Trial Outcomes & Findings for A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. (NCT NCT04680052)

NCT ID: NCT04680052

Last Updated: 2025-12-22

Results Overview

PD, positron emission tomography (PET): score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, computed tomography (CT): abnormal individual node/lesion with longest diameter (LDi ) \>1.5 centimeters (cm) and increase by ≥50% from the product of the perpendicular diameters (PPD) nadir and increase in LDi or shortest diameter (SDi) from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

654 participants

Primary outcome timeframe

up to approximately 34 months

Results posted on

2025-12-22

Participant Flow

Participant milestones

Participant milestones
Measure
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Placebo + Rituximab + Lenalidomide
Participants with FL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Study
STARTED
53
273
275
53
Overall Study
COMPLETED
0
0
0
0
Overall Study
NOT COMPLETED
53
273
275
53

Reasons for withdrawal

Reasons for withdrawal
Measure
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Placebo + Rituximab + Lenalidomide
Participants with FL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Study
Ongoing
46
244
229
39
Overall Study
Death
1
15
22
7
Overall Study
Lost to Follow-up
1
3
2
0
Overall Study
Withdrawal by Subject
5
11
19
7
Overall Study
Missing
0
0
1
0
Overall Study
Hypersensitivity to Rituximab; Did Not Receive Treatment
0
0
1
0
Overall Study
Physician Decision
0
0
1
0

Baseline Characteristics

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
n=275 Participants
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Placebo + Rituximab + Lenalidomide
n=53 Participants
Participants with FL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
n=53 Participants
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Total
n=654 Participants
Total of all reporting groups
Age, Continuous
64.6 years
STANDARD_DEVIATION 10.89 • n=18 Participants
63.7 years
STANDARD_DEVIATION 11.69 • n=102 Participants
68.3 years
STANDARD_DEVIATION 10.69 • n=30 Participants
67.9 years
STANDARD_DEVIATION 11.40 • n=37 Participants
64.8 years
STANDARD_DEVIATION 11.33 • n=127 Participants
Sex: Female, Male
Female
123 Participants
n=18 Participants
126 Participants
n=102 Participants
27 Participants
n=30 Participants
26 Participants
n=37 Participants
302 Participants
n=127 Participants
Sex: Female, Male
Male
150 Participants
n=18 Participants
149 Participants
n=102 Participants
26 Participants
n=30 Participants
27 Participants
n=37 Participants
352 Participants
n=127 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
31 Participants
n=18 Participants
24 Participants
n=102 Participants
4 Participants
n=30 Participants
8 Participants
n=37 Participants
67 Participants
n=127 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
228 Participants
n=18 Participants
226 Participants
n=102 Participants
45 Participants
n=30 Participants
41 Participants
n=37 Participants
540 Participants
n=127 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
14 Participants
n=18 Participants
25 Participants
n=102 Participants
4 Participants
n=30 Participants
4 Participants
n=37 Participants
47 Participants
n=127 Participants
Race/Ethnicity, Customized
White
219 Participants
n=18 Participants
219 Participants
n=102 Participants
43 Participants
n=30 Participants
41 Participants
n=37 Participants
522 Participants
n=127 Participants
Race/Ethnicity, Customized
Black or African-American
1 Participants
n=18 Participants
0 Participants
n=102 Participants
0 Participants
n=30 Participants
1 Participants
n=37 Participants
2 Participants
n=127 Participants
Race/Ethnicity, Customized
Asian
40 Participants
n=18 Participants
42 Participants
n=102 Participants
7 Participants
n=30 Participants
6 Participants
n=37 Participants
95 Participants
n=127 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=18 Participants
0 Participants
n=102 Participants
0 Participants
n=30 Participants
1 Participants
n=37 Participants
1 Participants
n=127 Participants
Race/Ethnicity, Customized
Not Reported
11 Participants
n=18 Participants
10 Participants
n=102 Participants
3 Participants
n=30 Participants
4 Participants
n=37 Participants
28 Participants
n=127 Participants
Race/Ethnicity, Customized
Captured as "Other" in Database
2 Participants
n=18 Participants
4 Participants
n=102 Participants
0 Participants
n=30 Participants
0 Participants
n=37 Participants
6 Participants
n=127 Participants

PRIMARY outcome

Timeframe: up to approximately 34 months

Population: Follicular Lymphoma (FL) Full Analysis Set: all randomized participants with FL. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.

PD, positron emission tomography (PET): score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, computed tomography (CT): abnormal individual node/lesion with longest diameter (LDi ) \>1.5 centimeters (cm) and increase by ≥50% from the product of the perpendicular diameters (PPD) nadir and increase in LDi or shortest diameter (SDi) from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=275 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First
13.93 months
Interval 11.53 to 16.39
22.37 months
Interval 19.22 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.

PRIMARY outcome

Timeframe: up to 2 years

Population: FL Full Analysis Set. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.

PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=275 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
6 months
78.2 percent probability
Interval 72.7 to 82.7
92.4 percent probability
Interval 88.3 to 95.1
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
12 months
54.0 percent probability
Interval 47.1 to 60.5
79.0 percent probability
Interval 72.8 to 84.0
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
18 months
38.5 percent probability
Interval 30.8 to 46.1
61.9 percent probability
Interval 53.4 to 69.3
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
2 years
31.8 percent probability
Interval 23.6 to 40.2
41.7 percent probability
Interval 28.4 to 54.6

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.

PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=328 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=326 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
16.39 months
Interval 13.86 to 18.66
23.95 months
Interval 22.34 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.

SECONDARY outcome

Timeframe: up to 2 years

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.

PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=328 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=326 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
6 months
80.0 percent probability
Interval 75.0 to 84.0
92.7 percent probability
Interval 89.0 to 95.1
Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
12 months
58.7 percent probability
Interval 52.4 to 64.4
79.7 percent probability
Interval 74.1 to 84.2
Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
18 months
44.7 percent probability
Interval 37.6 to 51.5
64.1 percent probability
Interval 56.7 to 70.6
Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
2 years
33.1 percent probability
Interval 24.1 to 42.3
48.0 percent probability
Interval 36.1 to 59.0

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: FL FDG-avid Set: all randomized participants with FL and with a PET scan at Baseline with a resulting Deauville score of 4 or 5. Participants who did not have a post-baseline PET scan were considered to be "not assessed," but were included in the analysis. The 95% confidence intervals were calculated using the Clopper-Pearson method.

CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake \> mediastinum but ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=254 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=251 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria
39.8 percentage of participants
Interval 33.7 to 46.07
49.4 percentage of participants
Interval 43.06 to 55.76

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: FL Full Analysis Set. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.

Overall survival was defined as the time from randomization until death from any cause.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=275 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Overall Survival
NA months
The median and the upper and lower limits of the confidence interval were not estimable because too few participants died.
NA months
Interval 27.93 to
The median and the upper limit of the confidence interval were not estimable because too few participants died.

