 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 58.8	—
Tafasitamab Serum Concentrations Cycle 1 Day 1, 1 hour post-dose	2.45 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 37.1	—
Tafasitamab Serum Concentrations Cycle 1 Day 2, pre-dose	2.06 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 30.2	—
Tafasitamab Serum Concentrations Cycle 1 Day 3, pre-dose	1.63 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 30.4	—
Tafasitamab Serum Concentrations Cycle 1 Day 4, pre-dose	1.34 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 33.5	—
Tafasitamab Serum Concentrations Cycle 1 Day 4, 1 hour post-dose	3.84 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 31.8	—
Tafasitamab Serum Concentrations Cycle 1 Day 15, pre-dose	2.14 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 39.1	—
Tafasitamab Serum Concentrations Cycle 1 Day 15, 1 hour post-dose	4.68 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 31.9	—
Tafasitamab Serum Concentrations Cycle 2 Day 1, pre-dose	2.37 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 55.1	—
Tafasitamab Serum Concentrations Cycle 2 Day 1, 1 hour post-dose	4.80 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 32.8	—
Tafasitamab Serum Concentrations Cycle 2 Day 15, pre-dose	2.73 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 42.4	—
Tafasitamab Serum Concentrations Cycle 2 Day 15, 1 hour post-dose	5.20 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 44.4	—
Tafasitamab Serum Concentrations Cycle 3 Day 1, pre-dose	2.92 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 43.5	—
Tafasitamab Serum Concentrations Cycle 3 Day 1, 1 hour post-dose	5.38 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 32.2	—
Tafasitamab Serum Concentrations Cycle 3 Day 15, pre-dose	3.14 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 38.3	—
Tafasitamab Serum Concentrations Cycle 3 Day 15, 1 hour post-dose	5.54 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 30.1	—
Tafasitamab Serum Concentrations Cycle 4 Day 1, pre-dose	3.27 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 43.2	—
Tafasitamab Serum Concentrations Cycle 5 Day 1, pre-dose	1.95 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 54.6	—
Tafasitamab Serum Concentrations Cycle 6 Day 1, pre-dose	1.60 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 61.2	—
Tafasitamab Serum Concentrations Cycle 7 Day 1, pre-dose	1.14 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 75.3	—
Tafasitamab Serum Concentrations Cycle 9 Day 1, pre-dose	1.79 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 50.3	—
Tafasitamab Serum Concentrations Cycle 11 Day 1, pre-dose	1.73 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 58.1	—
Tafasitamab Serum Concentrations Cycle 13 Day 1, pre-dose	1.81 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 66.4	—
Tafasitamab Serum Concentrations Cycle 15 Day 1, pre-dose	1.83 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 55.8	—
Tafasitamab Serum Concentrations Cycle 17 Day 1, pre-dose	1.86 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 48.3	—
Tafasitamab Serum Concentrations Cycle 19 Day 1, pre-dose	1.98 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 36.4	—
Tafasitamab Serum Concentrations Cycle 21 Day 1, pre-dose	1.91 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 52.0	—
Tafasitamab Serum Concentrations Cycle 23 Day 1, pre-dose	1.88 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 55.2	—
Tafasitamab Serum Concentrations Cycle 25 Day 1, pre-dose	2.24 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 37.7	—
Tafasitamab Serum Concentrations Cycle 27 Day 1, pre-dose	1.92 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 12.6	—
Tafasitamab Serum Concentrations Cycle 29 Day 1, pre-dose	2.05 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 21.3	—
Tafasitamab Serum Concentrations Cycle 31 Day 1, pre-dose	1.64 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 23.9	—
Tafasitamab Serum Concentrations Cycle 33 Day 1, pre-dose	1.45 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation NA Dispersion cannot be calculated for a single participant.	—
Tafasitamab Serum Concentrations Cycle 35 Day 1, pre-dose	1.51 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 2.7	—

