A Trial to Evaluate the Efficacy and Safety of Tafasitama... | NCT02763319

ID	Type	Description	Link
2014-004689-11	EudraCT Number

Label	Type	Description	Intervention Names
Tafasitamab and bendamustine	Experimental	Tafasitamab and bendamustine	Drug: Tafasitamab Drug: Bendamustine (BEN)
Rituximab and bendamustine	Active Comparator	Rituximab and bendamustine	Drug: Rituximab (RTX) Drug: Bendamustine (BEN)

Name	Type	Description	Arm Group Labels	Other Names
Rituximab (RTX)	Drug	Rituximab: Dose: 375 mg/m2 IV	Rituximab and bendamustine

Measure	Description	Time Frame
Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Overall Population	Progression-free survival was defined as the time from randomization to tumor progression or death from any cause.	up to 41.4 months
Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup	Progression-free survival was defined as the time from randomization to tumor progression or death from any cause.	up to 46.5 months

Measure	Description	Time Frame
Best Objective Response Rate (ORR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population	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.

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

Age ≥18 years
Histologically confirmed diagnosis, according to the World Health Organization (WHO, 2008) classification, of: DLBCL NOS, THRLBCL, EBV-positive DLBCL, composite lymphoma with a DLBCL component with a DLBCL relapse subsequent to DLBCL treatment, disease transformed from an earlier diagnosis of low grade lymphoma (i.e. an indolent pathology such as follicular lymphoma, marginal zone lymphoma) into DLBCL with a DLBCL relapse subsequent to DLBCL treatment.
Fresh tumour tissue for central pathology review must be provided as an adjunct to participation in this study. Should it not be possible to obtain a fresh tumour tissue sample, archival paraffin embedded tumour tissue acquired ≤3 years prior to screening for this protocol must be available for this purpose.
Patients must have:
1. relapsed or refractory DLBCL
2. at least one bidimensionally measurable disease site. The lesion must have a greatest transverse diameter of ≥1.5 cm and greatest perpendicular diameter of ≥1.0 cm at baseline. The lesion must be positive on PET scan
3. received at least one, but no more than three previous systemic therapy lines for the treatment of DLBCL. At least one previous therapy line must have included a CD20-targeted.
4. ECOG 0 to 2
Patients after failure of ASCT or patients considered in the opinion of the investigator currently not eligible for HDC with subsequent ASCT.
Patients must meet the following laboratory criteria at Screening:
1. ANC ≥1.5 × 109/L (unless secondary to bone marrow involvement by DLBCL)
2. PLTs ≥90 × 109/L (unless secondary to bone marrow involvement by DLBCL) and absence of active bleeding
3. total serum bilirubin ≤2.5 × ULN unless secondary to Gilbert's syndrome (or pattern consistent with Gilbert's) or documented liver involvement by lymphoma. Patients with Gilbert's syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is ≤5 x ULN
4. ALT, AST and AP ≤3 × ULN or <5 × ULN in cases of documented liver involvement by lymphoma
5. serum creatinine ≤2.0 x ULN or creatinine clearance must be ≥40 mL/min calculated using a standard Cockcroft-Gault formula (Cockroft & Gault, 1976)
For a female of childbearing potential (FCBP), a negative pregnancy test must be confirmed before enrolment. An FCBP must commit to take highly effective contraceptive precautions without interruption during the study and for 3, 6 or 12 months after the last dose of Tafasitamab, BEN or RTX respectively, whichever is later. An FCBP must refrain from breastfeeding and donating blood or oocytes during the course of the study and for 3, 6 or 12 months after the last dose of Tafasitamab, BEN or RTX respectively, whichever is later. Restrictions concerning blood donations apply as well to females who are not of childbearing potential.
Males must use an effective barrier method of contraception without interruption during the study and for 3, 6 or 12 months after the last dose of Tafasitamab, BEN or RTX respectively, whichever is later, if the patient is sexually active with an FCBP. Males must refrain from donating blood or sperm during study participation and for 3, 6 or 12 months after the last dose of Tafasitamab, BEN or RTX respectively, whichever is later.
In the opinion of the investigator, the patients must:
1. be able to comply with all study-related procedures, medication use, and evaluations
2. be able to understand and give informed consent
3. not be considered to be potentially unreliable and/or not cooperative.