SECONDARY outcome

Timeframe: up to 2 years

Population: FL Full Analysis Set. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.

Overall survival was defined as the time from randomization until death from any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=275 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Kaplan-Meier Estimates of Overall Survival
2 years
85.5 percent probability
Interval 76.2 to 91.4
92.5 percent probability
Interval 87.0 to 95.8
FL Population: Kaplan-Meier Estimates of Overall Survival
6 months
96.2 percent probability
Interval 93.1 to 98.0
99.3 percent probability
Interval 97.1 to 99.8
FL Population: Kaplan-Meier Estimates of Overall Survival
12 months
93.7 percent probability
Interval 90.0 to 96.1
96.4 percent probability
Interval 92.8 to 98.2
FL Population: Kaplan-Meier Estimates of Overall Survival
18 months
90.1 percent probability
Interval 84.8 to 93.6
93.8 percent probability
Interval 89.1 to 96.5

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: Overall FDG-avid Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Participants who did not have a post-baseline PET scan were considered to be "not assessed," but were included in the analysis. The 95% confidence intervals were calculated using the Clopper-Pearson method.

CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake \> mediastinum but ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. The Overall FDG-avid Set included all randomized participants with a PET scan at Baseline with a resulting Deauville score of 4 or 5.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=293 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=290 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria
41.3 percentage of participants
Interval 35.6 to 47.17
50.7 percentage of participants
Interval 44.78 to 56.58

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: FL MRD Blood-Evaluable Set: all participants in the Full Analysis Set with FL who received at least 1 dose of study treatment with identifiable clonality in blood samples at Cycle 1 Day 1. The 95% confidence intervals were calculated using the Clopper-Pearson method. Participants who did not have a post-baseline assessment were considered to be "not assessed," but were included in the analysis.

The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10\^-5 cells. MRD status was only analyzed with a threshold of ≤10\^-5 cells for MRD negativity.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=66 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=57 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment
18.2 percentage of participants
Interval 9.76 to 29.61
26.3 percentage of participants
Interval 15.54 to 39.66

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: Overall MRD Blood-Evaluable Set. As pre-specified in the Statistical Analysis Plan, the MZL population was a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 95% confidence intervals were calculated using the Clopper-Pearson method. Participants who did not have a post-baseline assessment were considered to be "not assessed," but were included in the analysis.

The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10\^-5 cells. MRD status was only analyzed with a threshold of ≤10\^-5 cells for MRD negativity. The Overall MRD Blood-Evaluable Set included all participants in the Full Analysis Set who received at least 1 dose of study treatment with identifiable clonality in blood samples at Cycle 1 Day 1.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=86 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=74 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: MRD-negativity Rate (at Threshold of 10-5) at End of Treatment
15.1 percentage of participants
Interval 8.3 to 24.46
21.6 percentage of participants
Interval 12.89 to 32.72

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: FL Full Analysis Set. The 95% confidence intervals were calculated using the Clopper-Pearson method.

PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=275 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment
72.4 percentage of participants
Interval 66.67 to 77.56
83.5 percentage of participants
Interval 78.57 to 87.72

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 95% confidence intervals were calculated using the Clopper-Pearson method.

PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=328 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=326 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment
72.0 percentage of participants
Interval 66.75 to 76.75
82.8 percentage of participants
Interval 78.28 to 86.76

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: FL Full Analysis Set. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Only those participants who achieved an objective response (CR or PR) were analyzed.

PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=199 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=228 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Duration of Response (DOR; the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
13.60 months
Interval 12.42 to 18.56
21.19 months
Interval 19.48 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.

SECONDARY outcome

Timeframe: up to 2 years

Population: FL Full Analysis Set. Only those participants who achieved an objective response (CR or PR) were analyzed. Kaplan-Meier estimates indicate the percent probability of a participant still having a CR or PR at the indicated time after treatment start. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.

PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=199 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=228 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
6 months
77.8 percent probability
Interval 70.9 to 83.2
91.5 percent probability
Interval 86.6 to 94.6
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
12 months
59.1 percent probability
Interval 50.3 to 66.9
76.3 percent probability
Interval 68.4 to 82.4
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
18 months
42.9 percent probability
Interval 33.1 to 52.4
63.7 percent probability
Interval 53.4 to 72.2
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
2 years
33.3 percent probability
Interval 20.5 to 46.6
39.5 percent probability
Interval 21.4 to 57.1

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Only participants who achieved an objective response (CR or PR) were analyzed.

PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=236 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=270 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
17.77 months
Interval 13.37 to 19.88
22.24 months
Interval 19.81 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.

SECONDARY outcome

Timeframe: up to 2 years

Population: Overall Full Analysis Set. Per the SAP, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population (main analysis population). Participants who achieved CR or PR were analyzed. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.

PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=236 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=270 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
6 months
80.5 percent probability
Interval 74.6 to 85.3
90.8 percent probability
Interval 86.3 to 93.8
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
12 months
64.4 percent probability
Interval 56.6 to 71.1
78.1 percent probability
Interval 71.4 to 83.4
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
18 months
47.6 percent probability
Interval 38.4 to 56.2
66.6 percent probability
Interval 57.8 to 73.9
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
2 years
35.1 percent probability
Interval 23.0 to 47.4
43.4 percent probability
Interval 27.2 to 58.6

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.

Overall survival was defined as the time from randomization until death from any cause.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=328 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=326 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: Overall Survival
NA months
The median and the upper and lower limits of the confidence interval were not estimable because too few participants died.
NA months
The median and the upper and lower limits of the confidence interval were not estimable because too few participants died.

SECONDARY outcome

Timeframe: up to 2 years

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.

Overall survival was defined as the time from randomization until death from any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=328 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=326 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: Kaplan-Meier Estimates of Overall Survival
2 years
88.3 percent probability
Interval 81.1 to 92.8
90.1 percent probability
Interval 84.4 to 93.7
Overall Population: Kaplan-Meier Estimates of Overall Survival
2 months
94.4 percent probability
Interval 91.2 to 96.5
96.4 percent probability
Interval 93.4 to 98.1
Overall Population: Kaplan-Meier Estimates of Overall Survival
18 months
91.7 percent probability
Interval 87.4 to 94.5
92.2 percent probability
Interval 87.7 to 95.1
Overall Population: Kaplan-Meier Estimates of Overall Survival
6 months
96.5 percent probability
Interval 93.8 to 98.1
98.7 percent probability
Interval 96.7 to 99.5

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: FL Full Analysis Set. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.

PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=275 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
16.00 months
Interval 13.86 to 21.06
NA months
Interval 19.29 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.

SECONDARY outcome

Timeframe: up to 2 years

Population: FL Full Analysis Set. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.

PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=275 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
6 months
80.3 percent probability
Interval 74.9 to 84.7
94.0 percent probability
Interval 90.2 to 96.3
FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
12 months
59.8 percent probability
Interval 52.9 to 66.1
83.1 percent probability
Interval 77.1 to 87.7
FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
18 months
45.8 percent probability
Interval 37.3 to 53.8
67.5 percent probability
Interval 58.8 to 74.8
FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
2 years
35.0 percent probability
Interval 24.7 to 45.6
53.9 percent probability
Interval 41.9 to 64.4

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.

PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=328 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=326 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
20.73 months
Interval 15.38 to 23.1
NA months
Interval 22.08 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.

SECONDARY outcome

Timeframe: up to 2 years

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.

PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=328 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=326 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
6 months
82.5 percent probability
Interval 77.7 to 86.4
93.9 percent probability
Interval 90.4 to 96.1
Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
12 months
63.7 percent probability
Interval 57.5 to 69.3
84.5 percent probability
Interval 79.2 to 88.5
Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
18 months
52.0 percent probability
Interval 44.5 to 59.0
68.9 percent probability
Interval 61.1 to 75.4
Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
2 years
38.8 percent probability
Interval 28.3 to 49.1
56.0 percent probability
Interval 45.1 to 65.6

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: FL Full Analysis Set. The 95% confidence intervals were calculated using the Clopper-Pearson method.

PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=275 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review
73.5 percentage of participants
Interval 67.82 to 78.58
85.7 percentage of participants
Interval 80.99 to 89.64

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 95% confidence intervals were calculated using the Clopper-Pearson method.

PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=328 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=326 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review
72.6 percentage of participants
Interval 67.39 to 77.32
83.7 percentage of participants
Interval 79.28 to 87.58

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: FL Full Analysis Set. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Only those participants who achieved an objective response (CR or PR) were analyzed.

PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=202 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=234 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: DOR the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
18.23 months
Interval 12.94 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
NA months
Interval 19.02 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.

SECONDARY outcome

Timeframe: up to 2 years

Population: FL Full Analysis Set. Only those participants who achieved an objective response (CR or PR) were analyzed. Kaplan-Meier estimates indicate the percent probability of a participant still having a CR or PR at the indicated time after treatment start. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.

PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=202 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=234 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
6 months
78.7 percent probability
Interval 71.8 to 84.0
92.4 percent probability
Interval 87.6 to 95.3
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
12 months
61.4 percent probability
Interval 52.4 to 69.3
78.8 percent probability
Interval 70.9 to 84.8
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
18 months
52.2 percent probability
Interval 41.7 to 61.7
64.3 percent probability
Interval 53.1 to 73.5
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
2 years
35.5 percent probability
Interval 21.3 to 50.0
58.2 percent probability
Interval 44.9 to 69.4

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Only participants who achieved an objective response (CR or PR) were analyzed.

PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=238 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
18.83 months
Interval 16.89 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
NA months
Interval 19.52 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.

SECONDARY outcome

Timeframe: up to 2 years

Population: Overall Full Analysis Set. Per the SAP, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population (main analysis population). Participants who achieved CR or PR were analyzed. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.

PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=238 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
6 months
81.5 percent probability
Interval 75.5 to 86.2
93.1 percent probability
Interval 88.9 to 95.7
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
12 months
65.6 percent probability
Interval 57.6 to 72.5
80.0 percent probability
Interval 73.0 to 85.3
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
18 months
56.5 percent probability
Interval 46.9 to 65.0
65.7 percent probability
Interval 55.8 to 73.8
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
2 years
40.9 percent probability
Interval 27.8 to 53.6
56.0 percent probability
Interval 41.5 to 68.2

SECONDARY outcome

Timeframe: up to approximately 34 months

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

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) version 3 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=275 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Role Functioning
76.2 scores on a scale
Standard Deviation 29.09
77.3 scores on a scale
Standard Deviation 26.75
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Emotional Functioning
79.2 scores on a scale
Standard Deviation 19.03
79.2 scores on a scale
Standard Deviation 19.04
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Emotional Functioning
79.1 scores on a scale
Standard Deviation 21.36
79.0 scores on a scale
Standard Deviation 20.79
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Cognitive Functioning
87.0 scores on a scale
Standard Deviation 17.25
88.0 scores on a scale
Standard Deviation 19.06
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Cognitive Functioning
82.4 scores on a scale
Standard Deviation 21.03
83.6 scores on a scale
Standard Deviation 20.45
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Social Functioning
83.4 scores on a scale
Standard Deviation 22.50
84.7 scores on a scale
Standard Deviation 19.77
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Social Functioning
81.2 scores on a scale
Standard Deviation 23.63
79.8 scores on a scale
Standard Deviation 25.77
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Fatigue
26.9 scores on a scale
Standard Deviation 24.71
27.0 scores on a scale
Standard Deviation 23.43
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Fatigue
31.0 scores on a scale
Standard Deviation 25.39
30.5 scores on a scale
Standard Deviation 25.06
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Nausea and Vomiting
2.9 scores on a scale
Standard Deviation 9.62
2.7 scores on a scale
Standard Deviation 7.91
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Nausea and Vomiting
3.7 scores on a scale
Standard Deviation 11.61
3.2 scores on a scale
Standard Deviation 10.61
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Pain
17.6 scores on a scale
Standard Deviation 23.97
16.0 scores on a scale
Standard Deviation 21.06
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Pain
20.2 scores on a scale
Standard Deviation 27.15
17.8 scores on a scale
Standard Deviation 23.40
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Dyspnea
16.0 scores on a scale
Standard Deviation 24.88
14.3 scores on a scale
Standard Deviation 23.79
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Dyspnea
17.5 scores on a scale
Standard Deviation 25.01
15.7 scores on a scale
Standard Deviation 23.54
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Sleep
25.3 scores on a scale
Standard Deviation 27.50
26.1 scores on a scale
Standard Deviation 27.86
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Sleep
27.7 scores on a scale
Standard Deviation 27.75
25.0 scores on a scale
Standard Deviation 28.67
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Appetite Loss
11.4 scores on a scale
Standard Deviation 20.45
10.2 scores on a scale
Standard Deviation 23.21
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Appetite Loss
12.3 scores on a scale
Standard Deviation 22.60
12.5 scores on a scale
Standard Deviation 23.46
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Constipation
11.4 scores on a scale
Standard Deviation 20.86
9.2 scores on a scale
Standard Deviation 19.55
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Constipation
12.5 scores on a scale
Standard Deviation 24.96
11.4 scores on a scale
Standard Deviation 22.16
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Diarrhea
5.7 scores on a scale
Standard Deviation 15.00
7.0 scores on a scale
Standard Deviation 14.98
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Diarrhea
12.5 scores on a scale
Standard Deviation 21.86
12.7 scores on a scale
Standard Deviation 24.74
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Financial Difficulties
12.0 scores on a scale
Standard Deviation 20.37
12.2 scores on a scale
Standard Deviation 23.34
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Financial Difficulties
12.7 scores on a scale
Standard Deviation 22.69
11.8 scores on a scale
Standard Deviation 21.70
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Global Health Status
68.6 scores on a scale
Standard Deviation 21.93
68.6 scores on a scale
Standard Deviation 20.44
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Global Health Status
67.5 scores on a scale
Standard Deviation 21.00
67.7 scores on a scale
Standard Deviation 21.37
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Physical Functioning
84.1 scores on a scale
Standard Deviation 19.54
84.7 scores on a scale
Standard Deviation 17.44
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Physical Functioning
81.0 scores on a scale
Standard Deviation 22.67
80.1 scores on a scale
Standard Deviation 21.02
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Role Functioning
82.8 scores on a scale
Standard Deviation 24.72
83.1 scores on a scale
Standard Deviation 22.72

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Only participants with available data were analyzed.