Adverse Events

Tafasitamab + Bendamustine

Serious events: 115 serious events

Other events: 206 other events

Deaths: 129 deaths

Rituximab + Bendamustine

Serious events: 100 serious events

Other events: 199 other events

Deaths: 127 deaths

Serious adverse events

Measure	Tafasitamab + Bendamustine n=219 participants at risk Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=225 participants at risk Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
General disorders Death	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.89% 2/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Abdominal infection	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Abdominal pain	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Renal and urinary disorders Acute kidney injury	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.89% 2/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.89% 2/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Vascular disorders Aneurysm	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Angina unstable	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Vascular disorders Aortic stenosis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Appendicitis	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Musculoskeletal and connective tissue disorders Arthralgia	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
General disorders Asthenia	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	1.3% 3/225 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Atrial fibrillation	1.4% 3/219 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Atrial flutter	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Atypical pneumonia	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Renal and urinary disorders Azotaemia	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Musculoskeletal and connective tissue disorders Back pain	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Bacteraemia	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Bacterial sepsis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.91% 2/219 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Bronchitis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.89% 2/225 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations COVID-19	4.1% 9/219 • Number of events 9 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	2.7% 6/225 • Number of events 6 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations COVID-19 pneumonia	1.8% 4/219 • Number of events 4 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	2.7% 6/225 • Number of events 6 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Cardiac arrest	0.91% 2/219 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Cardiac failure	1.4% 3/219 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	1.8% 4/225 • Number of events 4 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Cardiac failure acute	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Cardiac failure congestive	0.91% 2/219 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Cardiomyopathy	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Cardiopulmonary failure	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Cellulitis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.89% 2/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Central nervous system infection	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Cerebral infarction	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Cerebrovascular accident	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Hepatobiliary disorders Cholelithiasis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Renal and urinary disorders Chronic kidney disease	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Clostridial sepsis	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Clostridium difficile colitis	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Injury, poisoning and procedural complications Compression fracture	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Constipation	0.46% 1/219 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Cystitis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Cytomegalovirus infection	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Decreased appetite	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Vascular disorders Deep vein thrombosis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.89% 2/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Dehydration	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Psychiatric disorders Delirium	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Product Issues Device malfunction	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Device related infection	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Diarrhoea	0.91% 2/219 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
General disorders Discomfort	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Disseminated tuberculosis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Diverticulum oesophageal	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Skin and subcutaneous tissue disorders Drug eruption	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Dysbiosis	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Dyspepsia	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.89% 2/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Enterococcal sepsis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Enterocolitis	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Erysipelas	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Escherichia sepsis	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Injury, poisoning and procedural complications Fall	0.91% 2/219 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
General disorders Fatigue	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Febrile infection	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Blood and lymphatic system disorders Febrile neutropenia	1.8% 4/219 • Number of events 4 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	2.7% 6/225 • Number of events 7 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Injury, poisoning and procedural complications Flatback syndrome	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Injury, poisoning and procedural complications Fracture	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Gastritis erosive	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Gastroenteritis	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Gastroenteritis viral	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
General disorders General physical health deterioration	1.4% 3/219 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Haemophilus sepsis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Hemiparesis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Hepatobiliary disorders Hepatic cirrhosis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Herpes simplex	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Herpes zoster	1.8% 4/219 • Number of events 4 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Herpes zoster disseminated	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Herpes zoster reactivation	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Vascular disorders Hypertensive crisis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Hypoglycaemia	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Hyponatraemia	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Vascular disorders Hypotension	0.91% 2/219 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Ileus	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
General disorders Illness	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Infection	0.46% 1/219 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Influenza	1.4% 3/219 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	2.2% 5/225 • Number of events 5 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
General disorders Influenza like illness	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	1.3% 3/225 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Ischaemic stroke	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Klebsiella infection	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Large intestine infection	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Limbic encephalitis	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Liver abscess	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Lower respiratory tract infection	1.4% 3/219 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	1.3% 3/225 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.89% 2/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma recurrent	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Eye disorders Macular oedema	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Mouth ulceration	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
General disorders Mucosal inflammation	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
General disorders Multiple organ dysfunction syndrome	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.89% 2/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Blood and lymphatic system disorders Myelosuppression	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Myocardial infarction	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Nausea	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Neuropathy peripheral	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Blood and lymphatic system disorders Neutropenia	2.3% 5/219 • Number of events 5 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	1.8% 4/225 • Number of events 4 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Neutropenic sepsis	1.4% 3/219 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer recurrent	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Oropharyngeal candidiasis	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Pancreatitis	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Parainfluenzae virus infection	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Peripheral sensorimotor neuropathy	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Pharyngitis	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Pneumonia	11.9% 26/219 • Number of events 29 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	7.6% 17/225 • Number of events 17 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Pneumonia bacterial	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.89% 2/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Pneumonia staphylococcal	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Pneumonia streptococcal	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Post herpetic neuralgia	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Skin and subcutaneous tissue disorders Pruritus	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.4% 3/219 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Pulmonary sepsis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Pyelonephritis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Pyelonephritis acute	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
General disorders Pyrexia	4.1% 9/219 • Number of events 12 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	2.2% 5/225 • Number of events 5 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Rectal abscess	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Renal and urinary disorders Renal impairment	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.89% 2/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Rhinovirus infection	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Salmonella bacteraemia	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Sciatica	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Seizure	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Sepsis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	2.2% 5/225 • Number of events 5 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Septic shock	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	1.8% 4/225 • Number of events 4 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Vascular disorders Shock haemorrhagic	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Skin infection	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Small intestinal perforation	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	1.4% 3/219 • Number of events 5 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	1.4% 3/219 • Number of events 4 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Staphylococcal sepsis	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Status epilepticus	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Streptococcal sepsis	0.46% 1/219 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Supraventricular tachyarrhythmia	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Syncope	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	1.3% 3/225 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Tachycardia	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Blood and lymphatic system disorders Thrombocytopenia	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Toxic encephalopathy	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.89% 2/225 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Upper respiratory tract infection	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Urinary tract infection	1.4% 3/219 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.89% 2/225 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Urosepsis	0.91% 2/219 • Number of events 2 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Varicella zoster virus infection	0.46% 1/219 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.00% 0/225 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Ventricular tachycardia	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Vomiting	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	1.3% 3/225 • Number of events 3 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Weil's disease	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/219 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	0.44% 1/225 • Number of events 1 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.