EXCLUSION CRITERIA:

Patients who have: any other histological type of lymphoma including, e.g., primary mediastinal (thymic) large B-cell lymphoma (PMBL) or Burkitt's lymphoma, primary refractory DLBCL, patients with known "double/triple hit" DLBCL genetics, CNS lymphoma involvement in present or past medical history
Patients who had a major surgery less than 30 days prior to Day 1 dosing
Patients who have, within 14 days prior to Day 1 dosing:
1. not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy
2. received live vaccines
3. required parenteral antimicrobial therapy for active, intercurrent systemic infections
Patients who:
1. in the opinion of the investigator, have not recovered sufficiently from the adverse toxic effects of prior therapies, major surgeries or significant traumatic injuries
2. were previously treated with CD19-targeted therapy or BEN
3. have a history of previous severe allergic reactions to compounds of similar biological or chemical composition to Tafasitamab, RTX, murine proteins or BEN, or the excipients contained in the study drug formulations
4. have undergone ASCT within a period of ≤3 months prior to signing the informed consent form. Patients who have a more distant history of ASCT must exhibit full haematological recovery before enrolment into the study.
5. have undergone previous allogeneic stem cell transplantation
6. concurrently use other anticancer or experimental treatments
Prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ≥3 years prior to Screening. Exceptions to the ≥3-year time limit include history of the following:
1. basal cell carcinoma of the skin
2. squamous cell carcinoma of the skin
3. carcinoma in situ of the cervix, breast and bladder
f) incidental histological finding of prostate cancer (Tumour/Node/Metastasis [TNM] stage of T1a or T1b)
Patients with:
1. positive hepatitis B and/or C serology
2. known seropositivity for or history of active viral infection with HIV
3. evidence of active, severe uncontrolled systemic infections or sepsis
4. a history or evidence of severely immunocompromised state
5. a history or evidence of severe hepatic impairment (total serum bilirubin > 3 mg/dL), jaundice unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma
6. a history or evidence of clinically significant cardiovascular, cerebrovascular, CNS and/or other disease that, in the investigator's opinion, would preclude participation in the study or compromise the patient's ability to give informed consent

Name	Affiliation	Role
Incyte Medical Director	Incyte Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
MorphoSys Research Site		Anaheim	California	92801	United States
MorphoSys Research Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 10, 2024	May 22, 2025

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Overall Population

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

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.

Posted

Median

95% Confidence Interval

months

up to 41.4 months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000226 OG001227

Title

Denominators

Categories

Title	Measurements
	OG0007.10(5.800 to 8.500) OG0018.30(5.600 to 11.500)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Inverse normal test	The Inverse Normal method combines information (p-value) from the interim analysis and information from the final analysis.	0.468		Hazard Ratio (HR)	1.06			2-Sided	95	0.837	1.351			The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per the Interactive Web Response System (IWRS). Rituximab + bendamustine was the reference treatment group.		Superiority

Primary

Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup

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

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.

Posted

Median

95% Confidence Interval

months

up to 46.5 months

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Best Objective Response Rate (ORR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population

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.

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

Posted

Number

95% Confidence Interval

percentage of participants

up to 77 months

ID	Title	Description
OG000	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.
OG001	Rituximab + Bendamustine

Secondary

Best ORR by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup

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.

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

Posted

Number

95% Confidence Interval

percentage of participants

up to 77 months

ID	Title	Description
OG000	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.
OG001	Rituximab + Bendamustine

Secondary

Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Overall Population

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.

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.

Posted

Median

95% Confidence Interval

months

up to 40.2 months

ID	Title	Description
OG000	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.

Secondary

Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup

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.

Posted

Median

95% Confidence Interval

months

up to 44.7 months

ID	Title	Description
OG000	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.

Secondary

Kaplan-Meier Estimate of Overall Survival in the Overall Population

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

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.

Posted

Median

95% Confidence Interval

months

up to 50.0 months

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Kaplan-Meier Estimate of Overall Survival in the Natural Killer Cell Count-Low Subgroup

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

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.

Posted

Median

95% Confidence Interval

months

up to 50.6 months

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Disease Control Rate (DCR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population

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).