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) version 3 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=328 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=326 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Global Health Status
67.3 scores on a scale
Standard Deviation 22.67
68.5 scores on a scale
Standard Deviation 20.59
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Global Health Status
66.6 scores on a scale
Standard Deviation 21.24
68.2 scores on a scale
Standard Deviation 20.96
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Physical Functioning
82.8 scores on a scale
Standard Deviation 20.20
83.2 scores on a scale
Standard Deviation 18.07
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Physical Functioning
80.2 scores on a scale
Standard Deviation 22.34
80.3 scores on a scale
Standard Deviation 21.21
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Role Functioning
81.1 scores on a scale
Standard Deviation 25.48
82.2 scores on a scale
Standard Deviation 23.85
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Role Functioning
75.5 scores on a scale
Standard Deviation 28.94
78.1 scores on a scale
Standard Deviation 26.41
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Emotional Functioning
78.8 scores on a scale
Standard Deviation 19.31
79.5 scores on a scale
Standard Deviation 19.36
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Emotional Functioning
79.1 scores on a scale
Standard Deviation 21.22
80.2 scores on a scale
Standard Deviation 20.55
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Cognitive Functioning
86.8 scores on a scale
Standard Deviation 17.03
87.6 scores on a scale
Standard Deviation 18.79
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Cognitive Functioning
82.6 scores on a scale
Standard Deviation 20.87
83.6 scores on a scale
Standard Deviation 20.09
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Social functioning
82.3 scores on a scale
Standard Deviation 23.47
84.6 scores on a scale
Standard Deviation 19.94
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Social Functioning
81.5 scores on a scale
Standard Deviation 22.86
81.0 scores on a scale
Standard Deviation 25.37
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Fatigue
28.3 scores on a scale
Standard Deviation 25.77
28.5 scores on a scale
Standard Deviation 24.55
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Fatigue
31.0 scores on a scale
Standard Deviation 25.08
30.1 scores on a scale
Standard Deviation 24.52
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Nausea and Vomiting
2.9 scores on a scale
Standard Deviation 9.16
2.8 scores on a scale
Standard Deviation 9.31
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Nausea and Vomiting
4.1 scores on a scale
Standard Deviation 12.34
3.4 scores on a scale
Standard Deviation 10.56
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Pain
17.8 scores on a scale
Standard Deviation 23.89
17.2 scores on a scale
Standard Deviation 22.35
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Pain
19.7 scores on a scale
Standard Deviation 26.42
17.9 scores on a scale
Standard Deviation 23.73
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Dyspnea
17.2 scores on a scale
Standard Deviation 26.27
15.8 scores on a scale
Standard Deviation 24.79
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Dyspnea
18.5 scores on a scale
Standard Deviation 25.80
16.2 scores on a scale
Standard Deviation 24.50
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Sleep
25.9 scores on a scale
Standard Deviation 27.20
27.8 scores on a scale
Standard Deviation 29.41
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Sleep
26.8 scores on a scale
Standard Deviation 27.81
25.7 scores on a scale
Standard Deviation 29.33
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Appetite Loss
11.5 scores on a scale
Standard Deviation 20.31
11.2 scores on a scale
Standard Deviation 24.51
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Appetite Loss
12.9 scores on a scale
Standard Deviation 23.40
12.6 scores on a scale
Standard Deviation 23.35
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Constipation
10.8 scores on a scale
Standard Deviation 20.46
9.8 scores on a scale
Standard Deviation 20.70
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Constipation
12.7 scores on a scale
Standard Deviation 24.62
11.7 scores on a scale
Standard Deviation 23.37
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Diarrhea
5.6 scores on a scale
Standard Deviation 14.81
7.5 scores on a scale
Standard Deviation 16.02
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Diarrhea
13.7 scores on a scale
Standard Deviation 23.53
12.5 scores on a scale
Standard Deviation 23.95
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Baseline, Financial Difficulties
12.5 scores on a scale
Standard Deviation 21.20
11.9 scores on a scale
Standard Deviation 22.58
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
End of Treatment, Financial Difficulties
12.2 scores on a scale
Standard Deviation 21.99
11.4 scores on a scale
Standard Deviation 21.12

SECONDARY outcome

Timeframe: up to approximately 34 months

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

The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=264 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=264 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
Baseline
73.6 scores on a scale
Standard Deviation 19.13
72.5 scores on a scale
Standard Deviation 18.15
FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
End of Treatment
72.5 scores on a scale
Standard Deviation 19.17
73.7 scores on a scale
Standard Deviation 18.21

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Only participants with available data were analyzed.

The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=313 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=315 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
Baseline
72.6 scores on a scale
Standard Deviation 19.67
72.2 scores on a scale
Standard Deviation 18.78
Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
End of Treatment
72.0 scores on a scale
Standard Deviation 19.21
74.2 scores on a scale
Standard Deviation 18.37