Other adverse events

Measure	Tafasitamab + Bendamustine n=219 participants at risk Participants received intravenous (IV) tafasitamab 12.0 milligrams per kilogram (mg/kg) in combination with IV bendamustine 90 mg/meters squared (m\^2) in 28-day cycles for a maximum of 6 cycles. During Cycles 1 to 3, participants received tafastiamab on Days 1, 8, 15, and 22, plus a loading dose on Day 4 of Cycle 1. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.	Rituximab + Bendamustine n=225 participants at risk Participants received IV rituximab 375 mg/m\^2 in combination with IV bendamustine 90 mg/m\^2 in 28-day cycles for a maximum of 6 cycles. Participants received rituximab on Day 1 of each cycle until disease progression. Participants received bendamustine on either Days 2 and 3 or Days 1 and 2 of Cycles 1 to 6. Participants with an ongoing response of at least partial response at the end of Cycle 6, as per local assessment, continued tafasitamab or rituximab monotherapy per initially allocated treatment until disease progression. Treatment was stopped due to disease progression, unacceptable toxicity, death, or discontinuation for any other reason, whichever came first.
Gastrointestinal disorders Abdominal pain	14.2% 31/219 • Number of events 41 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	6.7% 15/225 • Number of events 16 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Investigations Alanine aminotransferase increased	5.0% 11/219 • Number of events 14 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	4.4% 10/225 • Number of events 16 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Blood and lymphatic system disorders Anaemia	27.4% 60/219 • Number of events 94 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	21.3% 48/225 • Number of events 73 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Musculoskeletal and connective tissue disorders Arthralgia	6.8% 15/219 • Number of events 19 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	4.9% 11/225 • Number of events 11 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Investigations Aspartate aminotransferase increased	5.5% 12/219 • Number of events 15 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	3.6% 8/225 • Number of events 13 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Hypomagnesaemia	5.9% 13/219 • Number of events 15 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	3.1% 7/225 • Number of events 10 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
General disorders Asthenia	18.3% 40/219 • Number of events 51 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	11.1% 25/225 • Number of events 32 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Musculoskeletal and connective tissue disorders Back pain	7.3% 16/219 • Number of events 19 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	11.6% 26/225 • Number of events 30 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Investigations Blood creatinine increased	8.2% 18/219 • Number of events 25 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	4.4% 10/225 • Number of events 17 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Constipation	22.8% 50/219 • Number of events 63 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	18.2% 41/225 • Number of events 46 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Respiratory, thoracic and mediastinal disorders Cough	18.7% 41/219 • Number of events 68 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	11.1% 25/225 • Number of events 33 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Decreased appetite	21.5% 47/219 • Number of events 63 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	16.0% 36/225 • Number of events 45 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Diarrhoea	26.5% 58/219 • Number of events 103 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	19.1% 43/225 • Number of events 61 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Dizziness	11.9% 26/219 • Number of events 32 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	6.2% 14/225 • Number of events 15 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Dyspepsia	8.2% 18/219 • Number of events 24 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	6.2% 14/225 • Number of events 15 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.8% 28/219 • Number of events 33 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	8.0% 18/225 • Number of events 21 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