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

Posted

Number

95% Confidence Interval

percentage of participants

up to 77 months

ID	Title	Description
OG000	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.
OG001

Secondary

DCR by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup

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).

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

Posted

Number

95% Confidence Interval

percentage of participants

up to 77 months

ID	Title	Description
OG000	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.
OG001

Secondary

Kaplan-Meier Estimate of Time to Progression by Independent Radiology/Clinical Review Committee Assessment in the Overall Population

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.

Posted

Median

95% Confidence Interval

months

up to 25.8 months

ID	Title	Description
OG000	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.
OG001	Rituximab + Bendamustine

Secondary

Kaplan-Meier Estimate of Time to Progression by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup

Posted

Median

95% Confidence Interval

months

up to 40.6 months

ID	Title	Description
OG000	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.
OG001

Secondary

Kaplan-Meier Estimate of Time to Next Treatment in the Overall Population

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.

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.

Posted

Median

95% Confidence Interval

months

up to 59.4 months

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Kaplan-Meier Estimate of Time to Next Treatment in the Natural Killer Cell Count-Low Subgroup

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.

Posted

Median

95% Confidence Interval

months

up to 70.1 months

ID	Title	Description
OG000	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.
OG001	Rituximab + Bendamustine

Secondary

Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

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.

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

Posted

Number

participants

up to 77 months

ID	Title	Description
OG000	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.

Secondary

Number of Participants With Any Grade 3 or Higher TEAE

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.

Safety Analysis Set

Posted

Number

participants

up to 77 months

ID	Title	Description
OG000	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.
OG001	Rituximab + Bendamustine

Secondary

Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population

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.

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

Posted

Mean

Standard Deviation

scores on a scale

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

ID	Title	Description
OG000	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.

Secondary

Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup

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

Posted

Mean

Standard Deviation

scores on a scale

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

ID	Title	Description
OG000	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.

Secondary

Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Overall Population

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.

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

Posted

Mean

Standard Deviation

scores on a scale

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

ID	Title	Description
OG000	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.

Secondary

Change From Baseline (CFB) in EQ-5D-5L VAS Score at End of Treatment in the Overall Population

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

Posted

Mean

Standard Deviation

scores on a scale

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

ID	Title	Description
OG000	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.

Secondary

Change From Baseline (CFB) in EQ-5D-5L VAS Score at End of Treatment in the Natural Killer Cell Count-Low Subgroup

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

Posted

Mean

Standard Deviation

scores on a scale

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

ID	Title	Description
OG000	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.

Secondary

Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup

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

Posted

Mean

Standard Deviation

scores on a scale

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

ID	Title	Description
OG000	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.

Secondary

Tafasitamab Serum Concentrations

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms per milliliter (µg/mL)

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

ID	Title	Description
OG000	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.
OG001	Rituximab + Bendamustine

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	129	226	115	219	206	219
EG001	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.	127	227	100	225	199	225