SECONDARY outcome

Timeframe: up to approximately 34 months

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

The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=275 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Mobility, Score 1
198 Participants
185 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Mobility, Score 2
34 Participants
58 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Mobility, Score 3
25 Participants
16 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Mobility, Score 4
8 Participants
4 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Mobility, Score 5
0 Participants
1 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Mobility, Score 1
126 Participants
122 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Mobility, Score 2
34 Participants
39 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Mobility, Score 3
17 Participants
14 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Mobility, Score 4
9 Participants
9 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Mobility, Score 5
1 Participants
2 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Self-care, Score 1
243 Participants
250 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Self-care, Score 2
16 Participants
9 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Self-care, Score 3
4 Participants
3 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Self-care, Score 4
1 Participants
1 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Self-care, Score 5
1 Participants
1 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Self-care, Score 1
166 Participants
165 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Self-care, Score 2
9 Participants
12 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Self-care, Score 3
7 Participants
6 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Self-care, Score 4
5 Participants
3 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Self-care, Score 5
0 Participants
0 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Usual Activities, Score 1
184 Participants
179 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Usual Activities, Score 2
50 Participants
59 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Usual Activities, Score 3
26 Participants
17 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Usual Activities, Score 4
4 Participants
4 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Usual Activities, Score 5
1 Participants
5 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Usual Activities, Score 1
114 Participants
107 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Usual Activities, Score 2
47 Participants
58 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Usual Activities, Score 3
16 Participants
13 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Usual Activities, Score 4
5 Participants
7 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Usual Activities, Score 5
5 Participants
1 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Pain/Discomfort, Score 1
141 Participants
144 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Pain/Discomfort, Score 2
82 Participants
92 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Pain/Discomfort, Score 3
34 Participants
25 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Pain/Discomfort, Score 4
7 Participants
2 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Pain/Discomfort, Score 5
1 Participants
1 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Pain/Discomfort, Score 1
104 Participants
106 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Pain/Discomfort, Score 2
51 Participants
55 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Pain/Discomfort, Score 3
21 Participants
17 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Pain/Discomfort, Score 4
8 Participants
8 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Pain/Discomfort, Score 5
3 Participants
0 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Anxiety/Depression, Score 1
152 Participants
138 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Anxiety/Depression, Score 2
79 Participants
98 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Anxiety/Depression, Score 3
26 Participants
22 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Anxiety/Depression, Score 4
7 Participants
5 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Anxiety/Depression, Score 5
1 Participants
1 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Anxiety/Depression, Score 1
103 Participants
107 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Anxiety/Depression, Score 2
60 Participants
58 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Anxiety/Depression, Score 3
20 Participants
18 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Anxiety/Depression, Score 4
4 Participants
1 Participants
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Anxiety/Depression, Score 5
0 Participants
2 Participants

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Only participants with available data were analyzed.

The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=328 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=326 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Mobility, Score 1
226 Participants
212 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Mobility, Score 2
47 Participants
68 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Mobility, Score 3
30 Participants
24 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Mobility, Score 4
11 Participants
10 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Mobility, Score 5
0 Participants
1 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Mobility, Score 1
149 Participants
149 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Mobility, Score 2
47 Participants
46 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Mobility, Score 3
22 Participants
17 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Mobility, Score 4
10 Participants
13 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Mobility, Score 5
1 Participants
3 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Self-care, Score 1
284 Participants
294 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Self-care, Score 2
22 Participants
12 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Self-care, Score 3
6 Participants
4 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Self-care, Score 4
1 Participants
2 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Self-care, Score 5
1 Participants
3 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Self-care, Score 1
202 Participants
198 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Self-care, Score 2
15 Participants
15 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Self-care, Score 3
7 Participants
9 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Self-care, Score 4
5 Participants
5 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Self-care, Score 5
0 Participants
1 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Usual Activities, Score 1
208 Participants
207 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Usual Activities, Score 2
64 Participants
74 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Usual Activities, Score 3
33 Participants
23 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Usual Activities, Score 4
5 Participants
6 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Usual Activities, Score 5
4 Participants
5 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Usual Activities, Score 1
135 Participants
133 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Usual Activities, Score 2
62 Participants
68 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Usual Activities, Score 3
21 Participants
15 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Usual Activities, Score 4
6 Participants
11 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Usual Activities, Score 5
5 Participants
1 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Pain/Discomfort, Score 1
161 Participants
168 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Pain/Discomfort, Score 2
104 Participants
108 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Pain/Discomfort, Score 3
40 Participants
35 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Pain/Discomfort, Score 4
8 Participants
3 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Pain/Discomfort, Score 5
1 Participants
1 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Pain/Discomfort, Score 1
124 Participants
129 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Pain/Discomfort, Score 2
70 Participants
68 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Pain/Discomfort, Score 3
23 Participants
21 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Pain/Discomfort, Score 4
9 Participants
10 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Pain/Discomfort, Score 5
3 Participants
0 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Anxiety/Depression, Score 1
177 Participants
173 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Anxiety/Depression, Score 2
98 Participants
110 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Anxiety/Depression, Score 3
30 Participants
25 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Anxiety/Depression, Score 4
8 Participants
6 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Baseline, Anxiety/Depression, Score 5
1 Participants
1 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Anxiety/Depression, Score 1
126 Participants
136 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Anxiety/Depression, Score 2
74 Participants
68 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Anxiety/Depression, Score 3
24 Participants
20 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Anxiety/Depression, Score 4
5 Participants
2 Participants
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
End of Treatment, Anxiety/Depression, Score 5
0 Participants
2 Participants

SECONDARY outcome

Timeframe: up to approximately 34 months

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

The FACT-Lymphoma (v4) is composed of 42 items with a 5-point Likert-type scale and 5 subscales. Physical well-being (PWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Social/family well-being (SWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Emotional well-being (EWB) subscale: 6 items measured on 0- to 4-point scale; total score = 0-24. Functional well-being (FWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Lymphoma (LymS) subscale includes 15 items; total score = 0-60. Three total scores can be derived by adding the subscales: FACT-Lymphoma Trial Outcome Index (TOI): (PWB score) + (FWB score) + (LymS score); total score = 0-116. FACT-G total score: (PWB score) + (SWB score) + (EWB score) + (FWB score); total score = 0-108. FACT-Lymphoma total score: (PWB score) + (SWB score) + (EWB score) + (FWB score) + (LymS score); total score = 0-168. The higher the score, the better the quality of life.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=275 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=273 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
Baseline, PWB subscale
24.3 scores on a scale
Standard Deviation 4.07
24.0 scores on a scale
Standard Deviation 4.26
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
End of Treatment, PWB subscale
23.2 scores on a scale
Standard Deviation 5.42
23.5 scores on a scale
Standard Deviation 4.68
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
Baseline, SWB subscale
20.5 scores on a scale
Standard Deviation 5.92
20.9 scores on a scale
Standard Deviation 5.82
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
End of Treatment, SWB subscale
19.9 scores on a scale
Standard Deviation 5.31
19.9 scores on a scale
Standard Deviation 5.95
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
Baseline, EWB subscale
18.3 scores on a scale
Standard Deviation 4.06
18.2 scores on a scale
Standard Deviation 4.21
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
End of Treatment, EWB subscale
18.1 scores on a scale
Standard Deviation 4.80
18.3 scores on a scale
Standard Deviation 4.39
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
Baseline, FWB subscale
17.8 scores on a scale
Standard Deviation 5.98
17.6 scores on a scale
Standard Deviation 6.12
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
End of Treatment, FWB subscale
16.3 scores on a scale
Standard Deviation 6.19
16.5 scores on a scale
Standard Deviation 6.24
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
Baseline, FACT-LymS
47.7 scores on a scale
Standard Deviation 7.88
47.7 scores on a scale
Standard Deviation 8.87
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
End of Treatment, FACT-LymS
48.0 scores on a scale
Standard Deviation 8.98
48.0 scores on a scale
Standard Deviation 9.41
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
Baseline, FACT-Lymphoma TOI
89.8 scores on a scale
Standard Deviation 15.51
89.3 scores on a scale
Standard Deviation 16.07
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
End of Treatment, FACT-Lymphoma TOI
87.3 scores on a scale
Standard Deviation 18.59
88.0 scores on a scale
Standard Deviation 17.80
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
Baseline, FACT-G Total Score
80.9 scores on a scale
Standard Deviation 15.08
80.7 scores on a scale
Standard Deviation 15.04
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
End of Treatment, FACT-G Total Score
77.3 scores on a scale
Standard Deviation 17.02
78.3 scores on a scale
Standard Deviation 16.63
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
Baseline, FACT-Lymphoma Total Score
128.6 scores on a scale
Standard Deviation 21.27
128.4 scores on a scale
Standard Deviation 21.81
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
End of Treatment, FACT-Lymphoma Total Score
125.2 scores on a scale
Standard Deviation 24.65
126.1 scores on a scale
Standard Deviation 24.39

SECONDARY outcome

Timeframe: up to approximately 34 months

Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Only participants with available data were analyzed.