General disorders Fatigue	25.6% 56/219 • Number of events 78 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	16.4% 37/225 • Number of events 45 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Nervous system disorders Headache	13.7% 30/219 • Number of events 38 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	11.1% 25/225 • Number of events 36 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Hyperglycaemia	7.3% 16/219 • Number of events 31 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	6.7% 15/225 • Number of events 33 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Vascular disorders Hypertension	5.9% 13/219 • Number of events 16 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	4.9% 11/225 • Number of events 13 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Metabolism and nutrition disorders Hypokalaemia	12.8% 28/219 • Number of events 48 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	13.3% 30/225 • Number of events 41 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Vascular disorders Hypotension	7.8% 17/219 • Number of events 18 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	5.3% 12/225 • Number of events 12 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Injury, poisoning and procedural complications Infusion related reaction	3.7% 8/219 • Number of events 8 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	6.7% 15/225 • Number of events 15 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Psychiatric disorders Insomnia	9.1% 20/219 • Number of events 22 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	8.0% 18/225 • Number of events 21 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Blood and lymphatic system disorders Leukopenia	9.6% 21/219 • Number of events 37 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	6.2% 14/225 • Number of events 40 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Blood and lymphatic system disorders Lymphopenia	9.1% 20/219 • Number of events 26 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	8.4% 19/225 • Number of events 39 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Nasopharyngitis	5.9% 13/219 • Number of events 15 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	6.2% 14/225 • Number of events 17 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Nausea	35.2% 77/219 • Number of events 133 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	27.6% 62/225 • Number of events 92 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Blood and lymphatic system disorders Neutropenia	53.0% 116/219 • Number of events 304 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	43.6% 98/225 • Number of events 347 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
General disorders Oedema peripheral	11.4% 25/219 • Number of events 30 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	7.6% 17/225 • Number of events 18 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Musculoskeletal and connective tissue disorders Pain in extremity	6.8% 15/219 • Number of events 20 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	4.0% 9/225 • Number of events 10 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Pneumonia	4.1% 9/219 • Number of events 10 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	5.3% 12/225 • Number of events 13 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Respiratory, thoracic and mediastinal disorders Productive cough	5.9% 13/219 • Number of events 19 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	2.7% 6/225 • Number of events 6 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Skin and subcutaneous tissue disorders Pruritus	4.6% 10/219 • Number of events 18 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	11.6% 26/225 • Number of events 32 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
General disorders Pyrexia	17.4% 38/219 • Number of events 57 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	15.6% 35/225 • Number of events 49 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Skin and subcutaneous tissue disorders Rash	8.2% 18/219 • Number of events 22 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	6.2% 14/225 • Number of events 18 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Cardiac disorders Tachycardia	5.9% 13/219 • Number of events 14 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	3.1% 7/225 • Number of events 7 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Blood and lymphatic system disorders Thrombocytopenia	30.6% 67/219 • Number of events 112 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	26.7% 60/225 • Number of events 101 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Upper respiratory tract infection	8.2% 18/219 • Number of events 29 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	9.3% 21/225 • Number of events 31 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Infections and infestations Urinary tract infection	7.8% 17/219 • Number of events 21 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	8.9% 20/225 • Number of events 31 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Gastrointestinal disorders Vomiting	14.2% 31/219 • Number of events 43 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	9.8% 22/225 • Number of events 38 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.
Investigations Weight decreased	6.8% 15/219 • Number of events 15 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.	8.9% 20/225 • Number of events 20 • up to approximately 7.5 years All-Cause Mortality was assessed in the Full Analysis Set, comprised of all participants who were randomized to either treatment arm. Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least one dose of tafasitamab, bendamustine, or rituximab.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: medinfo@incyte.com

Results disclosure agreements

• Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
• Publication restrictions are in place

Restriction type: OTHER