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.
ACTIVE_NOT_RECRUITING
PHASE3
654 participants
up to approximately 34 months
2025-12-22
Participant Flow
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
| 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
| 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 monthsPopulation: 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
| 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 yearsPopulation: 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
| 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 monthsPopulation: 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
| 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 yearsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 yearsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 yearsPopulation: 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
| 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 monthsPopulation: 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
| 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 yearsPopulation: 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
| 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 monthsPopulation: 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
| 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 yearsPopulation: 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
| 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 monthsPopulation: 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
| 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 yearsPopulation: 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
| 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 monthsPopulation: 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
| 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 yearsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 yearsPopulation: 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
| 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 monthsPopulation: 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
| 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 yearsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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
Placebo + Rituximab + Lenalidomide
Total
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
| 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
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