The FACT-Lymphoma (v4) is composed of 42 items with a 5-point Likert-type scale and 5 subscales. Physical well-being (PWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Social/family well-being (SWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Emotional well-being (EWB) subscale: 6 items measured on 0- to 4-point scale; total score = 0-24. Functional well-being (FWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Lymphoma (LymS) subscale includes 15 items; total score = 0-60. Three total scores can be derived by adding the subscales: FACT-Lymphoma Trial Outcome Index (TOI): (PWB score) + (FWB score) + (LymS score); total score = 0-116. FACT-G total score: (PWB score) + (SWB score) + (EWB score) + (FWB score); total score = 0-108. FACT-Lymphoma total score: (PWB score) + (SWB score) + (EWB score) + (FWB score) + (LymS score); total score = 0-168. The higher the score, the better the quality of life.

Outcome measures

Outcome measures
Measure
FL and MZL: Placebo + Rituximab + Lenalidomide
n=328 Participants
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL: Tafasitamab + Rituximab + Lenalidomide
n=326 Participants
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
MZL: Placebo + Rituximab + Lenalidomide
Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
Baseline, PWB subscale
24.1 scores on a scale
Standard Deviation 4.20
23.8 scores on a scale
Standard Deviation 4.41
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
End of Treatment, PWB subscale
23.2 scores on a scale
Standard Deviation 5.21
23.6 scores on a scale
Standard Deviation 4.71
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
Baseline, SWB subscale
20.2 scores on a scale
Standard Deviation 6.06
20.8 scores on a scale
Standard Deviation 5.82
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
End of Treatment, SWB subscale
19.8 scores on a scale
Standard Deviation 5.34
20.2 scores on a scale
Standard Deviation 5.89
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
Baseline, EWB subscale
18.1 scores on a scale
Standard Deviation 4.12
18.2 scores on a scale
Standard Deviation 4.20
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
End of Treatment, EWB subscale
18.1 scores on a scale
Standard Deviation 4.67
18.7 scores on a scale
Standard Deviation 4.31
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
Baseline, FWB subscale
17.3 scores on a scale
Standard Deviation 6.08
17.3 scores on a scale
Standard Deviation 6.19
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
End of Treatment, FWB subscale
16.2 scores on a scale
Standard Deviation 6.22
16.8 scores on a scale
Standard Deviation 6.29
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
Baseline, FACT-LymS
47.6 scores on a scale
Standard Deviation 7.98
47.4 scores on a scale
Standard Deviation 8.91
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
End of Treatment, FACT-LymS
48.2 scores on a scale
Standard Deviation 8.71
48.7 scores on a scale
Standard Deviation 9.17
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
Baseline, FACT-Lymphoma TOI
89.0 scores on a scale
Standard Deviation 15.72
88.7 scores on a scale
Standard Deviation 16.40
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
End of Treatment, FACT-Lymphoma TOI
87.4 scores on a scale
Standard Deviation 18.14
89.0 scores on a scale
Standard Deviation 17.74
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
Baseline, FACT-G Total Score
79.7 scores on a scale
Standard Deviation 15.43
80.2 scores on a scale
Standard Deviation 15.39
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
End of Treatment, FACT-G Total Score
77.1 scores on a scale
Standard Deviation 16.80
79.2 scores on a scale
Standard Deviation 16.65
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
Baseline, FACT-Lymphoma Total Score
127.3 scores on a scale
Standard Deviation 21.57
127.7 scores on a scale
Standard Deviation 22.18
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
End of Treatment, FACT-Lymphoma Total Score
125.2 scores on a scale
Standard Deviation 24.18
127.8 scores on a scale
Standard Deviation 24.26

Adverse Events

Tafasitamab + Rituximab + Lenalidomide

Serious events: 125 serious events
Other events: 318 other events
Deaths: 22 deaths

Placebo + Rituximab + Lenalidomide

Serious events: 110 serious events
Other events: 315 other events
Deaths: 24 deaths

Total

Serious events: 235 serious events
Other events: 633 other events
Deaths: 46 deaths