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0012 events2 affected225 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0012 events2 affected225 at risk
Aneurysm	Vascular disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Angina unstable	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Aortic stenosis	Vascular disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Appendicitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Asthenia	General disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0013 events3 affected225 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0003 events3 affected219 at risk EG0012 events1 affected225 at risk
Atrial flutter	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Atypical pneumonia	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Azotaemia	Renal and urinary disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Bacteraemia	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Bacterial sepsis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0003 events2 affected219 at risk EG0011 events1 affected225 at risk
Basosquamous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Bronchitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0013 events2 affected225 at risk
COVID-19	Infections and infestations	MedDRA 27	Systematic Assessment	EG0009 events9 affected219 at risk EG0016 events6 affected225 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 27	Systematic Assessment	EG0004 events4 affected219 at risk EG0016 events6 affected225 at risk
Cardiac arrest	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0002 events2 affected219 at risk EG0011 events1 affected225 at risk
Cardiac failure	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0003 events3 affected219 at risk EG0014 events4 affected225 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0002 events2 affected219 at risk EG0010 events0 affected225 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Cellulitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0012 events2 affected225 at risk
Central nervous system infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Cerebral infarction	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0012 events1 affected225 at risk
Clostridial sepsis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Constipation	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0002 events1 affected219 at risk EG0011 events1 affected225 at risk
Cystitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Death	General disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0012 events2 affected225 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0011 events1 affected225 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0012 events2 affected225 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0011 events1 affected225 at risk
Delirium	Psychiatric disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Device malfunction	Product Issues	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Device related infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0011 events1 affected225 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0002 events2 affected219 at risk EG0010 events0 affected225 at risk
Discomfort	General disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Diverticulum oesophageal	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Dysbiosis	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0012 events2 affected225 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0011 events1 affected225 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Erysipelas	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Escherichia sepsis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0002 events2 affected219 at risk EG0011 events1 affected225 at risk
Fatigue	General disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0011 events1 affected225 at risk
Febrile infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 27	Systematic Assessment	EG0004 events4 affected219 at risk EG0017 events6 affected225 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Flatback syndrome	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Gastroenteritis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
General physical health deterioration	General disorders	MedDRA 27	Systematic Assessment	EG0003 events3 affected219 at risk EG0010 events0 affected225 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Haemophilus sepsis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Hemiparesis	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Herpes simplex	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Herpes zoster	Infections and infestations	MedDRA 27	Systematic Assessment	EG0004 events4 affected219 at risk EG0010 events0 affected225 at risk
Herpes zoster disseminated	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Herpes zoster reactivation	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Hypertensive crisis	Vascular disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0011 events1 affected225 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Hypotension	Vascular disorders	MedDRA 27	Systematic Assessment	EG0002 events2 affected219 at risk EG0011 events1 affected225 at risk
Ileus	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0012 events1 affected225 at risk
Illness	General disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0003 events1 affected219 at risk EG0011 events1 affected225 at risk
Influenza	Infections and infestations	MedDRA 27	Systematic Assessment	EG0003 events3 affected219 at risk EG0015 events5 affected225 at risk
Influenza like illness	General disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0013 events3 affected225 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Klebsiella infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Large intestine infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Limbic encephalitis	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Liver abscess	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0003 events3 affected219 at risk EG0013 events3 affected225 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0012 events2 affected225 at risk
Lung adenocarcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Macular oedema	Eye disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Mucosal inflammation	General disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0012 events2 affected225 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Myocardial infarction	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0011 events1 affected225 at risk
Nausea	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 27	Systematic Assessment	EG0005 events5 affected219 at risk EG0014 events4 affected225 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0003 events3 affected219 at risk EG0010 events0 affected225 at risk
Non-small cell lung cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Pharyngitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Pneumonia	Infections and infestations	MedDRA 27	Systematic Assessment	EG00029 events26 affected219 at risk EG00117 events17 affected225 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0012 events2 affected225 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0003 events3 affected219 at risk EG0010 events0 affected225 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0013 events1 affected225 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Pyelonephritis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0011 events1 affected225 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Pyrexia	General disorders	MedDRA 27	Systematic Assessment	EG00012 events9 affected219 at risk EG0015 events5 affected225 at risk