Serious adverse events

Serious adverse events
Measure
Tafasitamab + Rituximab + Lenalidomide
n=327 participants at risk
Participants with follicular lymphoma (FL) or marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Placebo + Rituximab + Lenalidomide
n=325 participants at risk
Participants with FL or MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Total
n=652 participants at risk
Total
Gastrointestinal disorders
Abdominal pain
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
1.5%
5/325 • Number of events 5 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.77%
5/652 • Number of events 5 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Cardiac disorders
Acute coronary syndrome
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Renal and urinary disorders
Acute kidney injury
2.8%
9/327 • Number of events 9 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
1.8%
6/325 • Number of events 6 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
2.3%
15/652 • Number of events 15 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Cardiac disorders
Acute myocardial infarction
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.62%
2/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.46%
3/652 • Number of events 3 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Blood and lymphatic system disorders
Anaemia
0.92%
3/327 • Number of events 3 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.62%
2/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.77%
5/652 • Number of events 5 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Anal infection
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Anal ulcer
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Cardiac disorders
Angina unstable
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Psychiatric disorders
Anxiety
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Appendicitis
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Musculoskeletal and connective tissue disorders
Arthritis
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Asthenia
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Cardiac disorders
Atrial fibrillation
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Atypical pneumonia
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Musculoskeletal and connective tissue disorders
Back pain
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Bacteraemia
0.61%
2/327 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Bacterial sepsis
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Hepatobiliary disorders
Bile duct stone
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Breast abscess
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Bronchitis
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Bronchopulmonary aspergillosis
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Investigations
C-reactive protein increased
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
COVID-19
6.4%
21/327 • Number of events 27 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
2.5%
8/325 • Number of events 9 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
4.4%
29/652 • Number of events 36 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
COVID-19 pneumonia
5.2%
17/327 • Number of events 19 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
2.2%
7/325 • Number of events 8 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
3.7%
24/652 • Number of events 27 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Renal and urinary disorders
Calculus urinary
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Campylobacter gastroenteritis
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Candida infection
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour in the large intestine
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Cardiac disorders
Cardiac arrest
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Cardiac disorders
Cardiac failure
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.62%
2/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Cellulitis
0.61%
2/327 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.62%
2/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.61%
4/652 • Number of events 4 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Nervous system disorders
Cerebral haemorrhage
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Nervous system disorders
Cervicobrachial syndrome
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Hepatobiliary disorders
Cholecystitis acute
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Clostridium difficile infection
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Nervous system disorders
Cognitive disorder
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Colitis
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Psychiatric disorders
Confusional state
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Immune system disorders
Cytokine release syndrome
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Death
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Vascular disorders
Deep vein thrombosis
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.62%
2/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.46%
3/652 • Number of events 3 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Device related infection
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Device related thrombosis
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Diarrhoea
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.92%
3/325 • Number of events 3 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.46%
3/652 • Number of events 3 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.61%
2/327 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.62%
2/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.61%
4/652 • Number of events 4 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Vascular disorders
Embolism
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Vascular disorders
Embolism venous
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Empyema
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Enteritis infectious
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Enterobacter bacteraemia
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Enterocolitis haemorrhagic
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Nervous system disorders
Epilepsy
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Erysipelas
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Escherichia sepsis
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Injury, poisoning and procedural complications
Fall
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Fatigue
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Febrile infection
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Blood and lymphatic system disorders
Febrile neutropenia
2.8%
9/327 • Number of events 10 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
3.1%
10/325 • Number of events 11 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
2.9%
19/652 • Number of events 21 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Injury, poisoning and procedural complications
Femoral neck fracture
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Food poisoning
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Gastroenteritis
0.61%
2/327 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Gastroenteritis rotavirus
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Generalised oedema
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Immune system disorders
Haemophagocytic lymphohistiocytosis
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Haemophilus bacteraemia
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Nervous system disorders
Headache
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Hepatobiliary disorders
Hepatobiliary disease
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Hepatobiliary disorders
Hepatosplenomegaly
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Injury, poisoning and procedural complications
Hip fracture
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.62%
2/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Metabolism and nutrition disorders
Hyperglycaemia
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Immune system disorders
Hypersensitivity
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Vascular disorders
Hypertensive crisis
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Hyperthermia
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Immune system disorders
Hypogammaglobulinaemia
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Metabolism and nutrition disorders
Hyponatraemia
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Vascular disorders
Hypotension
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.62%
2/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Ileus
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Infection
0.61%
2/327 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Infective exacerbation of asthma
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Influenza
0.61%
2/327 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Injury, poisoning and procedural complications
Infusion related reaction
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Laryngitis
0.31%
1/327 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Investigations
Liver function test increased
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Lower respiratory tract infection
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
0.31%
1/327 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.62%
2/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.46%
3/652 • Number of events 4 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Vascular disorders
Lymphatic fistula
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Vascular disorders
Lymphoedema
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Malaise
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.62%
2/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Moraxella infection
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Multiple organ dysfunction syndrome
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Cardiac disorders
Myocardial infarction
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Cardiac disorders
Myopericarditis
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Blood and lymphatic system disorders
Neutropenia
0.61%
2/327 • Number of events 5 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.92%
3/325 • Number of events 4 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.77%
5/652 • Number of events 9 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Non-cardiac chest pain
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Norovirus infection
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Pancreatitis acute
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Parainfluenzae virus infection
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Injury, poisoning and procedural complications
Pelvic fracture
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Vascular disorders
Peripheral artery occlusion
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Vascular disorders
Peripheral ischaemia
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Peritonitis bacterial
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.61%
2/327 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.62%
2/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.61%
4/652 • Number of events 4 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Pneumocystis jirovecii pneumonia
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Pneumonia
7.6%
25/327 • Number of events 33 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
4.6%
15/325 • Number of events 18 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
6.1%
40/652 • Number of events 51 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Pneumonia adenoviral
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Pneumonia moraxella
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Pneumonia pneumococcal
0.61%
2/327 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.46%
3/652 • Number of events 3 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Pneumonia viral
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Hepatobiliary disorders
Portal vein thrombosis
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Nervous system disorders
Presyncope
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Progressive multifocal leukoencephalopathy
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Prostatic abscess
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Pseudomonal sepsis
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Pseudomonal skin infection
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.62%
2/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.46%
3/652 • Number of events 3 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Pulmonary sepsis
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.62%
2/325 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.46%
3/652 • Number of events 3 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Pyelonephritis
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Pyrexia
1.8%
6/327 • Number of events 7 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
3.4%
11/325 • Number of events 12 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
2.6%
17/652 • Number of events 19 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Skin and subcutaneous tissue disorders
Rash
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Skin and subcutaneous tissue disorders
Rash vesicular
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Renal and urinary disorders
Renal failure
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Respiratory tract infection
0.92%
3/327 • Number of events 3 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.92%
3/325 • Number of events 3 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.92%
6/652 • Number of events 6 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Injury, poisoning and procedural complications
Rib fracture
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Sepsis
1.2%
4/327 • Number of events 4 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
1.5%
5/325 • Number of events 5 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
1.4%
9/652 • Number of events 9 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Septic shock
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Injury, poisoning and procedural complications
Seroma
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Immune system disorders
Serum sickness
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Cardiac disorders
Sinus node dysfunction
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Skin infection
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Small intestinal obstruction
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Injury, poisoning and procedural complications
Spinal fracture
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Injury, poisoning and procedural complications
Splenic rupture
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
0.61%
2/327 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Staphylococcal bacteraemia
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Staphylococcal infection
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Nervous system disorders
Syncope
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Blood and lymphatic system disorders
Thrombocytopenia
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.92%
3/325 • Number of events 3 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.61%
4/652 • Number of events 4 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Metabolism and nutrition disorders
Tumour lysis syndrome
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Upper respiratory tract infection
0.61%
2/327 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Urinary tract infection
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.92%
3/325 • Number of events 3 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.61%
4/652 • Number of events 4 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Urosepsis
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Varicella zoster pneumonia
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Varicella zoster virus infection
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Vascular disorders
Vena cava thrombosis
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.00%
0/325 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Vomiting
0.00%
0/327 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.15%
1/652 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Wound infection
0.31%
1/327 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
1/325 • Number of events 1 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
0.31%
2/652 • Number of events 2 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).