Rectal abscess	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Renal impairment	Renal and urinary disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0011 events1 affected225 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0012 events2 affected225 at risk
Rhinovirus infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Salmonella bacteraemia	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Sciatica	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Seizure	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Sepsis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0015 events5 affected225 at risk
Septic shock	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0014 events4 affected225 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Skin infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0005 events3 affected219 at risk EG0011 events1 affected225 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0004 events3 affected219 at risk EG0011 events1 affected225 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Status epilepticus	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0002 events1 affected219 at risk EG0010 events0 affected225 at risk
Supraventricular tachyarrhythmia	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Syncope	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0013 events3 affected225 at risk
Tachycardia	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0012 events1 affected225 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0012 events2 affected225 at risk
Tumour necrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Urinary tract infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0003 events3 affected219 at risk EG0013 events2 affected225 at risk
Urosepsis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0002 events2 affected219 at risk EG0011 events1 affected225 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected225 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0013 events3 affected225 at risk
Weil's disease	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected225 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG00041 events31 affected219 at risk EG00116 events15 affected225 at risk
Alanine aminotransferase increased	Investigations	MedDRA 27	Systematic Assessment	EG00014 events11 affected219 at risk EG00116 events10 affected225 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 27	Systematic Assessment	EG00094 events60 affected219 at risk EG00173 events48 affected225 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG00019 events15 affected219 at risk EG00111 events11 affected225 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 27	Systematic Assessment	EG00015 events12 affected219 at risk EG00113 events8 affected225 at risk
Asthenia	General disorders	MedDRA 27	Systematic Assessment	EG00051 events40 affected219 at risk EG00132 events25 affected225 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG00019 events16 affected219 at risk EG00130 events26 affected225 at risk
Blood creatinine increased	Investigations	MedDRA 27	Systematic Assessment	EG00025 events18 affected219 at risk EG00117 events10 affected225 at risk
Constipation	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG00063 events50 affected219 at risk EG00146 events41 affected225 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG00068 events41 affected219 at risk EG00133 events25 affected225 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG00063 events47 affected219 at risk EG00145 events36 affected225 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG000103 events58 affected219 at risk EG00161 events43 affected225 at risk
Dizziness	Nervous system disorders	MedDRA 27	Systematic Assessment	EG00032 events26 affected219 at risk EG00115 events14 affected225 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG00024 events18 affected219 at risk EG00115 events14 affected225 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG00033 events28 affected219 at risk EG00121 events18 affected225 at risk
Fatigue	General disorders	MedDRA 27	Systematic Assessment	EG00078 events56 affected219 at risk EG00145 events37 affected225 at risk
Headache	Nervous system disorders	MedDRA 27	Systematic Assessment	EG00038 events30 affected219 at risk EG00136 events25 affected225 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG00031 events16 affected219 at risk EG00133 events15 affected225 at risk
Hypertension	Vascular disorders	MedDRA 27	Systematic Assessment	EG00016 events13 affected219 at risk EG00113 events11 affected225 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG00048 events28 affected219 at risk EG00141 events30 affected225 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG00015 events13 affected219 at risk EG00110 events7 affected225 at risk
Hypotension	Vascular disorders	MedDRA 27	Systematic Assessment	EG00018 events17 affected219 at risk EG00112 events12 affected225 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0008 events8 affected219 at risk EG00115 events15 affected225 at risk
Insomnia	Psychiatric disorders	MedDRA 27	Systematic Assessment	EG00022 events20 affected219 at risk EG00121 events18 affected225 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 27	Systematic Assessment	EG00037 events21 affected219 at risk EG00140 events14 affected225 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 27	Systematic Assessment	EG00026 events20 affected219 at risk EG00139 events19 affected225 at risk
Nasopharyngitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG00015 events13 affected219 at risk EG00117 events14 affected225 at risk
Nausea	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG000133 events77 affected219 at risk EG00192 events62 affected225 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 27	Systematic Assessment	EG000304 events116 affected219 at risk EG001347 events98 affected225 at risk
Oedema peripheral	General disorders	MedDRA 27	Systematic Assessment	EG00030 events25 affected219 at risk EG00118 events17 affected225 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG00020 events15 affected219 at risk EG00110 events9 affected225 at risk
Pneumonia	Infections and infestations	MedDRA 27	Systematic Assessment	EG00010 events9 affected219 at risk EG00113 events12 affected225 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG00019 events13 affected219 at risk EG0016 events6 affected225 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG00018 events10 affected219 at risk EG00132 events26 affected225 at risk
Pyrexia	General disorders	MedDRA 27	Systematic Assessment	EG00057 events38 affected219 at risk EG00149 events35 affected225 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG00022 events18 affected219 at risk EG00118 events14 affected225 at risk
Tachycardia	Cardiac disorders	MedDRA 27	Systematic Assessment	EG00014 events13 affected219 at risk EG0017 events7 affected225 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27	Systematic Assessment	EG000112 events67 affected219 at risk EG001101 events60 affected225 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG00029 events18 affected219 at risk EG00131 events21 affected225 at risk
Urinary tract infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG00021 events17 affected219 at risk EG00131 events20 affected225 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG00043 events31 affected219 at risk EG00138 events22 affected225 at risk
Weight decreased	Investigations	MedDRA 27	Systematic Assessment	EG00015 events15 affected219 at risk EG00120 events20 affected225 at risk

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Term
D000069283	Rituximab
C000613469	tafasitamab
D000069461	Bendamustine Hydrochloride