Other adverse events

Other adverse events
Measure
Tafasitamab + Rituximab + Lenalidomide
n=327 participants at risk
Participants with follicular lymphoma (FL) or marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Placebo + Rituximab + Lenalidomide
n=325 participants at risk
Participants with FL or MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
Total
n=652 participants at risk
Total
Gastrointestinal disorders
Abdominal pain
7.6%
25/327 • Number of events 33 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
8.6%
28/325 • Number of events 30 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
8.1%
53/652 • Number of events 63 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Investigations
Alanine aminotransferase increased
5.8%
19/327 • Number of events 28 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
7.1%
23/325 • Number of events 36 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
6.4%
42/652 • Number of events 64 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Blood and lymphatic system disorders
Anaemia
16.2%
53/327 • Number of events 97 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
14.2%
46/325 • Number of events 73 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
15.2%
99/652 • Number of events 170 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Musculoskeletal and connective tissue disorders
Arthralgia
7.3%
24/327 • Number of events 25 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
8.3%
27/325 • Number of events 36 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
7.8%
51/652 • Number of events 61 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Asthenia
13.5%
44/327 • Number of events 58 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
10.8%
35/325 • Number of events 48 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
12.1%
79/652 • Number of events 106 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Musculoskeletal and connective tissue disorders
Back pain
9.8%
32/327 • Number of events 41 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
5.5%
18/325 • Number of events 21 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
7.7%
50/652 • Number of events 62 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Bronchitis
5.2%
17/327 • Number of events 21 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
4.3%
14/325 • Number of events 14 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
4.8%
31/652 • Number of events 35 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
COVID-19
26.3%
86/327 • Number of events 98 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
22.2%
72/325 • Number of events 81 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
24.2%
158/652 • Number of events 179 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Chills
4.3%
14/327 • Number of events 14 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
5.2%
17/325 • Number of events 18 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
4.8%
31/652 • Number of events 32 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Constipation
27.5%
90/327 • Number of events 110 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
24.9%
81/325 • Number of events 100 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
26.2%
171/652 • Number of events 210 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Respiratory, thoracic and mediastinal disorders
Cough
19.0%
62/327 • Number of events 81 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
16.9%
55/325 • Number of events 69 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
17.9%
117/652 • Number of events 150 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Metabolism and nutrition disorders
Decreased appetite
11.0%
36/327 • Number of events 39 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
9.2%
30/325 • Number of events 32 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
10.1%
66/652 • Number of events 71 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Diarrhoea
37.6%
123/327 • Number of events 219 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
31.1%
101/325 • Number of events 162 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
34.4%
224/652 • Number of events 381 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Nervous system disorders
Dizziness
8.0%
26/327 • Number of events 34 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
7.1%
23/325 • Number of events 28 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
7.5%
49/652 • Number of events 62 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Respiratory, thoracic and mediastinal disorders
Dyspnoea
6.7%
22/327 • Number of events 26 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
9.2%
30/325 • Number of events 32 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
8.0%
52/652 • Number of events 58 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Fatigue
20.5%
67/327 • Number of events 80 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
16.3%
53/325 • Number of events 64 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
18.4%
120/652 • Number of events 144 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Nervous system disorders
Headache
10.4%
34/327 • Number of events 47 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
7.7%
25/325 • Number of events 30 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
9.0%
59/652 • Number of events 77 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Metabolism and nutrition disorders
Hypokalaemia
8.3%
27/327 • Number of events 44 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
12.6%
41/325 • Number of events 60 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
10.4%
68/652 • Number of events 104 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Vascular disorders
Hypotension
6.1%
20/327 • Number of events 22 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
4.3%
14/325 • Number of events 16 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
5.2%
34/652 • Number of events 38 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Injury, poisoning and procedural complications
Infusion related reaction
15.9%
52/327 • Number of events 58 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
15.1%
49/325 • Number of events 61 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
15.5%
101/652 • Number of events 119 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Psychiatric disorders
Insomnia
7.6%
25/327 • Number of events 25 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
7.1%
23/325 • Number of events 23 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
7.4%
48/652 • Number of events 48 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Musculoskeletal and connective tissue disorders
Muscle spasms
16.2%
53/327 • Number of events 68 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
17.5%
57/325 • Number of events 64 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
16.9%
110/652 • Number of events 132 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Musculoskeletal and connective tissue disorders
Myalgia
6.1%
20/327 • Number of events 21 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
4.6%
15/325 • Number of events 20 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
5.4%
35/652 • Number of events 41 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Nasopharyngitis
5.8%
19/327 • Number of events 22 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
6.5%
21/325 • Number of events 22 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
6.1%
40/652 • Number of events 44 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Nausea
18.0%
59/327 • Number of events 76 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
14.5%
47/325 • Number of events 58 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
16.3%
106/652 • Number of events 134 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Blood and lymphatic system disorders
Neutropenia
50.2%
164/327 • Number of events 470 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
47.4%
154/325 • Number of events 388 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
48.8%
318/652 • Number of events 858 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Investigations
Neutrophil count decreased
7.3%
24/327 • Number of events 65 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
7.1%
23/325 • Number of events 60 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
7.2%
47/652 • Number of events 125 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Oedema peripheral
7.6%
25/327 • Number of events 27 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
13.5%
44/325 • Number of events 45 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
10.6%
69/652 • Number of events 72 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
8.9%
29/327 • Number of events 37 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
4.3%
14/325 • Number of events 15 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
6.6%
43/652 • Number of events 52 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Musculoskeletal and connective tissue disorders
Pain in extremity
7.0%
23/327 • Number of events 28 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
3.4%
11/325 • Number of events 12 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
5.2%
34/652 • Number of events 40 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Skin and subcutaneous tissue disorders
Pruritus
15.6%
51/327 • Number of events 70 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
11.7%
38/325 • Number of events 49 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
13.7%
89/652 • Number of events 119 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
General disorders
Pyrexia
18.3%
60/327 • Number of events 85 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
15.1%
49/325 • Number of events 63 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
16.7%
109/652 • Number of events 148 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Skin and subcutaneous tissue disorders
Rash
22.0%
72/327 • Number of events 103 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
21.5%
70/325 • Number of events 115 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
21.8%
142/652 • Number of events 218 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Skin and subcutaneous tissue disorders
Rash maculo-papular
5.5%
18/327 • Number of events 22 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
4.9%
16/325 • Number of events 26 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
5.2%
34/652 • Number of events 48 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Respiratory tract infection
6.4%
21/327 • Number of events 33 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
8.0%
26/325 • Number of events 32 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
7.2%
47/652 • Number of events 65 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Blood and lymphatic system disorders
Thrombocytopenia
14.7%
48/327 • Number of events 121 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
18.2%
59/325 • Number of events 91 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
16.4%
107/652 • Number of events 212 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Upper respiratory tract infection
8.6%
28/327 • Number of events 37 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
11.1%
36/325 • Number of events 40 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
9.8%
64/652 • Number of events 77 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Infections and infestations
Urinary tract infection
8.0%
26/327 • Number of events 34 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
6.5%
21/325 • Number of events 27 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
7.2%
47/652 • Number of events 61 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
Gastrointestinal disorders
Vomiting
7.3%
24/327 • Number of events 28 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
4.9%
16/325 • Number of events 20 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).
6.1%
40/652 • Number of events 48 • from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Safety was not expected to be different between each histological subtype (FL versus MZL).

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

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